Lpath Receives Key European Patent Related to Isonep Drug Program

Lpath, Inc. LPTN, the industry leader in bioactive lipid-targeted therapeutics, received official notification from European Patent Office (EPO) that the company has been issued a key patent covering monoclonal antibodies against sphingosine-1-phosphate (S1P), including sonepcizumab(TM). S1P is a bioactive lipid that has been validated as a target in multiple disease states. This newly granted patent, European patent No. 1 948 234, claims, among other things, humanized monoclonal antibodies directed against S1P for use in treating a wide range of ocular conditions, including age-related macular degeneration (AMD), diabetic retinopathy and others. ASONEP(TM) and iSONEP(TM) are different formulations of sonepcizumab, a first-in-class therapeutic antibody against S1P developed by Lpath's ImmuneY2(TM) drug-discovery engine. Antibodies developed via this discovery engine are designed to target bioactive signaling lipids, such as S1P, that are involved in the proliferation and spread of cancer, AMD, inflammatory and auto-immune disorders, and many other diseases. Lpath recently completed two early-stage clinical trials using the two anti-S1P antibody formulations: iSONEP was evaluated in a Phase 1 trial in wet-AMD subjects, and ASONEP was evaluated in a Phase 1 trial in cancer subjects. Lpath has initiated a Phase 2 clinical trial for iSONEP, called Nexus, which is evaluating the anti-S1P antibody's safety and efficacy in wet-AMD patients. Lpath entered into an agreement with Pfizer PFE in 2010 that provides Pfizer an exclusive option for a worldwide license to develop and commercialize iSONEP. Lpath is also independently pursuing an ASONEP Phase 2 trial in renal cell carcinoma and will open this trial soon. Lpath was also recently granted a Russian patent (2009120052) and a U.S. patent (8,222,373) with composition and methods claims relating to sonepcizumab.