Amgen's Promising MGDF For Thrombocytopenia

Amgen's PEG-rHuMGDF (polyethylene glycol-conjugated human megakaryocytegrowth and development factor) has demonstrated potent stimulation of platelet production in patients undergoing chemotherapy for advanced lung cancer, and may be beneficial in the prophylaxis and treatment of thrombocytopenia, a complication of chemotherapy, according to a study published in the New England Journal of Medicine (February 6). Jay Silverman of Wertheim Schroeder told the Marketletter that this study turns the tide from the negative perception of an earlier human trial.

In this Phase I/II safety and dose-ranging trial, 53 patients receiving chemotherapy with carboplatin and Bristol-Myers Squibb's Taxol (paclitaxel) for advanced-stage (III or IV) non-small cell lung cancer, were randomized to receive either placebo or MGDF at a dose of 0.03mcg, 0.1mcg, 0.3mcg, 1.0mcg, 3.0mcg or 5.0mcg per kg per day.

In six patients (three in each group), either placebo or MGDF was injected subcutaneously every day for 10 days and this was followed by a four-day period of patient observation prior to receiving chemotherapy. Of this group, two MGDF patients and one placebo patient did not continue treatment into the post-chemotherapy stage. The three remaining patients were observed in both the preliminary phase of the study and after chemotherapy.