ALKERMES COMPLETES PATIENT ENROLLMENT IN THREE PHASE II RMP-7 BRAIN TUMOR STUDIES; 219 Patients Enrolled in Studies of Intravenous RMP-7 and Carboplatin.CAMBRIDGE, MA--(BUSINESS WIRE)--June 3, 1996 -- 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) ) today announced the completion of patient enrollment in three Phase II clinical trials of RMP-7 and the chemotherapeutic agent chemotherapeutic agent An agent used to treat CA, administered in 'regimens'-one or more 'cycles' that combine 3 or more agents over wks; CAs are toxic to any cell with a high rate of proliferation–the CA itself, the GI tract–causing N&V, carboplatin administered intravenously in patients with recurrent malignant 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. . In total, 219 patients have been enrolled in the three studies. With the completion of patient enrollment, the patient assessment phase of all three clinical trials is expected to be completed by year-end 1996. One Phase II study is being conducted in the U.S. and two are being conducted in Europe. The U.S. study is a 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. , blinded, controlled study comparing treatment with the combination of RMP-7 and carboplatin against treatment with carboplatin alone. The U.S. study began in March 1995 and has enrolled a total of 131 patients at ten medical centers. The European studies are open-label studies in which all patients receive RMP-7 and carboplatin. The European studies commenced in February 1995 and have enrolled a total of 88 patients at 20 medical centers. RMP-7 is a proprietary compound developed by Alkermes to increase the delivery of drugs to the brain by transiently increasing the permeability of the blood-brain barrier blood-brain barrier n. Abbr. BBB A physiological mechanism that alters the permeability of brain capillaries so that some substances, such as certain drugs, are prevented from entering brain tissue, while other substances are allowed to (BBB BBB A medium grade assigned to a debt obligation by a rating agency to indicate an adequate ability to pay interest and repay principal. However, adverse developments are more likely to impair this ability than would be the case for bonds rated A and above. ). In addition to trials using conventional intravenous administration, RMP-7 is also currently being tested when administered intra-arterially with carboplatin in a multi-center U.S. Phase II clinical trial in patients with brain tumor. Intra-arterial dosing involves administration of RMP-7 and carboplatin through a small catheter positioned in the major 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. supplying the brain tumor. RMP-7 is being developed by Alkermes for Alkermes Clinical Partners, L.P., a limited partnership which raised $46 million in 1992 to develop RMPs. Alkermes has the option to purchase the partnership's technology. Alkermes is a leader in the development of products based on sophisticated drug delivery technologies. Alkermes' focus is on two important drug delivery opportunities: (1) controlled, sustained release of injectable drugs lasting several days to several weeks; and (2) the delivery of drugs into the brain past the BBB. In addition to its Cambridge, Massachusetts headquarters, Alkermes operates a manufacturing facility in Ohio and a medical affairs office in Cambridge, England. CONTACT: Richard F. Pops Press Relations: Inv. Relations: Chief Executive Officer Thomas A. Pearson Reagan Codner Alkermes, Inc. Pearson Communications Burns McClellan (617) 494-0171 (610) 995-9730 (212) 505-1919 |
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