Provectus Pharma Updates Shareholders on 2009 Year-to-date Accomplishments
Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com) reports on its year-to-date clinical and corporate accomplishments in a letter to shareholders from Craig Dees, Ph.D., CEO of Provectus.
Dear Shareholders:
I am pleased to report that 2009 has already been a year of continued progress and excitement for Provectus. Our clinical trials for both PV-10 and PH-10 have shown promising results. We have completed patient accrual in two of our ongoing Phase 2 trials—PV-10 for metastatic melanoma and PH-10 for atopic dermatitis.
We believe the results show that PV-10 can be a viable treatment for metastatic melanoma, and we are focusing our efforts on completing the 80 patient study, while also making plans for our next steps in development. Those next steps include seeking licensure agreements and/or partnerships to proceed through final development, and ultimately, bringing the product to market. In addition, we intend to meet with the FDA to determine exactly what steps we need to take to obtain approval of PV-10 for metastatic melanoma.
Compelling data was presented at the American Society of Clinical Oncology (ASCO) meeting in May/June 2009. Interim data from the first 40 subjects in our Phase 2 clinical trial for the treatment of metastatic melanoma demonstrated an objective response (i.e. meaningful response) in 60% of subjects, with 75% of subjects achieving locoregional disease control of their treated lesions. Just over half (52%) of subjects had one or more evaluable untreated bystander lesions, and 48% of these subjects exhibited an objective response in those lesions. This bystander response was strongly correlated with successful destruction of the subject’s PV-10 injected lesions, with 69% of these bystander responses occurring among subjects whose injected lesions responded to PV-10.
Researchers concluded that PV-10 is well-tolerated, eliciting a robust response in a majority of patients. The safety and efficacy profile compare favorably with existing and emerging therapies, making PV-10 suitable for repeat treatment of patients with partially-responsive lesions or new lesions to maximize response and long-term outcome.
What does this mean? These interim data demonstrate that PV-10, injected directly into melanoma tumors, can selectively kill the cancerous tumor tissue, and may also stimulate the patient’s immune system to destroy untreated tumors elsewhere in the body. Continue reading the entire article at Provectus’ website.
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