| Dendreon Completes Target Enrollment of 500 Patients in Phase 3 IMPACT ...
SEATTLE, Oct. 23 /PRNewswire-FirstCall/ -- Dendreon Corporation (NASDAQ: DNDN) today announced that the Company has completed enrollment of over 500 patients in the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE (sipuleucel-T), the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. The IMPACT study is a double-blind, randomized, placebo-controlled Phase 3 trial designed to measure overall survival in men with metastatic hormone-refractory prostate cancer receiving PROVENGE versus placebo. Earlier this year, following a positive recommendation from an outside panel of experts, Dendreon received a complete response letter from the U.S. Food and Drug Administration (FDA) that asked for additional evidence that would support the efficacy of PROVENGE.
Dendreon Promotes Dr. Mark Frohlich to Senior Vice President of ...
SEATTLE, Dec. 7 /PRNewswire-FirstCall/ -- Dendreon Corporation (NASDAQ: DNDN) today announced that the Company has promoted Mark Frohlich, M.D. to the position of senior vice president of clinical affairs and chief medical officer. Dr. Frohlich, a urologic oncologist with over a decade of oncology drug development and patient treatment experience in the public and private sectors, was instrumental to the filing of the company's Biologics License Application (BLA) for PROVENGE(R) (sipuleucel-T) and has also had responsibility for monitoring the progress of the company's ongoing Phase 3 IMPACT trial (D9902B), a pivotal trial for Dendreon, the results of which could support the licensure of PROVENGE. Dr. Frohlich was promoted from the position of vice president of clinical affairs. "Mark has been an exemplary leader who has led Dendreon's clinical efforts during a very active time for the organization with the ongoing regulatory approval process of PROVENGE -- a process which Mark and the rest of our team remain committed to seeing through to the approval of this promising immunotherapy for prostate cancer," stated Mitchell H.
A Wing and a Prayer for Amgen
Also expected are results from a trial testing it as a treatment for bone loss in patients undergoing prostate-cancer treatment. If all goes according to plan, Amgen will file a marketing application for denosumab with the FDA later this year. Amgen announced its acquisition of Abgenix in 2005. Its main reason for doing the more than $2.2 billion deal was to eliminate the royalties it would have to pay on sales of denosumab, as well as on colorectal cancer treatment Vectibix, if the drugs were approved for marketing. Vectibix received marketing approval in 2006, but sales haven't been what investors were hoping for after the drug failed an important label-expanding clinical trial. The market for osteoporosis drugs will be in the billions this year, even with Merck's blockbuster Fosamax losing patent in the coming months.
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