Genitope Corp. (NASDAQ:GTOP) probably just made sure the workers’ kids won’t be getting much more than coal this year. Genitope announced that its pivotal Phase 3 clinical trial examining the use of MyVax® personalized immunotherapy in previously untreated follicular B-cell non-Hodgkin’s lymphoma patients did not meet its primary endpoint.
In the primary analysis, there was no statistically significant difference in the progression-free survival (PFS) of patients receiving MyVax® personalized immunotherapy compared to patients receiving the control substance. Importantly, analysis of a pre-specified endpoint in the MyVax® personalized immunotherapy arm showed a highly statistically significant difference in PFS between patients who mounted a positive immune response to the tumor-specific target and those who did not.
This fell 38% to $2.59 in regular trading as word of the trials came out at the end of the day. But now shares are down 60% to roughly $1.00 in after-hours trading. This had a prior 52-week trading range of $3.00 to $4.93.
The company generates zero revenues and has been burning about $16 million per quarter. On its last balance sheet it had almost $40 million in cash and securities and held $47.1 million in long-term debt. What is interesting is that if you look at the quote, they are trying to smooth is over:
- Dan W. Denney, Jr., Ph.D., Chairman & CEO" “We are excited by these results because the data clearly show that MyVax personalized immunotherapy is a safe and active drug for follicular lymphoma patients. Both arms of the trial appear to show activity. Patients who received MyVax personalized immunotherapy and mounted a positive immune response to the tumor-specific target demonstrated superior clinical outcomes compared to patients who did not mount this specific immune response. While we recognize that the regulatory path would be clearer had the trial met its primary endpoint, we are pleased with the outcome of the trial. We are working closely with the FDA to determine the path forward for MyVax personalized immunotherapy.” Maybe he should change his name to Dr. Pangloss.
This has been public since 2004 and has been a less promising stock since Summer of 2006. Zombie movies can be fun to watch, but no one likes biotech zombies. This one isn’t officially at zombie status yet, but it isn’t far.
Jon C. Ogg
December 20, 2007
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