Alkermes completes patient enrollment in Phase II brain tumor study; 51 patients enrolled in study of Intra-Arterial RMP-7 and carboplatin.CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sept. 25, 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 a multi-center Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II 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 intra-arterially 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. . The Phase II trial commenced in March 1996 and is being conducted at nine major medical centers in the United States. The trial is designed to test the safety and initial efficacy of treatment with the combination of RMP-7 and carboplatin. With the completion of patient enrollment, the patient assessment phase of this clinical trial is expected to be completed by the end of the first half of 1997. 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 . Intra-arterial administration of RMP-7 and carboplatin is a neurosurgical procedure in which the drugs are administered 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. Intra-arterial therapy provides a second, alternative means of administering RMP-7 and chemotherapy in addition to more conventional intravenous administration. Alkermes is also testing RMP-7 when administered intravenously in three multi-center Phase II clinical trials with carboplatin in patients with recurrent, malignant brain tumor. Patient enrollment in these three studies was completed in May 1996 and the patient assessment phase of the studies is expected to be completed by year-end 1996. 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 partnerships's technology. Alkermes is a leader in the development of pharmaceutical 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 blood-brain barrier. In addition to its Cambridge, Mass. headquarters, Alkermes operates a manufacturing facility in Ohio and a medical affairs office in Cambridge, England. CONTACT: Alkermes Inc. Michael J. Landine, 617/494-0171 or Press Relations: Pearson Communications Thomas A. Pearson, 610/995-9730 or Investor Relations Investor relations The process by which the corporation communicates with its investors. : Burns/McClellan Reagan Codner, 212/505-1919 |
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