BiotechTracker - Revmid Able to Affect Anemia But Not Other Aspects of MDSg
May 16, 2003. Updated data presented at the 7th International Symposium on Myelodysplastic Syndromes suggest that development of Celgene’s (NASDAQ: CELG) Revmid (CC-5013) is limited in much the same fashion as are other compounds on the market and in development for the management of myelodysplastic syndrome (MDS). While Revmid remains on track in terms of managing the effects of the refractory anemia associated with MDS, substantive evidence of robust, clinically relevant effects at the level of comprehensive bone marrow stimulation are lacking.  Many developmental compounds, including Millennium’s (NASDAQ: MLNM) Velcade and Telik’s (NASDAQ: TELK) TLK-199, have been able to offer clinically relevant stimulation of a single bone marrow cell lineage, especially white blood cells. However, “pan-stimulation” of white cells, red cells, and platelets has been an elusive achievement. Last December’s American Society of Hematology meetings featured preliminary evidence of Revmid’s potential to offer more comprehensive marrow stimulation, and since then it has gained fast track designation from the FDA for the treatment of MDS (see April 16, 2003 BT News).  Revmid should be thought of as an anti-anemia drug in the management of MDS, and would therefore compete with packed red blood cell transfusion as well as Procrit and other erythropoeitin (epo) products from Amgen (NASDAQ: AMGN), Johnson & Johnson (NYSE: JNJ), and Roche (Swiss: ROG). Depending upon the merits of future study, Revmid’s effects at the level of red blood cell production has significant potential to prove more clinically and commercially relevant than white blood cell stimulation in this disorder, given the consideration that MDS patients’ difficulties most often arise due to their refractory anemia as opposed to refractory neutropenia or thrombocytopenia. Data show that Revmid provides a clinically significant effect in terms of reducing or eliminating red blood cell transfusion requirements in anemic MDS patients. Its oral delivery makes it especially compelling.  16 of 25 (64%) evaluable Revmid recipients experienced a response of their marrow’s red blood cell lineage. Response was defined as at least a 50% decrease in the number of transfusions required or an increase in hemoglobin blood levels of 2 g/dl. Of responders, 11 no longer required transfusions, and 4 experienced a transfusion rate reduction of greater than 50%. A patient who had not been requiring red cell transfusions experienced a clinically significant increase in his hemoglobin levels. Moreover, 9 of 12 (75%) early-stage MDS patients with refractory anemia and 15 of 21 (71%) patients with low- and intermediate-risk MDS proved Revmid-responsive. A preliminary complete response profile suggests sustained response for a median duration of 36 weeks.  Revmid’s effects at the level of the white cell lineage appeared potentially suppressive and adverse, and suggested that the agent would have to be used with white cell support such as Neupogen or Neulasta, both recombinant granulocyte colony-stimulating factors from Amgen.
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