SOURCE: Lpath, Inc.

May 15, 2008 08:00 ET

Lpath's iSONEP™ IND Application Gets Green Light From FDA

Anti-Bioactive-Lipid Category Leader to Initiate Phase 1 Clinical Trial for the Use of iSONEP in Patients With AMD

SAN DIEGO, CA--(Marketwire - May 15, 2008) - Lpath, Inc. (OTCBB: LPTN), the category leader in therapeutic agents against bioactive lipids, announced the FDA, after review of the company's April 2008 Investigational New Drug (IND) submittal, has allowed Lpath to administer iSONEP™ to patients suffering from exudative AMD (age-related macular degeneration) in a Phase 1 clinical trial.

The Phase 1 protocol calls for a multi-center, open-label, single-arm, dose-escalation trial in the United States. Investigators will assess the safety and tolerability of an intravitreal injection of iSONEP in subjects with choroidal neovascularization secondary to AMD. Other endpoints include pharmacokinetics, immunogenicity, and visual acuity. Subjects will receive a single dose of iSONEP in one eye, with doses escalating from 0.2 mg to 1.8 mg.

iSONEP, generated via Lpath's proprietary ImmuneY2™ drug discovery engine, is a humanized monoclonal antibody that neutralizes sphingosine 1-phosphate ("S1P"), a bioactive lipid that contributes to the inflammation, scarring, and angiogenesis that are characteristic of exudative (or "Wet") AMD patients.

iSONEP is the first ocular drug candidate ever to target a bioactive lipid.

"Given how well iSONEP performed in a series of successful mouse, rabbit, and non-human-primate studies, we anticipate iSONEP will be safe in AMD patients at dose levels that we believe will be efficacious," said William Garland, Ph.D., Lpath's vice president of drug development.

Glenn Stoller, M.D., the head of Lpath's ocular division, stated: "Based on our own studies and on the body of S1P-related scientific literature, we propose that iSONEP deprives fibroblasts, pericytes, endothelial cells, and inflammatory cells of important growth and survival factors. By doing so, we target the multiple maladaptive processes of Wet AMD that ultimately result in the loss of photoreceptors, their supporting cells, and overall visual acuity."

Lpath's founder and chief scientific officer, Roger Sabbadini, Ph.D., added, "We believe iSONEP -- a single therapeutic agent that simultaneously addresses the multiple processes that contribute to Wet-AMD-related vision loss -- will likely have a competitive advantage over current therapeutics in the market, which address only one component of the pathology."

Although Lpath will conduct this Phase 1 trial in Wet AMD patients, the company considers iSONEP, with its multiple mechanisms of action, to be a potential treatment for a broad range of ocular diseases, including Dry AMD, diabetic retinopathy, glaucoma-related surgeries, proliferative retinopathy, and other therapeutic areas with significant unmet medical needs.

This news follows FDA authorization in February allowing Lpath to begin dosing ASONEP™ in solid-tumor cancer patients in a separate Phase 1 trial. ASONEP is also an S1P-antibody product candidate, but is formulated for systemic administration.

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™ is an antibody against S1P that is presently in Phase 1 clinical trials for the treatment of cancer and also holds promise against multiple sclerosis and various other disorders. 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 to add to its pipeline. For more information, visit www.Lpath.com.

About Forward-Looking Statements:

Except for statements of historical fact, the matters discussed in this press release are forward-looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that results will be timely, necessary regulatory approvals will be obtained, the proposed treatments will prove to be safe or effective, or required clinical trials will be ultimately successful. Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, our limited experience in the development of therapeutic drugs, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on research grants, current and future competition, and other risks described from time to time in our filings with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.

Contact Information