SAN DIEGO, CA--(Marketwire - March 30, 2010) - Lpath, Inc. (OTCBB: LPTN), the category leader in lipidomics-based therapeutics, announced positive summary results of its dose-escalation Phase 1 clinical trial of the investigational drug ASONEP(TM) in cancer patients with a wide variety of solid tumors.
Study results included demonstration that lymphocyte counts in the vascular space were reduced in a dose-related fashion. As such, Lpath achieved an objective established by Merck KGaA (Darmstadt, Germany) and received a $2 million payment according to the terms of Lpath’s license agreement with Merck KGaA.
The summary results also show that the Phase 1 trial met its primary endpoint of identifying safe dose levels for investigation in the Phase 2 setting. ASONEP was well tolerated at all the dose-levels studied, which ranged from 1 mg/kg to 24 mg/kg. More than half the patients that completed the initial four-treatment evaluation period showed stable disease. Durable stable disease was observed in several patients.
According to Michael Gordon, M.D., the principal investigator in this Phase 1 trial, “These Phase 1 results with ASONEP are encouraging. The safety of ASONEP as demonstrated in this study allows for its evaluation as a single agent or in combination with standard therapies without expectation of significant overlapping toxicities. This safety profile, along with the observation of stable disease in several late-stage cancer patients, provides strong justification for investigation of ASONEP in Phase 2 clinical trials.”
Dr. Gordon will be presenting more detailed results of the ASONEP Phase 1 trial at the annual meeting of the American Society of Clinical Oncology in Washington, D.C. on June 7, 2010.
Scott R. Pancoast, Lpath president and CEO, commented: “Our Phase 1 trial further validates our novel approach of targeting bioactive signaling lipids and underscores the potential of our ImmuneY2(TM) drug-discovery engine. Moreover, achievement of the milestone provides evidence that ASONEP is having the expected pharmacological effect in human subjects, which is important with a first-in-class drug candidate.”
About Lymphocytes
A lymphocyte is a type of white blood cell that plays an integral role in the body’s defenses. The finding of a reduction in blood lymphocyte counts is consistent with the known role of S1P in stimulating the movement of lymphocytes out of lymph tissue into the blood. As such, ASONEP does not kill lymphocytes; rather, it merely results in a temporary sequestering of them in lymph tissues (e.g., lymph nodes).
About Lpath
San Diego-based Lpath, Inc., 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(TM) drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease. The company is currently advancing three drug candidates, two of which -- ASONEP(TM) for cancer and iSONEP(TM) for wet age-related macular degeneration (AMD) -- have completed Phase 1 clinical trials. For more information, go to 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 interpretation of the results of its Phase 1 clinical trial for ASONEP and the Company’s ability to complete additional discover 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 outcome of the final analyses of the data from the Phase 1 clinical trial may vary from the Company’s initial conclusions; the results of any future clinical trials for ASONEP may not be favorable and the Company may never receive regulatory approval for ASONEP; Merck KGaA may elect not to support further development of ASONEP under the license-agreement; and the Company’s ability to secure the funds necessary to support its clinical trial and product 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.
Lpath, Inc.
Scott R. Pancoast
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