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Biotech / Medical : Genitope GTOP
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From: Paul Lee3/14/2008 5:29:46 PM
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Genitope Corp. will slim down to about 20 workers from nearly 200 and will seek approval for its MyVax personalized immunotherapy for cancer in other countries.

MyVax failed in a 287-person Phase III trial to show it could halt the progression of one of the 30 types of non-Hodgkin's lymphoma, which collectively affects more than 54,000 people annually in the United States.

CEO Dan Denney Jr. had held out hope that he could convince the Food and Drug Administration to consider MyVax's success with a subset of patients. Instead, Genitope disclosed March 10 that the FDA said it wanted one or more additional trials.

"No one wants to wait another seven to eight years to get the answer," Denney said, adding that MyVax is "a phenomenal, safe drug."

Denney described the FDA as "closed and bureaucratic" and "schizophrenic" in remarks after a shareholders meeting in Fremont on Friday. At that meeting, shareholders approved issuing 125 million more shares.

"I honestly have no idea what's going through those people's heads," said Denney about the FDA. He said more than 40 percent of the patients in Genitope's clinical trial "will live out their life free from lymphoma."

Fremont-based Genitope (NASDAQ: GTOP) didn't name any other countries where it might seek regulatory approval for MyVax. It plans to present data from its clinical testing at a cancer conference in Los Angeles next month.

Even with the severance costs from these job cuts, the company will have enough money to keep going through the middle of this year.
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