SAN DIEGO, CA--(Marketwire -08/15/11)- Lpath, Inc. (OTC.BB: LPTN.OB - News), the industry leader in lipidomics-based therapeutics, announced the Type 1 Diabetes Preclinical Testing Program of the National Institutes of Health (NIH) will provide financial support for the further study of Lpathomab's efficacy in animal models of disease, particularly diabetic neuropathy.
"Bristol Myers Squibb's recent $325 million acquisition of Amira, whose lead program is an LPA-receptor antagonist with Phase 1 results, underscores the potential value of a compound that neutralizes the LPA signaling pathway," said Lpath's CEO Scott Pancoast. "With assistance from the NIH for neuropathic pain and from various partners/collaborators for other central-nervous-system disorders and for fibrosis, we believe we can generate compelling data that validates Lpath's unique approach to neutralizing LPA with Lpathomab."
As a monoclonal antibody, Lpathomab functions like a 'molecular sponge' that binds to and neutralizes the bioactive lipid signaling molecule, lysophosphatidic acid (LPA), thus silencing LPA receptors associated with the transmission of pain through the nervous system. Lpathomab was generated using Lpath's proprietary ImmuneY2™ technology.
In collaboration with researchers at the University of California, San Diego (UCSD), Lpath has generated impressive data -- and reproduced those results -- in a well-recognized animal model of diabetes in which significant pain relief was observed in diabetic rats after Lpathomab treatment.
NIH's Division of Diabetes, Endocrinology & Metabolic Diseases (NIDDK) granted this new award, which will provide NIH contract resources to conduct in vivo studies in diabetic neuropathy where diabetic rats will be treated with Lpathomab. Diabetic peripheral neuropathy (DPN) is the most common long-term complication of diabetes mellitus and is experienced by the majority of patients. Among those with either type I or type II diabetes, about 50% experience DPN. Patients with DPN often experience debilitating pain symptoms that affect day-to-day functioning and quality of life. In addition, many patients with DPN-related pain do not respond adequately to any treatment option currently available; thus there is a strong unmet need to develop new, more efficacious drugs.
According to Roger Sabbadini, Lpath's chief scientific officer: "NIDDK's commitment to our development of this novel anti-LPA antibody in diabetic pain reflects the potential of this drug to meet this significant unmet need. These studies could lead eventually to a therapeutic agent that would alleviate pain and suffering that afflicts millions of diabetic patients."
About Lpathomab and Lpath's proprietary ImmuneY2™ technology
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 an entire 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.
It is important to note that no other company or research institution has demonstrated a similar capability to generate monoclonal antibodies against lipids and that Lpath has intellectual property surrounding the technology.
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 successfully completed Phase 1 trials. Lpath entered into an agreement with Pfizer (NYSE: PFE - News) 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 Type 1 Diabetes Preclinical Testing Program (T1D-PTP)
The NIDDK recently established the T1D-PTP program to provide investigators with access to the established facilities and expertise needed to extend, enhance, and validate preclinical studies of promising new therapeutics in the diabetes arena -- see www.t1diabetes.nih.gov/T1D-PTP.
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 eventual commercial viability of the Company's drug programs and the eventual revenues and profitability that the Company would attain if the drug eventually gets approved. 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 preclinical and clinical trials may not be favorable, and the Company may never receive regulatory approval for any of its drug candidates; and 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.