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SAN DIEGO, May 23, 2013 (GLOBE NEWSWIRE) -- Lpath, Inc. (Nasdaq:LPTN), the industry leader in bioactive lipid-targeted therapeutics,has initiated dosing in a Phase 2a single-arm trial where ASONEP™ is being investigated as a treatment for renal cell carcinoma (RCC) in subjects that have failed the standard of care treatment with FDA-approved agents that block VEGF signaling (e.g. Sutent®/sunitinib maleate) and the mTOR pathway (e.g. Afinitor®/everolimus).
Sumanta Pal, M.D., from City of Hope, Duarte, California, dosed the first subject.
ASONEP is a humanized antibody that binds to and neutralizes sphingosine-1-phosphate (S1P). S1P is a bioactive lipid that has been validated as a drug target in multiple sclerosis and that has been shown to contribute to progression of several cancer types.
Many scientific publications have concluded that S1P is a tumorigenic and angiogenic bioactive lipid that cancer cells use to escape therapy. In collaboration with Rupal Bhatt, M.D., of Beth Israel Deaconess Medical Center, Lpath has demonstrated that levels of S1P are upregulated in blood of subjects with RCC. Moreover, Dr. Bhatt has demonstrated efficacy of Lpath's anti-S1P antibodies in treating mice with human RCC tumors after they had failed treatment with Sutent.
This current proof-of-concept Phase 2 trial follows the successful completion of the ASONEP Phase 1 safety study. The Phase 1 study, conducted in subjects with solid tumors, showed that ASONEP was well tolerated across all doses, including the highest dose of 24 mg/kg. In addition, of the 21 subjects that completed the initial four treatments in the Phase 1 study over a 5-week period, 11 showed stable disease at the end of five weeks; eight had stable disease at two months, six had stable disease at three months and two were stable for longer than 12 months.
According to Datamonitor, there are currently about 225,000 new cases of renal cell cancer worldwide each year, a figure that is projected to approach 300,000 by the year 2020.