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Genitope's MyVax Vaccine Falls Short

Genitope (GTOP) said Thursday that its non-Hodgkin's lymphoma vaccine MyVax failed to meet the primary endpoint in a pivotal phase III study.

The negative outome of the MyVax study is a significant setback for Genitope, which has hitched its entire future on developing MyVax as a new treatment for non-Hodgkin's lymphoma, a cancer that targets B cells, a part of the immune system.

Genitope issued a press release earlier Thursday annoucing its upcoming MyVax conference call, driving shares down nearly 40% to close at $2.59. Following the news, Genitope fell another 79 cents in recent after-hours trading to $1.75.

In the primary analysis of the study, there was no statistically significant difference in the progression-free survival (PFS) of patients receiving MyVax compared to patients receiving a control substance, Genitope said.

In a phone interview conducted earlier Thursday, Genitope CEO Dan Denny acknowledged that MyVax patients didn't even show a trend toward prolonged PFS compared to the control patients.

But Denny remains optimistic about MyVax's future because of a secondary analysis from the study showing a subgroup of MyVax patients who did get a significant clinical benefit from the vaccine.

Genitope plans to discuss these positive data with the Food and Drug Administration, said Denny, hinting that the company will more than likely file for approval based on the subgroup analysis.
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