By: Adam Feuerstein | 01/24/14 - 01:41 PM ESTProvectus Biopharmaceuticals (PVCT: Pink Sheets) now says it will submit data from its phase II study of the melanoma drug PV-10 to the FDA, seeking breakthrough therapy designation (BTD), as expected.
As expected? Sure, because as I've already made clear, Provectus has been unable and/or unwilling to start the phase III study of PV-10 in melanoma for the past two years, as promised. Consider this BTD filing, which will be completed later this quarter, a Hail Mary. The ball is now in the air for the next 60 days as FDA mulls the PV-10 BTD request and reaches a decision.
By the way, BTD does not equal drug approval. Nowhere in today's update does Provectus confirm that FDA will allow an approval filing or actual review for approval PV-10 based on a tiny phase II study, even if BTD is granted. BTD in the absence of well-designed clinical trials demonstrating clear efficacy and safety doesn't mean much.
Did FDA actually encourage Provectus to seek BTD status for PV-10? Here's what the Provectus press release says:
In reference to discussions on the potential for breakthrough therapy designation, "FDA advised Provectus to provide objective response rates with adequate information to evaluate the symptomatic treatment effects (e.g. pain, infection, bleeding) in patients presenting with locally advanced cutaneous melanoma who received PV-10 to all lesions."
The Agency may yet recommend and it may be in the best interest of Provectus to undertake a small, short bridging study in patients where all tumor burden can be injected. This would allow more frequent dosing than was permitted in the Phase 2 study, presumably akin to the dosing schedule currently used to treat nearly 100 patients under our expanded access protocol, and allow symptomatic endpoints to be prospectively correlated with objective response criteria.
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