During its third-quarter conference call yesterday, GPC Biotech (Nasdaq: GPCB ) gave investors an idea of what to expect down the road, now that it has to regroup in the wake of surprisingly negative study results on its lead drug.
Last week, GPC announced that in a phase 3 study, its chemotherapy treatment Satraplatin failed to improve overall survival rates in late-stage prostate cancer patients, compared with a control group. The company didn't give any updates on the multiple subgroup analyses, but as GPC's CEO has said, it's now best to consider Satraplatin a phase 2 compound.
Satraplatin is still a viable drug candidate, based on the data it has produced so far. But now that GPC has to push the drug through phase 2 studies and start phase 3 testing all over again, it will almost certainly take years before Satraplatin reaches the market -- if it ever gets that far at all.
With the near-term revenue from Satraplatin now probably gone -- barring a surprise approval in the European Union -- GPC expects to implement a substantial reorganization, so that its approximately $87 million in cash will last until the end of 2009.
Besides Satraplatin, GPC has a phase 1 monoclonal antibody in development, along with several anti-tumor preclinical small-molecule compounds. In the first half of the upcoming year, GPC expects to bring one of these small-molecule drug candidates into phase 1 testing.
In more encouraging news for Satraplatin, a data-monitoring board recommended a few days ago that the phase 2 study of Satraplatin in combination with Genentech's (NYSE: DNA ) Tarceva for non-small cell lung cancer (NSCLC) continue. No worrisome safety concerns have yet popped up in the still-enrolling 120-person study. Another NSCLC study of Satraplatin, which is currently in phase 1/2 testing in combination with radiation therapy, will also move into phase 2, following positive results from the phase 1 portion of the study.
GPC also announced this week that it won an arbitration hearing with Spectrum Pharmaceuticals (Nasdaq: SPPI ) over Satraplatin. Spectrum had claimed it was owed some of the milestone payments that European marketing partner Pharmion (Nasdaq: PHRM ) paid to GPC, and also said it should have the rights to market Satraplatin in the United States.
But with marketing approval on Satraplatin such a distant hope, and other new therapies all vying for a spot in a continuously more crowded cancer-treatment market, it's impossible to recommend shares of GPC, even at these reduced levels. There are just too many other oncology-focused investment options out there that could serve you better.
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