Provectus Cancer Treatment Drug Shows Strong Potential
Provectus Pharmaceuticals, Inc. (PVCT), which competes with companies like Genta Incorporated (GETA) and Celldex Therapeutics, Inc. (CLDX), is developing a cancer treatment drug that has a melanoma indication that has nearly completed its Phase II trial along with breast and liver cancer indications completed and undergoing Phase I trials with the FDA, respectively.
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.
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