KNOXVILLE, Tenn., June 1 /PRNewswire-FirstCall/ -- Provectus Pharmaceuticals, Inc. CEO Craig Dees today issued the following open letter to shareholders and interested members of the investment community in order to update all parties on the Company’s recent operational and clinical progress.
Dear Provectus Pharmaceuticals shareholder:
The entire team at Provectus is very excited about our recent achievements in the clinical trials of Provecta(TM) (PV-10) for melanoma and breast cancer. Provecta has the potential to change the paradigm in oncology because its effects are almost exclusively focused on diseased tissue. Our pre-clinical studies support this assertion since a high percentage of animals treated with Provecta were free of tumors upon completion of a single course of therapy while systemic side effects were negligible or absent. A significant finding in animals using Provecta was that the use of the drug on one tumor could cause the disappearance of other untreated tumors. This remarkable finding is called the “bystander effect.”
This spring we reached another significant milestone by achieving our Phase 1 clinical trial objectives for treatment of metastatic melanoma in Stage III patients. Success with this initial clinical effort with Provecta led us to expand the final portion of the study to include patients with more advanced Stage IV disease and to increase the number of lesions treatable. This expanded portion of the study will allow us to quickly assess study design criteria for Phase 2/3 testing. To date, no cancer patient has suffered any significant systemic or severe local adverse effect from treatment with Provecta. Effects at the treatment site have been comparable to that observed in pre-clinical animal models, characterized by dramatic, rapid tumor destruction with no apparent harmful effects in the surrounding normal tissue. Further, the “bystander effect” has been observed in several subjects during the Phase 1 study. To my knowledge this has never been reported in melanoma patients or any other cancers of humans.
We also successfully achieved our clinical objectives in our Phase 1 trial of Provecta for recurrent breast cancer, showing that the drug was well tolerated and capable of eliciting selective tumor destruction. As in the case of melanoma, we have elected to expand the study to assure optimum design of the next round of trials as we progress to Phase 2/3 studies. While expanding the scope of these studies might appear to delay progress toward approval, it can actually shortcut the path to approval by maximizing the likelihood of success during the next, far more extensive round of study. Moreover, all of our studies are designed to facilitate early approval by regulatory agencies in the U.S. and abroad, including application for accelerated approval.
Looking ahead, we have begun final pre-clinical studies in animals designed to support expansion of our clinical program for Provecta to include treatment of liver cancer patients at one or more sites in Australia. We also anticipate beginning Phase 2/3 clinical trials of our topical drug, Xantryl(TM), for psoriasis later this year. We are also in the preliminary planning process to extend use of Xantryl for treatment of eczema.
We continue to advance the licensing of our over-the-counter (OTC) products and other non-core technologies that include biotechnologies and medical devices. We are also examining the potential for “spinning out” our OTC business with a separate management team, creating new shareholder value in the separately-traded public company focused exclusively in the OTC market arena.
The team at Provectus is also happy with the recognition the financial markets have shown for the milestones we have achieved as evidenced by the increasing daily trading volume of our common stock. To expand familiarity with the Company, we have participated in several large investment conferences and numerous smaller meetings with shareholders, fund managers and brokers in cities across the United States. We will continue these efforts with a goal of increasing shareholder value while continuing to pursue innovations that can dramatically improve the quality and quantity of life for patients with critical or chronic diseases.
Craig Dees, Ph.D., CEO Provectus Pharmaceuticals, Inc. About Provectus Pharmaceuticals, Inc.:
Provectus Pharmaceuticals, Inc. is a pioneering pharmaceutical company actively engaged in the design, development, and marketing of pharmaceutical technologies for the treatment of breast cancer, liver cancer, and metastatic melanoma. In addition, Provectus is preparing to begin Phase 2 clinical studies for the Company’s topical agent Xantryl(TM), a treatment for psoriasis.
The Company’s offices and laboratory are located at 7327 Oak Ridge Highway, Suite A, Knoxville, TN 37931; telephone: 865-769-4011. For more information, contact the Company at info@pvct.com or visit the corporate Web site: http://www.pvct.com .
This release and others statements issued or made from time to time by the company or its representatives contain comments that may constitute forward- looking statements. Those include statements regarding the intent, belief or current expectations of the company and members of its management teams, as well as the assumptions on which the statements are based. Prospective investors are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward- looking statements.
Provectus Pharmaceuticals, Inc.
CONTACT: Investors, Matt Clawson of Allen & Caron Inc., for ProvectusPharmaceuticals, Inc., +1-949-474-4300, matt@allencaron.com; PeterCulpepper of Provectus Pharmaceuticals, Inc., +1-865-769-4011,culpepper@pvct.com
Web site: http://www.pvct.com/