SOURCE: Lpath, Inc.

Lpath, Inc.

September 09, 2010 15:35 ET

iSONEP Phase 1 Results Highlighted at Three Major Scientific Meetings

Various Abstracts Touting iSONEP as a Novel Potential Therapy for Wet AMD and RPE Detachment Accepted for Presentation at Key Ophthalmology Meetings

SAN DIEGO, CA--(Marketwire - September 9, 2010) -  Lpath, Inc. (OTCBB: LPTN), the category leader in bioactive-lipid-targeted therapeutics, announced that abstracts were accepted for presentation at three key ophthalmology meetings in North America. The presentations showed the encouraging data generated from Lpath's Phase 1 trial with iSONEP and concluded that iSONEP holds potential as a novel therapy for wet AMD and RPE detachment.

Thomas Ciulla, M.D. of the Midwest Eye Institute, presented an abstract titled, "A Phase 1 Investigation of iSONEP, a Sphingosine-1-Phosphate Monoclonal Antibody, for Wet AMD in a Subset of Subjects with PED," during a poster session at the American Society of Retinal Specialists held August 28 to September 1 in Vancouver, Canada. (PED is a persistent complication of wet AMD and is often referred to as "RPE detachment.")

Dr. Ciulla's poster drew the following conclusions, based on results from Lpath's iSONEP Phase 1 clinical trial:

  • iSONEP was well tolerated in all subjects at doses up to 1.8 mg, and a maximum tolerated dose was not reached;
  • Out of ten subjects that had potential to show biologic activity, eight showed signs of biological activity;
  • Several subjects experienced substantial regression of the underlying CNV lesion;
  • S1P (the bioactive lipid that iSONEP binds to and neutralizes) appears to be a mediator in the pathogenesis of wet AMD;
  • iSONEP has biologic activity in this subject population and holds promise as a new therapeutic agent; and
  • 100% of subjects with PEDs (two of two) resolved completely with a single injection of iSONEP by Day 45.

Patients with PED were excluded from Lucentis's MARINA and ANCHOR Phase 3 trials, and it is generally understood that Lucentis and other anti-VEGF therapies typically do not resolve PEDs, especially with a single dose. 

Dr. Ciulla stated: "Although limited in number, the two subjects with a PED at study entry showed remarkable improvement with a single injection of iSONEP, at fairly low doses (0.2mg and 1.0mg, respectively). There was no need for further anti-VEGF treatment for at least three months in both cases. iSONEP may indeed have potential as a new therapeutic agent in the treatment of PED."

According to Scott Pancoast, CEO of Lpath, "Lpath plans to further investigate the efficacy of iSONEP in a follow-on trial with 20-30 subjects that have PEDs. There is clearly a significant unmet need here and given that about 20% of wet AMD patients have a PED, the market opportunity exceeds $2 billion per year."

This poster presentation follows on the heels of a podium presentation given by Glenn Stoller, M.D., the head of Lpath's ocular division, at the 2010 Annual Meeting of ARVO (the Association for Research in Vision and Ophthalmology) in Ft. Lauderdale this past May titled, "iSONEP™, an Anti-S1P Monoclonal Antibody for Investigation in Exudative AMD: Results from a Phase 1 Prospective Open-Label Dose-Escalating Multi-Center Study." To a sizeable audience, Dr. Stoller reviewed the scientific basis for targeting S1P and the encouraging results of the iSONEP trial. He ended by concluding that iSONEP holds considerable promise as a potential therapeutic agent.

In addition, Michael J. Tolentino, M.D., the director of clinical research at the Centre for Retina and Macular Disease in Winter Haven, Florida, will review iSONEP phase 1 results at a podium presentation at The Retina Society annual meeting in San Francisco on September 26 during a session entitled, "Pediatrics, Genetics, and Novel Therapies." 

Pancoast noted, "Lpath plans a second, larger trial to investigate the efficacy of iSONEP -- in as many as 120 patients without PEDs -- that will help determine how to position iSONEP in the broader wet AMD market, which is projected to include over five million patients by the year 2025."

About Lpath
San Diego-based Lpath, a therapeutic antibody company, is the category leader in lipidomics-based 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 is currently advancing three drug candidates, two of which -- ASONEP™ for cancer and iSONEP™ for wet AMD -- have completed Phase I clinical trials and will soon begin Phase II trials. For more information, go to 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 within the meaning of Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements may be identified by words such as "believe," "intend," "expect," "may," "could," "would," "will," "should," "plan," "project," "contemplate," "anticipate," or similar statements. These include, but are not limited to, 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. 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 design of future clinical studies may change due to various risks associated with the regulatory process; the timeline of any future clinical trials may slip due to regulatory hurdles, financial difficulties, or failure to execute; the results of any future clinical trials for iSONEP may not be favorable; the Company may never receive regulatory approval for any of its drug candidates; and the Company may fail to secure the funds necessary to support its 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.

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