Provectus Pharmaceuticals to Offer Compassionate Use of PV-10 for Non-Visceral Indications in Cancer Patients
Monday June 22, 2009
Program Has Begun With Patients in Australia, Expects to Begin Program in the U.S.
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Pharmaceuticals, Inc. (OTCBB:
PVCT,
http://www.pvct.com),
a development-stage oncology and dermatology biopharmaceutical company,
has begun a compassionate use program for PV-10 and has made the agent, which is in development as a therapeutic agent for a broad spectrum of cancers, available for select cancer patients.
Initially, the compassionate use program will only be 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. 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, while the U.S. program is expected to be under the FDA's regulations covering Treatment Use of an investigational new drug. 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. Compassionate use programs provide experimental therapeutics to patients prior to final FDA approval.
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. "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," said
Dr. McMasters. 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."
About Provectus Pharmaceuticals, Inc. (www.pvct.com)
Provectus Pharmaceuticals is a development stage company that specializes in oncology and dermatology therapies that are safer, more effective,
less invasive and more economical than conventional therapies. Provectus is currently conducting Phase 2 clinical trials of its proprietary
drugs PV-10 as a therapy for metastatic melanoma and PH-10 as a topical treatment for psoriasis and atopic dermatitis. Information about
these and the Company's other clinical trials can be found at the NIH registry,
www.clinicaltrials.gov.
The Company has received orphan drug designation from the FDA for its melanoma indication. 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. 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, 866-594-5999 #30
or
Porter, LeVay & Rose, Inc.
Marlon Nurse, VP - Investor Relations
Bill Gordon, SVP - Media Relations
212-564-4700