Provectus Reports Further Positive Phase 2 Data on PV-10 for Metastatic Melanoma at ASCO
Friday May 21, 2010
Additional Visceral Data to be Presented at ASCO
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has announced further positive data on the first forty 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. These data were included in Abstract #8534, entitled "Chemoablation of metastatic melanoma with rose bengal (PV-10)", to be presented by Dr. Sanjiv Agarwala at the American Society of Clinical Oncology 2010 Annual Meeting, on Sunday, June 6, 2010 in General Poster Session #209, Melanoma/Skin Cancers.
Key Data From the First 40 Subjects in the Phase 2 Study Include:
Objective Response of PV-10 injected lesions was achieved in 61% of subjects, with a Complete Response ("CR") in 33% of subjects and locoregional disease control (Stable Disease, "SD", or better) in 79% of subjects;
An OR was achieved in untreated bystander lesions in 43% of subjects having an evaluable bystander lesion at baseline;
Mean Progression Free Survival ("PFS") was 8.5 months for all subjects, while the OR cohort had a significantly longer PFS estimated to be at least 11.1 months vs. 2.8 months or less for SD or Progressive Disease ("PD") subjects;
Adverse Experiences during the study interval were generally mild to moderate, locoregional and transient, with no deaths or life-threatening experiences attributable to PV-10.
Dr. Sanjiv Agarwala, Chief of Medical Oncology and Hematology at St. Luke's Hospital and Health Network in Bethlehem, PA, and Principal Investigator for Provectus's Phase 2 PV-10 trial site at St. Luke's, said, "These data are very exciting in many respects, with a lengthy Progression Free Survival being particularly encouraging. Since subjects were only observed for 12 months, it wasn't possible to document time to progression in the substantial fraction of subjects achieving a highly durable response. Nonetheless, the marked difference in estimated PFS among PV-10 responsive subjects versus those who failed to respond bodes very well for responsive subjects, while allowing non-responsive subjects to commence alternate therapies without significant delay. With additional data being tabulated since the abstract was submitted, including key data on outcome of untreated visceral lesions, we should have very interesting supplemental information for presentation at the conference."
Craig Dees, Ph.D., CEO of Provectus said, "The results of Phase 2 clinical trial are gratifying, providing additional validation of our hypothesis that PV-10 is a safe and effective treatment for metastatic melanoma. These data, combined with the results of our recent End-of-Phase 2 meeting with the FDA, provide greater confidence that we are getting closer to a viable treatment for this deadly disease. The FDA meeting provided us the guidance to design the protocol for a pivotal Phase 3 randomized controlled study suitable for Special Protocol Assessment ("SPA"). An SPA would affirm that our Phase 3 clinical trial design, endpoints, sample size, planned conduct and statistical analyses are acceptable for regulatory approval, defining the regulatory pathway for PV-10 as a treatment for metastatic melanoma. We look forward to implementing the next steps in our clinical development, bringing us closer to commercialization of PV-10."
Background and Summary of the Data Being Presented at ASCO (Abstract # 8534)
Methods: Phase 2 testing commenced in October 2007 in 80 subjects with Stage III or IV melanoma, and enrollment was completed in May 2009 at seven sites in Australia and the United Sates. After initial treatment of 1-20 cutaneous, subcutaneous or nodal lesions, new or incompletely responsive lesions could be retreated at weeks 8, 12 or 16, with follow-up at 52 weeks. Another 1-2 lesions, including visceral lesions, could remain untreated for assessment of bystander response. The primary end-point is OR of injected lesions; secondary endpoints include OR of bystander lesions, PFS of target lesions and plasma pharmacokinetic assessment.
Results: The first 40 subjects completing the study (median age 75, age range 37 - 92) received PV-10 into 486 lesions (mean 1.9 treatment sessions per subject). Adverse experiences ("AEs") were predominantly mild to moderate, locoregional and transient, the most common being pain at the treatment site (82% of subjects), vesicles or edema (50% each), followed by swelling, pruritus, skin discoloration or headache (18% each), with no Grade 4 or 5 AEs attributed to PV-10.
Among all 40 subjects, 33% achieved CR, 28% PR and 18% SD of their target lesions; 33% of 21 subjects with evaluable bystander lesions achieved CR in these lesions, along with 10% PR and 14% SD. Mean PFS was 8.5 months for all subjects, while the OR cohort had significantly longer PFS (11.1 months) than SD or PD ("Progressive Disease") subjects (2.8 and 2.7 months, respectively).
Conclusion: Overall the safety and efficacy profile of PV-10 compares favorably with available and emerging options for this patient population.
PV-10 is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for nearly thirty years by ophthalmologists to assess damage to the eye. It has also been used as an intravenous diagnostic to detect ailments of the liver. Rose Bengal is a small molecule agent with an established safety history, a short half-life in the bloodstream, and is excreted via the liver and kidneys. Provectus has discovered a novel use for Rose Bengal based on the observation that it is selectively toxic to cancer calls via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis.
About Provectus Pharmaceuticals, Inc. (www.pvct.com)
Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its lead oncology agent, PV-10, is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and metastatic liver cancer. The Company has received orphan drug designation from the FDA for its melanoma indication. Its lead dermatological drug, PH-10, also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed enrollment in three of Phase 2 trials -- PV-10 as a therapy for metastatic melanoma, and PH-10 as a topical treatment for atopic dermatitis and for psoriasis. It has also recently initiated a Phase 1 trial of PV-10 for liver cancer. Information about these and the Company's other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus please visit the Company's website at www.pvct.com or contact Porter, LeVay & Rose, Inc.
FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.