Lpath, Inc. Granted Key European Patent Related To iSONEP And ASONEP Programs
SAN DIEGO, Oct. 20, 2014 /PRNewswire/ -- Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, received official notification from the European Patent Office that the company has been granted another key patent supporting its iSONEP and ASONEP programs.
This newly issued patent, European patent No. 2087002, claims compositions of matter related to sonepcizumab, the drug substance in Lpath's two lead compounds, iSONEP and ASONEP. Sonepcizumab is an antibody that binds to and inhibits sphingosine-1-phosphate (S1P), a bioactive lipid that has been validated as a target in multiple disease states.
Specifically, this patent claims antibody compositions and nucleic acids encoding heavy and light chains of antibodies and antibody fragments to S1P, as well as engineered plasmids and host cells designed to express a humanized monoclonal antibody to S1P. Utility claims are also granted for using anti-S1P antibodies to treat neovascularization, angiogenesis, endothelial-cell proliferation, and fibrogenesis.
iSONEP (formulated for ocular administration) and ASONEP (formulated for systemic administration) 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 bind and neutralize 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.
"This patent provides key coverage in Europe for use of our anti-S1P antibodies and complements our other recently issued patents in the U.S. as well as patent claims we have been granted in Europe for wet AMD, cancer, and other conditions," said Roger Sabbadini, Lpath's vice president, founder, and an inventor of the issued patent.
Lpath is conducting a double-blind, four-arm Phase 2 clinical trial (the "Nexus" trial), which is evaluating iSONEP's safety and efficacy in wet-AMD patients that have not responded well to existing anti-VEGF therapies (Lucentis®, Avastin® and Eylea®). Lpath entered into an agreement with Pfizer in 2010 that provides Pfizer an exclusive option for a worldwide license to develop and commercialize iSONEP.
Additionally, Lpath is conducting a Phase 2a trial in renal cell carcinoma patients with ASONEP; results thus far have been encouraging and suggest that additional efficacy studiesin renal cell carcinoma and/or other tumor typesare warranted.
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 whichiSONEP for wet AMD and ASONEP for cancerare currently being investigated in Phase 2 trials. The other candidates are an anti-LPA antibody, Lpathomab, a soon-to-be Phase 1 compound for neuropathic pain and neurotrauma and an anti-leukotriene antibody, Altepan, which is being studied in models of respiratory disease and inflammation. 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.
SOURCE Lpath, Inc.