Feuerstein's Biotech Mailbag TheStreet.com June 23,2007
Coley Pharmaceuticals (COLY - Cramer's Take - Stockpickr - Rating) fell 59% Wednesday after its partner Pfizer (PFE - Cramer's Take - Stockpickr - Rating) dropped development of the cancer drug PF-3512676. An interim look at two phase III lung cancer studies showed no benefit in favor of "676," prompting Pfizer to shut down the studies.
I didn't follow Coley much to point any of this out in advance, but it is good to go back and see if there were any previously reported data on '676 that might have hinted at this bust-up. In fact, there were:
Check out this 2005 ASCO presentation of data from a phase II lung cancer study. The trial was randomized, which is a good thing, and it purports to show a statistically significant increase in response rate (tumor shrinkage) in favor of '676 (37% vs. 19%), plus a strong trend toward a survival benefit, with '676 patients living for 11.7 months compared with 6.8 months for control patients.
But if you dive into the slides, you'll see some potential problems. In slide 4, the response rate assessed independently, i.e., not by the doctors who treated patients, is lower -- 24% for the '676 patients compared with 14% for the control patients. This trends in favor of Coley's drug, but it was not statistically significant.
Slide 5 shows the respective survival curves for '676 and control. While there does seem to be a survival trend benefiting '676, notice that the two curves cross relatively early, which means that at that point in time, the control patients were living longer than the '676 patients.
I'm not a biostatistical whiz, but the early crossing of survival curves is a red flag indicating a problem either with the drug or the conduct of the trial.
Before Wednesday, Coley pointed to data from this phase II trial as evidence suggesting that the phase III studies would be successful. But in fact, there was probably just as much data there to point accurately to Wednesday's failed outcome.
At $3.57, Coley shares are trading at or near cash (about $3.70 per share). The cancer drug program with Pfizer might be mortally wounded, but Coley has a pipeline of other drugs in earlier stages of development.
surf's up......crikey
