Provectus Pharmaceuticals, Inc. (OTC BB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has signed an agreement with Numoda Capital Innovations LLC (http://www.numodacapital.com) to license its TruPoints® strategic partnering platform.

Provectus will use Numoda’s TruPoints to facilitate transactions with potential licensing partners for PH-10, its therapy for the treatment of serious dermatological diseases, which recently showed positive Phase 2 clinical trial results in both Atopic Dermatitis and Psoriasis. The TruPoints platform will organize all due diligence material relating to the Phase 2 clinical trials, including business, scientific and contract manufacturing information and has the unique ability to include appropriate live trial information. All of this is expected to significantly facilitate the flow of information to potential licensees. Numoda’s TruPoints platform has a strong track record of helping numerous development stage biotech companies secure big pharma licensing agreements.

Craig Dees, Ph.D., CEO of Provectus said, “As we actively seek to out-license PH-10, Numoda TruPoints will enable the exchange of scientific and business information between Provectus and potential partners. We expect this platform to play a critical role in the out-licensing process when we formally engage an investment banker.”

About Provectus Pharmaceuticals, Inc. (www.pvct.com)

Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its lead oncology agent, PV-10, is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and metastatic liver cancer. The Company has received orphan drug designation from the FDA for its melanoma indication. Its lead dermatological drug, PH-10, also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed enrollment in three Phase 2 trials — PV-10 as a therapy for metastatic melanoma, and PH-10 as a topical treatment for atopic dermatitis and for psoriasis. It has also recently initiated a Phase 1 trial of PV-10 for liver cancer. Information about these and the Company’s other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus please visit the Company’s website at www.pvct.com or contact Porter, LeVay & Rose, Inc.

FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.

ImmunoCellular Therapeutics Ltd. (OTC-BB: IMUC) is a $20 million company developing its own cancer drug based upon the same premise as Dendreon’s Provenge. But unlike its larger competitor, IMUC is focused on a number of different antigens rather than just one. And unlike other development-stage companies, it has a strong focus on cost-containment and building long-term shareholder value.

Run by a former venture capitalist who left his career to pursue this opportunity, ImmunoCellular is a unique “diamond in the rough” in the often-troublesome OTC-BB marketplace, with both a promising cancer treatment drug and a cash stockpile to see it through development.

A Promising Cancer Drug in Development

ImmunoCellular’s ICT-107 is a novel immune-based dendritic cell cancer therapy that targets six glioma-specific peptides several of which are highly expressed on cancer stem cells. Since the unique approach targets multiple antigens, instead of just one like Dendreon’s Provenge, the company believes that the drug will prove far more effective and versatile in treating a number of different types of cancer.

During the industry’s flagship ASCO Conference in June, IMUC unveiled the results of its 20-patient Phase I study for ICT-107. The clinical trials demonstrated a 100% survival rate in one year and an 80% survival rate in two years, compared to a historical 61% survival rate in one year and 27% survival rate in two years, observed in the standard treatment. This data compares favorably with Avastin (Roche: RHHBY) and CDX-110 (Celldex:CLDX) as only ICT-107 has demonstrated greater than 75% survival at 2 years which is quite unheard of in glioblastoma.

Meanwhile, the safety data also compared favorably to the current treatments with no serious adverse effects reported, and only minor side-effects related to fatigue, skin rash and pruritis. As a result, the company’s ICT-107 appears to be a promising potential treatment for a number of cancers with limited or no treatment options, including the Phase I study candidate, brain cancer.

Currently, the company is designing a well powered Phase II study to better determine the efficacy of its treatment. But if Phase I results are any indication, investors may want to get in this stock early to take advantage of the large run-up that any successful clinical trials would bring. After all, even half of the efficacy seen in previous trials would have far reaching potential for patients and investors.

A Lean Company with Cash and Prospects

Unlike many development-stage companies, ImmunoCellular also has a healthy $8 million in cash that it believes will fund its clinical trials well into Phase II, where it will likely seek a commercialization partner in order to contain costs and maintain shareholder value. As a result, investors have less risk of dilution or excessive debt being taken on than in some other names like Genta Incorporated (GETA).

IMUC is also working on developing other cancer therapeutic and diagnostic products, such as ICT-69 and ICT-121. The company recently entered a research and license option agreement with Roche (RHHBY) for up to $32 million in milestone and development payments for its ICT-69 drug, while the Phase I study of its ICT-121 drug is expected to yield results in mid to late 2011.

In the end, investors looking for the next Dendreon (DNDN) may want to consider taking a closer look at ImmunoCellular (IMUC) as a potential investment. While clinical trial results aren’t expected in the near-term, the firm has a number of catalysts that could drive the stock higher and maintains a pristine balance sheet that minimizes risk of dilution of shareholder-unfriendly actions.

The nationally syndicated ABC featured the Rose Bengal-based drug and its success in one patient in a story that aired in 2008. Here is a copy of the ground-breaking ABC report:

Provectus Reports Successful End-of-Phase II Meeting with FDA

On April 29, 2010, Provectus Pharmaceuticals, Inc. announced that it has held an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to seek consensus on clinical program scope and endpoints for licensure of PV-10 for metastatic melanoma. The meeting was held at the Agency’s White Oak Campus in Silver Spring, MD.

Craig Dees, Ph.D., CEO of Provectus said, “This meeting provided an opportunity to thoroughly review the clinical data we have amassed through our Phase 1 and Phase 2 studies with PV-10. As expected, the meeting was fruitful and provided a forum for discussion of appropriate endpoints for assessment of clinical benefit of PV-10 in melanoma patients and for definition of the pathway leading to licensure.”

Dr. Dees continued, “Based on consultation with senior Agency officials during this meeting, we expect to hold a second end-of-Phase 2 meeting in the coming months to finalize design of a pivotal Phase 3 randomized controlled study suitable for Special Protocol Assessment (SPA).”

Dr. Dees concluded, “We are fortunate that our capital resources afford flexibility to consider pursuing both the conventional Phase 3 pathway, as well as an accelerated route to licensure. While we believe the Phase 3 with an SPA represents an industry standard path to approval, we believe the door may still be open for accelerated approval.”

Read the Entire Press Release

Provectus Reports Positive Phase II Trial Data at ASCO Conference

On May 21, 2010, Provectus Pharmaceuticals, Inc. followed up with investors by presenting at the ASCO conference in Chicago, IL. At the conference, the company announced further positive data on the first forty subjects in its Phase 2 clinical trial of PV-10 for metastatic melanoma, with an objective response (“OR”) observed in 61% of subjects and a mean Progression Free Survival (“PFS”) of at least 11.1 months among those subjects achieving an OR.

These data were included in Abstract #8534, entitled “Chemoablation of metastatic melanoma with rose bengal (PV-10)”, to be presented by Dr. Sanjiv Agarwala at the American Society of Clinical Oncology 2010 Annual Meeting, on Sunday, June 6, 2010 in General Poster Session #209, Melanoma/Skin Cancers.

Read the Entire Press Release

Conclusions

Provectus Pharmaceuticals, Inc. (OTC-BB: PVCT) is rapidly progressing through its PV-10 clinical trials, as its drug continues to show both safety and efficacy. The company is now focused on setting up and completing a Phase III trial, while searching for a development partner. And both of these events could lead to strong catalysts to propel the stock higher.

Provectus Pharmaceuticals, Inc. (OTC-BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has announced additional positive data from its Phase 2 clinical trial of PV-10 for metastatic melanoma. The data, on changes in visceral and nodal metastases following chemoablation of cutaneous melanoma lesions with PV-10, was presented by Dr. Sanjiv Agarwala at the American Society of Clinical Oncology 2010 Annual Meeting, on Sunday, June 6, 2010, in the General Poster Session on Melanoma/Skin Cancers, Abstract #8534. Positive improvement observed in these remote, untreated lesions, including metastases to the lungs, liver and brain, illustrate a potential systemic effect in visceral organs to which melanoma has spread. Dr. Agarwala’s updated information included data from both the initial 40 subjects and the final 40 subjects enrolled in the Phase 2 trial.

A multi-media news release containing video is available at the following link: http://multivu.prnewswire.com/mnr/pvct/43978/.

(Photo: http://photos.prnewswire.com/prnh/20100607/MM11825 )

(Photo: http://www.newscom.com/cgi-bin/prnh/20100607/MM11825 )

Summary data on 20 subjects, including initial data on 4 subjects from the final 40 subjects in the study, who had evidence of macroscopic metastases of the lung, liver, brain or lymph nodes at screening, were presented. Among the first 40 study participants, 7 of the 16 subjects (44%) with visceral or macroscopic nodal metastases at screening exhibited stasis or regression of their lesions, including complete regression of multiple pulmonary metastases measuring up to 1.1 cm in one subject. Detailed data were presented on one Stage IV subject who experienced complete regression of multiple lung metastases and partial regression of multiple brain metastases over the study interval.

Dr. Agarwala, Chief of Medical Oncology and Hematology at St. Luke’s Hospital and Health Network in Bethlehem, PA, and Principal Investigator for Provectus’s Phase 2 PV-10 trial site at St. Luke’s, noted, “I believe these data on visceral lesions that have not been injected with PV-10 are an additional positive indicator of the apparent immunologic response that PV-10 chemoablation can elicit against untreated lesions. With a single exception, these outcomes were associated with a positive response to PV-10 in these subjects’ injected lesions, a correlation that is consistent with an immunologic-based process. Together with the similar correlation that has been observed between successful PV-10 chemoablation and resolution of uninjected cutaneous bystander lesions, this ‘remote bystander response’ is a very exciting development that illustrates the potential of PV-10 to trigger a beneficial systemic response.”

Agarwala continued, “I look forward to being part of a research team being assembled to begin investigating the immunologic mechanism of action underlying these results through an anticipated Phase 2B clinical study. By looking at potential immune markers in peripheral blood and tumor tissue, we expect to learn how PV-10 chemoablation recruits and sensitizes immune cells to exposed tumor antigens. This should provide crucial confirmation of our clinical results, and more importantly allow us to fully understand and apply PV-10′s potential in oncology.”

Agarwala further noted, “Half of the initial ‘N=40′ cohort were Stage IIIB (in transit metastatic disease) upon enrollment, while a quarter had demonstrated visceral disease of the lungs, liver or brain (Stage IV M1b or M1c). Interestingly, outcome of these subjects’ injected target lesions was not clearly dependent on disease stage, and there was no obvious evidence of a dependence of outcome on prior treatment history. I believe this highlights a potentially broad role PV-10 could play in management of melanoma, since it has now been employed early and late in the treatment of patients.”

Craig Dees, PhD, CEO of Provectus said, “The additional information that Dr. Agarwala presented at ASCO is very exciting and meaningful, underscoring the importance of immunology in the fight against cancer, and the potential that PV-10 has in battling the disease. This new information deepens our confidence that PV-10 will be a viable treatment for metastatic melanoma, and that its immunological potential is significant. To my knowledge, this is the first time that local therapy with a small molecule drug has shown repeatable activation of the immune system against non-treated tumors. As we follow the guidance that we received from the FDA during our End-of-Phase 2 meeting, we are designing a protocol for a pivotal Phase 3 randomized controlled study suitable for Special Protocol Assessment, and look forward to our next steps that will bring us closer to commercialization of PV-10. We also look forward to commencing our proposed Phase 2B clinical trial to examine the immunologic markers behind the fascinating data presented by Dr. Agarwala.”

The supplemental data presented at ASCO is in addition to data announced on May 21, 2010, which included 52-week data on the first 40 subjects enrolled in the study:

• Objective Response of PV-10 injected lesions was achieved in 60% of subjects, with a Complete Response (“CR”) in 33% of subjects and locoregional disease control (Stable Disease, “SD”, or better) in 80% of subjects;
• An OR was achieved in untreated bystander lesions in 43% of subjects having an evaluable bystander lesion at baseline;
• Mean Progression Free Survival (“PFS”) was 8.5 months for all subjects, while the OR cohort had a significantly longer PFS estimated to be at least 11.1 months vs. 3.0 months for SD and Progressive Disease (“PD”) subjects; and
• PV-10 was well tolerated, with Adverse Experiences (“AEs”) that were generally mild to moderate, locoregional and transient, with no deaths or life-threatening experiences attributable to PV-10.

Key conclusions from the poster were that:

• A majority of subjects exhibited a robust response in their injected lesions;
• Response appeared to be unrelated to disease stage or prior treatment history;
• Locoregional treatment with PV-10 may elicit systemic benefit in untreated visceral lesions; and
• The overall safety and efficacy profile of PV-10 compares favorably with available and emerging options for metastatic melanoma patients.

Provectus expects to announce complete final study results at Melanoma 2010 in Sydney, Australia, November 4-7, 2010.

The poster presentation can be accessed by the following link:

http://www.pvct.com/publications/ASCO_Poster-2010.pdf

About PV-10

PV-10 is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for nearly thirty years by ophthalmologists to assess damage to the eye. It has also been used as an intravenous diagnostic to detect ailments of the liver. Rose Bengal is a small molecule agent with an established safety history, a short half-life in the bloodstream, and is excreted unmetabolized via the liver and kidneys. Provectus has discovered a novel use for Rose Bengal based on the observation that it is selectively toxic to cancer calls via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis.

About Provectus Pharmaceuticals, Inc. (www.pvct.com)

Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its lead oncology agent, PV-10, is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and metastatic liver cancer. The Company has received orphan drug designation from the FDA for its melanoma indication. Its lead dermatological drug, PH-10, also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed enrollment and final follow-up in three Phase 2 trials — PV-10 as a therapy for metastatic melanoma, and PH-10 as a topical treatment for atopic dermatitis and for psoriasis. It has also recently initiated a Phase 1 trial of PV-10 for liver cancer. Information about these and the Company’s other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus please visit the Company’s website at www.pvct.com or contact Porter, LeVay & Rose, Inc.

FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.

Melanoma is a type of cancerous tumor that is found predominantly in skin that affects approximately 60,000 new patients per year. While it is not a common form of skin cancer, it accounts for approximately 75% of the deaths associated with skin cancer. According to a WHO report, approximately 48,000 patients die from the disease worldwide each year.

Despite biotechnology companies having invested significant time and money into finding a cure, the greatest chance of survival remains early surgical resection of thin tumors. Subsequent to the removal, adjuvant treatment, chemotherapy, immunotherapy and radiation therapy are also used, but are often extremely costly and painful with lasting adverse side-effects.

Fortunately, there are many drugs in various stages of clinical trials that promise to help combat melanoma. One of these drugs is Provectus Pharmaceuticals’ (OTC-BB: PVCT) PV-10, which utilizes a dye called Rose Bengal to selectively target and kill cancer cells. Currently, the drug is preparing to begin Phase III trials, after showing promise in its Phase II trial results.

During its Phase II trials, scientists found that PV-10 showed an Objective Response in 61% of subjects, with a Complete Response in 33% of subjects, and a logoregional disease control in 79% of subjects. Meanwhile, the compound also achieved an Objective Response in 43% of subjects with an evaluable bystander lesion.

The end result was a mean Progression Free Survival time of 8.5 months for all subjects, while the Objective Response subjects had significant longer rates estimated to be at least 11.1 months. Meanwhile, Adverse Experiences were generally mild to moderate, with no deaths or life-threatening experiences attributable to PV-10.

The drug is also being made available to severe patients through the FDA’s Compassionate Use Program. Since the drug has been used as a staining dye to find scratches in the eye for years, regulators view it as being relatively low-risk.

In the end, Provectus Pharmaceuticals, Inc. (OTC-BB: PVCT) and other cancer treatment companies are getting close to some real solutions as Melanoma Month draws to an end.

Craig Dees, Ph.D., CEO of Provectus, proclaims the Phase 2 clinical trial has provided an additional validating hypothesis, revealing the PV-10 metastatic melanoma treatment to be a safe and effective solution. Dr. Sanjiv Agarwala, Chief of Medical Oncology and Hematology at St. Luke’s Hospital and Health Network in Bethlehem, PA, and Principal Investigator for Provectus’s Phase 2 PV-10, also reports observational data to be very exciting, and particularly encouraging.

A 40-subject experimentation, detailed in the following press release, has provided very positive results, revealing overall safety and efficiency of PV-10 treatment to be relatively favorable in comparison with alternative treatments.

Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has announced further positive data on the first forty subjects in its Phase 2 clinical trial of PV-10 for metastatic melanoma, with an objective response (“OR”) observed in 61% of subjects and a mean Progression Free Survival (“PFS”) of at least 11.1 months among those subjects achieving an OR. These data were included in Abstract #8534, entitled “Chemoablation of metastatic melanoma with rose bengal (PV-10)”, to be presented by Dr. Sanjiv Agarwala at the American Society of Clinical Oncology 2010 Annual Meeting, on Sunday, June 6, 2010 in General Poster Session #209, Melanoma/Skin Cancers.

Key Data From the First 40 Subjects in the Phase 2 Study Include:

• Objective Response of PV-10 injected lesions was achieved in 61% of subjects, with a Complete Response (“CR”) in 33% of subjects and locoregional disease control (Stable Disease, “SD”, or better) in 79% of subjects;
• An OR was achieved in untreated bystander lesions in 43% of subjects having an evaluable bystander lesion at baseline;
• Mean Progression Free Survival (“PFS”) was 8.5 months for all subjects, while the OR cohort had a significantly longer PFS estimated to be at least 11.1 months vs. 2.8 months or less for SD or Progressive Disease (“PD”) subjects;
• Adverse Experiences during the study interval were generally mild to moderate, locoregional and transient, with no deaths or life-threatening experiences attributable to PV-10.

Dr. Sanjiv Agarwala, Chief of Medical Oncology and Hematology at St. Luke’s Hospital and Health Network in Bethlehem, PA, and Principal Investigator for Provectus’s Phase 2 PV-10 trial site at St. Luke’s, said, “These data are very exciting in many respects, with a lengthy Progression Free Survival being particularly encouraging. Since subjects were only observed for 12 months, it wasn’t possible to document time to progression in the substantial fraction of subjects achieving a highly durable response. Nonetheless, the marked difference in estimated PFS among PV-10 responsive subjects versus those who failed to respond bodes very well for responsive subjects, while allowing non-responsive subjects to commence alternate therapies without significant delay. With additional data being tabulated since the abstract was submitted, including key data on outcome of untreated visceral lesions, we should have very interesting supplemental information for presentation at the conference.”

Craig Dees, Ph.D., CEO of Provectus said, “The results of Phase 2 clinical trial are gratifying, providing additional validation of our hypothesis that PV-10 is a safe and effective treatment for metastatic melanoma. These data, combined with the results of our recent End-of-Phase 2 meeting with the FDA, provide greater confidence that we are getting closer to a viable treatment for this deadly disease. The FDA meeting provided us the guidance to design the protocol for a pivotal Phase 3 randomized controlled study suitable for Special Protocol Assessment (“SPA”). An SPA would affirm that our Phase 3 clinical trial design, endpoints, sample size, planned conduct and statistical analyses are acceptable for regulatory approval, defining the regulatory pathway for PV-10 as a treatment for metastatic melanoma. We look forward to implementing the next steps in our clinical development, bringing us closer to commercialization of PV-10.”

Background and Summary of the Data Being Presented at ASCO (Abstract # 8534)

Methods: Phase 2 testing commenced in October 2007 in 80 subjects with Stage III or IV melanoma, and enrollment was completed in May 2009 at seven sites in Australia and the United Sates. After initial treatment of 1-20 cutaneous, subcutaneous or nodal lesions, new or incompletely responsive lesions could be retreated at weeks 8, 12 or 16, with follow-up at 52 weeks. Another 1-2 lesions, including visceral lesions, could remain untreated for assessment of bystander response. The primary end-point is OR of injected lesions; secondary endpoints include OR of bystander lesions, PFS of target lesions and plasma pharmacokinetic assessment.

Results: The first 40 subjects completing the study (median age 75, age range 37 – 92) received PV-10 into 486 lesions (mean 1.9 treatment sessions per subject). Adverse experiences (“AEs”) were predominantly mild to moderate, locoregional and transient, the most common being pain at the treatment site (82% of subjects), vesicles or edema (50% each), followed by swelling, pruritus, skin discoloration or headache (18% each), with no Grade 4 or 5 AEs attributed to PV-10.

Among all 40 subjects, 33% achieved CR, 28% PR and 18% SD of their target lesions; 33% of 21 subjects with evaluable bystander lesions achieved CR in these lesions, along with 10% PR and 14% SD. Mean PFS was 8.5 months for all subjects, while the OR cohort had significantly longer PFS (11.1 months) than SD or PD (“Progressive Disease”) subjects (2.8 and 2.7 months, respectively).

Conclusion: Overall the safety and efficacy profile of PV-10 compares favorably with available and emerging options for this patient population.

About PV-10

PV-10 is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for nearly thirty years by ophthalmologists to assess damage to the eye. It has also been used as an intravenous diagnostic to detect ailments of the liver. Rose Bengal is a small molecule agent with an established safety history, a short half-life in the bloodstream, and is excreted unmetabolized via the liver and kidneys. Provectus has discovered a novel use for Rose Bengal based on the observation that it is selectively toxic to cancer calls via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis.

About Provectus Pharmaceuticals, Inc. (www.pvct.com)

Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its lead oncology agent, PV-10, is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and metastatic liver cancer. The Company has received orphan drug designation from the FDA for its melanoma indication. Its lead dermatological drug, PH-10, also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed enrollment in three of Phase 2 trials — PV-10 as a therapy for metastatic melanoma, and PH-10 as a topical treatment for atopic dermatitis and for psoriasis. It has also recently initiated a Phase 1 trial of PV-10 for liver cancer. Information about these and the Company’s other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus please visit the Company’s website at www.pvct.com or contact Porter, LeVay & Rose, Inc.

FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.

Provectus Pharmaceuticals, Inc. (PVCT), which is developing cancer and psoriasis treatments based on the Rose Bengal compound, continues to make significant headway in its clinical trials with the U.S. Food and Drug Administration (FDA). But how does this process work, and exactly where does the company stand with its treatments?

The Clinical Trial Process

Phase I trials involve researchers testing an experimental drug or treatment in a small group of between 20 and 80 people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Next, Phase II trials involve larger groups of 100 to 300 people and are designed to test effectiveness and further evaluate its safety.

The pivotal Phase III trials provide the drug to large groups of 1,000 to 3,000 people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. After these trials, the drug or treatment is proposed to the FDA for commercial approval.

Some Exceptions to the Process

Of course, there are some exceptions to these rules that affect companies like Provectus Pharmaceuticals, since its Rose Bengal compound has a well-established safety profile and its drug is regarded as very important for terminally ill patients.

The company’s “compassionate use” program allows its treatment to be administered to seriously ill patients that are not enrolled in clinical trials, under a very strict program overseen by the FDA. Meanwhile, an expected Special Protocol Assessment (SPA) could significantly de-risk the Phase III trial, unless accelerated approval is achieved, as an NDA could be submitted with greater likelihood of approval after a potential Phase III trial has been completed.

Where is Provectus in these Trials?

Recently, Provectus announced that it held its end of Phase II meeting with the FDA to seek consensus on clinical program scope and endpoints for licensure of PV-10 for metastatic melanoma. A second meeting will be held in the coming months to design a pivotal Phase III randomized controlled study suitable for Special Protocol Assessment (SPA).

Meanwhile, the company is also developing its PH-10 treatment for psoriasis using the same Rose Bengal compound. After initiating its Phase II trials in 2007, it is now working through the trial towards meeting its clinical endpoints. And finally, the company has initiated Phase I and II trials for both treatments in other indications as well.

In the end, Provectus is rapidly proceeding through its clinical trials and has realized many benefits that aren’t typically made available through the FDA, including a “compassionate use” program and a potential Special Protocol Assessment for its Phase III trial. As a result, this remains a stock worth watching for investors looking for an emerging biotech stock!

Provectus Pharmaceuticals, Inc. (PVCT), a pharmaceutical company focused on the development of cancer and psoriasis treatments based on the Rose Bengal compound, has rallied more than 60% since the beginning of 2010, as it continues to develop its promising drug portfolio.

Rose Bengal is a red dye that was previously used to test for corneal scratches because it is preferentially absorbed by damaged cells. Provectus found that a highly specialized version of this dye is also absorbed in irregular or damaged cancerous cells.

As the cancerous cells continue to take in more and more PV-10, they begin to rupture and eventually go into cell necrosis (death). The entire process also occurs without any radiation, which gives the treatment a substantial edge over existing treatments with side-effects.

Earlier this year, Provectus announced that the results from its Phase II PV-10 study in melanoma would be unveiled at this year’s ASCO meeting on June 6-7, 2010. Many investors are confident that the results will be similar to those seen during its previous interim analysis.

The American Society of Clinical Oncology (ASCO) meeting is widely recognized as one of the most important events of the year for companies conducting cancer research. The meeting houses thousands of oncology field practitioners, as well as several companies posting trial results.

On April 29, 2010, Provectus also announced that it held an end-of-Phase II meeting with the U.S. Food and Drug Administration to seek consensus on the scope and endpoints for its clinical program for licensure of PV-10 for metastatic melanoma.

Based on the results of the meeting, the company expects to hold a second end-of-Phase II meeting in the coming months to finalize the design of a pivotal Phase III randomized controlled study suitable for Special Protocol Assessment, but the door could still be open for an accelerated approval, according to Dr. Dees, CEO of Provectus.

In the end, Provectus has a number of near-term catalysts that make the stock both a compelling short-term play and long-term holding.

Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced today that it has held an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to seek consensus on clinical program scope and endpoints for licensure of PV-10 for metastatic melanoma. The meeting was held at the Agency’s White Oak Campus in Silver Spring, MD.

“Based on consultation with senior Agency officials during this meeting, we expect to hold a second end-of-Phase 2 meeting in the coming months to finalize design of a pivotal Phase 3 randomized controlled study suitable for Special Protocol Assessment (SPA).”

Craig Dees, Ph.D., CEO of Provectus said, “This meeting provided an opportunity to thoroughly review the clinical data we have amassed through our Phase 1 and Phase 2 studies with PV-10. As expected, the meeting was fruitful and provided a forum for discussion of appropriate endpoints for assessment of clinical benefit of PV-10 in melanoma patients and for definition of the pathway leading to licensure.”

Dr. Dees continued, “Based on consultation with senior Agency officials during this meeting, we expect to hold a second end-of-Phase 2 meeting in the coming months to finalize design of a pivotal Phase 3 randomized controlled study suitable for Special Protocol Assessment (SPA).”

Dr. Dees concluded, “We are fortunate that our capital resources afford flexibility to consider pursuing both the conventional Phase 3 pathway, as well as an accelerated route to licensure. While we believe the Phase 3 with an SPA represents an industry standard path to approval, we believe the door may still be open for accelerated approval.”

About PV-10

PV-10 is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for nearly thirty years by ophthalmologists to assess damage to the eye. It has also been used as an intravenous diagnostic to detect ailments of the liver. Rose Bengal is a small molecule agent with an established safety history, a short half-life in the bloodstream, and is excreted via the liver and kidneys. Provectus has discovered a novel use for Rose Bengal based on the observation that it is selectively toxic to cancer calls via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis.

About Provectus Pharmaceuticals, Inc. (www.pvct.com)

Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its lead oncology agent, PV-10, is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing systemic side effects. Its oncology focus is on melanoma, breast cancer and metastatic liver cancer. The Company has received orphan drug designation from the FDA for its melanoma indication. Its lead dermatological drug, PH-10, also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed enrollment in three of its Phase 2 trials — PV-10 as a therapy for metastatic melanoma, and PH-10 as a topical treatment for atopic dermatitis and for psoriasis. It has also recently initiated a Phase 1 trial for PV-10 for liver cancer. Information about these and the Company’s other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus please visit the Company’s website at www.pvct.com or contact Porter, LeVay & Rose, Inc.

FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.

Provectus Pharmaceuticals, Inc. (PVCT), which is developing a cancer treatment based on the Rose Bengal compound, continues to receive positive press highlighting the effectiveness and promise of its new PV-10 drug for the treatment of metastatic melanoma.

An article in ScienceDirect, entitled “New era in metastatic melanoma,” highlights the company’s phase II PV-10 trials, which stimulated “intrigue and interest” among delegates at the 3rd World Meeting of Interdisciplinary Melanoma/Skin Cancer Centres.

Of particular note, according to Dr. Agarwala, a principal investigator in the Phase II study, has been the “by-stander effect” where the agent also elicits spontaneous regression of nearby melanoma tumors that have not been injected.

Follow-up survival data from the Phase II study for the first 20 subjects showed that patients who were responsive had a mean overall survival rate of 11.8 months, compared to 9.9 months for those who did not achieve a robust response. Furthermore, two of five subjects displayed the by-stander effects with regression of visceral or nodal metastases that had not been injected.

“In melanoma the overall effect appears similar to that of recent melanoma vaccines with the important additional features that PV-10 reduces overall disease burden by destroying the injected lesion,” said Eric Wachter, who was quoted in the article. “The process occurs insitu so the patient’s specific melanoma antigens are presented in the proper immunologic context.”

While PV-10 is unlikely to play a role in patients with widespread organ involvement, Agarwala believes it offers the possibility to intervene early in the metastatic process, according to the article.

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Provectus Pharmaceuticals, Inc. (PVCT), whose PV-10 drug is in Phase II trials targeting metastatic melanoma, could see effectiveness against many other types of cancer too. The unique process by which PV-10 targets irregular cancerous cells suggests an ability to kill multiple forms of the deadly disease, which equates to a much larger market for the drug.

Provectus’ PV-10 treatment uses a special dye called Rose Bengal, which has the unique ability to be absorbed by damaged cells. Since cancer cells are often irregular in many ways, PV-10 is able to penetrate the cell. Due to PH differences, these cancer cells continue taking in so much PV-10 that they shatter, which leads to the death of the cancerous cell.

As a result of this belief, Provectus has initiated its Phase I study of PV-10 for liver metastasis in October 2009, and has already completed a Phase I trial of PV-10 for breast cancer in July 2008. Meanwhile, PV-10’s robust safety profile means that it is typically allowed to be used on a “compassionate use” basis, which should quickly confirm its effectiveness.

Provectus’ PV-10 has also demonstrated a unique “bystander effect,” which could prove extremely beneficial for combating cancer. Scientists have observed immune cells being recruited following the destruction of the initial cancer cell, and these immune cells are circulated in the system and influence distant tumors as well.

Meanwhile, cancer continues to be a growing problem, particularly in the developed world. Last year, ReportBuyer forecast that the global market for pharmaceutical cancer treatments would reach $103.9 billion by 2010, which would be up from just $66.2 billion in 2007. Currently, Amgen leads the pack with $11.1 billion in cancer sales in 2007.

Given the positive results from Provectus’ recent PV-10 Phase II trials, investors may want to keep an eye on this company. Meanwhile, PV-10’s potential to combat other forms of cancer and even realize a “bystander effect” in patients makes it all the more valuable, if it is eventually commercialized after an FDA approval.

Provectus Pharmaceuticals, Inc. (PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that Dr. Sanjiv Agarwala, in his presentation at the Seventh International Symposium on Melanoma and Other Cutaneous Malignancies on March 12, 2010, commented on the involvement of the immune system in response to PV-10 therapy and its role in the “bystander effect” in treating metastatic melanoma. Dr. Agarwala’s presentation, entitled “Chemoablation in Melanoma: An Update,” was given in the session entitled “Unique Approaches to Melanoma Therapy.”

Dr. Agarwala, Chief, Medical Oncology and Hematology at St. Luke’s Hospital and Health Network in Bethlehem, PA, and Principal Investigator for Provectus’s Phase 2 PV-10 trial site at St. Luke’s, noted, “PV-10 is of particular interest to me as an oncologist because it appears to recruit immune cells to the ablation site, leading to the potential of a systemic benefit. Efficacy data from Phase 1 and from the current Phase 2 study demonstrate a close correlation between objective response in treated lesions and response in uninjected lesions. Survival data from both studies further support a conclusion that patients that respond well to PV-10 respond well overall.”

Dr. Agarwala also discussed plans to conduct research into PV-10’s immunologic mechanism of action. He said, “I look forward to seeing the results of this research so we can fully understand the potential PV-10 may have in treating not only melanoma, but also other indications in oncology.”

Craig Dees, PhD, CEO of Provectus said, “We are encouraged by Dr. Agarwala’s remarks at a time when the medical community has begun to recognize the fundamental importance of immunology in the ongoing fight against cancer. Having completed final follow-up on the first 60 patients enrolled in our Phase 2 study, we look forward to presenting the survival and progression free survival data from at least 40 subjects in June. Further, with our Type B meeting to chart the path to licensure on the FDA schedule, we look forward to reporting on the outcome of that meeting shortly after it occurs.”

About PV-10

PV-10 is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for nearly thirty years by ophthalmologists to assess damage to the eye. It has also been used as an intravenous diagnostic to detect ailments of the liver. Rose Bengal is a small molecule agent with an established safety history, a short half-life in the bloodstream, and is excreted via the liver and kidneys. Provectus has discovered a novel use for Rose Bengal based on the observation that it is selectively toxic to cancer calls via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis.

About The Seventh International Symposium on Melanoma and Other Cutaneous Malignancies

The Seventh International Symposium on Melanoma and Other Cutaneous Malignancies will continue a strong history and provide participants with a comprehensive overview of state-of-the-art care of patients with these diseases. Specific topics to be highlighted at this symposium include current risk assessment factors and diagnostic technologies, new prognostic and predictive biomarkers with clinical potential for individualizing treatment, and promising emerging systemic immunotherapies, targeted therapies, and regional therapies for advanced melanoma and other cutaneous malignancies. These topics and the implications for practice will be presented by leading experts in the treatment of these different tumor types. This interactive symposium will also cover practical issues concerning surgical management and adjuvant therapy for these patients. These concepts and practical diagnostic issues will be further reinforced through 2 interactive case-based discussion sessions with the faculty to provide expert insights into their application in practice. Throughout the symposium, participants will also learn about currently accruing high-priority trials and the relevant patient eligibility criteria to enhance enrollment into trials evaluating novel therapeutic regimens in the adjuvant and advanced disease settings for melanoma and other cutaneous malignancies.

About Provectus Pharmaceuticals, Inc. (www.pvct.com)

Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its lead oncology agent, PV-10, is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing systemic side effects. Its oncology focus is on melanoma, breast cancer and metastatic liver cancer. The Company has received orphan drug designation from the FDA for its melanoma indication. Its lead dermatological drug, PH-10, also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed enrollment in three of its Phase 2 trials — PV-10 as a therapy for metastatic melanoma, and PH-10 as a topical treatment for atopic dermatitis and for psoriasis. It has also recently initiated a Phase 1 trial for PV-10 for liver cancer. Information about these and the Company’s other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus please visit the Company’s website at www.pvct.com or contact Porter, LeVay & Rose, Inc.

FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.

Provectus Pharmaceuticals, Inc. (PVCT), a development stage biopharmaceutical company focused on developing products to treat cancer and psoriasis, has been entered into the Mentor Capital Cancer Immunotherapy Index as of February 22, 2010. Simultaneously, the fund purchased an initial stake in the firm, as it does with all of its Index companies.

Mentor Capital is designed as a pure financing vehicle to raise approximately $140 million in steps for operating entities like those in the Cancer Immunotherapy Index. The funds, raised through the issue of warrants, are invested in the index in order to provide liquidity for portfolio company shareholders, provide public shares and cash for acquisitions and support growth.

“Provectus has the strong balance sheet, executive and science teams, and especially the breakthrough medical technology that warrants long-term inclusion on the Cancer Immunotherapy Index that we look for and that merits substantial institutional interest,” commented Mentor Capital CEO Chet Billingsley.

With melanoma affecting some 62,000 patients and killing about 8,000 per year, Provectus’ PV-10 offers real hope with a 69% objective response being reported. In addition to melanoma, PV-10 may also be applicable to breast, liver or perhaps any other well defined solid tumor that can be targeted for treatment injections.

Mentor Capital also offered its own excellent explanation of how PV-10 works:

In the Provectus treatment regime, these lesions are injected with PV-10, a very specialized version of the red dye, Rose Bengal, that ophthalmologists use to test for corneal scratches because it is preferentially absorbed by damaged cells. The smooth lipid layer of healthy cell membranes excludes the Rose Bengal product like wax paper sheds water. Cancerous cells are often physically or chemically irregular and the PV-10 penetrates into the cell as water would find its way through the thinner creases in wax paper that has been tightly crumpled. Because of PH differences, the cancerous cells continue to uptake more and more PV-10, which is further pulled into lysosomes (cell stomachs) until these rupture, leading to a complete rupture of the cancer cell.

The cold cell rupture casts whole cancer protein fragments adrift that have not been chemically modified by heat, chemicals or radiation. These unaltered cancer fragments in the otherwise healthy tissue excite an immune response to those cancer proteins in the lesion location. When a piece of cancer protein is passed to a killer T-Cell, that T-Cell will spend the rest of its days bouncing through the blood stream looking to match up that protein once more and attack.

If the T-Cell does find another matching cancer protein on the surface of a Melanoma cell that has slipped away, it latches on. Then the T-Cell secretes perforin which punches holes in the cell membrane allowing the cytoplasm to ooze out. Enzymes are injected that dissolve the mitochondria that power cell functions, and finally, granzymes are injected that chop up the DNA in the nucleus like a molecular Pac-Man.

In the end, inclusion into the Mentor Cancer Immunotherapy Index is good news because it validates the company’s technologies and provides shareholders with additional liquidity. Many investors are hoping that this interest will be followed by additional institutional interest, especially as the company begins to commercialize its ground-breaking technologies.

Provectus Pharmaceuticals, Inc. (PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that it has received gross proceeds of approximately $8 million in a private placement offering to institutional and accredited investors. In connection with the closing, the Company issued approximately 10.0 million shares of its convertible preferred stock and warrants to purchase approximately 5.0 million shares of its common stock at an exercise price of $1.00 per share. The Company expects to close on additional gross proceeds of approximately $450,000 on or before March 15. The shares issued to the investors and the shares underlying the warrants have not been and will not be registered under the Securities Act of 1933, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. This press release shall not be deemed an offer to sell or a solicitation of an offer to buy any securities of the Company, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The Company intends to use the proceeds of the private placement for working capital purposes. Peter Culpepper, the Company’s CFO and COO said, “With the closing of this offering, Provectus has strengthened its operational activities and expanded its shareholder base to include new individual and institutional investors. We believe we have now raised enough capital to fully finance existing clinical trials through to completion, and do not anticipate the need for any further capital in order to bring our existing metastatic melanoma therapy to completion of clinical trials. As our discussions with the FDA regarding an accelerated path continues, we wanted to make sure we are prepared to move ahead with our development activities if a Phase 3 study is needed. We intend to continue to work with the FDA and other authorities to rapidly register our groundbreaking therapies, so that we can serve the many patients who need them.”

He continued, “Provectus also believes that it is well positioned to execute on its growth strategy by developing its oncology and dermatology therapies through clinical trials, strategic partnerships and licensing agreements. We remain committed to further develop our dermatology therapies with an industry partner, and expect to continue to develop our other oncology indications.”

Maxim Group LLC served as the Company’s exclusive placement agent for the transaction.
About Provectus Pharmaceuticals, Inc. (www.pvct.com)

Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its lead oncology agent, PV-10, is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing systemic side effects. Its oncology focus is on melanoma, breast cancer and metastatic liver cancer. The Company has received orphan drug designation from the FDA for its melanoma indication. Its lead dermatological drug, PH-10, also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed enrollment in three of its Phase 2 trials — PV-10 as a therapy for metastatic melanoma, and PH-10 as a topical treatment for atopic dermatitis and for psoriasis. It has also recently initiated a Phase 1 trial for PV-10 for liver cancer. Information about these and the Company’s other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus please visit the Company’s website at www.pvct.com or contact Porter, LeVay & Rose, Inc.

FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.

Provectus Pharmaceuticals, Inc. (PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that Dr. Sanjiv Agarwala, Principal Investigator for Provectus’ Phase 2 PV-10 trial site at St. Luke’s Hospital & Health Network in Bethlehem, PA, will present an update on the Company’s ongoing Phase 2 trial of PV-10 for metastatic melanoma at the Seventh International Symposium on Melanoma and Other Cutaneous Malignancies on March 12, 2010, in New York City.

Dr. Agarwala’s presentation, “Chemoablation in Melanoma: An Update,” will be presented during the session entitled “Unique Approaches to Melanoma Therapy.”

Craig Dees, Ph.D., CEO of Provectus said, “We look forward to Dr. Agarwala’s update to the medical community on the clinical progress that has been made with PV-10 for metastatic melanoma since last year’s conference. From our research, we believe that PV-10 is proving to have great promise as a safe and effective therapeutic for this devastating cancer that affects so many people each year, and for which there are few viable treatments. Dr. Agarwala’s presentation should highlight many of the reasons we are excited about the data from PV-10’s clinical trials.”

According to the American Cancer Society, there were over 68,000 new cases of melanoma, and over 8,600 deaths in the U.S. in 2009. Further, the World Health Organization has estimated that 48,000 patients globally died from melanoma in 2008.

About The Seventh International Symposium on Melanoma and Other Cutaneous Malignancies

The Seventh International Symposium on Melanoma and Other Cutaneous Malignancies will continue a strong history and provide participants with a comprehensive overview of state-of-the-art care of patients with these diseases. Specific topics to be highlighted at this symposium include current risk assessment factors and diagnostic technologies, new prognostic and predictive biomarkers with clinical potential for individualizing treatment, and promising emerging systemic immunotherapies, targeted therapies, and regional therapies for advanced melanoma and other cutaneous malignancies. These topics and the implications for practice will be presented by leading experts in the treatment of these different tumor types. This interactive symposium will also cover practical issues concerning surgical management and adjuvant therapy for these patients. These concepts and practical diagnostic issues will be further reinforced through 2 interactive case-based discussion sessions with the faculty to provide expert insights into their application in practice. Throughout the symposium, participants will also learn about currently accruing high-priority trials and the relevant patient eligibility criteria to enhance enrollment into trials evaluating novel therapeutic regimens in the adjuvant and advanced disease settings for melanoma and other cutaneous malignancies.

About Provectus Pharmaceuticals, Inc. (www.pvct.com)

Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its lead oncology agent, PV-10, is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing systemic side effects. Its oncology focus is on melanoma, breast cancer and metastatic liver cancer. The Company has received orphan drug designation from the FDA for its melanoma indication. Its lead dermatological drug, PH-10, also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed enrollment in three of its Phase 2 trials — PV-10 as a therapy for metastatic melanoma, and PH-10 as a topical treatment for atopic dermatitis and for psoriasis. It has also recently initiated a Phase 1 trial for PV-10 for liver cancer. Information about these and the Company’s other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus please visit the Company’s website at www.pvct.com or contact Porter, LeVay & Rose, Inc.

FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.

Provectus Pharmaceuticals, Inc. (PVCT), a biotechnology company focused on developing cancer and psoriasis treatments using the Rose Bengal compound, found in recent Phase I and II studies that its lead PV-10 compound demonstrates a unique “bystander effect” that results in improvements in other melanoma tumors that were not directly treated.

The occurrence suggests that PV-10 is able to not only safely and effectively treat cancerous tumors, but also jumpstart the body’s own immune system to combat cancer in adjacent regions that were not directly treated. As a result, PV-10 could be even more effective than first envisioned when it comes to completely eradicating cancer from a patient.

PV-10 studies have shown that thick, oily red dye exhibits preferential uptake into lysosomes of cancer cells but it is excluded from normal cells, resulting in selective necrosis in multiple melanoma lines. Essentially, this means that the Rose Bengal compound is able to selectively kill cancer cells without damaging the surrounding cells.

Meanwhile, scientists also noticed that bystander lesions that were not directly treated also improved, in about 50% of cases, within the study follow-up. The company believes that the exposure of tumor antigens in context from the cells that are destroyed is what promotes the activity, but further study is necessary to show more completely how it works.

Over the past 50+ years, scientists have also clearly demonstrated that the compound is not metabolized in the body. Rather, it is excreted rapidly and has minimal toxicity in healthy tissues. These attributes have helped PV-10 conduct current compassionate use studies under the auspices of the FDA and could help fast-track PV-10 further through any remaining clinical trial.

In the end, Provectus’ PV-10 candidate is showing great promise in not only treating tumors, but also jumpstarting the body’s own immune system to fight surrounding cancer cells. As a result, scientists are increasingly confident in the drug’s ability to one-day make a lasting impact in the world’s fight against cancer.

Click Here to Learn More about Provectus Pharmaceuticals (PVCT)

Provectus Pharmaceuticals, Inc. (PVCT), a pharmaceutical company focused on developing cancer and psoriasis treatments using the Rose Bengal compound could see some regulatory clarity on the horizon as its PV-10 drug nears the end of its Phase 2 clinical trial.

The cancer treatment can elicit selective ablation of solid tumors and an apparent bystander response in untreated lesions. In Phase 1 studies, a single injection led to an objective response in 40% of subjects and locoregional disease control in 75% of subjects. Phase 2 results are even better.

Moreover, Provectus’ drug was well tolerated with one notable Grade 3 adverse event and modest transient pain at the treatment site followed by local inflammation or infection in some patients. It is this solid safety profile that has led to the drug’s quick progression through its clinical trials.

The company’s PV-10 treatment for metastatic melanoma is seeking an accelerated path with the FDA, which could provide clarity in the early part of the second quarter. Meanwhile, the company is also continuing to assess PV-10’s chemoablation of liver and breast cancers.

In its latest ASCO presentation, Provectus’ data showed that the immune system responses provoked by the treatment are real, and more world-class scientists are looking to learn more about it. Here is a clip from its ASCO Presentation in 2009 showing robust efficacy:

Thanks to these results, the FDA has already given Provectus a green light for a compassionate use program. The tightly controlled program enables medical professionals to use the PV-10 treatment on seriously ill patients, oftentimes when no other suitable treatments are available.

The company’s PV-10 drug has already proven to be an effective treatment for cancer in that it selectively targets harmful cancer cells and forces them to undergo chemoablation (cell death), according to data published in its nearly completed Phase 2 trial.

Thus far, the Phase 2 trial showed an objective response in 60% of patients with locoregional disease control in 75% of patients. Meanwhile, the response of untreated bystander lesions was also consistent with observations in Phase 1 trials, which bodes even better for the treatment.

In the end, investors are looking forward to some near-term results from the robust PV-10 clinical trials that could help move the stock. Meanwhile, the positive results from the Phase 1 and 2 clinical trials suggest a high probability of success.

Provectus Pharmaceuticals, Inc. (PVCT), a biopharmaceutical company focused on developing cancer and psoriasis treatments using the Rose Bengal compound, broke out from its 52-week high today ahead of key clinical trial results.

Provectus announced updates to its Phase 2 trial data back in November 2009 and found that its PV-10 for the treatment of metastatic melanoma was safe and over a one year period. Moreover, PV-10 showed markedly longer overall and disease specific survival in subjects.

Subsequently, Provectus presented early results from its Phase 2 trial during the annual meeting of the American Society of Clinical Oncology (ASCO) in June of 2009. Researchers found that an objective response was seen in 60% of subjects with locoregional disease control in 75%.

Interestingly, Provectus also observed a “bystander effect” whereby untreated bystander lesions also responded to treatment. The company believes that Rose Bengal may induce the patient’s own immune system to attack and shrink untreated tumors.

Meanwhile, Provectus’ PH-10 for the treatment of psoriasis is also in late-stage clinical trials. The company announced Phase 2 trial results in December of 2009, and stated that it was looking to license the drug going forward with the help of a financial advisor.

With its PV-10 in ongoing trials and a compassionate use program underway and PH-10 in late-stage development, many investors are looking ahead to future results being announced, which could represent a very positive catalyst for the stock price going forward.

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Provectus Pharmaceuticals, Inc. (PVCT), a development-stage oncology and dermatology biopharmaceutical company, announces the publication of an article, entitled “A novel treatment for metastatic melanoma with intralesional rose bengal and radiotherapy: a case series,” authored by Dr. Matthew C. Foote, Dr. Bryan H. Burmeister, Janine Thomas, and Dr. B. Mark Smithers, in the current issue of the peer-reviewed journal, Melanoma Research (20(1):48-51, February 2010).

The article is based on the authors’ observations while treating patients previously enrolled in the ongoing Phase 2 clinical trial of PV-10 for metastatic melanoma. PV-10 is Provectus’ formulation of rose bengal for intralesional (IL) injection into solid tumors. The authors stated, “Three patients with metastatic melanoma were treated with intralesional rose bengal followed by external beam radiotherapy. In all cases patients had an impressive response without significant increase in acute radiation reaction.” A copy of the article can be accessed at the following link: http://www.pvct.com/melanoma_update.html.

The patients cited in the article were part of the Phase 2 study investigating the effectiveness of PV-10 for locoregional treatment of metastatic melanoma. The authors said, “All of the impressive responses occurred in previously injected lesions, non-injected lesions and other lesions that developed in the local area, which may have been exposed to rose bengal.”

The authors continued, “Although a range of [radiation] dose and fractionation schedules were used in these cases, the responses that were noted after radiotherapy, even for large volume disease, after IL rose bengal were significantly more than our experience would have predicted with all three of the patients treated having a complete in-field response.”

“There are several radiobiological rationales that may explain our observation including radiosensitization by the rose bengal, additive cell kill or augmentation of the host immune response by the interaction of the two modalities. As radiation was applied many weeks after rose bengal dosing, and effects also occurred in new lesions not present when rose bengal was administered, this phenomenon may not arise solely from conventional radiosensitization,” added the authors.

Craig Dees, Ph.D., President and CEO of Provectus said, “Each of the patients cited in this article were part of the Phase 2 clinical study prior to subsequent radiation therapy, and had aggressive cases of metastatic melanoma. Because the Phase 2 study protocol limited the investigator’s dosing options, Dr. Smithers and his team were not able to match the allowed dosing regimen to the natural disease course for these patients. Six to 12 weeks after receiving their final PV-10 dose, the patients received supplemental radiotherapy that led to the remarkable responses noted in the article. Dr. Smithers is now part of our compassionate use program for PV-10 which allows far more flexibility in dosing, and we look forward to assessing results from this program and their implications for optimizing how PV-10 is administered to metastatic tumors. We also anticipate additional studies to confirm these initial observations using PV-10 in conjunction with radiotherapy.”

About Provectus Pharmaceuticals, Inc. (www.pvct.com)

Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its lead oncology agent, PV-10, is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing the potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and metastatic liver cancer. The Company has received orphan drug designation from the FDA for its melanoma indication. Its lead dermatological drug, PH-10, also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed enrollment in three of its Phase 2 trials — PV-10 as a therapy for metastatic melanoma, and PH-10 as a topical treatment for atopic dermatitis and for psoriasis. It has also recently initiated a Phase 1 trial for PV-10 for liver cancer. Information about these and the Company’s other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus please visit the Company’s website at www.pvct.com or contact Porter, LeVay & Rose, Inc.

FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.

Genta Incorporated (GETA), which is engaged in pharmaceutical research and development, saw its shares rise more than 20 percent after two scientific studies showed that the active ingredient in the firm’s program to develop orally available gallium-containing compounds showed that it significantly increased bone strength in standard models of osteoporosis.

Bell Microproducts Inc. (BELM), which distributes and resells data storage and server products and solutions, saw its shares jump more than 10 percent after preliminary fourth quarter sales that increased 8-10% sequentially to between $796 million and $819 million. The largest increase came in its components and peripherals category.

Ecosphere Technologies, Inc. (ESPH), which provides water engineering and services, saw its shares jump more than 10 percent after issuing a letter to shareholders and reporting record operating revenues that exceeded $1 million in the fourth quarter. The company also noted its excitement about the acceptance and demand for its Ecosphere Ozonix technology.

Provectus Pharmaceuticals, Inc. (PVCT), which specializes in developing oncology and dermatology therapies, is developing a treatment designed to more effectively combat cancer while lessening the harmful side-effects seen in other treatments like chemotherapy. The treatment is largely based on a staining compound known as Rose Bengal.

Provectus discovered a novel use for Rose Bengal – a small molecule agent with an established safety history and a short half-life in the bloodstream – based on the observation that it is selectively toxic to cancer cells via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis.

The American Cancer Society estimates that there are 120,000 Americans diagnosed with Stage III or Stage IV melanoma, and 68,000 more new cases will be diagnosed in 2009. On a global scale, the World Health Organization estimates that 48,000 people died of Stage III and Stage IV melanoma in 2008.

Clinical Trials Show Safety and Efficacy

Provectus announced updates to its Phase I trial data back in November 2009 and found that its PV-10 demonstrated the drug’s safety in patients using it over a one-year period. Moreover, PV-10 also showed markedly longer overall and disease specific survival for subjects that were responsive to the drug relative to those who did not experience a robust response.

Subsequently, Provectus presented early results from its Phase II trial during the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida in June 2009. Researchers found that an objective response was observed in 60% of subjects and locoregional disease control of treated lesions was observed in 75% of subjects.

Provectus also observed a so-called “bystander effect” whereby untreated bystander lesions also responded to the treatment. The company believes that this could be because the drug induced the patient’s own immune system to attack and shrink untreated tumors. This would be of enormous benefit given that some cancers spread to difficult-to-treat areas like the neck.

Strong Near-term Catalysts…

Full follow-up data from the  first 40 subjects in its Phase II study is expected to become available in the first quarter of 2010, while the company prepares for its Phase III trials to begin, if necessary since it is pursuing accelerated approval.

Meanwhile, the company has also expanded its access program for PV-10 through compassionate use for qualified patients. Combined, this data could go a long way in attracting a potential partner and/or moving forward with anticipated approval of the drug.

Provectus specializes in developing cancer therapies that are safer, more effective and less invasive than conventional therapies. While leaving healthy tissue alone, small-molecule drugs are used to target and isolate diseased tissue. This attribute could enable the company to use a single drug to combat multiple forms of cancer with little additional modification.

At the heart of the Provectus story is Rose Bengal, which is a compound with an established safety history and a short half-life that has been used in many unrelated treatments. The company discovered that the compound is selectively toxic to cancer cells via a process called chemoablation whereby cells undergo a form of cell death that mimics necrosis and apoptosis.

During clinical trials, the drug utilizing RB as an active ingredient was well-tolerated and led to a durable objective response (OR) in 60% of subjects in their injected lesions, and loco-regional disease control in 75% of subjects. At the same time, RB was also found to be effective as a topical treatment in separate studies conducted by the company to treat psoriasis.

Currently, Provectus is preparing to begin commercialization of its drug pipeline through licensing or partnering with larger companies in the space. The company expects final data completion for primary outcomes by February 2010 for its psoriasis drug, while its melanoma application stands in Phase 2 now and could be fast-tracked through the remaining FDA trials.

Provectus also has ample cash to complete its Phase 2 melanoma study and other clinical trials, while potential licensing or partnering with its psoriasis drug could provide additional cushion. And with three Phase 2 trials in progress, the company has several milestones for value creation in the near-term with little risk of financial downside in terms of a risky and uncertain cash burn.

In the end, Provectus represents a promising and relatively undiscovered play on a new way to treat cancer, and could make a great high-risk, high-reward play for any stock portfolio! For more information, visit www.pvct.com.