| 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.
GPC Regroups
During its third-quarter conference call yesterday, GPC Biotech (Nasdaq: GPCB) gave investors an idea of what to expect down the road, now that it has to regroup in the wake of surprisingly negative study results on its lead drug. Last week, GPC announced that in a phase 3 study, its chemotherapy treatment Satraplatin failed to improve overall survival rates in late-stage prostate cancer patients, compared with a control group. The company didn't give any updates on the multiple subgroup analyses, but as GPC's CEO has said, it's now best to consider Satraplatin a phase 2 compound. Satraplatin is still a viable drug candidate, based on the data it has produced so far. But now that GPC has to push the drug through phase 2 studies and start phase 3 testing all over again, it will almost certainly take years before Satraplatin reaches the market -- if it ever gets that far at all.
QLT's move to auction block lifts shares
Shares in QLT Inc. shot up almost 25 per cent Wednesday after the company put itself on the auction block with the announcement it is exploring strategic alternatives that could include the sale of some or all of its assets. The move pushed QLT shares up to $4.80 on the Toronto Stock Exchange by Wednesday's close, bolstering a flagging performance that saw them down at $3.88 on Tuesday, close to the 52-week low of $3.44 and far below highs in February of $11.67. The Vancouver biotechnology pioneer and University of B.C. spinoff, which rocketed to success with its anti-blindness treatment Visudyne, has been struggling as competition for the drug eroded revenues and new initiatives in its pipeline have failed to fill the gap. It has also faced costly court challenges related to Visudyne and to its prostate cancer drug Eligard.
|
