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Melanoma drug PV-10 increases overall survival rates in patients: Provectus

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Monday, November 30, 2009, 14:28 This news item was posted in Clinical Trials category and has 0 Comments so far.

PV-10, an experimaental drug by Provectus Pharmaceuticals, to treat metastatic melanoma, has shown to be increasing the overall survival rate in patients.

The initial one year overall survival data from the first 20 subjects using PV-10 in the current Phase 2 trial showed comparable trends to Phase 1 survival data, Provectus said in an official release.

Earlier phase 1 study of PV-10 for metastatic melanoma  showed markedly longer overall and disease specific survival for subjects that were responsive tothe drug relative to those who did not experience a robust response. Survival data was available through early November 2009.

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.

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.

“…these results are consistent with the expectation of a favorable long-term outcome for responsive patients, ” noted 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.Prof. Thomson¬† presented these data at the 3rd World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers on November 21, in Berlin, Germany entitled “PV-10 in the Local Treatment of Melanoma Metastasis.”

PV-10 is an 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.

The 3rd World Meeting of Interdisciplinary Melanoma/Skin Cancers. This meeting provided an 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.

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company. Provectus 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 two of its Phase 2 trials — PV-10 as a therapy for metastatic melanoma, and PH-10 as a topical treatment for atopic dermatitis. It is currently conducting a Phase 2 clinical trial for PH-10 as a topical treatment for psoriasis.

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