I sat in on the Keryx presentation at the BIO CEO conference. Regarding the phase III study of perifosine in colon cancer (the most important near-term event), CEO Ron Bentsur once again said the 360th patient death -- which will trigger the final survival analysis -- had not yet occurred. He still expects Keryx to report top-line results from the perifosine study before the end of this quarter.
My sense from Bentsur's comments (and I tweeted this Monday) is that he was hinting about perifosine colon cancer study results being delayed or pushed back into the second quarter. The current quarter is half over and it can take eight to 10 weeks for data to be cleaned up enough to analyze and release, which leaves little time for Keryx to meet its first-quarter perifosine guidance.
If Keryx does announce a delay in the timing of the perifosine data, I can guarantee that many investors will interpret it as good news, i.e., these patients must be living longer than expected, which means perifosine works! I'd be very careful in making that assumption, but then I'm already on record as predicting perifosine's failure.David P. asks, "Can you share an opinion on BioCryst Pharmaceuticals (BCRX) and its new hepatitis C drug?" I'm not a medicinal chemist or an expert in the replicon activity assay so I'm not going to even try to decipher or weigh in on the preclinical data on BCX5191. You can peruse BioCryst's slide deck yourself. Here's what I'm told from investor sources (guys with MDs and PhDs behind their name) have told me: The preclinical data on BCX5191 reads well. Maybe the drug is as potent as Gilead Sciences' (GILD) GS-7977, but then again, maybe it's not. ['5191 is a nucleoside while '7977 is a nucleotide -- with the current bias favoring the latter.] "Structure doesn't matter to me as long as it works in humans, so we'll wait for that," one hedge fund investor -- very active in hepatitis C drug stocks -- told me this morning. BioCryst expects to begin human clinical trials of '5191 by the end of the year.
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