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Proteolix Presents Positive Clinical Data for Carfilzomib in Multiple Myeloma at the 2009 ASCO Annual Meeting
Date:6/1/2009

enrolled a total of forty-six heavily pre-treated multiple myeloma patients who had failed all other approved agents. Of 39 evaluable patients who received a dose of 20mg/m(2), 18 percent achieved an overall response and 26 percent achieved a clinical benefit response. An additional 41 percent achieved stable disease. Importantly, responses have also been sustained; patients achieving partial or minor responses stayed on therapy for a median treatment duration of 240 days, or approximately 8 months, and the median duration of response was 7.4 months. Ten percent of patients completed twelve cycles of treatment and an extension study has been initiated for patients who have stayed on drug for one year.

All patients enrolled in the Phase 2 trial have relapsed following treatment with bortezomib and an immunomodulatory agent, such as thalidomide or lenalidomide, and were refractory to their last treatment. Eighty percent of patients received at least four prior treatments. Of 26 patients enrolled who were refractory to treatment with bortezomib, 19 percent achieved a clinical benefit response.

Carfilzomib was generally well tolerated and toxicities were manageable. The most common adverse events reported were fatigue, anemia and thrombocytopenia. Of note to this patient population, treatment with carfilzomib was associated with a low incidence of peripheral neuropathy, a common side effect associated with the approved proteasome inhibitor, bortezomib. Exacerbation of pre-existing peripheral neuropathy was rare and did not result in dose reductions or discontinuation of therapy. Overall, adverse events did not limit treatment duration, even among patients with several co-morbidities.

These data were presented by Dr. Jagannath in an oral presentation titled "Final results of PX-171-003-A0, part 1 of an open-label, single-arm, Phase II study of carfilzomib in patients with relapsed and refractory multiple m
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SOURCE Proteolix, Inc.
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