Healthcare Industry News: Age-related Macular Degeneration
News Release - April 18, 2006
Lpath Introduces Ocular DivisionDivision to Focus on Potential Breakthrough Drug for Age-related Macular Degeneration and Other Eye Diseases
SAN DIEGO, April 18 (HSMN NewsFeed) -- Lpath, Inc. (OTC: LPTN ), the category leader in therapeutic agents against bioactive lipids, announced today the creation of an ocular division to be headed by a leading retinal specialist. The new division will initially focus on a potentially breakthrough drug for the treatment of Age-related Macular Degeneration (AMD) and other eye diseases.
On the strength of compelling preliminary results from a well-established animal model of AMD, the company believes its lead drug candidate Sphingomab(TM) has multiple applications in the treatment of eye diseases that lead to blindness.
In addition to performing follow-on work in the AMD arena, Lpath will immediately begin investigating the use of Sphingomab in animal models of diabetic retinopathy (DR) and glaucoma and in ocular diseases characterized by scar formation, like proliferative vitreoretinopathy (PVR). AMD and DR are the two leading causes of vision loss in the Western World.
Lpath's ocular division will be headed by Glenn L. Stoller, M.D., a practicing eye surgeon and assistant clinical professor at New York Presbyterian Hospital (New York Weill Campus). As a noted retinal specialist, he has extensive experience in the pre-clinical and clinical development of ocular therapeutic agents, and has served as an advisor to Genentech and OSI Eyetech.
"I am very excited to lead the development of Sphingomab for eye disease," says Stoller. "Sphingomab is a novel and fascinating compound. Inhibiting bioactive lipids is a unique approach towards treating eye disease and could prove to be groundbreaking."
Scott Pancoast, Lpath's president and CEO, comments, "We are fortunate to have Dr. Stoller leading our ocular division. He brings a wealth of experience and knowledge, as well as extensive contacts in the ocular field."
The recent introduction of agents that inhibit vascular endothelial growth factor (VEGF) represents a major advance in the treatment of AMD, but the majority of patients receiving these treatments are not expected to experience improvement in their vision over the long-term course of the disease. Therefore, there is still a well-defined need to develop therapeutic agents that target other pathological steps in AMD and other eye diseases.
According to Stoller, Sphingomab may be a well-timed solution. "Sphingomab has multiple mechanisms of action," notes Stoller. "It is strongly anti-angiogenic, via VEGF- and non-VEGF-dependent pathways. Moreover, it is a validated inhibitor of inflammation and scar formation, which are key steps in the pathogenesis of vision loss that are not adequately addressed by existing therapies. I believe Sphingomab has the potential not only to be an effective monotherapy, but also to act synergistically when used with existing anti-VEGF agents."
OSI Eyetech currently markets MacugenŽ, the leading AMD therapy. Later this year, Genentech is expected to receive FDA approval to commercialize Lucentis(TM), a drug candidate that is widely predicted to out-perform Macugen. Neither of these drugs has been shown to directly inhibit either inflammation or scar formation in AMD.
Lpath plans to enter a humanized version of Sphingomab into Phase I clinical trials in AMD patients by the end of 2007. This will coincide with Lpath's plans to enter humanized Sphingomab into Phase I trials for both cancer and heart-failure patients.
Lpath, headquartered in San Diego, is a theranostics company focused on bioactive signaling lipids as targets for treating and diagnosing important human diseases, including cancer, heart failure, and a variety of ocular disorders. Lpath's lead product candidate, Sphingomab, has demonstrated compelling results against seven different forms of solid-tumor and blood-borne cancers in pre-clinical studies. Like AvastinŽ (Genentech's blockbuster cancer drug), Sphingomab is anti-angiogenic, but Sphingomab has other mechanisms of action that may prove advantageous in the clinical setting. As such, although Genentech pioneered the anti-angiogenesis approach to treating cancer, Lpath believes Sphingomab may prove to be the next generation of anti-angiogenesis-based therapeutics.
Lpath's unique ability to generate antibodies against bioactive lipids is based on its ImmuneY2(TM) technology. The Company is currently applying the ImmuneY2 process to other important lipid-signaling agents that are validated targets for disease treatment, thereby creating a pipeline of antibody-based drug candidates and positioning the company as the category leader in lipidomic therapeutics.
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that required clinical trials will be successful, necessary regulatory approvals will be obtained, or the proposed treatments will prove to be safe or effective. Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, our limited experience in the development of therapeutic drugs, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on research grants, current and future competition, and other risks described from time to time in our filings with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
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