KNOXVILLE, Tenn., Aug. 11 /PRNewswire-FirstCall/ -- Provectus Pharmaceuticals, Inc. reports on its year-to-date clinical and corporate accomplishments in a letter to shareholders from Craig Dees, Ph.D., CEO of Provectus.
Dear Shareholders:
We believe the results show that PV-10 can be a viable treatment for metastatic melanoma, and we are focusing our efforts on completing the 80 patient study, while also making plans for our next steps in development. Those next steps include seeking licensure agreements and/or partnerships to proceed through final development, and ultimately, bringing the product to market. In addition, we intend to meet with the FDA to determine exactly what steps we need to take to obtain approval of PV-10 for metastatic melanoma.
Researchers concluded that PV-10 is well-tolerated, eliciting a robust response in a majority of patients. The safety and efficacy profile compare favorably with existing and emerging therapies, making PV-10 suitable for repeat treatment of patients with partially-responsive lesions or new lesions to maximize response and long-term outcome.
Why are we so excited about these results? As many of you know, no new treatments have been approved in over a decade for this devastating disease. It is a very difficult disease to treat, as evidenced by recent disappointments in clinical trials for other developmental therapies. Our encouraging results with PV-10 suggest that the prognosis for this disease could improve in the future.
We also have instituted a compassionate use program for PV-10. Compassionate use programs make investigational drugs available to patients prior to FDA approval. Under this program, PV-10 will be available only 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, melanoma and non-melanoma skin cancers, and head and neck cancers. Provectus has begun its compassionate use program for PV-10 in certain Australian “Centers of Excellence,” including our Phase 2 sites in Sydney and Brisbane, and we plan to 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 expanded access to an investigational new drug. There has been quite a bit of demand for PV-10, and we are pleased to be able to provide a limited supply through this program.
As large pharma continues to seek ways to increase their new product pipelines, through licensing agreements or acquisitions, we are pleased to see the interest in the area of melanoma treatments. We believe that Provectus’ PV-10 is a compelling therapy that could add significant value to these pipelines. As Provectus has reached that important stage of its development, our business development team is pursuing opportunities with other companies and/or organizations to further the development of our lead product candidates while maximizing shareholder value.
Sincerely,
About Provectus Pharmaceuticals, Inc. (www.pvct.com)
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: Investor and Media Contacts, Peter R. Culpepper, CFO, Provectus
Pharmaceuticals, Inc., +1-866-594-5999 #30; or Marlon Nurse, VP - Investor
Relations, or Bill Gordon, SVP - Media Relations, both of Porter, LeVay &
Rose, Inc., +1-212-564-4700
Web site: http;//www.pvct.com/