Interim Phase 2 Survival Data for PV-10 Shows Markedly Longer Overall and Disease Specific Survival for Subjects Responsive to PV-10
--First Evidence Of Bystander Effect On Visceral Metastases--
--Data Presented By Professor John F. Thompson, MD At 3rd World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers in Berlin--
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Nov 23, 2009 - Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that initial one year overall survival data from the first 20 subjects in the current Phase 2 trial showed comparable trends to Phase 1 survival data. Survival data for the Phase 1 study of PV-10 for metastatic melanoma continues to show markedly longer overall and disease specific survival for subjects that were responsive to PV-10 relative to those who did not experience a robust response. Survival data was available through early November 2009.
Additionally, several subjects in the responsive group also exhibited one or more indicators of the bystander effect (spontaneous regression of untreated tumors after PV-10 treatment of other tumors), including the first evidence of regression of visceral metastases in two of five subjects in this group who had documented visceral metastases at enrollment.
Professor John F. Thompson, MD, Professor of Melanoma and Surgical Oncology at the University of Sydney, Director of the Melanoma Institute Australia, and Lead Investigator of the Phase 2 study of PV-10 for Metastatic Melanoma, presented these data at the 3rd World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers on November 21, 2009 in Berlin, Germany. His presentation was entitled “PV-10 in the Local Treatment of Melanoma Metastasis.” Professor Thompson noted that “these results are consistent with the expectation of a favorable long-term outcome for responsive patients.”
In addition to the overall survival data for the Phase 1 and Phase 2 trials, Professor Thompson also provided an update on data from the expanded access use of PV-10 in Australia and the United States (“Compassionate Use”). Thompson noted that a total of 15 subjects have commenced treatment with PV-10 under the program, which has been implemented at five of the Phase 2 study centers. This includes 7 subjects that have crossed over from the Phase 2 study to receive further treatment with PV-10, five of whom are now in long-term follow-up. An additional eight subjects with metastatic melanoma have initiated treatment with PV-10 under the program, with five continuing in long-term follow-up.
Craig Dees, PhD, CEO of Provectus said, “We are very excited by these new results presented by Professor Thompson, especially the first reported objective evidence of potential systemic benefit in visceral organs. We look forward to the possibility of augmenting these results with data from the next 20 subjects, which we expect will be available in the first quarter of 2010. Progress with our expanded access program for PV-10, the means through which certain qualified patients can receive PV-10 on a compassionate use basis, is also heartening as we continue development of the agent toward licensure.”
About the 3rd World Meeting of Interdisciplinary Melanoma/Skin Cancers
This meeting provided a unique opportunity for melanoma clinicians and researchers, who are part of multidisciplinary melanoma/skin cancer centers to interact, learn from one another, establish collaborations and set an agenda for the further evolution of multidisciplinary melanoma care and research. The conference featured Plenary Session and Symposia speakers recognized as experts in melanoma treatment and research.
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 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 its 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 for 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.
Contact: Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, CFO, COO
Porter, LeVay & Rose, Inc.
Marlon Nurse, VP – Investor Relations
Bill Gordon, SVP – Media Relations
Posted: November 2009