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    Lpath Inc. surged 66% over the last month on solid progress of iSONEP trials

    Shares of Lpath Inc. (OTC BB: LPTN) reached $0.93 yesterday, up 66% since September 8 low of $0.56. The huge recovery came after the company announced encouraging results from its phase 1 trial with iSONEP and concluded that iSONEP holds potential as a novel therapy for wet AMD and RPE detachment. In addition, the company is soon to announce the grant plan for 2011 and there are speculations that LPTN could report a research partnership with a big pharmaceutical company. The daily trading activity for LPTN has improved by more than 50% over the last month, when compared to the average for the last three months, and reached 45,000 shares.

    LPTN is a research and development company involved in lipid-based therapeutics, an emerging field of medical science whereby bioactive signaling lipids are targeted for treating important human diseases. The company’s ability to generate antibodies against bioactive lipids is based on its proprietary ImmuneY2™ drug-discovery engine. LPTN is currently applying the ImmuneY2™ technology to important bioactive lipid targets, many of which are involved in important disease processes (e.g. inflammation, cancer, pain, asthma, sepsis and others) thereby building it pipeline of novel antibody-based drug candidates.

    The company’s leading product candidate, ASONEP™, is a monoclonal antibody against a validated cancer target, sphingosine-1-phosphate (S1P) that has completed enrollment in a phase I clinical trial in cancer patients, where it was deemed well tolerated at dose levels up to 24 mg/kg. ASONEP™ is potently anti-angiogenic, yet it has other mechanisms of action that may prove advantageous in the clinical setting. As such, LPTN believes ASONEP™ may represent the next generation of anti-angiogenesis-based therapeutics.

    The company’s second product candidate, iSONEP™, has completed a phase I clinical trial in wet AMD patients. iSONEP has met its primary endpoint of being well tolerated in all 15 patients at dose-levels ranging from 0.2 mg. to 1.8 mg. per intravitreal injection. iSONEP has also succeeded in meeting a critical secondary endpoint in that positive biological effects were observed in an encouraging number of patients. iSONEP™ has also demonstrated excellent results in various preclinical AMD models and first-in-class results in a preclinical model of diabetic retinopathy.

    Over the next 12 months, LPTN is planning to commence a 20-patient phase 1b/2a iSONEP trial in patients with RPE Detachment, a persistent complication in patients with the occult form of Wet AMD. Of the 15 patients in the phase 1 iSONEP trial for Wet AMD, two patients were diagnosed with RPE Detachment. With only a single dose of iSONEP, both of these patients experienced complete resolution of the condition — neither Lucentis® nor Avastin® produces this type of clinical benefit with a single dose (typically, they will not resolve the condition with 12 or more monthly injections).

    LPTN’s third product candidate, Lpathomab™, is a monoclonal antibody against lysophosphatidic acid (LPA), a key bioactive lipid that has long been recognized as a significant promoter of cancer-cell growth and metastasis, fibrosis and neuropathic pain. To date, Lpathomab has demonstrated strong preclinical activity in several animal models of these diseases.

    Going further, LPTN is planning a larger phase 1a/2b iSONEP trial in Wet-AMD patients with some form of occult disease. In order to secure the cash flows needed to continue research, LPTN is considering out-licensing certain rights to iSONEP. To date, LPTN reported negotiations with potential partners to out-license the rights to ASONEP and Lpathomab and is expecting the results of confirmatory animal studies to report the progress of these negotiations.

    If successful, the Company would generate the necessary cash flows to continue phase 1/2 trials with iSONEP and to initiate other preclinical trials and leverage its ImmuneY2™ drug-discovery engine. The eventual partnerships and the grant program announcements could add significantly to LPTN valuation.

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