By Patrick Crutcher
Provectus Pharmaceuticals, Inc. (OTC:PVCT) is a small-cap pharmaceutical company focused on developing treatments for oncology and dermatology. Shares of PVCT have started to gain some momentum the past few weeks in anticipation of clinical data that is being presented in November.
The data comes from its Phase 2 study of PV-10 in metastatic melanoma. This will be presented at the 7th International Melanoma Research Congress in Sydney, Australia, on November 4, 2010 at 4:30 p.m.
PVCT will be presenting efficacy data on the full study population, which will include response rate, progression-free-survival and overall survival. These are very important numbers for the future of PVCT and PV-10. At ASCO 2010, they presented data on the “first 40 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. Agarwala has previously said that PV-10 could play an important part in the management/treatment of melanoma because of the efficacy it has shown in early and late stages of melanoma. It's also noteworthy that PV-10 has demonstrated a very benign safety profile, with no serious adverse events either.
PV-10 is an interesting molecule whose immunological mechanism will be studied in a Phase 2 study to provide additional evidence of PV-10’s bystander effect. It is currently a part of the FDA’s Compassionate Use Program which provides experimental therapeutics to patients prior to final FDA approval. Provectus is also exploring the use of PV-10 in liver (currently in Phase 1) and breast cancer (completed Phase 1). Provectus is planning for a Phase 2 study of PV-10 for recurrent breast cancer.
Based on their meetings with FDA officials at the April 2010 End-of-Phase 2 meeting, they are planning for a 2nd meeting to finalize designs of a pivotal Phase 3 randomized controlled study suitable for a Special Protocol Assessment (SPA). It is expected that a Phase 3 trial may begin in early 2011. A SPA for their Phase 3 clinical trial would define the regulatory pathway for PV-10 as a treatment for metastatic melanoma, especially if PV-10 were to eventually post positive Phase 3 results.
Craig Dees, Ph.D., CEO of Provectus Pharmaceuticals' recent commentary on the potential PV-10 has for the treatment of melanoma is insightful. "The final follow-up on all 80 subjects enrolled in the Phase 2 study was completed in May 2010. We are extremely excited about the efficacy, progression-free-survival and overall survival data to be presented, which we believe will be comparable to the interim data presented at the ASCO meeting in June. These data confirm our belief that PV-10 compares favorably with available and emerging options for this patient population, making it an attractive candidate for commercial development, and we look forward to Dr. Agarwala's presentation."
One would think that their results will be very encouraging based on interim results and recent actions by management. Pursuing an SPA for a pivotal Phase 3 trial for PV-10 is definitely an indicator of management's intentions. In this report by the Maxim Group on PVCT.OB, they have a $3.50 12-month price target (from May 2010). They also speak quite favorably of the potential for PV-10. I look forward to watching them over the next few months.
Disclosure: No positions