Lpath, Inc.'s Scientists and Collaborators Present Favorable New Study Data of Leading Cancer Drug Candidate, ASONEP(TM)

DENVER, CO--(Marketwire - April 20, 2009) - Lpath, Inc. (OTCBB: LPTN), the category leader in bioactive-lipid-targeted therapeutics, reported convincing proof-of-principle data in a mouse model of renal cell carcinoma (RCC) for it leading cancer drug candidate, ASONEP™, and provided a status update of its ongoing Phase 1 clinical trial.

The RCC data were presented today by Rupal Bhatt, M.D., Ph.D. of the Beth Israel Deaconess Medical Center (a major Harvard Medical School affiliate) at the 100th Annual Meeting of the American Association for Cancer Research (“AACR”) in Denver, Colorado. Dr. Bhatt demonstrated that the murine (or mouse) version of ASONEP, as a single agent in naïve mice, significantly delays the progression of disease. “The single-agent results are encouraging and at least as good as what is often seen in xenograft studies with VEGF-Receptor-Tyrosine-Kinase Inhibitors (TKIs), the standard of care for treatment of RCC,” said Bhatt.

Scott Pancoast, Lpath president and chief executive officer, commented, “The results from this new study are exciting, as they suggest ASONEP could be used to treat RCC as a single agent. The market potential of such a scenario is substantial, given the two TKIs on the market -- Sutent® and Nexavar® -- generated 2008 revenues of over $1.5 billion, a level that is growing rapidly.”

Dr. Bhatt also presented evidence suggesting the pathway targeted by ASONEP could be involved in resistance to TKI therapy. Nearly all RCC patients treated with TKIs develop resistance and experience renewed progression of disease with a “mean time to disease progression” of 1.9 months after initialization of TKI treatment. Moreover, agents approved for dosing after TKI-therapy failure add another two months of progression-free survival. As such, there is a great unmet need for agents that will delay progression of renal cell cancer for longer durations of time. According to Bhatt, “Lpath’s ASONEP, which neutralizes a tumorigenic pathway that is quite distinct from the VEGF pathway, holds promise to further delay disease progression.”

Dr. James Mier, also from Beth Israel Deaconess Medical Center and a collaborator with Dr. Bhatt, said, “ASONEP has single agent activity in a renal cancer xenograft model that looks as encouraging as the results obtained with any of the available VEGF receptor antagonists.”

A separate presentation at AACR was made by Dr. Roger Sabbadini, founder and chief scientific officer of Lpath, who provided an update on the ASONEP Phase 1 clinical trial in cancer. The ASONEP trial, which is nearing completion, is testing the safety and tolerability of this first-in-class anti-cancer agent. Dr. Sabbadini noted that investigators have not reported any drug-related serious adverse events, even at the higher doses, and Lpath is now focused on which cancer types to target in its Phase 2 trials.

Lpath believes ASONEP could someday treat many of the deadliest solid and liquid tumors. ASONEP binds to and inhibits the bioactive lipid Sphingosine-1-Phosphate (S1P), which is a multifunctional mediator that can become dysfunctional and contribute directly to the pathophysiology of cancer.

About Lpath

Lpath, Inc., headquartered in San Diego, 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 Sphingosine-1-Phosphate (S1P), is currently in a Phase 1 clinical trial in cancer and also holds promise against multiple sclerosis and various other disorders. ASONEP is being developed with the support of partner Merck-Serono as part of a worldwide exclusive license. A second product candidate, iSONEP™ (the ocular formulation of the S1P antibody), has demonstrated superior results in various preclinical models of age-related macular degeneration (AMD) and retinopathy and is in a Phase 1 clinical trial in wet-AMD patients. Lpath’s third product candidate, Lpathomab™, is an antibody against Lysophosphatidic Acid (LPA), a key bioactive lipid that has been long recognized as a valid disease target (cancer, neuropathic pain, fibrosis). 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, go to www.Lpath.com