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Lpath plummets on Asonep RCC failure

This article was originally published in Scrip

Executive Summary

Lpath saw its share price plummet by up to 25% on news that a Phase IIa study of its anticancer candidate Asonep failed to meet the primary endpoint of progression-free survival in patients with advanced renal cell carcinoma (RCC) who had failed on at least one prior anti-vascular endothelial growth factor (VEGF) agent (e.g., Sutent) and no more than one mTOR inhibitor (e.g., Afinitor). Asonep is the systemic formulation of a first-in-class humanized antibody that binds and neutralizes the bioactive lipid, sphingosine-1-phosphate (S1P). In 2008, Merck KGaA agreed to pay Lpath $23m in upfront payments and R&D support to complete a Phase I trial of Asonep, but then decided not to extend its option agreement. Pfizer then signed an exclusive option agreement in 2010 for a worldwide license to an ocular formulation, Isonep, for wet AMD, and right of first refusal on Asonep. Phase II data with Isonep are due shortly. According Lpath, the latest data suggest that in some patients with lower risk of disease progression, Asonep may produce prolonged disease stability. It also said that a recent analysis of the expression profile of the S1P pathway suggests Asonep might perform better in other cancers where S1P pathway dysregulation plays a larger role.



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