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New Published Paper Shows Efficacy of Lpath's Anti-LPA Antibody, Lpathomab, in Traumatic Brain Injury Models

Eddie Staley

Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, has brought scientists one step closer to finding a potential treatment for traumatic brain injury (TBI) with a recent publication showing that Lpathomab™, a therapeutic antibody, reverses much of the damage caused by trauma to the nervous system.

As published by the Journal of Neuroinflammation (vol. 11, article 37), Lpathomab can be used to reduce the size of a TBI and to improve functional behavioral outcomes in experimental animal models. The antibody works as a molecular sponge by soaking up lysophosphatidic acid (LPA), a molecule that can damage neurons and promote dangerous inflammatory responses in the central nervous system.

In collaboration with scientists at the University of Melbourne, the antibody was tested in mice that had TBIs. A key finding of the study was the significant efficacy of administering Lpathomab after an injury, thus demonstrating a potential therapeutic benefit. Also shown for the first time in this groundbreaking paper was that human patients with TBI exhibited substantial increases in the levels of LPA in the cerebrospinal fluid (CSF) after injury, a finding also seen in the injured mouse model of TBI; such data suggest that LPA is a valid target for therapeutic intervention.

Lpath and its Melbourne collaborators have recently shown that Lpathomab provides protection against neuronal cell death and scarring in experimental models of spinal cord injury (SCI), published recently in the American Journal of Pathology (Goldschmit et al., vol. 181, p. 978-992). Currently, there are no FDA-approved drugs for the treatment of neurotrauma such as TBI and SCI.

"This research provides new hope for therapeutic treatments for many forms of neurotrauma, including TBI and SCI as well as other forms of neurodegenerative disorders," said Roger Sabbadini, Ph.D., vice president and founder of Lpath and co-author on the paper. "We believe that LPA may be a biomarker that could be used to aid in the diagnosis of TBI, as the 'LPA pulse' that occurs in the injured brain can also be detected in blood."

The research team was comprised of Lpath scientists and collaborators from the University of Melbourne, Monash University and the University of Kentucky.

As a promoter of tumorigenesis, metastasis and fibrotic disease, LPA is a well-validated drug target and has been shown to play a significant role in neuropathic pain and now neurotrauma. The role of LPA in the nervous system has been described in a recent review published in the International Review of Cellular and Molecular Biology (Frisca et al., vol. 296, p. 273-322).

Lpathomab is currently in IND-enabling studies 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 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. 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 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. With this platform, 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 developing other candidates such as 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 potential benefits and therapeutic uses of Lpathomab, the Company's ability to successfully complete additional preclinical studies, development activities and clinical trials for Lpathomab and its other 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 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.

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