Genaera Corporation announced the issuance by the European Patent Office of a patent covering the use of squalamine to inhibit the growth of endothelial cells. Included in this patent are claims to uses of squalamine as an anti-angiogenic agent for the treatment of multiple diseases including macular degeneration, diabetic retinopathy, cancer, rheumatoid arthritis, and psoriasis, among others listed.
Squalamine is currently being evaluated in a Phase 1-2 clinical trial for the treatment of wet age-related macular degeneration (AMD), for which the Company recently announced positive interim results. The initial trial of squalamine in AMD demonstrated early evidence of squalamine activity, as demonstrated by shrinkage of the size of the choroidal neovascularization lesions associated with AMD in some patients, and stabilization of these lesions in other patients. In addition, early trends for visual acuity showed improvement, of up to greater than 3 lines of vision, in some patients, and stabilization of vision in all patients thus far.
"This patent is important to Genaera as we further secure and expand our intellectual property position surrounding squalamine's use in AMD and cancer," noted Roy C. Levitt, President and CEO. "Coupled with our exciting interim clinical trial results, we believe squalamine is now positioned nicely to compete with any therapies in development or currently available for wet AMD."
Systemically administered squalamine inhibits abnormal angiogenesis in rodent models of retinopathy of prematurity, and the development of choroidal neovascular membranes in rat models of AMD. Additional preclinical studies have demonstrated that systemic squalamine administration is effective in reaching abnormal ocular blood vessels in primates, and leads to partial regression and inhibition of new abnormal vessels in the eye. The dose for squalamine to produce these effects in primates is less than 10% of that currently being used successfully in squalamine clinical trials for patients with advanced cancers. These results support that squalamine may have a role in the treatment of human choroidal neovascular membrane formation that underlies the pathology of wet AMD.
Angiogenesis resulting from AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. About 25-30 million people are affected globally. This number is expected to triple over the next 25 years.
AMD appears to come in two types: the "dry" form and the more severe "wet" form. Dry AMD, the more common and milder form of AMD, accounts for 85% to 90% of all cases. Dry AMD results in varying forms of sight loss and may or may not eventually develop into the wet form. Although the wet form of AMD accounts for only 10% to 15% of all AMD, the chance for severe sight loss is much greater. It is responsible for 90% of severe vision loss associated with AMD. Approximately 500,000 new cases of wet AMD are diagnosed annually worldwide. In North America alone, approximately 200,000 new cases of wet AMD are diagnosed each year. Wet AMD is caused by the growth of abnormal blood vessels, or choroidal neovascularization, under the central part of the retina, the macula.