Provectus now compassionate use (limited BC use)
 

http://wellspringhealthandstyle.com/...ncer-patients/

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.
http://wellspringhealthandstyle.com/...pe-300x281.jpgThe 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 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.

Re: Provectus now compassionate use (limited BC use)
 

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



(For Immediate Release, March 1, 2010)

SAN DIEGO, Mentor Capital, Inc. (PINK SHEETS:MNTR) announced today that it has added Provectus Pharmaceuticals, Inc. (PVCT:OB) to Mentor Capital's proprietary Cancer Immunotherapy Index effective as of February 22, 2010. To add Provectus to the CI Index, Mentor Capital has recently taken a significant initial position in Provectus through Mentor Capital's managed fund. Mentor notes that Provectus has advanced 23% during this first trading week on the Index and those results are reported on the current CI Index update.
Mentor Capital CEO, Chet Billingsley, highlights, "Provectus has the strong balance sheet, executive and science teams, and especially the breakthrough medical technology that warrants long-term inclusion on the Cancer Immunotherapy Index that we look for and that merits substantial institutional interest."
Provectus targets Melanoma, which is a particularly deadly form of cancer affecting 62,000 and killing 8,000 patients in the USA each year. Cancerous Melanocytes are especially lethal because in their natural form they move ameba-like to lay out protecting melanin rather than staying bound in the static formations of their skin cell brethren. The lesions are inherently metastatic.
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

Re: Provectus now compassionate use (limited BC use)
 

Interim Phase 2 Survival Data for PV-10 Shows Markedly Longer Overall and Disease Specific Survival for Subjects Responsive to PV-10
Monday November 23, 2009
-- First Evidence Of Bystander Effect On Visceral Metastases --

-- Data Presented By Professor John F. Thompson, MD At 3rd World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers in Berlin --
Provectus announced today that initial one year overall survival data from the first 20 subjects in the current Phase 2 trial showed comparable trends to Phase 1 survival data. Survival data for the Phase 1 study of PV-10 for metastatic melanoma continues to show markedly longer overall and disease specific survival for subjects that were responsive to PV-10 relative to those who did not experience a robust response. Survival data was available through early November 2009.
Additionally, 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 who had documented visceral metastases at enrollment.
In addition to the overall survival data for the Phase 1 and Phase 2 trials, Professor Thompson also provided an update on data from the expanded access use of PV-10 in Australia and the United States ("Compassionate Use"). Thompson noted that 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.
The complete press release is available at Provectus' website at:
http://www.pvct.com/pressrelease.html?article=20091123.



Details of Compassionate Use Program for PV-10 Added to ClinicalTrials.gov
Thursday December 16, 2010

Information on the Compassionate Use Program for PV-10 has been added to the U.S. National Institute of Health's ClinicalTrials.gov website. Details of this expanded access study, officially titled "Expanded Access Protocol for PV-10 for Cutaneous or Subcutaneous Tumors", are available at http://www.clinicaltrials.gov/ct2/show/NCT01260779?term=provectus&rank=9 on ClinicalTrials.gov.