Provectus Pharmaceuticals, Inc. (OTC BB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, presented positive preliminary data from fully monitored study data for the entire study population of 80 subjects in its Phase 2 clinical trial of PV-10 for metastatic melanoma. An Objective Response (“OR”) was observed in 49% of subjects, with 71% of subjects achieving locoregional disease control (stable disease or better) in their injected lesions. A mean Progression Free Survival (“PFS”) of 11.7 months was observed among subjects achieving an OR. These data, along with findings on changes in visceral and nodal metastases following chemoablation of cutaneous melanoma lesions with PV-10, were included in a presentation entitled “Chemoablation of Metastatic Melanoma with PV-10,” which was delivered by Dr. Sanjiv Agarwala at the 4th Interdisciplinary Melanoma & Skin Cancer Centres Meeting, held at the Melanoma 2010 Congress in Sydney, Australia on November 4, 2010. These data were statistically equivalent to the interim Phase 2 data on the first 40 subjects, presented by Dr. Agarwala at ASCO in June 2010.
Key 52-week data from the 80 subjects in the Phase 2 study include:
- A Complete Response (CR) of PV-10 injected lesions was achieved in 24% of subjects, Partial Response (PR, requiring at least a 30% reduction in tumor volume) in 25% of subjects and Stable Disease (SD, requiring less than 20% increase in tumor volume) in 18% of subjects, with 23% of subjects experiencing disease progression (PD, 20% or greater increase in tumor volume);
- Response was considerably higher in the 55 subjects with cutaneous or nodal disease only (55% OR and locoregional disease control in 78% of subjects) than in the 25 subjects with visceral metastases (35% OR with a 56% rate of disease control);
- An OR was achieved in untreated bystander lesions in 37% of subjects having an evaluable bystander lesion at baseline, with 55% of subjects achieving locoregional disease control in their bystander lesions;
- Bystander response was closely correlated with successful ablation of injected lesions, with 67% of subjects achieving an OR of their bystander lesions if they achieved an OR in their injected lesions vs. 5% in subjects who did not achieve an OR in their injected lesions;
- Mean Progression Free Survival was 8.2 months for all subjects, while the OR cohort had a significantly longer PFS estimated to be 11.7 months vs. 4.1 months for SD or PD subjects; subjects with cutaneous or nodal disease achieved a mean PFS of 8.8 months vs. 6.2 months for subjects with visceral metastases:
- Adverse Experiences (“AE”) during the study interval were generally mild to moderate, locoregional and transient, with no deaths or life-threatening experiences attributable to PV-10.
Dr. Agarwala also presented data on changes in visceral metastases following chemoablation of cutaneous melanoma lesions with PV-10, highlighting response in two Stage IV subjects who experienced complete regression of their lung metastases following 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 Principal Investigator for the study at St. Luke’s, said, “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 cohort of 40 subjects, reported in June at ASCO, 8 subjects had Stage IV-M1b disease (lung metastases) and 2 subjects 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). In the full study cohort of 80 subjects covered in Dr. Agarwala’s presentation in Sydney, 14 subjects had Stage IV-M1b melanoma and 11 subjects had Stage IV-M1c (the most advanced stage, characterized by metastases to the liver, brain or other visceral sites).
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 said, “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.”
The presentation will be accessible via the Provectus website, www.pvct.com, in the following days.
The American Cancer Society reports that in 2010 there were will be approximately 68,000 new cases of invasive melanoma diagnosed in the U.S., leading to more than 8,700 deaths, while the World Health Organization projected that 48,000 patients died from melanoma in 2008.
Source: Provectus Pharmaceuticals, Inc.