FDA Lifts Clinical Hold on Lpath, Inc.'s iSONEP
Published: Aug 27, 2012
SAN DIEGO, CA--(Marketwire - August 27, 2012) - Lpath, Inc. (OTCQB: LPTN), the industry leader in bioactive lipid-targeted therapeutics, reported that the FDA has lifted the clinical hold on iSONEP™, Lpath's anti-S1P monoclonal antibody that is being developed as a potential treatment for wet AMD and possibly other ocular disorders.
The hold was placed on iSONEP in late January 2012 after the FDA deemed that the company's fill/finish contractor was not in compliance with the FDA's Good Manufacturing Practice (cGMP) requirements for approximately a three-year period (2008-2010) -- and it was during this period that the previous iSONEP clinical vials were filled.
iSONEP was well tolerated by all patients in the Phase 1 trial, as well as by all patients treated in the PEDigree and Nexus studies before dosing was suspended in January. The company has not received any claims raising safety concerns with iSONEP.
Lpath has since manufactured new clinical material, utilizing a different fill/finish supplier. The manufacturing process and new drug supply met all specifications, leading to the FDA's action to allow the Nexus trial to continue.
Lpath's Nexus study is now open for enrollment, with plans to treat the first patient in mid-September.
Nexus is a Phase 2 double-blind, multi-site trial in which Lpath plans to dose 160 subjects that 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 change in best corrected visual acuity (BCVA), change in retinal thickness, and change in lesion size. The Nexus trial will also look at iSONEP's ability to flatten Pigmented Epithelial Detachments (PEDs), a complication that is secondary to wet AMD and one that does not respond well to anti-VEGF treatments. Given this, the PEDigree Phase 1b study, which focused primarily on iSONEP's ability to treat PEDs, has been de-prioritized.
In Lpath's 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 twelve-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).
"Although the VEGF inhibitors have raised the bar considerably in the treatment of wet AMD, there is significant room for improvement," noted Glenn Stoller, M.D., head of Lpath's ocular division. "The VEGF inhibitors treat retinal edema and vascular leakage, but they do little to eliminate or even reduce the lesion themselves, resulting in treatments that must be administered monthly or bi-monthly for life. We are hopeful the reduction of lesion size we saw in the iSONEP Phase 1 trial will be repeated in larger groups of patients, like in this Nexus trial."
Scott Pancoast, Lpath's president and chief executive officer, added: "We are pleased to be open for enrollment and look forward to continuing the Nexus trial. We continue to have high hopes for iSONEP and believe that the Nexus study will help 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, the market potential for a drug that can provide additive benefits in wet AMD is substantial."
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. 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. 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.
Scott R. Pancoast
President & CEO
Lpath Investor Relations
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