Provectus reports on end-of-Phase 2 meeting with FDA on licensure of PV-10 for metastatic melanoma

Provectus reports on end-of-Phase 2 meeting with FDA on licensure of PV-10 for metastatic melanoma

News and Articles
Apr 29 2010

Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced today that it has held an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to seek consensus on clinical program scope and endpoints for licensure of PV-10 for metastatic melanoma. The meeting was held at the Agency’s White Oak Campus in Silver Spring, MD.

“Based on consultation with senior Agency officials during this meeting, we expect to hold a second end-of-Phase 2 meeting in the coming months to finalize design of a pivotal Phase 3 randomized controlled study suitable for Special Protocol Assessment (SPA).”

Craig Dees, Ph.D., CEO of Provectus said, “This meeting provided an opportunity to thoroughly review the clinical data we have amassed through our Phase 1 and Phase 2 studies with PV-10. As expected, the meeting was fruitful and provided a forum for discussion of appropriate endpoints for assessment of clinical benefit of PV-10 in melanoma patients and for definition of the pathway leading to licensure.”

Dr. Dees continued, “Based on consultation with senior Agency officials during this meeting, we expect to hold a second end-of-Phase 2 meeting in the coming months to finalize design of a pivotal Phase 3 randomized controlled study suitable for Special Protocol Assessment (SPA).”

Dr. Dees concluded, “We are fortunate that our capital resources afford flexibility to consider pursuing both the conventional Phase 3 pathway, as well as an accelerated route to licensure. While we believe the Phase 3 with an SPA represents an industry standard path to approval, we believe the door may still be open for accelerated approval.”

SOURCE Provectus Pharmaceuticals, Inc.

www.pvct.com 

Source: www.news-medical.net

Rate article
Add a comment