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Keryx Biopharmaceuticals, Inc. Announces Phase 1 and Phase 2 Data on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Multiple Myeloma at 49th Annual Meeting of American Society of Hematology
Date:12/10/2007

1 days as the selected phase 2 dose.

Phase 2 Perifosine +/- Dexamethasone (dex)

Poster 318-I: MULTI-CENTER PHASE 2 STUDY OF PERIFOSINE (KRX-0401) ALONE AND IN COMBINATION WITH DEXAMETHASONE (DEX) FOR PATIENTS WITH RELAPSED OR RELAPSED/REFRACTORY MM: PROMISING ACTIVITY AS COMBINATION THERAPY WITH MANAGEABLE TOXICITY

Sixty-seven highly pre-treated MM patients (median age 62 yrs) were treated with perifosine at 150 mg qd to assess the single agent activity in this patient population. Patients had a median of 4 lines of prior therapy (range 1 - 11) and 94% of patients were previously treated with at least one course of dex. If a patient progressed on perifosine alone, dex (20mg twice weekly) was added to their perifosine regimen. Toxicity was manageable with no DVT or peripheral neuropathy reported. Twenty-one patients had perifosine reduced from 150 to 100 mg qd with no difference in response noted. In this heavily pre-treated and relapsed/refractory patient population, perifosine as monotherapy appears to have modest activity with 33 of 50 evaluable patients (66%) achieving SD. Dex was added in 39 of 55 pts with progressive disease. Out of 29 patients currently evaluable for response on the combination. an ORR (CR+PR+MR) of 35% (10/29) was achieved, with an additional 52% (15/29) of patients achieving SD. Six patients remain on treatment with duration of response ranging from 15 - 70 weeks. Enrollment objectives were met and the study is now closed.

One additional clinical poster was presented as follows:

Phase 1 Perifosine + REVLIMID(R) + dexamethasone (dex)

Poster 323-I: A MULTIPLE MYELOMA RESEARCH CONSORTIUM (MMRC) MULTICENTER PHASE I TRIAL OF PERIFOSINE (KRX-0401) IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (MM): UPDATED RESULTS

"The data presented further demonstrates perifosine's promising activity in combination with bortezomib, lenolidomide and dexa
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SOURCE Keryx Biopharmaceuticals, Inc.
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