SOURCE: Lpath, Inc.

Lpath, Inc.

February 03, 2011 08:20 ET

Lpath Issued Two Key Patents Related to Lead Cancer Drug Candidate, ASONEP

Composition of Matter and a Wide Variety of Clinical Uses Are Now Protected

SAN DIEGO, CA--(Marketwire - February 3, 2011) - Lpath, Inc. (OTCBB: LPTN), the industry leader in lipidomics-based therapeutics, has received official notification from the U.S. Patent and Trademark Office (USPTO) and the European Patent Office (EPO) that Lpath was issued two key patents related to ASONEP™, one of the company's two lead drug candidates that will be studied in Phase II trials through next year.

ASONEP is a unique therapeutic antibody developed by Lpath's ImmuneY2™ drug-discovery engine designed to target bioactive signaling lipids involved in the proliferation and spread of cancer and in other diseases.

The new U.S. patent No. 7,862,812 claims methods of decreasing an immune response and treating diseases or conditions characterized by an aberrant, excessive, or undesired immune response using an antibody that inhibits a sphingolipid or sphingolipid metabolite, such as S1P.

The European patent No. 98923666.6 claims methods for early detection of heart disease, including compositions for antibodies and diagnostic kits that measure sphingolipids in blood and tissues.

Dr. Laurel Bernstein, executive director of intellectual property for Lpath, commented: "By issuing these patents, the USPTO and EPO have further validated the novelty and utility of Lpath's use of S1P-neutralizing monoclonal antibodies for the diagnosis and treatment of multiple and diverse diseases."

These awards follow two other U.S. patents granted to Lpath in November: U.S. patent No. 7,829,674, which covered claims for composition of matter of anti-S1P antibody that is differentially formulated as ASONEP and iSONEP™; and U.S. patent No. 7,169,390, which covers uses of anti-S1P antibodies in the treatment of cancer.

Lpath recently completed two early-stage clinical trials using the anti-S1P antibody: iSONEP was evaluated in a Phase I trial in wet-AMD subjects; and ASONEP was evaluated in a Phase I trial in cancer subjects.

Lpath is about to initiate two iSONEP Phase II trials, one in patients with RPE Detachment (PED), for which there is no approved drug, and another in wet-AMD patients without PED. Lpath entered into an agreement with Pfizer (NYSE: PFE) in 2010 that provides Pfizer an exclusive option for a worldwide license to develop and commercialize iSONEP. Lpath is also independently pursing two ASONEP Phase II trials in two distinct cancer indications.

According to Roger Sabbadini, Lpath's chief scientific officer and main inventor of the issued patents: "Lpath now has patent protection not only on our drug candidates, iSONEP and ASONEP, but also on the methods of use in the treatment of several ocular diseases, as well as cancer, cardiac, autoimmune, and inflammatory disorders. The strength of Lpath's patent portfolio is key to the successful commercialization of both iSONEP and ASONEP."

About Lpath's Patent Portfolio
Over the course of the company's development, Lpath has achieved a broad and deep intellectual-property position in the bioactive-lipid area. The company's comprehensive patent portfolio now includes 20 issued patents (including four international) and 105 patent applications (including 70 international). These patents primarily concern the use of reagents and methods designed to interfere with the actions of bioactive lipids involved in human disease. Lpath's intellectual-property portfolio includes compositions of matter that specifically bind to sphingolipids and sphingolipid metabolites. These agents, including antibodies, could be used in the diagnosis and treatment of various diseases and disorders, including cardiovascular and cerebrovascular disease, cancer, inflammation, autoimmune disorders, ocular disease, and angiogenesis.

Lpath has also obtained issued claims on sphingolipid targets (e.g., receptors and signaling sphingolipids) and methods for using such targets in drug-discovery screening efforts.

The company believes its patent estate provides broad, commercially significant coverage of antibodies, receptors, enzymes, or other moieties that bind to a lysolipid (or a sphingolipid metabolite) for diagnostic, therapeutic, or screening purposes.

About Lpath
San Diego-based Lpath (OTCBB: LPTN), a therapeutic antibody company, is the category leader in lipidomics-based therapeutics, an emerging field of medicine that targets bioactive signaling lipids for treating a wide range of human disease. Lpath's ImmuneY2 drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease. The company is advancing three drug candidates, two of which -- iSONEP for wet AMD and RPE Detachment and ASONEP for cancer -- will soon be studied in Phase II trials. 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 the agreement between Lpath and Pfizer will continue for any length of time or that the milestones stated in such agreement will be met. In addition, there is 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.

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