Cell Geneysis saw some nice validation for its GVAX prostate cancer vaccine candidate,” notes biotech expert John McCamant in The Medical Technology Stock Letter.

“The final results from the second of the company’s two Phase 2 trials were published in the online issue of Cancer—which is a prestigious, peer-reviewed scientific journal that is published by the American Cancer Society.

“For those not familiar with the background, the patients in this trial — who received a dose that is comparable to the dose being used in the ongoing and extensive Phase 3 program for GVAX for prostate cancer — experienced an overall median survival of 35.0 months.

“This is nearly identical to the overall median survival achieved in the first Phase 2 prostate cancer trial (34.9 months in the patients who received the dose comparable to that being used in Phase 3).

“Just as important, if not more so, is the fact that the results from both Phase 2 trials dwarf the published data on Taxotere (plus prednisone) in the hormone-refractory prostate cancer (HRPC) treatment setting. The importance lays in the fact that this combination represents the current standard of care for these patients.)

“To be perfectly clear, these Phase 2 results on GVAX are going to mean very little if neither of the ongoing Phase 3 trials is successful. Our point all along, however, has been that the company has done an excellent job of taking the correct steps to position GVAX as best as possible for success.

“Using overall survival as the primary endpoint in both Phase 3 trials, and using a dose similar to that used in prior Phase 2 testing—which proved successful—are two of the things that CEGE has done exactly right.  As an aside, we would also note that CEGE indicated that the Phase 3 program is still on track as previously guided for.

“Patient enrollment in VITAL-2 (the second of the two Phase 3 trials) is still expected to wrap up in the first half of next year, and the triggering of the final analysis of VITAL-1 (the first of the two Phase 3 trials) is still anticipated to take place in the second half of 2009.  CEGE is a buy under $4.”

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