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Lpath Granted Key U.S. Patent Related to Ocular Drug Program, iSONEP

Patent Provides Coverage for Lpath's Anti-S1P Antibody in the Treatment of a Wide Variety of Ocular Disorders, Including Wet AMD

SAN DIEGO, Jan. 22, 2014 /PRNewswire/ -- Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, received official notification from the U.S. Patent and Trademark Office that the company has been issued another key patent supporting its iSONEP™ program. The newly issued U.S. patent, No. 8,614,103, is entitled, "Compositions and Methods for Treating Ocular Conditions." It claims methods of using monoclonal antibodies (including iSONEP) that bind sphingosine-1-phosphate (S1P) in the treatment of a wide variety of ocular conditions, including wet age-related macular degeneration (AMD).

"This patent adds additional coverage in the U.S. for use of our anti-S1P antibodies in the treatment of a wide range of ocular disorders and complements another recently issued patent (US 8,444,970) and certain patent claims we have been granted in Europe (European patent No. 1 948 234) for wet AMD, cancer, and other conditions," said Roger Sabbadini, Lpath's vice president, founder, and an inventor of the issued patent. "These three patents together provide exclusivity in our pursuit of ocular disorders beyond wet AMD where we believe aberrant levels of S1P may be involved in pathogenesis of disease."

Lpath is conducting a Phase 2 clinical trial for iSONEP, the Nexus trial, which is evaluating the anti-S1P antibody's safety and efficacy in wet-AMD patients that have not responded well to existing anti-VEGF therapies including Lucentis®, Avastin® and Eylea®. 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.

Additionally, Lpath is independently conducting a Phase 2 trial in renal cell carcinoma patients with ASONEP™, an anti-S1P antibody that is formulated for systemic delivery.

Both iSONEP and ASONEP are first-in-class therapeutics developed using 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 cancer, AMD, inflammatory and auto-immune disorders, and many other diseases.

About Lpath's Patent Portfolio
Lpath has achieved a broad and deep intellectual property position in the bioactive-lipid area and t its comprehensive patent portfolio now includes 29 issued patents and 27 patent applications in the U.S., with corresponding international patents and applications. These patents primarily relate to 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 coverage of compositions of matter that specifically bind to sphingolipids and sphingolipid metabolites. These compositions, 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 patent 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 portfolio provides broad and 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, Inc. (NASDAQ: LPTN), an antibody-platform company, is the category leader in lipid-targeted therapeutics. The company'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 four drug candidates, two of which—iSONEP for wet AMD and ASONEP for cancer—are currently being investigated in Phase 2 trials. The other candidates are an anti-LPA antibody, Lpathomab, that is currently in IND-enabling studies for neuropathic pain and neurotrauma and an anti-leukotriene antibody, Altepan, which is being studied in models of respiratory disease. 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 the Company's preclinical studies and clinical trials may not support further clinical development and/or the commercialization of its drug candidates; the Company may not successfully complete additional clinical trials for its product candidates on a timely basis, or at all; the Company may fail to obtain required governmental approvals for any of its drug candidates; the Company may not be successful in maintaining its commercial relationship with Pfizer Inc. or any third party that acquires Pfizer's exclusive option to iSONEP; and the Company may not be able to secure the funds necessary to support its preclinical-development and clinical-development plans. More detailed information about the risk factors and uncertainties that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (the "SEC"), including its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q, and its other filings with the SEC. Such documents may be read free of charge on the SEC's website 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.

CONTACT:


Scott R. Pancoast


President and CEO


Lpath, Inc.


858-926-3200


[email protected] 




INVESTOR CONTACTS:


Westwicke Partners, LLC


Stefan Loren, Ph.D. 

 Robert H. Uhl

Managing Director 

 Managing Director

(443) 213-0507 

 (858) 356-5932

[email protected]

 [email protected]

SOURCE Lpath, Inc.

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