Anti-S1P Antibody Treatment Produces Near-Complete Mitigation Of Choroidal Neovascularization In AMD Model

Main Category: Eye Health / Blindness
Article Date: 09 Oct 2008 - 4:00 PDT

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Lpath, Inc. (OTCBB: LPTN) announced it has published two papers showing the role of sphingosine-1-phosphate (S1P) in ocular disorders. Dr. Maria Grant's laboratory at the University of Florida collaborated with Lpath on both papers.

The papers present compelling proof-of-concept data that Lpath's therapeutic anti-S1P antibody, iSONEP(TM), can mitigate not only choroidal neo-vascular (CNV) lesions but also fibrotic lesions in a standard animal model of human exudative (or "wet") AMD.

The results were published online ahead of print in the journal Experimental Eye Research.

The first paper, titled "Anti-sphingosine-1-phosphate monoclonal antibodies inhibit angiogenesis and sub-retinal fibrosis in a murine model of laser-induced choroidal neovascularization," shows how iSONEP almost completely mitigated the CNV lesions produced by laser-induced choroidal damage in a mouse model that mimics the pathologic neovascularization experienced by patients with wet AMD. Both the murine form and the humanized form of the anti-S1P antibody were effective in nearly eliminating the lesions.

The paper also revealed sub-retinal fibrosis was reduced in the lesions. This ability of iSONEP to mitigate fibrotic lesions was consistent with a companion paper entitled "Sphingosine-1-phosphate (S1P) is a novel fibrotic mediator in the eye," which presents how S1P, the molecular target of iSONEP, not only was produced by ocular cells, but in fact acted on those cells to promote fibrotic responses responsible for scarring.

"This is the first published paper demonstrating that S1P is a mediator of CNV in an AMD model," said Glenn Stoller, MD, head of Lpath's Ocular Division. "The results illustrate that antibody-mediated inhibition of S1P may be highly effective in preventing abnormal-blood-vessel growth and fibrosis beneath the retina."

Scott Pancoast, Lpath's president and CEO, added, "This near-complete mitigation of CNV establishes compelling pre-clinical efficacy for iSONEP. Inhibition of S1P is a novel approach to treating AMD, and it provides additional mechanisms of action as compared with the category-leading anti-VEGF compounds and the newer experimental versions under development at various pharmaceutical and biotech companies. Moreover, this anti-fibrotic mechanism opens the door to a host of other ocular indications, including glaucoma-related surgeries, proliferative vitreo-retinopathy, and various anterior-segment diseases."

Lpath has received approval from the FDA to commence a Phase 1 clinical trial with iSONEP in wet AMD patients, which is scheduled to begin soon.

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(TM) 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(TM) (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(TM), 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(TM) drug-discovery engine, which the company is leveraging to add to its pipeline. For more information, visit http://www.Lpath.com.

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 Lpath's 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 Lpath's operations and business environment, including, without limitation, its limited experience in the development of therapeutic drugs, its dependence upon proprietary technology, its history of operating losses and accumulated deficits, its reliance on research grants, current and future competition, and other risks described from time to time in the company's filings with the Securities and Exchange Commission. Lpath 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.

Lpath, Inc.