Alkermes presentation at New York Society of Security Analysts.NEW YORK--(BUSINESS WIRE)--March 13, 1995--The following is a summary of a presentation today at the New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of Society of Security Analysts by Alkermes Inc. In a presentation today at The New York Society of Security Analysts Inc., Alkermes Inc. (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 : ALKS ALKS Alkermes, Inc. (stock symbol) ) announced the commencement of patient enrollment in the second of three planned Phase II clinical trials of RMP-7 administered in combination with an FDA-approved chemotherapeutic, carboplatin, for the treatment of recurrent glioma glioma /gli·o·ma/ (gli-o´mah) a tumor composed of neuroglia in any of its states of development; sometimes extended to include all intrinsic neoplasms of the brain and spinal cord, as astrocytomas, ependymomas, etc. , a type of primary brain tumor primary brain tumor Neurology A tumor that arises in the brain–eg, ependymoma, astrocytoma grade 3 or 4, glioblastoma multiforme, glioma, medulloblastoma, meningioma, neuroglioma, oligodendroglioma. See Metastatic brain tumor. . The study is being conducted in several European countries at up to 10 hospitals and will involve up to 50 patients. The trial is designed to test the preliminary efficacy of RMP-7 and carboplatin in the treatment of recurrent glioma is measured by tumor response and clinical status. The study is the second of three planned Phase II studies of RMP-7 in the treatment of recurrent glioma initiated by Alkermes this quarter. The third will be conducted at several hospitals in the U.S. and is expected to commence in early 1995. The Phase II studies follow the successful completion of patient enrollment and preliminary data analysis in two Phase I/II (safety) studies of RMP-7 and carboplatin in patients with brain tumor Brain Tumor Definition A brain tumor is an abnormal growth of tissue in the brain. Unlike other tumors, brain tumors spread by local extension and rarely metastasize (spread) outside the brain. and the completion of a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I showing RMP-7's effect on increasing brain tumor permeability to a pharmaceutical compound. Also in today's presentations, Alkermes provided an update on the status of its ProLease(R) drug delivery technology for sustained release of biopharmaceutical agents. Alkermes has recently announced collaborations for the development of ProLease products with Boehringer Mannheim-Therapeutics and Genentech Inc. and is conducting preclinical experiments and process development in preparation for commencing clinical trials of its first ProLease formulations. RMP-7 Background RMP-7 is a proprietary compound developed by Alkermes to increase transiently the permeability of the blood-brain and blood-ocular barriers. Following injection, Alkermes believes that RMP-7 binds to receptors on these barriers and triggers a brief relaxation of their tight cellular junctions. RMP-7 exerts its effect on the blood vessel blood vessel n. An elastic tubular channel, such as an artery, a vein, a sinus, or a capillary, through which the blood circulates. blood vessel(s), n the network of muscular tubes that carry blood. walls and does not itself bind to or serve as a carrier for compounds administered with it. RMP-7 can be administered either intravenously or intra-arterially and is intended to be used as an independent adjunct to increase the utility of other therapeutic and diagnostic compounds. Drugs that could be administered along with RMP-7 include cancer chemotherapeutic and anti-infective drugs not currently used effectively in central nervous system and ocular disorders because of limited penetration of the blood-brain or blood-ocular barriers. ProLease Background ProLease is a drug delivery system designed to enable sustained release formulations lasting for weeks to months to be made of protein-based and other pharmaceutical drugs or vaccines. The ProLease delivery system is composed of injectable microspheres containing the desired bioactive molecule incorporated into a matrix of poly lactic lactic /lac·tic/ (lak´tik) pertaining to milk. lac·tic adj. Of, relating to, or derived from milk. lactic pertaining to milk. co-glycolic (PLGA PLGA Poly-Lactic-Co-Glycolic Acid PLGA Plastic Land Grid Array PLGA Physically Limited Golfers Association ). ProLease microspheres are administered by subcutaneous or intra muscular injection. The microspheres release the bioactive molecule by simultaneous diffusion and biodegradation. Release profiles from ProLease can be controlled and adjusted by the selection of polymer molecular weight and formulation variables and through control of the fabrication process. Alkermes is developing sophisticated products based on innovative drug delivery technologies. In addition to its Cambridge, Mass. headquarters, the company operates a medical affairs office in Cambridge, England. The company currently employs approximately 100 people worldwide. CONTACT: Alkermes Inc. Richard F. Pops, 617/494-0171 PRESS: Pearson Communications Thomas A. Pearson, 610/995-9730 INVESTOR RELATIONS Investor relations The process by which the corporation communicates with its investors. : Burns McClellan Clarence Swearngan Jr., 212/505-1919 |
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