PVCT- halted @8:22- released this statement yet remains halted.
Provectus says FDA declines request for breakthrough destination for PV-10
Provectus Biopharmaceuticals announced it has received notification from the Food and Drug Administration that the data upon which the company based its request for designation of PV-10, the company’s novel investigational drug for solid tumors, as a Breakthrough Therapy for the treatment of patients with locally advanced cutaneous melanoma was insufficient to demonstrate substantial improvement over existing therapies. As a result, the FDA has declined to designate PV-10 as a Breakthrough Therapy at this time. Further data may cause the Agency to revisit this decision at a later date. In the notification letter the FDA stated, “We have reviewed your request and while we have determined that treatment of ‘locally advanced cutaneous melanoma’ meets the criteria for a serious or life-threatening disease or condition, the preliminary clinical evidence you submitted does not indicate that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Therefore, designation as a Breakthrough Therapy cannot be granted at this time.” Provectus CEO Craig Dees said, “We are carefully weighing the advice of the Agency and will provide an outline of the path forward for melanoma in our poster presentation June 2nd at ASCO. We continue to enroll our currently active protocols examining the effect of PV-10 on tumors of the liver; providing expanded access treatment of cutaneous and subcutaneous tumors; and probing the immunologic mechanism of action resulting from tumor ablation with PV-10. With adequate available capital we are in a strong position to execute the necessary steps to bring PV-10 to market for solid tumors and continue development of PH-10 for dermatologic indications...Given that only about one third of requests are granted, and no intralesional drugs have received designation, we fully understand the regulatory challenges these types of drugs face. This effort, while not initially successful, will benefit the company in pursuing available approaches for approval of PV-10." The management of Provectus Biopharmaceuticals will host a conference call today at 4 pm Eastern today.
