SAN DIEGO, CA--(Marketwire - March 22, 2013) - Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, received official notification from the European Patent Office (EPO) and the U.S. Patent and Trademark Office (USPTO) that the company has been issued three key patents.
The patents cover methods of detecting sphingolipid levels, as well as covering monoclonal antibodies, including ASONEP™ and iSONEP™, that bind to and neutralize sphingosine-1-phosphate (S1P). S1P is a bioactive lipid that has been validated as a target in multiple disease states.
The newly issued U.S. patent, No. 8,361,465, claims ASONEP and fragments of ASONEP for the treatment of cancer in combination with chemotherapeutic agents and optionally surgery or radiation therapy.
European patent No. EP 1 812 797 claims anti-S1P antibodies for use in treating a wide range of hyperproliferative disorders, including cancer, tumor angiogenesis, age-related macular degeneration (AMD), cardiac failure, inflammation, and scarring. Claims are also granted in Europe for anti-S1P antibodies in combination with other treatments.
A third patent, EP 2 027 142, was also granted in Europe. It has claims to reagents and methods useful in diagnostic tests for detecting and measuring certain sphingolipid levels in clinical tissue or bodily fluid samples. Many scientific publications have suggested that S1P is a tumorigenic and angiogenic bioactive lipid that cancer cells use to escape therapy. In collaboration with Dr. Rupal Bhatt of Beth Israel Deaconess Medical Center, Lpath has demonstrated that levels of S1P are upregulated in blood of patients with renal cell carcinoma (RCC). Moreover, Dr. Bhatt has demonstrated efficacy of Lpath's anti-S1P antibodies in treating mice with human RCC tumors.
"In addition to previously issued Lpath patents, these key patents provide additional exclusivity for ASONEP in the U.S. for cancer, as well as exclusivity for all anti-S1P antibodies in Europe for wet AMD," said Roger Sabbadini, Lpath's vice president, founder, and an inventor of the granted patents. "Lpath will continue to pursue other disease indications and corresponding intellectual property in the future."
ASONEP™ and iSONEP™ are different formulations of sonepcizumab, a first-in-class therapeutic antibody against S1P 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.
Lpath has initiated a Phase 2 clinical trial for iSONEP, called Nexus, which is evaluating the anti-S1P antibody's safety and efficacy in wet-AMD patients. 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 is independently conducting an ASONEP Phase 2 trial in RCC patients, which is currently open for enrollment.
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 35 issued patents (including ten international) and 112 patent applications (including 85 international). 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.
San Diego-based Lpath, Inc., a therapeutic antibody company, is the category leader in lipid-targeted therapeutics. The company's ImmuneY2™ drug-discovery engine has the unique ability to generate monoclonal antibodies that bind to and inhibit bioactive lipids that contribute to disease. The company is developing three drug candidates: iSONEP™ is being studied in a Phase 2 trial in wet AMD patients; ASONEP™ is being studied in a Phase 2 trial in renal cell carcinoma patients; and Lpathomab is a preclinical drug candidate that holds promise in pain, neurotrauma, and other diseases. 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 outcome of the final analyses of the data from the Phase 1 clinical trial may vary from the Company's initial conclusions; 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 or ASONEP or any of its drug candidates; and the Company's 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 with the SEC. 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.