SAN DIEGO, May 23, 2013 (GLOBE NEWSWIRE) -- Lpath, Inc. (Nasdaq:LPTN), the industry leader in bioactive lipid-targeted therapeutics,has initiated dosing in a Phase 2a single-arm trial where ASONEP™ is being investigated as a treatment for renal cell carcinoma (RCC) in subjects that have failed the standard of care treatment with FDA-approved agents that block VEGF signaling (e.g. Sutent®/sunitinib maleate) and the mTOR pathway (e.g. Afinitor®/everolimus).
Sumanta Pal, M.D., from City of Hope, Duarte, California, dosed the first subject.
ASONEP is a humanized antibody that binds to and neutralizes sphingosine-1-phosphate (S1P). S1P is a bioactive lipid that has been validated as a drug target in multiple sclerosis and that has been shown to contribute to progression of several cancer types.
Many scientific publications have concluded that S1P is a tumorigenic and angiogenic bioactive lipid that cancer cells use to escape therapy. In collaboration with Rupal Bhatt, M.D., of Beth Israel Deaconess Medical Center, Lpath has demonstrated that levels of S1P are upregulated in blood of subjects with RCC. Moreover, Dr. Bhatt has demonstrated efficacy of Lpath's anti-S1P antibodies in treating mice with human RCC tumors after they had failed treatment with Sutent.
This current proof-of-concept Phase 2 trial follows the successful completion of the ASONEP Phase 1 safety study. The Phase 1 study, conducted in subjects with solid tumors, showed that ASONEP was well tolerated across all doses, including the highest dose of 24 mg/kg. In addition, of the 21 subjects that completed the initial four treatments in the Phase 1 study over a 5-week period, 11 showed stable disease at the end of five weeks; eight had stable disease at two months, six had stable disease at three months and two were stable for longer than 12 months.
According to Datamonitor, there are currently about 225,000 new cases of renal cell cancer worldwide each year, a figure that is projected to approach 300,000 by the year 2020.
The Phase 1 and Phase 2a clinical trials of ASONEP are partially funded by a $3.0 million grant from the National Cancer Institute (NCI) under its Small Business Innovation Research (SBIR) Program.
ASONEP, and its sister drug iSONEP™, are different formulations of sonepcizumab, a first-in-class therapeutic antibody against S1P developed using Lpath's ImmuneY2™ drug-discovery engine. Antibodies developed via this discovery engine are designed to target bioactive signaling lipids, such as S1P, that are involved in cancer, age-related macular degeneration (AMD), inflammatory and auto-immune disorders, and other diseases.
Lpath is also conducting a clinical trial called Nexus, which is a four-arm, double-blind Phase 2 study where iSONEP is being evaluated for safety and efficacy in wet-AMD subjects. Lpath entered into an agreement with Pfizer (NYSE:PFE) in 2010 that provides Pfizer an exclusive option for a worldwide license to develop and commercialize iSONEP. As part of that agreement, Lpath has granted to Pfizer a time-limited right of first refusal for ASONEP.
About Lpath
San Diego-based Lpath, Inc., a therapeutic antibody company, is the category leader in lipid-targeted therapeutics. The company's ImmuneY2™ drug-discovery engine has the unique ability to generate monoclonal antibodies that bind to and inhibit bioactive lipids that contribute to disease. The Company is developing three drug candidates: iSONEP™ is being studied in a Phase 2 trial in wet AMD subjects; ASONEP™ is being studied in a Phase 2 trial in renal cell carcinoma subjects; and Lpathomab is a preclinical drug candidate that holds promise in pain, neurotrauma, and other diseases. 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 protection against competition afforded by issued patents; the eventual commercial viability of the Company's drug programs; 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 outcome of the Phase 1 clinical trial may not be predictive of the results from the ongoing Phase 2 trial; the results of any future clinical trials for iSONEP or ASONEP may not be favorable and the Company may never receive regulatory approval for iSONEP or ASONEP or any of its drug candidates; and the Company may not be able 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.