Galardin Reduced Corneal Perforations in Clinical Trials; Glycomed Announces Phase II/III Results.ALAMEDA, Calif.--(BUSINESS WIRE)--Dec. 22, 1994--Glycomed Incorporated (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :GLYC) Thursday announced positive results from its two Phase II/III clinical trials of Galardin MPI MPI - Message Passing Interface for the treatment of infected corneal ulcers. Pooled data from both studies showed patients treated with Galardin had a statistically significant reduction in the incidence of corneal corneal pertaining to the cornea. See also keratitis, keratopathy. corneal anomaly includes microcornea, coloboma, megalocornea, dermoid, congenital opacity. corneal black body see corneal sequestrum (below). perforations, one of the most serious complications of corneal ulcers. Reduction in perforations can be used as a clinical endpoint to support an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any , according to preliminary discussions with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. . As previously announced, Glycomed will employ the positive results to secure a corporate partner for Galardin. Perforation per·fo·ra·tion n. 1. The act of perforating or the state of being perforated. 2. An abnormal opening in a hollow organ or viscus, as one made by rupture or injury. Perforation A hole. is caused by destruction of the full thickness of the cornea cornea: see eye. . It is one of the most serious complications associated with corneal ulcers and can lead to blindness. In addition to the reduction in perforations, there was also a significant reduction in the proportion of patients who progressed to very deep ulcers. There was no beneficial change in the time to or extent of healing of the corneal epithelium. This suggests that any beneficial effects of Galardin are on the healing of the deepest tissues of the cornea rather than on the superficial layer. Corneal perforation is a significant risk for an estimated 120,000 of the patients with corneal ulcers in the United States each year. Glycomed intends to complete development of Galardin and market the drug in conjunction with a development and marketing partner in the United States. The company believes an ally with an existing presence and expertise in the ophthalmic market will assist in developing a product approval strategy, including a decision on a final formulation for marketing. In addition the company believes a partner may wish to gather added clinical data to bolster the marketability of Galardin as well as its chances for rapid regulatory approval. The two studies comprising the Phase II/III effort were conducted at over eighty centers throughout the United States. The studies were randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double- masked and vehicle-controlled. A total of 556 patients were enrolled and compliance with the required dosing regimen was excellent. Patients self- medicated medicated /med·i·cat·ed/ (med´i-kat?id) imbued with a medicinal substance. medicated contains a medicinal substance. with eye drops containing either Galardin, at does of 800 mcg/ml, or vehicle without the active ingredient. Patients also received standard antibiotic therapy. Glycomed believes these were the largest and most rigorous trials ever conducted in patients with corneal disease. Data from the studies will be presented at the appropriate scientific forum. Galardin MPI is a synthetic, small molecule that inhibits a family of enzymes called metalloproteinases. This class of enzymes is implicated im·pli·cate tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates 1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot. 2. in the destruction of various tissues throughout the body as part of the inflammatory process. Glycomed retains all rights to this compound in the United States and Europe. In the Far East, Glycomed has licensed Galardin MPI to Sankyo Company, Ltd., a leading Japanese pharmaceutical company. Glycomed Incorporated is a leader in the discovery and development of a new class of pharmaceuticals based on complex carbohydrates. The company's drug discovery strategy is to create biologically-active small molecules for therapeutic use. Glycomed is using its unique carbohydrate technologies to commercialize products for the treatment of important diseases, such as inflammatory disorders and cancer. Galardin MPI is the company's initial product currently under development for the treatment of corneal ulcers. -0- Note to Editors: Galardin MPI is a trademark of Glycomed Incorporated. CONTACT: Glycomed Inc.
Mark Moran, 510/814-3243
Julie Wood, 510/814-3302
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