SBIR Grant from the National Institutes of Neurological Diseases and Stroke Provides Funds for IND-enabling Studies of Lpathomab
SAN DIEGO, May 5, 2014 /PRNewswire/ -- Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, received official notification from the National Institutes of Neurological Diseases and Stroke (NINDS) that it has been awarded a $1.7 million, 2.5-year grant to develop its antibody therapeutic, Lpathomab™, which is directed against the bioactive lipid lysophosphatidic acid (LPA) for the treatment of traumatic brain injury (TBI).
The Phase l amount of $224,000 will fund studies designed to repeat in rats the efficacy previously demonstrated (several times in mice) in a controlled-cortical-impact model of TBI. Contingent on Phase I success, Phase II funds of almost $1.5 million will be used to advance Lpathomab through safety, pharmacology, and toxicology studies needed to file an IND.
The National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Fast Track Program was created to provide grants to accelerate the transition from development stage to commercialization of innovative technologies that improve human health and advance the mission of the NIH. The program also aims to foster partnerships among a variety of R&D collaborators working toward these goals. To this end, Lpath has partnered this project with the UCLA Department of Neurosurgery and its prestigious Brain Injury Research Center with Neil Harris, Ph.D., as a co-principal investigator on the project.
"With this award, the NINDS recognizes the therapeutic potential of Lpathomab in addressing a completely unmet need as there are no FDA approved drugs for TBI treatment," said Scott Pancoast, Lpath's Chief Executive Officer.
Roger Sabbadini, Ph.D., Lpath's founder and co-principal investigator on the TBI project, commented, "Lpath is grateful to the NINDS for its generosity and for recognizing the significant value of funding further development of Lpathomab. We believe our novel approach of targeting bioactive lipids holds great promise, and this is validated by the financial commitment by the NINDS."
Lpath has experience in using NIH support to translate bioactive-lipid-targeted products into the clinic through substantial grants from the National Eye Institute for Lpath's iSONEP™ program and from the National Cancer Institute for Lpath's ASONEP™ program.
Currently, Lpath is conducting a Phase 2 clinical trial for iSONEP, which is evaluating the anti-S1P antibody's safety and efficacy in wet-AMD patients that have not responded well to the existing anti-VEGF therapies, 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 2a trial in renal cell carcinoma patients with ASONEP™, an anti-S1P antibody that is formulated for systemic delivery.
Like Lpathomab, 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 and LPA, that are involved in cancer, AMD, inflammatory and auto-immune disorders, and many other diseases.
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 Company's ability to qualify for the entire $1.7 million grant; the eventual commercial viability of any of the Company's drug programs; and the Company's ability to complete additional discovery and development activities for drug candidates. 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, including Phase 2 of the NINDS grant; 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.
Scott R. Pancoast
President and CEO
Westwicke Partners, LLC
Robert H. Uhl
SOURCE Lpath, Inc.