BioCentury
ARTICLE | Clinical News

Sphingomab: Phase Ib halted

January 30, 2012 8:00 AM UTC

Lpath suspended dosing in the Phase Ib PEDigree and Phase IIa Nexus trials because its fill/finish contractor, Formatech Inc. (Andover, Mass.), did not meet cGMP requirements. Lpath said the move is precautionary and it has received no reports of safety concerns associated with iSONEP. The company identified an alternative fill/finish contractor and plans to resume dosing in both trials within 4-6 months. Pfizer Inc. (NYSE:PFE, New York, N.Y.) has an option to license exclusive, worldwide rights to iSONEP following completion of the trials (see BioCentury, Jan. 3, 2011).

The open-label, U.S. PEDigree trial is evaluating up to 3 monthly intravitreous injections of 0.5 or 2 mg iSONEP in about 32 patients who have PED secondary to wet age-related macular degeneration (AMD) or polypoidal choroidal vasculopathy (PCV). ...