SOURCE: Lpath, Inc.

Lpath, Inc.

April 07, 2011 08:31 ET

Lpath Initiates Enrollment of iSONEP Phase 1b/2a Proof-of-Concept Trial

PEDigree Trial to Study Effects of iSONEP in Wet AMD and PCV Patients With RPE Detachment

SAN DIEGO, CA--(Marketwire - April 7, 2011) - Lpath, Inc. (OTCBB: LPTN), the industry leader in lipidomics-based therapeutics, has initiated enrollment in its PEDigree clinical trial of iSONEP™, the company's ocular drug candidate with which it has partnered with Pfizer (NYSE: PFE).

In this Phase 1b/2a trial, Lpath plans to dose 32 subjects that have retinal pigment epithelium detachment (PED) that is secondary to wet age-related macular degeneration (wet AMD) or polypoidal choroidal vasculopathy (PCV).

PED is a potentially serious condition that is often part of the pathology of wet AMD and PCV, yet no drug has yet been approved to treat PED. Even though patients with PED were excluded from the Lucentis® pivotal trials, this drug is often used to treat such patients, but with incomplete success. In addition, PCV frequently does not respond well to Lucentis and is often misdiagnosed as wet AMD.

Subjects in the PEDigree trial will receive up to three monthly intravitreal injections of iSONEP, and two dose levels will be tested. The primary safety endpoint is the tolerability of consecutive monthly injections, and the primary efficacy endpoint is the percentage of subjects that experience flattening of their PED.

In Lpath's Phase 1 trial, where subjects with wet AMD received only one injection, iSONEP met its primary endpoint of being well tolerated in all 15 patients. It also succeeded in meeting a key secondary endpoint in that a positive biological effect -- with a single dose -- was observed in most patients, almost all of whom had failed to respond to Lucentis and/or Avastin® treatment.

One of the distinctive benefits in Phase 1 was the resolution (the complete flattening) of PEDs in two out of the two subjects that presented with PED. One of these patients received no further treatment (Lucentis or Avastin) during the entire 12-month monitoring period following the iSONEP injection. The other was not re-treated until day 105.

It is hypothesized that such distinctive benefits are due to iSONEP's powerful anti-inflammatory and anti-fibrotic mechanisms of action. In various animal models of disease, iSONEP was shown to substantially reduce inflammation in the eye (Campochiaro et al., Journal of Cellular Physiology, October 2008) and significantly mitigate ocular fibrosis (Grant et al., Experimental Eye Research, August 2008).

The potential market for a drug that fully resolves PED is significant. It is estimated that more than 500,000 people currently have PED, and with reasonable assumptions, the attainable market size is estimated to be more than $1.0 billion. These market-size figures are expected to grow significantly as the baby-boomers fill up the ranks of the 65+ age group.

Lpath plans to begin another iSONEP trial in June of this year, a Phase 2 human-proof-of-concept trial to study the efficacy and safety of iSONEP in wet AMD patients that do not have PED.

Glenn Stoller, MD, head of Lpath's ocular division, commented: "iSONEP is a first-in-class drug that has distinguished itself with promising animal data and, more recently, human data. A growing body of literature suggests that iSONEP's distinctive anti-inflammatory, anti-angiogenic and anti-fibrotic mechanisms could prevent both the early and the late stages of retinal damage, including the damage that often results when a PED fails to flatten over time."

Scott Pancoast, Lpath's president and chief executive officer, added: "Because the anti-VEGF agents have demonstrated lackluster results in the treatment of PED patients, there is a significant unmet medical need. Given that both subjects that presented with PED in our Phase 1 trial experienced a complete flattening of their PED, we like the odds of success in this larger group of patients."

Lucentis® and Avastin® are registered trademarks of Genentech, Inc.

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 has developed three drug candidates, two of which -- ASONEP™ for cancer and iSONEP™ for wet AMD -- have completed Phase 1 clinical trials. 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 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 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.

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