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01.02.2016 14:05
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Lpath Completes Dosing in the Lpathomab Phase 1 Safety Study
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PR Newswire
SAN DIEGO, Feb. 1, 2016
SAN DIEGO, Feb. 1, 2016 /PRNewswire/ -- Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, announced today completion of dosing in its Phase 1a double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of Lpathomab™ in healthy volunteers. Lpathomab has been well tolerated at all doses tested, and no serious adverse events or dose limiting toxicities have been observed to date.
Lpathomab is a humanized monoclonal antibody targeting the bioactive lipid, lysophosphatidic acid (LPA), which has been shown in the literature to be important in conditions of neuronal injury, such as neuropathic pain-related indications.
Lpathomab was administered in five different ascending dose cohorts at 0.5, 1.0, 3.0, 10.0 and 20.0 mg/kg. All 36 subjects, including those who received placebo, successfully completed dosing with a single intravenous infusion as planned. Complete pharmacokinetic and safety follow up data are anticipated to be available by April, 2016.
"We are very pleased that in this first-in-human study, Lpathomab appears to be safe and well-tolerated at doses as high as 20 mg/kg," commented Dario Paggiarino, M.D., Lpath's senior vice president and chief development officer. "Neuropathic pain is an area where the side effect profile of existing drugs is often so debilitating that the patients can't continue their treatment regimens. The fact that Lpathomab appears to be well-tolerated further underscores the potential value of our product candidate with a novel mechanism of action."
About Lpath
San Diego-based Lpath, Inc. (NASDAQ: 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 four drug candidates, has advanced the first two to mid-stage 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.
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, which includes Lpathomab, and the timing for the Company 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 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 on a timely basis, or at all; the Company may fail to obtain required governmental approvals for any of its drug candidates; 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 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 24, 2015 and its Quarterly Report on Form 10-Q filed with the SEC on Aug 11, 2015 and Nov 12, 2015. 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.
CONTACT:
Gary Atkinson
Chief Executive Officer
Lpath, Inc.
858-926-3202
gatkinson@lpath.com
PUBLIC RELATIONS CONTACT:
Canale Communications
David Rozul
619-849-5389
David@canalecomm.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/lpath-completes-dosing-in-the-lpathomab-phase-1-safety-study-300212489.html
SOURCE Lpath, Inc.
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