Provectus now compassionate use (limited BC use)

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New Hope for Cancer Patients

Tagged with: bio-pharma clinical-trials compassionate-use FDA NCI oncology pv-10
Launch of Compassionate-Use Drug Opens New Avenue in Fight Against Cancer
By Randy Lieberman

If there was any hope for finding a cure for cancer, this may be it.
Cancer takes more than 600,000 lives in the United States each year, according to National Cancer Institute.
A new ray of hope to these victims is the announcement that Provectus Pharmaceuticals Inc. has begun a compassionate use program for PV-10 and has made the agent, which is in development as a therapeutic drug for a broad spectrum of cancers, available for select cancer patients.
The development-stage oncology and dermatology bio-pharmaceutical company, Provectus will initially make the compassionate use program available for cancer indications that do not involve visceral organs and are not subject to enrollment in ongoing clinical trials. These indications include certain breast cancers, basal cell carcinoma, squamous cell carcinoma, certain head and neck cancers and melanoma.
PV-10 is a form of Rose Bengal that is injected directly into a tumor, and according to Dr. Agarwala, Principal Investigator for Provectus’ Phase 2 PV-10 trial site at St. Luke’s Hospital & Health Network in Bethlehem, PA, has shown a 60 percent efficacy rate with little, or no side effects.
Provectus has begun its compassionate program for PV-10 in certain Australian “Centers of Excellence,” including Sydney, Brisbane and Adelaide, and will expand it to the United States in coming months. The Australian program is under the guidelines of the Therapeutic Goods Administration’s Special Access Scheme.
The U.S. program on the other hand is expected to be under the FDA’s regulations covering Treatment Use of an investigational new drug. Compassionate use programs provide experimental therapeutics to patients prior to final FDA approval.
Provectus received orphan drug designation from the FDA for its melanoma indication in early January of 2007. Complementing their suite of proprietary drugs, Provectus has developed a number of intellectual properties and technologies in the areas of imaging, medical devices and biotechnology.
Dr. Kelly McMasters, a preeminent physician and investigator who is a member of Provectus’ Board of Directors and head of its Scientific Advisory Board, will advise the Company on candidates for the program who might be safely helped by PV-10.
McMasters said, “The potential for PV-10 to successfully treat metastatic melanoma, which has already been shown in humans, warrants its further use for melanoma and for other life-threatening scenarios on a compassionate use basis.”
Provectus is currently completing its Phase 2 clinical trial of PV-10 as a therapy for metastatic melanoma and has completed Phase 1 clinical testing of PV-10 for the treatment of recurrent breast carcinoma.
“We decided to initiate this program as we have had a continuing large number of requests by physicians and patients to make PV-10 available on a compassionate basis,” said Craig Dees, Ph.D., CEO of Provectus.
“Preliminary analysis of interim Phase 2 results from our melanoma clinical trial suggests that we can safely provide PV-10 for treatment of selected cancer patients, and that the agent has potential to benefit some of these patients. Knowing this information, we believe the ethical choice is to make the drug available on a compassionate use basis.”
Information about these and the Company’s other clinical trials can be found at the NIH registry, www.clinicaltrials.gov.
Interested parties are encouraged to visit Provectus’ website, www.pvct.com, where details on the compassionate use program and additional information will be posted in the near future.

Provectus News

Provectus Pharmaceuticals Completes Initial Enrollment in Phase 1 Trial of PV-10 for Liver Cancer
Tuesday September 14, 2010
-- First Three Subjects Treated, PV-10 Very Well Tolerated With Evidence of Substantial Efficacy --
-- Design of Phase 2 Study in Progress --
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com) announced today that it has completed enrollment in the first of two dose cohorts in its Phase 1 clinical trial of PV-10 for liver cancer, and that the therapy was very well tolerated by all three subjects treated, with substantial evidence of efficacy.
The complete article is available from http://www.pvct.com/pressrelease.html?article=20100914 on the Provectus website.