SAN DIEGO, CA--(Marketwire - Mar 12, 2012) - Lpath, Inc. (OTCBB: LPTN), the industry leader in lipidomics-based antibody therapeutics, plans to manufacture new antibody drug substance in preparation for the continuation of its PEDigree and Nexus trials.
In these trials, iSONEP™ is being tested as a treatment for wet AMD (Nexus) and a related complication called Pigmented Epithelial Detachment (PEDigree).
iSONEP was produced by Lpath's ImmuneY2™ drug-discovery engine, which has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease.
Lpath's long-time producer of antibody drug material will manufacture the new campaign of iSONEP antibody, and a preferred vendor has been recently engaged to perform the fill/finish step.
Lpath plans to submit the necessary documentation regarding the new drug material to the FDA by June and expects both trials will be open for enrollment in August.
"We are working diligently to continue dosing in both of the iSONEP trials as soon as possible," said Lpath President and CEO Scott Pancoast. "Given the positive results in our Phase 1 study, we feel strongly about the prospects of value creation by our PEDigree and Nexus studies."
"Specifically, in our Phase 1 study, two out of two subjects with RPE detachment experienced full resolution of their detachment; and four of five patients with occult-type wet AMD experienced significant reductions in lesion size, with two not requiring treatment of any kind for the entire one-year follow-up period after their iSONEP injection," added Pancoast. "We are seeking to replicate these patient benefits in larger patient populations in the PEDigree and Nexus studies."
Dosing in both trials was halted when Lpath learned its previous fill/finish contractor had not been in compliance with FDA's current Good Manufacturing Practice (cGMP) when iSONEP clinical vials were filled. iSONEP was well tolerated by all patients in the Phase 1 trial and by all patients thus far in the PEDigree and Nexus trials. The company has not received any claims raising safety concerns with iSONEP.
San Diego-based Lpath, a therapeutic antibody company, is the category leader in lipidomics-based antibody 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, one of which (iSONEP™ for wet AMD) has initiated mid-stage clinical trials and another of which (ASONEP™ for cancer) will soon begin mid-stage clinical trials. The third candidate is a pre-clinical anti-Lysophosphatidic Acid antibody, which has shown efficacy in animal models of neuro-trauma, fibrosis, and diabetic neuropathy. 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 eventual commercial viability of the Company's drug programs, the timeline to recommence the iSONEP clinical trials, and the eventual revenues that the Company would attain if the drug eventually gets approved. 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 and the time to complete any future clinical trials for iSONEP may not be favorable and the Company may never receive regulatory approval for iSONEP; 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.