Provectus Pharmaceuticals Initiates Compassionate Use Program of PV-10 for Non-Visceral Indications in Cancer Patients in U.S.
Wed Oct 14, 2009 7:00am EDT
KNOXVILLE, Tenn.--(Business Wire)--
Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and
dermatology biopharmaceutical company, has expanded its compassionate use
program for PV-10, making the agent, which is being developed as a therapeutic
agent for a broad spectrum of cancers, available for select cancer patients in
the United States. The program is already in progress in Australia, where it was
initiated in June 2009.
The program for PV-10 is being implemented under the FDA`s guidelines covering
compassionate use of an investigational new drug. The U.S. program commenced at
St. Luke`s Hospital & Health Network in Bethlehem, PA, under the direction of
Dr. Sanjiv Agarwala, Principal Investigator at that site for Provectus` Phase 2
melanoma trial. As in Australia,
PV-10 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. 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 patients with access to experimental therapeutics prior to
final FDA approval. Provectus expects to expand the compassionate use program to
other sites in the United States in coming months.
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
continue his role as advisor to the Company on candidates for the program who
might be safely helped by PV-10. Dr. McMasters said,
"Commencement of the
compassionate use program in the United States is timely, given the fact that
all patients in the Phase 2 trial for metastatic melanoma have now been treated.
Interim results from the Phase 2 trial demonstrate that PV-10 is well-tolerated,
eliciting a robust response in a majority of patients, with a safety and
efficacy profile that compares favorably with existing and emerging therapies.
These factors, along with completion of Phase 1 clinical testing of PV-10 for
treatment of recurrent breast cancer, are strong reasons to make PV-10 available
on a compassionate use basis."
Craig Dees, Ph.D., CEO of Provectus said, "We have received many requests from
physicians to make PV-10 available to their patients on a compassionate use
basis. Considering the encouraging interim results we have received from Phase 2
testing of PV-10, enabling patients access to the drug via a compassionate use
program is absolutely the right thing to do. We believe that PV-10 has the
potential to be effective for several indications, and are pleased to be able to
offer it in the United States and Australia through this program. In the
meantime, our developmental efforts continue for PV-10, and we look forward to
continued progress."
About PV-10
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.
Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, CFO, 866-594-5999 #30
or
Porter, LeVay & Rose, Inc.
Marlon Nurse, 212-564-4700
VP - Investor Relations
or
Bill Gordon, 212-564-4700
SVP - Media Relations
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