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


To: Icebrg who wrote (10014)1/14/2004 6:25:33 PM
From: Icebrg  Read Replies (2) | Respond to of 52153
 
JP Morgan - MEDX

I continue to be impressed by the results seen with MDX-010 in stage IV metastatic melanoma. According to DD they have a group of three patients (out of a group of 14), where the following responses have been recorded. Note these are late-stage patients who are heavily pre-treated.

One complete response 15,5 months and still ongoing.
One complete response 16,5 months and still ongoing.
One partial response 20,0 months and still ongoing

These are outstanding results.

Medarex is planning to initiate a pivotal trial (with a somewhat curious design) sometimes during H1 2004. If everything works out well they are planning to file their BLA during Q4 2005.

Given the progress reported by Dendreon in their Prostate Cancer vaccine trial, 2004 may well turn out to finally be the year of the cancer vaccine. Medarex is in their trial using an unapproved GP100 peptide cancer vaccine (from NCI). According to DD, FDA has however said that they see no problem with the fact that two unapproved agents are used in the same study.

Erik