Provectus Pharmaceuticals, Inc. (OTC:PVCT) Gains Considerable Recognition and Reports Accomplishments
Provectus Pharmaceuticals, Inc. (OTC:PVCT), which specializes in the development of clinical products designed to treat various cancers, similar to companies like Soligenix, Inc. (OTC:SNGX) and CTx, Inc. (NASDAQ:GTXI), reported positive results in its clinical trials, as well as a robust financial position.
Quick Profile of PVCT
The 12-year old company located in Knoxville, TN is engaged in the development of cancer fighting therapies. Provectus is operated by a group of dedicated scientists and a team of management staff with the goal of developing breakthrough technologies that can assist in the treatment of cancer diseases, and offer a safer and more effective treatment result for all patients.
The Company Gets the Spotlight Due to PV-10 Cancer Treatment
Provectus’s clinical results have attracted the attention of prominent medical trade publications and media stations across the globe.
Examples include:
• Dotor’s Guide
• Hem/Onc Today
• Oncology Business Review
• Skin & Aging
• Practical Dermatology
• Bioworld Insight and BioCentury
• Health Radio Network
• Pharmawire
PV-10 Clinical Treatment Update
For some time, Provectus has been working on developing PV-10 as a metastatic melanoma cancer, liver cancer, and breast cancer treatment. The company met with the U.S. Food and Drug Administration (FDA) on April of 2010, where it received guidance on how to approach the pivotal Phase 3 randomized controlled trial (RCT) of PV-10 for metastatic melanoma. A correct approach will ensure that the Phase 3 design will be suitable for Special Protocol Assessment (“SPA”), and ensure that the experimental clinical design would be acceptable for regulatory approval of PV-10. PVCT has made plans to schedule another meeting to further finalize the clinical trial design, and expects to begin Phase 3 in early 2011.
PV-10 Clinical Trials Continue to Impress
Dr. Sanjiv Agarwala, Chief of Medical Oncology and Hematology at St. Luke’s Cancer Center in Bethlehem, PA, presented an illustration of observed PV-10 results at the 2010 American Society of Clinical Oncology (“ASCO”) annual meeting. In the Phase 2 study, 40 subjects with visceral lesions (tissue abnormality) were injected with PV-10 treatment. After screening the subjects, results show that 7 of 16 subjects with visceral or macroscopic nodal metastases had experienced “stasis or regression” of their lesions. Also, the 40 subject study revealed PV-10 injections to offer an Objective Response Rate of 60%, with mild side effects and no life threatening incidents.
The company also reported great progress in its PV-10 compassionate use program. PVCT enrolled over 25 subjects at five different Phase 2 sites to participate in the program. Relating to the program, primary focus is on the treatment of melanoma using PV-10. In addition, recent application of PV-10 reveals great potential for future clinical studies aimed at treating recurrent squamous cell carcinoma. Also, the company is very pleased to announce that encouraging results have been found in the Phase 1 trial of PV-10 liver cancer treatment of two inoperable hepatocellular carcinoma tumors. The Phase 1 trial study will provide an assessment of safety, and “preliminary efficacy” of the treatment of cancers located in the liver, which may pave the way for possible expansion of the compassionate use program.
PH-10 Psoriasis and Atopic Dermatitis Clinical Details
The company had enrolled 30 subjects in a Phase 2 clinical trial of PH-10. PH-10 is designed to target and help alleviate stress caused by psoriasis (reddish skin rash). Reports reveal 70% of subjects to have experienced substantial improvement in their Psoriasis Severity Index (PSI). Also, 86% of subjects reported no or only mild itching within four weeks of the start of the trial, and no harmful occurrences were noted. Observations reveal that PH-10 treatment does have greater efficacy when used at higher doses or longer time spans. Therefore, the company is determined to continue PH-10 evaluation over a longer treatment period. After positive observation results have been revealed, PVCT plans to acquire assistance from a financial advisor in attempts to configure licensing procedures for the PH-10 treatment. Also, the company will be searching for a partner with strategic business implementation.
Summary
The company’s financial position enables managers to remain confident that completion of clinical programs will be achieved. Successful results offered by PV-10 clinical trials have provided the company with considerable recognition, enabling potential for future growth to remain strong. Promising results shown in the treatment of liver organs shown in the compassionate use program have also provided PVCT with great confidence for program expansion. Also, PH-10 treatment is another therapy that has shown great potential. Investors may want to look at PVCT as a potential blockbuster play on cancer treatment with its late-stage PV-10 trials. To learn more about current news related to PVCT visit http://www.pvct.com/.
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