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
Copyright Business Wire 2009
Provectus Pharmaceuticals, Inc. Added to Cancer Immunotherapy Index by Mentor Capital, Inc. Experiences 23% One-Week Gain
Quote:
In the Provectus treatment regime, these lesions are injected with PV-10, a very specialized version of the red dye, Rose Bengal, that ophthalmologists use to test for corneal scratches because it is preferentially absorbed by damaged cells. The smooth lipid layer of healthy cell membranes excludes the Rose Bengal product like wax paper sheds water. Cancerous cells are often physically or chemically irregular and the PV-10 penetrates into the cell as water would find its way through the thinner creases in wax paper that has been tightly crumpled. Because of PH differences, the cancerous cells continue to uptake more and more PV-10, which is further pulled into lysosomes (cell stomachs) until these rupture, leading to a complete rupture of the cancer cell.
The cold cell rupture casts whole cancer protein fragments adrift that have not been chemically modified by heat, chemicals or radiation. These unaltered cancer fragments in the otherwise healthy tissue excite an immune response to those cancer proteins in the lesion location. When a piece of cancer protein is passed to a killer T-Cell, that T-Cell will spend the rest of its days bouncing through the blood stream looking to match up that protein once more and attack.
If the T-Cell does find another matching cancer protein on the surface of a Melanoma cell that has slipped away, it latches on. Then the T-Cell secretes perforin which punches holes in the cell membrane allowing the cytoplasm to ooze out. Enzymes are injected that dissolve the mitochondria that power cell functions, and finally, granzymes are injected that chop up the DNA in the nucleus like a molecular Pac-Man.
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Because the Provectus PV-10 treatment gives rise to this robust immunotherapy response PV-10 is a natural candidate to be the first choice standard treatment for all Melanoma cases with a 69% objective response being reported. If needed, follow-on cancer treatments of other sorts can be applied. They will be buttressed by the PV-10 immunotherapy effect that has recorded an objective response of 27% to 44% in even untreated or bystander lesions. In addition to Melanoma treatments, PV-10 may also be applicable to breast, liver or perhaps any other well defined solid tumor that can be targeted for treatment injections.
The conclusions and discussions herein, while derived from published materials, are Mentor Capital's independent analysis of the underlying medical science. News updates and the weekly public market progress for Provectus and that of the ten other companies in the Cancer Immunotherapy Index can be followed in detailed updates presented at www.MentorCapital.com.
Forward Looking Statements, Safe Harbor and Risk Descriptions are Incorporated by Reference from the MNTR Company Web Site above.
For further information contact:
Chet Billingsley, CEO
Mentor Capital, Inc.
P.O. Box 1709
Ramona, CA 92065 (760) 788 - 470
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.
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