|FDA Calendar 14 Biotech Stocks Facing FDA Approval|
Bobby T. asks about Cell Therapeutics ( CTIC - Get Report). "Adam, do you feel that pixantrone will ever get to market?" No. Certainly not while the drug is owned by Cell Therapeutics. The company continues to be a serial dissembler of pixantrone's true benefits and risks. This week, Cell Therapeutics issued a press release touting the cardiac toxicity-sparing benefits of pixantrone in a phase II study that substituted pixantrone for the commonly used anthracycline doxorubicin in the standard "CHOP-Rituxan" regimen used to treat non-Hodgkin's lymphoma patients.
Rambabu D. writes, "I am looking for some insights on Antigenics ( AGEN - Get Report). It is in Phase 2 trial for glioma and Phase 3 for renal cell carcinoma. The company is learning the lessons from the previous denial of renal cell carcinoma in Europe just like Dendreon ( DNDN) and trying to make amends for possible approval. It has other vaccines under testing by GlaxosmithKline. Sounds like a very good investment as the stock is cheap relative to the potential. Please send your insights." I know everyone is excited about the approval of Dendreon's prostate cancer "vaccine" Provenge and that this gives investors like Rambabu hope that other companies may find similar success with drugs that harness a patient's immune system to kill tumors. I have my doubts about Antigenics turning into one of those lucky companies. I'm not saying anything new here, I'm a long-time Antigenics bear because the Oncophage data produced to date from failed phase III studies in kidney cancer and melanoma don't justify any optimism. (Leaving aside the problems that Antigenics has in manufacturing viable doses of Oncophage.) Thursday, Antigenics produced more "encouraging" data on Oncophage, this time from phase II study in glioma, or brain tumor, patients. Antigenics says glioma patients treated with Oncophage are living longer than expected, but the study is single arm, no comparator, which renders any survival analysis difficult, if not meaningless.