Reading “between the lines”, Gold’s presentation at UBS today seemed to place emphasis on dealing with an unacknowledged comparison to CEGE. If the FDA had approved Provenge in May, DNDN would have had a clear and substantial first to market advantage with Provenge over CEGE’s GVAX for AIPC/HRPC. Now it’s more of a competitive race. Items noted: (1) DNDN has a FDA inspected (small 12 work station) production facility in Hanover NJ (which the CFO apparently now concedes must be reinspected by the FDA whenever the Provenge BLA is refiled) (vs. a CEGE GVAX cGMP facility in California “suitable for commercial launch” but not yet inspected by the FDA in a preapproval inspection); (2) 3 Provenge infusions over a month (vs. a dozen visits to a doc for multiple GVAX interdermal injections over 6 months); (3) the 9902b Ph 3 trial builds on the 9901 Ph3 trial (vs. CEGE’s projections of a greater GVAX increase in median survival from a smaller group of Ph2 patients given the Ph3 higher Vital-1 dose); (4) 225 Ph 3 patients in 9901 & 9902a and 500 in 9902b (vs. 600 Ph3 patients in Vital 1, with continuing enrollment in, and later reporting, in Vital-2); (5) ongoing Ph3 P11 trial in earlier and larger ADPC patient group (vs. Vital 2 in later advanced AIPC/HRPC, and GVAX better positioned for an earlier approval in the EU); (6) pipeline of Neuvenge in Ph1 for HER2/neu breast cancer, licensed CEA and CA-9 antigens with possible applications in colon, lung and renal cancerand preclinical Trp-p8 work (vs. John Hopkins Ph2 GVAX trials in pancreatic cancer and leukemia and earlier stage GVAX breast cancer planning at JH, CEGE’s internal GVAX lung cancer planning and JV with Novartis on viral oncology therapies); and (7) antigen cassette platform technology processing patients’ own immune cells ex vivo (autologous) with fusion protein linking a single antigen with GM-CSF (vs. allogenic irradiated metastatic cancer cell lines expressing GM-CSF and recruiting immune cells at injection site designed to prime multiple antigens). A competitive race is on, which can only benefit cancer patients, and will, IMHO, eventually lead to FDA approval of both immunotherapy approaches. Even if one or both Provenge and GVAX have good interim data, the time required to refile a BLA in Provenge’ case, or to prepare and file in GVAX’s case, will delay any approval and commercial launch until 2009. Again, IMHO, if either or both immunotherapies achieve statistical significance for increased median survival, but not the higher bar of a lower allocation of alpha, the FDA should allow the refiling/filing of a BLA. FDA agreement in the SPA of each to allow this would be a reasonable and achievable goal of prostate cancer advocacy groups and probably be a quicker and more achievable goal than more generally directed targeting against AC conflicts of interest and FDA banishment of Dr. Pazdur. JMHO.
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