Genaera Begins Phase 1b Trial of Trodusquemine (MSI-1436) in Overweight and Obese Type 2...( PLYMOUTH MEETING Pa. Dec. 1 /- Genae...),Health

PLYMOUTH MEETING, Pa., Dec. 1 /PRNewswire-FirstCall/ --Genaera Corporation (Nasdaq: GENR) today announced that dosing of subjects has begun in study MSI-1436C-102 (Study 102), the multiple ascending dose Phase 1b study of trodusquemine (MSI-1436) in overweight and obese type 2 diabetics. MSI-1436 is a novel therapeutic for the treatment of type 2 diabetes and obesity which works centrally and peripherally to regulate insulin and leptin pathways through the highly selective inhibition of its novel target enzyme, PTP-1B.

Study 102 will establish multiple dose pharmacokinetics (PK) and expand the safety database for MSI-1436 in a population of overweight and obese adult type 2 diabetic subjects who are poorly controlled on metformin. The study will also evaluate key secondary outcomes in this population, including oral glucose tolerance and insulin sensitivity, satiety and weight loss.

"We hope that Study 102 will help establish proof-of-concept for MSI-1436 as a highly competitive treatment for both type 2 diabetes and obesity with a single drug," said Jack Armstrong, President and Chief Executive Officer of Genaera. "In two previous Phase 1 studies, single doses of MSI-1436 administered to over 60 subjects were well-tolerated with an acceptable adverse event profile, exhibited linear PK, produced dose-dependent weight loss and improved insulin sensitivity. We expect the multiple dose data from Study 102 to verify the exciting potential and positive efficacy results of this drug."

Study 102 is a double-blind, randomized, placebo-controlled, safety and PK study being conducted at two U.S. sites. The study will initially enroll 21 subjects at three dose levels (3, 6, and 10 mg/m2) of MSI-1436 with treatment occurring every three days over a 23 day period. Five subjects in each dosing group will receive
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