Lpath and Walter Reed Army Institute for Research Begin Efficacy Study Using Lpathomab in Traumatic Brain Injury Models

SAN DIEGO, April 23, 2014 /PRNewswire/ -- Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, and scientists from the Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research (WRAIR), have initiated a study that is the focus of a collaborative research agreement.

The collaboration involves the use of Lpathomab™,  an antibody to lysophosphatidic acid (LPA), in the treatment of brain injury induced by blast overpressure. The investigators at WRAIR are Dr. Joseph Long, a U.S. Army civilian and Chief, Blast Induced Neurotrauma Branch Center for Military Psychiatry and Neuroscience at WRAIR, and Dr. Peetthambaran Arun, from Clinical RM, both of whom have published widely in the area.

The use of improvised explosive devices and hand-held grenades in recent wars has increased the incidence of blast traumatic brain injury (TBI), which  is a major cause of disability among service members. The prevalence of concussions in soldiers returning from Iraq or Afghanistan has been estimated at approximately 19.6%, and accounts for 150,000 casualties. Blast TBI is the leading source of long-term rehabilitation problems suffered by veterans (e.g. Post-Traumatic Stress Disorder, or PTSD) and is a leading cause of death in military personnel after returning home from theatre. There are currently no FDA-approved drug treatments for any form of TBI. 

Lpathomab works as a molecular sponge by soaking up LPA, a molecule that can damage neurons and promote dangerous inflammatory responses in the central nervous system. Lpath and collaborators recently published work showing that Lpathomab reverses much of the damage caused by trauma to the nervous system in a controlled cortical-impact model of TBI in mice (Journal of Neuroinflammation vol 11(1):37). The Lpath-WRAIR collaboration will extend those studies to determine if Lpathomab can be used to reduce the size of a blast TBI and to improve functional behavioral outcomes in experimental animal models.

Lpath is currently conducting IND-enabling studies for Lpathomab and intends to enter Phase 1 clinical trials in early 2015 for neuropathic pain and neurotrauma.

Lpathomab was generated using Lpath's proprietary ImmuneY2™ technology, a drug-discovery engine that provides Lpath with a platform to generate antibodies against bioactive lipids, opening up a new array of unique therapeutic opportunities. 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 (Wenk, MR Nat Rev Drug Discov. 2005 vol 4:594-610) stated that bioactive lipids promise to occupy center-stage in cell biology research in the twenty-first century.

Lpath utilized its proprietary ImmuneY2 drug-discovery technology 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. In addition, the ImmuneY2 platform was used to generate Altepan™, an antibody against key leukotrienes that have been implicated in various respiratory diseases, including asthma.

About WRAIR
Headquartered in Silver Spring, Maryland and established in 1893, the Walter Reed Army Institute of Research (WRAIR) is the oldest, largest, and most programmatically diverse military research institute of the U.S. Army Medical Research and Materiel Command and Department of Defense. With overseas research units in Thailand, Germany, Kenya, and the Republic of Georgia, WRAIR is comprised of two Centers of Excellence, the Center for Infectious Disease Research, and the Center for Military Psychiatry and Neuroscience.

For more information, visit www.wrair.army.mil or follow on Twitter, @WRAIR.

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 which—iSONEP for wet AMD and ASONEP for cancer—are currently being investigated in Phase 2 trials. Lpath is also moving towards the clinic with Lpathomab for neuropathic pain and neurotrauma and is in the research phase with 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 potential benefits and therapeutic uses of Lpathomab and its other drug candidates; the Company's ability to successfully complete additional preclinical studies, development activities and clinical trials for its drug candidates; 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 drug 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 are effective 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.

CONTACT: 
Scott R. Pancoast
President and CEO
Lpath, Inc.
858-926-3200
[email protected]

INVESTOR CONTACTS:
Westwicke Partners, LLC
Robert H. Uhl
Managing Director                           
858-356-5932                                    
[email protected]

SOURCE Lpath, Inc.