Dendreon prostate cancer drug wins speedy review
Thursday September 4, 4:33 pm ET
By Jed Seltzer
NEW YORK, Sept 4 (Reuters) - Biotechnology company Dendreon Corp. (NasdaqNM:DNDN - News) said on Thursday U.S. regulators had granted an expedited review of its prostate cancer drug Provenge, lifting the company's shares by over 35 percent.
The U.S. Food and Drug Administration's (News - Websites) "fast-track" designation means the agency could reach a decision on the drug within six months, rather than the normal 12-month period.
"The FDA's decision is not unexpected," Quynh Pham, a biotechnology analyst for Delafield Hambrecht said, noting Dendreon had previously predicted the FDA would give Provenge a fast-track review.
Provenge is among a new class of experimental drugs called "therapeutic cancer vaccines," which are designed to train the immune system to recognize and attack the body's own abnormal cells.
It failed to prove effective in one Phase III study among a wide range of prostate cancer patients, including those with late-stage disease that had spread to other parts of the body.
But the FDA in June agreed to let Dendreon conduct a different Phase III trial that excludes patients with the most aggressive prostate tumors.
Dendreon has expressed confidence Provenge will be launched in 2005, if the new Phase III trial proves successful.
Previous clinical trials suggested the drug delays progression of the disease and reduces pain.
The treatment consists of taking immune-system cells called "dendrites" from the body and exposing them to a genetically engineered protein, or antigen, found only on prostate cancer cells.
The dendrites are then re-infused into the body, in the hope the immune system will recognize the antigen as an abnormal protein and destroy cells where it is found -- specifically the prostate cancer cells.
Patients with prostate cancer typically are treated with drugs that reduce the patient's production of the male hormone testosterone, which helps promote prostate tumors. They can also be treated with radiation or surgery.
"Many prostate cancer patients do not respond to hormone therapy, and surgery is not an option when their cancer spreads elsewhere in the body," Pham said.
The analyst said Provenge, and a rival prostate cancer vaccine being developed by Cell Genesys Inc. (NasdaqNM:CEGE - News), could open up an entirely new way of tackling tumors, if they prove effective
Shares of Dendreon closed up $2.30, or 37 percent, to $8.53 Thursday on the Nasdaq market, where it was one of the top percentage gainers.
Dendreon in July bought biotech company Corvas International in an $80 million stock deal, obtaining several Corvas cancer drugs now in early-stage development.
(Additional reporting by Ransdell Pierson)
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