Sphingomab: Phase Ib discontinued

Lpath and partner Pfizer Inc. (NYSE:PFE, New York, N.Y.) agreed to discontinue the Phase Ib PEDigree trial of iSONEP to focus on the Phase IIa Nexus trial in PED secondary to wet age-related macular degeneration (AMD). Lpath said that under the amended terms of its deal with Pfizer, Lpath can elect to continue the PEDigree trial at any time but would be responsible for any related costs. Lpath and Pfizer will continue to share costs for other trials of iSONEP. Lpath expects to complete the Nexus trial in 1Q14.

In September, Lpath resumed dosing of patients in the NEXUS trial after FDA lifted a clinical hold on iSONEP. FDA placed the hold after Lpath's fill/finish contractor, Formatech Inc. (Andover, Mass.), did not meet cGMP requirements. Lpath subsequently used a different fill/finish contractor to manufacture new product. At the time, Lpath said it "deprioritized" the PEDigree trial. The Nexus trial is comparing monthly intravitreous injections of 4 mg iSONEP alone and 0.5 or 4 mg iSONEP plus 1.25 mg Avastin bevacizumab or 0.5 mg Lucentis ranibizumab vs. Avastin or Lucentis alone for 4 months in 160 wet AMD patients (see BioCentury, Jan. 30 & Sept. 3). ...