Lpath Awarded Department of Defense Grant for Traumatic Brain Injury Pain Study

SAN DIEGO, June 20, 2016  -- Lpath, Inc. (LPTN), the industry leader in bioactive lipid-targeted therapeutics, has been awarded a $1.45 million two-year grant by the Defense Medical Research and Development Program (DMRDP), an agency of the U.S. Department of Defense (DoD). This grant will support the study of Lpathomab for the treatment of neuropathic pain associated with traumatic brain injury (TBI). Lpath is working with Professor David Yeomans, Ph.D. of Stanford University's Department of Anesthesia on this project and he will serve as co-principal investigator.

 

This DoD grant will fund preclinical studies designed to evaluate the ability of Lpathomab to alleviate pain following neurotrauma, and to confirm the potential efficacy of Lpathomab as previously demonstrated by Stanford University researchers in an animal model of TBI pain.

Roger Sabbadini, Ph.D., Lpath's founder and co-principal investigator on the TBI project, commented, "Lpath is grateful to the DoD 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 from the DoD's DMRDP."

 

Lpath has recently completed a Phase 1a double-blind, placebo-controlled, single ascending dose study to evaluate the safety and tolerability of Lpathomab in healthy volunteers. Lpathomab was tolerated at all doses tested, and no serious adverse events or dose limiting toxicities were observed.

 

Dario Paggiarino, M.D., Lpath's senior vice president and chief development officer commented, "Now that Lpath has successfully demonstrated safety and tolerability of Lpathomab in healthy volunteers, we anticipate testing Lpathomab in patients with neuropathic pain. The preclinical demonstration of Lpathomab's potential efficacy in TBI pain could support another important indication for further investigation."

 

Lpathomab is a first-in-class, humanized monoclonal antibody targeting lysophosphatidic acid (LPA), which has been shown in the literature to be important in conditions of neuronal injury. Lpathomab was discovered using Lpath's internal drug-discovery engine and antibodies developed via this discovery engine are designed to target bioactive signaling lipids that are involved in neuropathic pain, neurotrauma, cancer, inflammatory disorders, and other diseases.

 

Defense Health Program, Defense Medical Research and Development Program (DMRDP)

 

This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Defense Medical Research and Development Program (DMRDP), the Clinical and Rehabilitative Medicine Research Program, Neurosensory and Rehabilitation Research Award (under Award No. W81XWH-16-1-0098). Opinions, interpretations, conclusions and recommendations are those of the investigators and their organizations and not necessarily endorsed by the Department of Defense. In conducting research using animals, the investigators adhere to the laws of the United States and regulations of the Department of Agriculture. The objectives of the DMRDP are to discover and explore innovative approaches to protect, support, and advance the health and welfare of military personnel, families, communities, and the general public; to accelerate the transition of medical technologies into deployed products.

 

The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office.

 

About Lpath

 

San Diego-based Lpath, Inc. (LPTN) 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 and inhibit bioactive lipids that contribute to disease. The company has developed three drug candidates, has advanced all three into clinical trials, and built evidence to support its approach of targeting bioactive lipids to treat a wide range of diseases. For more information, visit www.lpath.com.

 

About Forward-Looking Statements

 

Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements include but are not limited to, statements regarding the Company's development plans, potential therapeutic uses for its drug candidates, including Lpathomab, and the Company's ability to successfully complete the project funded by the DMRDP or to commence further clinical trials of its 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 Company may be unable to complete a strategic transaction or secure the funds necessary to support its future operations or its preclinical-development and clinical-development plans beyond the third quarter of 2016, on a timely basis or at all; the final results of the Company's preclinical studies and clinical trials may be different from the Company's studies or interim clinical data results and may not support further clinical development and/or the commercialization of its drug candidates; the Company may not successfully complete its existing and any additional clinical trials for its drug candidates, or the project funded by the DMRDP, on a timely basis, or at all; the Company may not be successful in maintaining its listing on The NASDAQ Capital Market, which could seriously harm the liquidity of our stock and our ability to raise capital or complete a strategic transaction; the Company's current product candidate portfolio is limited and in the early stages of clinical development, which could limit its ability to raise the funds required to support its operations and the future development of its drug candidates; and the Company may fail to obtain required governmental approvals for any of its drug candidates. 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 (SEC), including its Annual Report on Form 10-K filed with the SEC on March 22, 2016. 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.