SAN DIEGO, CA--(Marketwire - October 03, 2012) - Lpath, Inc. (OTCQB: LPTN), the industry leader in bioactive lipid-targeted therapeutics, has initiated the dosing of iSONEP™ in its Nexus Phase 2 study, with several wet-AMD patients treated since September 21, 2012.
In the double-blind, multi-site trial, Lpath plans to dose 160 subjects who have not responded completely to a VEGF inhibitor (either Lucentis® or Avastin®). These subjects will be randomized into four arms: (1) VEGF inhibitor alone; (2) combination of a VEGF inhibitor and iSONEP (lower dose); (3) combination of a VEGF inhibitor and iSONEP (higher dose); and (4) iSONEP alone (higher dose).
Endpoints to be studied include changes in best corrected visual acuity (BCVA), retinal thickness, and lesion size. The Nexus trial will also investigate iSONEP's ability to flatten Pigmented Epithelial Detachments (PEDs), a complication of wet AMD that does not respond well to anti-VEGF treatments.
"We are seeing strong enrollment momentum in our Nexus study," said Scott Pancoast, Lpath's president and chief executive officer. "Our Nexus study seeks to determine how iSONEP can best be used to benefit wet-AMD patients. Whether as first-line single agent, as first-line in combination with anti-VEGF therapies, or as second-line, a drug that can provide additive benefits in the treatment of wet AMD would have a significant market potential."
In the Phase 1 trial, where subjects with wet AMD received a single injection of iSONEP, a positive biological effect was observed in most patients, almost all of whom had failed to respond to treatment with Lucentis and/or Avastin. One such positive effect was a significant reduction (30%+) in the size of the choroidal neovascular lesion in many of the subjects, all of whom were not responding well to treatment with the VEGF inhibitors at the time they were enrolled in the study. Significant reduction in lesion size with a single injection is not typically observed with VEGF inhibition.
One of these subjects experienced a 100% reduction in lesion size as of Day 45. This subject did not have to be re-injected with the "standard of care" (i.e., with Lucentis or Avastin) for the entire 12-month monitoring period following the iSONEP injection.
Another subject who had undergone 16 prior treatments of Lucentis and Avastin without much response was administered the highest dose of iSONEP studied (1.8 mg.). This subject experienced not only a 100% reduction in lesion size by Day 15, but also a complete elimination of retinal swelling. Like the other subject, this subject also did not have to be re-injected with Lucentis or Avastin for the entire 12-month monitoring period following the iSONEP treatment.
These extended times to re-treatment suggest that any benefit derived from iSONEP may be durable, a particularly important attribute in this market.
Lpath hypothesizes that such distinctive benefits are due to powerful anti-angiogenic, anti-inflammatory, and anti-fibrotic mechanisms of action of iSONEP, which binds to and neutralizes the bioactive lipid, S1P. In various animal models of disease, iSONEP was shown to substantially reduce inflammation and angiogenesis in the eye (Campochiaro et al., Journal of Cellular Physiology, January 2009) and significantly mitigate ocular fibrosis (Grant et al., Experimental Eye Research, March 2009).
Lpath entered into an agreement with Pfizer Inc. (NYSE: PFE) in 2010 that provides Pfizer an exclusive option for a worldwide license to develop and commercialize iSONEP. Lpath and Pfizer have collaborated extensively on design and goals of the Nexus Phase 2 study.
San Diego-based Lpath, Inc. (OTCQB: LPTN), a therapeutic antibody company, is the category leader in bioactive lipid-targeted therapeutics, an emerging field of medicine that targets bioactive signaling lipids for treating a wide range of human disease. Lpath'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 three drug candidates, two of which -- iSONEP™ for wet AMD and ASONEP™ for cancer -- have completed Phase 1 clinical trials. The third candidate is an anti-LPA antibody that holds promise in neuropathic pain, neurotrauma and other disease conditions. 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 Company's interpretation of the results of its Phase 1 clinical trial for iSONEP; the potential biological effects and indications for use of iSONEP; the market opportunity for iSONEP and the potential regulatory approval and commercial viability of the Company's 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 results of the Company's pre-clinical testing and its clinical trials may not support either further clinical development 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; none of the Company's drug candidates have received regulatory approval at this time, and the Company may fail to obtain required governmental approvals for its drug candidates; the Company has a history of net losses and may never achieve or maintain profitability; the Company may not be successful in maintaining its commercial relationship with Pfizer Inc.; and the Company may not be able to secure the funds necessary to support its preclinical- 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, 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.