Provectus' PV-10 and Radiotherapy Featured in Peer Reviewed Journal
Tuesday February 9, 2010
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Pharmaceuticals, Inc. (OTCBB:
PVCT,
http://www.pvct.com),
a development-stage oncology and dermatology biopharmaceutical company, announces the publication of an article, entitled
"A novel treatment for metastatic melanoma with intralesional rose bengal and radiotherapy: a case series," authored by Dr.
Matthew C. Foote, Dr. Bryan H. Burmeister, Janine Thomas, and Dr. B. Mark Smithers, in the current issue of the peer-reviewed
journal, Melanoma Research (20(1):48-51, February 2010).
The article is based on the authors' observations while treating patients previously enrolled in the ongoing Phase 2 clinical
trial of PV-10 for metastatic melanoma. PV-10 is Provectus' formulation of rose bengal for intralesional (IL) injection
into solid tumors. The authors stated, "Three patients with metastatic melanoma were treated with intralesional rose bengal
followed by external beam radiotherapy. In all cases patients had an impressive response without significant increase in
acute radiation reaction." A copy of the article can be accessed at the following link:
http://www.pvct.com/melanoma_update.html.
The patients cited in the article were part of the Phase 2 study investigating the effectiveness of PV-10 for locoregional
treatment of metastatic melanoma. The authors said, "All of the impressive responses occurred in previously injected lesions,
non-injected lesions and other lesions that developed in the local area, which may have been exposed to rose bengal."
The authors continued, "Although a range of [radiation] dose and fractionation schedules were used in these cases, the
responses that were noted after radiotherapy, even for large volume disease, after IL rose bengal were significantly more
than our experience would have predicted with all three of the patients treated having a complete in-field response."
"There are several radiobiological rationales that may explain our observation including radiosensitization by the rose
bengal, additive cell kill or augmentation of the host immune response by the interaction of the two modalities. As
radiation was applied many weeks after rose bengal dosing, and effects also occurred in new lesions not present when rose
bengal was administered, this phenomenon may not arise solely from conventional radiosensitization," added the authors.
Craig Dees, Ph.D., President and CEO of Provectus said, "Each of the patients cited in this article were part of the Phase 2
clinical study prior to subsequent radiation therapy, and had aggressive cases of metastatic melanoma. Because the Phase 2
study protocol limited the investigator's dosing options, Dr. Smithers and his team were not able to match the allowed
dosing regimen to the natural disease course for these patients. Six to 12 weeks after receiving their final PV-10 dose,
the patients received supplemental radiotherapy that led to the remarkable responses noted in the article. Dr. Smithers is
now part of our compassionate use program for PV-10 which allows far more flexibility in dosing, and we look forward to
assessing results from this program and their implications for optimizing how PV-10 is administered to metastatic tumors.
We also anticipate additional studies to confirm these initial observations using PV-10 in conjunction with radiotherapy."
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.
SOURCE: Provectus Pharmaceuticals, Inc.
Contact:
PProvectus Pharmaceuticals, Inc.
Peter R. Culpepper, CFO, COO
866-594-5999 #30
or
Porter, LeVay & Rose, Inc.
Marlon Nurse, VP - Investor Relations
Bill Gordon, SVP - Media Relations
212-564-4700
