Othera Pharmaceuticals Presents New AMD Data at Angiogenesis 2007 Symposium
In his study, Dr. Mousa employed a well-known model of angiogenesis (the Chick Chorioallantoic Membrane or CAM model) wherein a blood vessel growth factor (i.e., vascular endothelial growth factor, or VEGF) is applied to a chick embryo to rapidly generate neovascularization, a hallmark of wet AMD. Dr. Mousa then studied the effect of either Lucentis or Avastin treatment alone, or in combination with Othera's drug to inhibit the number of new blood vessels formed. The results from this model clearly demonstrate that when the Othera compound OT-551 is added to either Lucentis or Avastin treatment there is a synergistic effect versus either treatment alone.
These results, along with other data, provide sufficient preclinical support for moving OT-551 into a previously-announced Phase II clinical trial to evaluate OT-551 eye drop as an adjunctive therapy to Lucentis injections for the wet form of AMD. That trial, scheduled to begin enrollment in the second quarter of this year, will be conducted at leading eye research institutions across the U.S., with Dr. Philip Rosenfeld of the Bascom Palmer Eye Institute serving as the study's chairman.
"We're encouraged to enter Phase II testing in wet AMD, as these results demonstrate that OT-551 could potentially improve the outcome of patients already on Lucentis by treating the underlying macular degeneration and decreasing the need for frequent Lucentis injections," said Dr. Len Parver, Medical Director of Othera Pharmaceuticals. "Today, retinal specialists only have at their disposal invasive treatments, such as intravitreal needle injections, to use against this disease. Even Lucentis, which showed in its clinical trials superior efficacy to any other approved agent, does not treat the underlying macular degeneration, just the abnormal blood vessels. Our goal would be to use an eye drop like OT-551 to obtain even better visual acuity outcomes with fewer Lucentis intraocular injections. If this could be achieved with a topical medication, it would be a major breakthrough in treating this disease."
AMD is the leading cause of blindness in the U.S. in persons over age 55. AMD is a chronic degenerative disease that is initially classified as a 'dry' form, and which can progress to vision loss via either advanced dry AMD or the so-called 'wet' form of AMD. As many as one million or more Americans currently suffer from the wet form of AMD. Although only 10 percent of all people with AMD have this type, it accounts for 90 percent of all blindness from the disease. As dry AMD worsens, new blood vessels may begin to grow. Because these new blood vessels tend to be very fragile, they will often leak blood and fluid under the macula. This causes rapid damage to the macula that can lead to the loss of central vision in a short period of time. The treatment paradigm for wet AMD today includes repeated needle injections into the eye of biomolecules, such as Genentech's Lucentis and Avastin, which specifically target factors known to promote new blood vessel formation.
In addition to the planned Phase II wet AMD study, Othera also plans to initiate its own Phase II study in 2007 with OT-551 for geographic atrophy, an advanced form of dry AMD that affects about a million Americans. OT-551 is also currently being tested in Othera's Phase II trial for preventing or slowing the progression of post-vitrectomy nuclear cataract.
About Othera Pharmaceuticals
Othera Pharmaceuticals, Inc. is a privately-held, specialty pharmaceutical company located in Exton, PA. Othera is developing treatments for the leading causes of blindness and vision impairment in the world, including age-related macular degeneration (AMD), cataracts and glaucoma. Othera's lead compound, OT-551, an eye drop, is being developed to treat several major eye diseases and conditions, including the dry and wet forms of age-related macular degeneration (AMD), cataracts, and dry eye syndrome. Othera's second lead compound, OT-730, is a novel improved beta-blocker for the treatment of glaucoma. More information on Othera Pharmaceuticals is available on the company's website at www.othera.com.
Posted: February 2007