Provectus Pharmaceuticals, Inc. a development-stage oncology and dermatology biopharmaceutical company, reports continued progress in its compassionate use programme for PV-10. The programme 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 programme 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 centres across these two countries: St. Luke's Hospital and Health Network, Bethlehem, PA; M.D. Anderson Cancer Centre, 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, PhD 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.”
PV-10 is a proprietary, injectable formulation of Rose Bengal, a small molecule agent 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. 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.
The compassionate use program for PV-10 is only available for cancer indications that do not involve treatment of 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.
Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its novel oncology drug 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 cancers of the liver.