SAN DIEGO, CA--(Marketwire - April 25, 2012) - Lpath, Inc. (OTCBB: LPTN), the industry leader in lipidomics-based therapeutics, received official notification from the U.S. Patent and Trademark Office (USPTO) that it has been issued a key patent protecting Lpathomab™, a monoclonal antibody against lysophosphatidic acid (LPA).
The newly issued U.S. Patent No. 8,158,124 claims antibody compositions directed against LPA, a bioactive lipid that has been validated as a target in multiple disease states.
"The issuance of our first Lpathomab patent is a major milestone for Lpath and an essential step in the product's development," stated Roger Sabbadini, Lpath's founder, chief science officer and an inventor on the patent. "It provides further protection for our drug-development program that promises to solve important unmet clinical needs."
LPA is a well-validated drug target: peer-reviewed journals have established that LPA promotes tumorigenesis, metastasis and fibrotic disease and plays a significant role in neuropathic pain and in neurotrauma, including traumatic brain injury (TBI) and spinal cord injury (SCI).
Lpath and collaborators have recently shown that Lpathomab provides protection against neuronal cell death in TBI and SCI studies, where size of the injury was reduced after TBI; and behavioral function was improved after both TBI and SCI. Future studies will be directed toward examining Lpathomab's activity against a range of CNS disorders in which cell death is observed, including Alzheimer's disease and other neurodegenerative diseases.
Scott Pancoast, Lpath's president and CEO, commented: "The issuance of a composition-of-matter patent for an anti-LPA antibody significantly enhances the commercial value of our Lpathomab program. The LPA signaling pathway has been well implicated as a contributor to disease progression, and while others are intervening downstream at the LPA-receptor level, we believe the direct approach of neutralizing LPA itself has certain advantages that will prove out over time."
Lpathomab was generated using Lpath's proprietary ImmuneY2™ technology. This drug-discovery engine provides Lpath with a platform from which to generate antibodies against bioactive lipids, opening up a new array of drug-discovery possibilities. About 1,000 bioactive members of the lipidome are believed to exist, but the number could be considerably larger as the study of lipidomics continues to expand. Nature Reviews stated that bioactive lipids promise to occupy center-stage in cell biology research in the twenty-first century.
Lpath utilized ImmuneY2 to discover an antibody against another bioactive lipid, sphingosine-1-phosphate (S1P). This antibody, sonepcizumab, is formulated as iSONEP™ for ocular delivery and as ASONEP™ for systemic delivery. Both of these drug candidates will be further investigated in Phase 2 trials later this year.
San Diego-based Lpath, 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 has developed three drug candidates, two of which -- iSONEP™ for wet AMD and ASONEP™ for cancer -- have completed Phase 1 clinical trials. 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 timing of future studies; the advantages of the Company's approach (to neutralizing a drug target) versus other approaches. 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 from animal studies may not translate well in the clinic; pre-clinical toxicology and pharmacokinetic results may not support a trial in humans; the results of any future clinical trials may not be favorable and the Company may never receive regulatory approval for any of its drug candidates; the Company may not be able to secure the funds necessary to support its preclinical- and clinical-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.