Dendreon Holds Its Breath, Big Provenge Clinical Trial Result Coming In October
Dendreon’s David Urdal never fails to give off the impression that he’s a ballast for the company, at least in the dozens of times I’ve interviewed him in the past seven years. The even-keeled chief scientific officer has lived through all the ups and downs since he joined the Seattle biotech company back in its early days in 1995.
Now Urdal, 58, is gearing up for another turning point in October. It’s from a clinical trial of 500 prostate cancer patients, known as Impact. The company (NASDAQ: DNDN) will find out if that trial can crank out the kind of evidence needed to convince the FDA it truly has a drug that can help prostate cancer patients live longer. If it does, the company will sprint to bring that drug, Provenge, to the market as the first treatment of its kind to stimulate the immune system to fight cancer cells. But if the early peek at the data—an interim analysis—shows results that could even possibly be due to chance, then everyone will have to wait in suspense one more year for a final verdict.
“I think people here now can feel the moment coming,” Urdal says. “We’re within a couple of months of knowing new information, and there’s a high level of anticipation and excitement about it.”
Provenge has captivated the imaginations of doctors, patients, and investors (and journalists) for years. The treatment, called an immunotherapy, or a cancer vaccine, doesn’t work like a traditional cancer drug. Blood is drawn from a patient, and some white blood cells vital to the immune system, called dendritic cells, are separated in a lab. The cells are shipped to the company and incubated with a genetically engineered protein found on prostate cancer cells, called PAP. The white blood cells are supposed to recognize the protein as an invader and recruit the immune system’s arsenal to attack tumor cells that contain it. The revved-up white blood cells are shipped back and re-infused into the patient.
Without going too long on the history—that’s a book-length project—Dendreon thought it had done enough to get Provenge approved by the FDA a year ago. It asked the agency to clear the product for the sale mainly on a study of 127 men that showed it could extend patients’ lives by a median time of 4.5 months, with minimal side effects, like fever and chills. An FDA advisory panel agreed in March 2007 that the drug was safe and “substantially effective.” The next day, Dendreon became the heaviest traded stock on the entire Nasdaq exchange, rocketing from $5.22 a share to briefly more than $20 after the panel vote, as investors were betting that the FDA would follow the panel’s advice and approve the drug, as it usually does.
The operative word in that last sentence is “briefly.” Dendreon crashed back to earth in May of last year. That’s when the FDA chose not to approve the drug, preferring to wait for more evidence from the ongoing 500-patient Impact trial. Almost $1 billion of stock market value evaporated in a heartbeat.
So Dendreon knows about ups and downs. Now it could be in for some more. … Next Page »