Normally, medical conferences like that of the American Society of Clinical Oncology (ASCO) are a time for biopharmas to showcase their top compounds and tout their benefits. For drug developer Telik
Telcyta has been in phase 3 testing in ovarian and lung cancers for the past several years. Last year, Telik announced negative clinical trial results for the drug in three of these studies, but saved releasing the hard data until ASCO.
At the conference, Telik announced more of the data from these compounds. It was revealed that in two studies, patients treated with Telcyta had significantly reduced survival times compared to patients not on the drug.
In a lung cancer study, the median overall survival time for Telcyta-treated patients was 4.6 months compared to 6.1 months for the patients in the control group, or a 25% shortened length of survival. An ovarian cancer study was even worse, with median overall survival of 8.5 months for Telcyta-treated patients, compared to 13.6 months for the control arm -- a 38% reduced length of survival.
Furthermore, the drug appears to have failed to halt the progression of cancer, with progression-free survival also faring worse in the Telcyta arms of both studies. Oh, but the drug was "very well-tolerated," as Telik so glibly stated in a press release announcing these horrible study results.
The lead investigator for the Telcyta ovarian cancer studies called for continued development of the compounds, saying that preclinical testing of the drug "support[s] further studies with (Telcyta) in combination regimens in second line therapy (for ovarian cancer)."
Based on these study results -- which Telik had an ethical and possibly legal obligation to release sooner, considering how many doctors and patients would have stopped enrolling and quit the ongoing Telcyta studies -- the FDA formally put a hold on use of the drug in all ongoing clinical trials.
When combined with the other difficulties Telik has had, plus the company's lack of forthrightness about Telcyta and the lack of positive efficacy data, there will be years of more clinical trial work if the FDA and Telik are crazy enough to allow continued development of the drug. Even at this reduced share price, investors should stay far away from Telik.
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