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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (8820)	7/14/2003 7:37:32 PM
From: Miljenko Zuanic	Read Replies (2) \| Respond to of 52153

<<The study involved 50 randomized patients and evaluated satraplatin plus prednisone (N=27) versus prednisone alone (N=23) for use as a first-line chemotherapy treatment in hormone-refractory prostate cancer (HRPC).>> I am not up to date with what is today hot in PC, but SPPI data (IMW) are inconclusive. Prednisone (dose =?) is rarely used alone as first line in HRPC, so their data should be compared against similar combination (Pred. + Mitox). Sound to me that in SPPI trial placebo TTP and response (>50%) are on the low side than should be expected. J Urol. 2002 Dec;168(6):2439-43. Phase III study of mitoxantrone plus low dose prednisone versus low dose prednisone alone in patients with asymptomatic hormone refractory prostate cancer. Berry W, Dakhil S, Modiano M, Gregurich M, Asmar L. U.S. Oncology, Houston, Texas, USA. PURPOSE: We compared median time to treatment failure of men with asymptomatic, hormone refractory, progressive prostate cancer treated with mitoxantrone plus prednisone versus prednisone alone. MATERIALS AND METHODS: In a multicenter phase III trial 120 men with asymptomatic, progressive, hormone refractory prostate cancer were randomly assigned to treatment with mitoxantrone and prednisone or prednisone alone. Patients received 12 mg./m. mitoxantrone intravenously once every 3 weeks for 6 cycles and 5 mg. prednisone twice daily with or without mitoxantrone. Time to treatment failure was assessed as an aggregate end point comprised of time to disease progression, time to toxicity or death, or time to initiation of alternate therapy. RESULTS: Median followup was 21.8 months. Median time to treatment failure and median time to progression were the same: time to treatment failure and time to progression in the mitoxantrone and prednisone group was 8.1 months compared to 4.1 months in the prednisone alone group (p = 0.017 versus p = 0.018). More patients (27 or 48%) treated with mitoxantrone and prednisone achieved a 50% or greater reduction in prostate specific antigen levels than those who received only prednisone (15 or 24%, p = 0.007). There was no significant difference in median survival between the 2 groups, which was 23 and 19 months, respectively. Death was mainly attributable to disease progression. CONCLUSIONS: Patients with hormone refractory prostate cancer who are asymptomatic but had progressive disease had a significantly higher response rate when treated with mitoxantrone and prednisone as demonstrated by the 50% or greater decrease in prostate specific antigen compared to treatment with prednisone alone. Time to treatment failure was significantly prolonged in the chemotherapy treated group but survival rates were not different.

To: Biomaven who wrote (8820)	7/14/2003 8:15:15 PM
From: Icebrg	Read Replies (1) \| Respond to of 52153

>>MEDI has MDX-070 in a Phase I - this is an anti-PSMA antibody that looks interesting. (I think I recall this discussed at the MEDI analyst day webcast, but I'm not sure).>> A good thing that you hedged yourself. MDX-070 has nothing to do with MEDI. But there are a couple of other players in the field. MDX-070 is being developed as a naked antibody by Medarex. (Who bought the mAb from Northwest Biotherapeutics in a fire-sale, as the latter was about to go under). Millennium has two versions of anti-PSMA mAbs in the clinic. One radio-labelled and one a toxin-conjugate (IMGN's DM1). And finally the CYTO/PGNX are developing (or hoping to develop) as they announced today: - a novel therapeutic prostate cancer vaccine utilizing the PSMA protein and an adjuvant, for which the joint venture announced the initiation of a phase 1 clinical trial in December 2002; - a therapeutic vaccine that utilizes a viral vector designed to deliver the PSMA gene to immune system cells in order to generate a potent and specific dual-immune response, eliciting both antibodies and killer T cells directed to prostate cancer cells, for which the joint venture anticipates initiating phase 1 clinical studies in the first half of 2004; and - novel human monoclonal antibodies which bind to PSMA, for which the joint venture expect to begin clinical studies in 2004. So, there are a lot of activities ongoing in the PSMA sphere. MEDX/MLNM has some kind of crosslicensing agreement, while CYTO/PGNX work on their own. Erik