Full Phase II Investigation Data On Metastatic Melanoma Drug PV-10 Reported By Provectus

Provectus Pharmaceuticals, Inc. presented positive initial data from fully monitored investigation data for all 80 participants in their Phase II clinical trial of the drug PV-10 for metastatic melanoma. In 49% of participants an Objective Response (OR) was observed, with 71% of participants achieving locoregional disease control (stable disease or better) in their injected lesions. Among individuals who achieved an OR they found that the average Progression Free Survival (PFS) was 11.7 months.

This information, in addition to discoveries on changes in visceral and nodal metastases after chemoablation of cutaneous melanoma lesions with PV-10, were incorporated in the presentation called “Chemoablation of Metastatic Melanoma with PV-10.” The presentation was carried out by Dr. Sanjiv Agarwala at the 4th Interdisciplinary Melanoma & Skin Cancer Centers Meeting, which was held at the Melanoma 2010 Congress in Sydney, Australia on November 4, 2010. This information was statistically parallel to the interim Phase II data on the first 40 participants, presented by Dr. Agarwala at ASCO in June 2010.

Important data from the 80 participants at 52-weeks in the Phase II investigation include:

• In 24% of participants a Complete Response (CR) of PV-10 injected lesions was achieved, Partial Response (PR, requiring at least a 30% reduction in tumor volume) in 25% of participants and Stable Disease (SD, requiring less than 20% increase in tumor volume) in 18% of participants, with 23% of those participating experiencing disease progression (PD, 20% or greater increase in tumor volume).
• Response was significantly greater in the 55 participants with cutaneous or nodal disease only (55% OR and locoregional disease control in 78% of subjects) compared to the 25 participants with visceral metastases (35% OR with a 56% rate of disease control).
• An OR was achieved in bystander lesions that were untreated in 37% of participants having an evaluable bystander lesion at baseline, with 55% of participants achieving locoregional disease control in their bystander lesions.
• Bystander response was closely related with successful ablation of injected lesions, with 67% of participants achieving an OR of their bystander lesions if they achieved an OR in their injected lesions compared to 5% in those who did not achieve an OR in their injected lesions.
• For all participants the average progression free survival was 8.2 months, compared to those in the OR group who had a considerably longer PFS 11.7 months in comparison to 4.1 months for SD or PD participants; those with cutaneous or nodal disease achieved a mean PFS of 8.8 months compared 6.2 months for those with visceral metastases.
• Adverse effects during the investigation were in general mild to moderate, locoregional and transient, with no deaths or life-threatening experiences connected to the drug.

In addition, Dr. Agarwala presented information on changes in visceral metastases after chemoablation of cutaneous melanoma lesions with PV-10, he highlighted the response in two Stage IV participants who experienced complete regression of their lung metastases after ablation of their cutaneous lesions.

Dr. Agarwala, Chief of Medical Oncology and Hematology at St. Luke’s Hospital and Health Network in Bethlehem, PA, and chief researcher for the investigation at St. Luke’s, explained:

“The consistently positive data on all 80 subjects in the PV-10 trial are very encouraging, particularly in light of the large number of patients in the second half of the study who had very significantly advanced melanoma. The excellent response rate in patients with cutaneous or nodal disease illustrates the potential of the drug for these prime candidates for PV-10.”

In the first study, reported in June at ASCO, out of a total of 40 participants, 8 suffered from Stage IV-M1b disease with lung metastases and 2 participants had Stage IV-M1c disease, the most advanced stage, characterized by metastases to the liver, brain or other visceral sites and a very poor prognosis. Dr. Agarwala’s presentation in Sydney was conducted from a total of 80 participants, 14 of which suffered from Stage IV-M1b melanoma and 11 participants had Stage IV-M1c.

Dr. Agarwala continued:

“The bystander effect, which appears to result from an immunologic response stimulated by PV-10 chemoablation, is especially intriguing. The immunologic processes whereby PV-10 produces systemic response are the topic of a Phase 2B study, whose design is being finalized. With these impressive results for PV-10 as a potential treatment for metastatic melanoma, I am looking forward to being a part of that study.”

Craig Dees, PhD, CEO of Provectus Pharmaceuticals explained:

“These initial full study results for all 80 subjects enrolled in the Phase 2 study, which are statistically equivalent to those presented at ASCO in June despite the more advanced stage of the second group of subjects, are extremely gratifying as we complete this important milestone with PV-10. Our discussions with the FDA in the United States, as well as the TGA in Australia, are also continuing as we establish the pathway for commercializing PV-10. We are currently incorporating guidance that we received from the FDA during our End-of-Phase 2 meeting to finalize the protocol design for a pivotal Phase 3 randomized controlled trial suitable for Special Protocol Assessment.”

Dr. Dees concluded:

“We remain excited about the potential PV-10 has to treat metastatic melanoma for many reasons. In particular, with currently available treatment options seemingly benefiting only a small subset of patients who often suffer from severe side effects, PV-10’s profile, with a high OR, CR, mean progression free survival and favorable safety profile, make this, we believe, an attractive therapeutic option. We also eagerly anticipate the commencement of the Phase 2B study to examine the immunologic markers underlying the bystander data that Dr. Agarwala presented at the conference. We continue to believe the immunology will play an increasingly important role in the battle against cancer.”

According to The American Cancer Society in the U.S., in 2010, there were will be roughly 68,000 new cases of invasive melanoma diagnosed leading to over 8,700 deaths, The World Health Organization projected that in 2008, 48,000 patients died from melanoma.