Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, reports continued progress in its compassionate use program for PV-10. The program currently has enrolled more than 40 patients, ten of whom are expanded access patients from the company’s Phase 2 trial of PV-10 for metastatic melanoma, as well as more than 30 new patients.
The protocol for the compassionate use program enables subjects to undergo more frequent and extensive treatments of PV-10 over a longer period of time than was allowed under the protocol used for the Phase 2 trial of PV-10. Based on the success of the compassionate use program, its dose regimen is expected to serve as the blueprint for a potential Phase 3 study for metastatic melanoma. The majority of patients enrolled in the program have been treated for melanoma, with one patient treated for both melanoma and recurrent squamous cell carcinoma.
Originally instituted in Australia in June 2009, the program was expanded to the United States in October 2009, and is now active at six centers across these two countries:
• St. Luke’s Hospital and Health Network, Bethlehem, PA;
• M.D. Anderson Cancer Center, Houston, TX;
• University of Louisville, Louisville, KY;
• Melanoma Institute Australia, Sydney, Australia;
• Princess Alexandra Hospital, Brisbane, Australia; and
• Royal Adelaide Hospital, Adelaide, Australia.
Craig Dees, Ph.D. CEO of Provectus said, “We are pleased that our compassionate use program for PV-10 is providing patients access to this therapy. The success of the program is in addition to the very positive results from our Phase 1 and Phase 2 melanoma trials. More recently, early results from our Phase 1 liver cancer trial have also indicated that the treatment is well-tolerated with substantial evidence of potential efficacy. We intend to continue advancing PV-10 for both indications, and will continue providing access via the compassionate use program while we prepare for a Phase 2 mechanism of action trial and a pivotal Phase 3 melanoma trial to expedite approval in the U.S. and abroad.”
Date: November 23, 2010
Source: Provectus Pharmaceuticals, Inc.