Provectus (OTC-BB:PVCT) Continues to Make Progress in FDA Trials
Provectus Pharmaceuticals, Inc. (PVCT), which is developing a cancer treatment similar to companies like Dendreon Corporation (DNDN) and Genta Incorporated (GETA), is making significant headway in its clinical trials with the FDA.
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!
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