Read Reuters' Deena Beasley's full article here.
"RBC Capital Markets analyst Michael Yee said recently that the Amgen drug - talimogene laherparepvec, or T-Vec - will ultimately need to demonstrate that it improves overall survival by more than 15 percent."
"The trial also showed that patients with earlier-stage disease had the highest rates of durable response. That rate was 33 percent for stage III patients, compared with 8 percent for patients with the most advanced cancer." This success at earlier stage of disease for melanoma patients is key for PV-10. As a monotherapy, clinicians want to use PV-10 before surgery when the immune system is not, moderately or less severely compromised, by itself after surgery too, and in very late stage disease patients with other agents when the immune system is overwhelmed and severely compromised.
"David Chang, head of global oncology development at Amgen, said the company is currently in discussions with the U.S. Food and Drug Administration about how to move forward and seek regulatory approval. Melanoma is diagnosed in about 132,000 people worldwide each year. He also said the company is interested in testing its drug in combination with Yervoy and other new melanoma therapies." All of these groups of compounds are covered by Provectus' joint patent application with Pfizer for the combination of PV-10 and other therapies. The combination of PV-10 and CTLA4, PD-1, PDL-1 and OXO-40 agents are covered by the patent, and I believe these combinations have been investigated by Moffitt.
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