SOURCE: Lpath, Inc.

Lpath, Inc.

October 05, 2011 08:31 ET

Lpath Granted Two Additional U.S. Patents Related to iSONEP and ASONEP Drug Programs

New U.S. Patents Provide Added Protection on Compositions of Matter for Anti-S1P Antibody Therapeutics and Methods of Treating Cancer, as Well as Cardiovascular and Cerebrovascular Disease

SAN DIEGO, CA--(Marketwire - Oct 5, 2011) - Lpath, Inc. (OTCBB: LPTN), the industry leader in lipidomics-based antibody therapeutics, received official notification from the U.S. Patent and Trademark Office (USPTO) that Lpath has been issued two further patents to add to its expanding patent portfolio, which has grown now to 20 issued U.S. patents.

These newly issued patents, US 8,025,877 and US 8,026,342, claim methods and composition of matter for Lpath's anti-Sphingosine-1-Phosphate (S1P) antibody, sonepcizumab, the active component in Lpath's two lead compounds, iSONEP™ and ASONEP™. These patents cover the amino acid sequences of the light and heavy chains of sonepcizumab, and also have claims for the treatment of cancer, as well as cardiovascular and cerebrovascular disease.

iSONEP and ASONEP are different formulations of a first-in-class therapeutic antibody developed by Lpath's ImmuneY2™ drug-discovery engine. Antibodies developed via this discovery engine are designed to target bioactive signaling lipids, such as S1P, that are involved in the proliferation and spread of cancer, age-related macular degeneration (AMD), inflammatory and auto-immune disorders, and many other diseases.

Lpath recently completed two early-stage clinical trials using the two anti-S1P antibody formulations: 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 now moving forward with two iSONEP Phase 2 trials: the already-initiated PEDigree Study is evaluating the safety and efficacy of iSONEP in patients with RPE Detachment (PED), for which there is no approved drug, and the soon-to-begin Nexus Study will evaluate the safety and efficacy 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.

In addition, Lpath plans to initiate next year an ASONEP Phase 2 trial in renal cell carcinoma patients.

According to Roger Sabbadini, Lpath's chief scientific officer and main inventor of the issued patents, "These issued patents further expand Lpath's patent portfolio and thereby provide additional protection for our two lead programs in wet AMD and cancer, as well as cardiovascular-disease indications."

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 arena. The company's comprehensive patent portfolio now includes 25 issued patents (including 5 international) and 132 patent applications (including 87 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 ocular disease, inflammation, autoimmune disorders, cancer, angiogenesis, and cardiovascular and cerebrovascular disease.

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

About Lpath
San Diego-based Lpath, a therapeutic antibody company, is the category leader in lipidomics-based antibody 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 has developed three drug candidates, one of which (iSONEP™ for wet AMD) has initiated mid-stage clinical trials and another of which (ASONEP™ for cancer) will soon begin mid-stage clinical trials. The third candidate is a pre-clinical anti-LPA antibody, which has shown efficacy in models of pain, fibrosis, and traumatic brain injury. 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. For more information, visit www.Lpath.com.

About Forward-Looking Statements
The Company cautions you that the statements included in this press release that are not a description of historical facts are forward-looking statements. These include statements regarding: the protection against competition afforded by issued patents; the eventual commercial viability of the Company's drug programs; and the Company's ability to complete additional discovery and development activities for drug candidates utilizing its proprietary ImmuneY2 drug discovery process. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the Company's business, including, without limitation: the results of any future clinical trials for iSONEP or ASONEP may not be favorable, and the Company may never receive regulatory approval for iSONEP, ASONEP or any of its drug candidates; and the Company may not be able to secure the funds necessary to support its clinical-trial and product-development plans. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q filed. Such documents may be read free of charge on the SEC's web site at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

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