SOURCE: Lpath, Inc.

November 13, 2008 09:59 ET

Promising Proof-of-Concept Data for Lpath's Ocular Drug Candidate iSONEP™ Published

Prominent Clinician's Findings Broaden Potential of iSONEP Beyond Wet AMD to Include Possible Advantages in Diabetic Retinopathy and Dry AMD

SAN DIEGO, CA--(Marketwire - November 13, 2008) - Lpath, Inc. (OTCBB: LPTN) today announced that the laboratory of Peter Campochiaro, MD at Johns Hopkins University School of Medicine(1) recently published peer-reviewed findings of a research study of iSONEP™, Lpath's Phase 1 anti-S1P antibody, demonstrating promising results in various animal models of ocular disorders.

The findings of the study appeared online ahead of print in the Journal of Cellular Physiology (http://www3.interscience.wiley.com/journal/121402497/abstract).

The paper, titled "Blockade of Sphingosine-1-Phosphate Reduces Macrophage Influx and Retinal and Choroidal Neovascularization," presents preclinical proof-of-concept data that Lpath's iSONEP (1) mitigates blood vessel growth in the choroidal layer of the eye; (2) reduces formation of new blood vessels in the retina following retinal ischemia; and (3) suppresses the infiltration of macrophages, an important inflammatory response that is thought to contribute to the pathology of diabetic retinopathy and, possibly, the onset or exacerbation of dry AMD (age-related macular degeneration).

The authors suggest iSONEP could be promising in the treatment of diabetic retinopathy, the most significant cause of vision loss in working-age adults in developed countries.

The paper adds to the body of evidence that S1P, which iSONEP binds to and neutralizes, may have both independent and overlapping effects with VEGF and is therefore a particularly appealing ocular target. Because of this, the authors argue, iSONEP may provide a more optimal therapy for wet AMD when administered in combination with Lucentis® or Avastin®.

Among other findings, the paper reveals that intra-vitreal injections of iSONEP in 22 Cynomolgus monkeys did not cause identifiable toxicities at dose levels of 0.25mg (n=6), 0.70mg (n=6), and 1.80mg (n=10) per eye.

"This is the first published paper demonstrating that S1P is a mediator of key inflammatory processes in the eye," said Glenn Stoller, MD, head of Lpath's ocular division. "This anti-inflammatory mechanism of iSONEP appears to hold great promise for the treatment of diabetic retinopathy and possibly for dry AMD, representing two of the largest unmet medical needs in ophthalmology today."

Scott Pancoast, Lpath's president and CEO, added, "These study results, in combination with those recently published in Experimental Eye Research, demonstrate iSONEP's broad-ranging mechanisms of action in the eye. We believe that iSONEP may provide a comparative advantage in the treatment of various ocular diseases and that it represents a significant market opportunity for Lpath."

(1) Dr. Campochiaro, who holds the Eccles Professorship of Ophthalmology at Johns Hopkins University, is a member of Lpath's Ocular Advisory Board. He does not hold shares of Lpath stock, nor does he have any stock options. The studies described above were funded by Lpath. Participation by Dr. Campochiaro's laboratory in these studies does not constitute or imply endorsement by the Johns Hopkins University or any affiliation thereof.

Lucentis® and Avastin® are registered trademarks of Genentech, Inc.

About Lpath

Lpath, Inc., headquartered in San Diego, California, is the category leader in bioactive-lipid-targeted therapeutics, an emerging field of medical science whereby bioactive signaling lipids are targeted for treating important human diseases. ASONEP™, an antibody against S1P, is currently in Phase 1 clinical trials for the treatment of cancer and also holds promise against multiple sclerosis and various other disorders. ASONEP is being developed with the support of our partner, Merck-Serono. A second product candidate, iSONEP™ (the ocular formulation of the S1P antibody), has demonstrated superior results in various preclinical AMD and retinopathy models and has received FDA authorization to begin Phase 1 clinical trials. Lpath's third product candidate, Lpathomab™, is an antibody against LPA, a key bioactive lipid that has been long recognized as a valid disease target (fibrosis, cancer, neuropathic pain). The company's unique ability to generate novel antibodies against bioactive lipids is based on its ImmuneY2™ drug-discovery engine, which the company is leveraging as a means to expand its pipeline. For more information, visit www.Lpath.com.

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