Alkermes Commences Third Phase II Clinical Trial of RMP-7 in Brain Tumor Patients.CAMBRIDGE, Mass.--(BUSINESS WIRE)--March 24, 1995--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 today the commencement of patient enrollment in the third 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 double-blind, controlled study is being conducted at several locations in the U.S. and will involve up to 90 patients. The trial is designed to test the efficacy of the combination of RMP-7 and carboplatin versus carboplatin alone in the treatment of recurrent glioma as measured by time to tumor progression and deterioration of clinical status. The study is the third of three planned Phase II studies of RMP-7 in the treatment of recurrent glioma initiated by Alkermes this quarter. "With the initiation of patient enrollment in this Phase II study, Alkermes has commenced Phase II clinical trials in the glioma indication in the U.S., U.K. and Europe this quarter. In total, we will evaluate over 160 patients in the three clinical trials," said Richard F. Pops, Chief Executive Officer. 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. 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. 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 developing sophisticated products based on innovative drug delivery technologies. In addition to its Cambridge, Massachusetts This article is about the city of Cambridge in Massachusetts. For the English university town, see Cambridge, England. For other places, see Cambridge (disambiguation). Cambridge, Massachusetts is a city in the Greater Boston area of Massachusetts, United States. headquarters, the Company operates a medical affairs office in Cambridge, England. The Company currently employs approximately 100 people worldwide. CONTACT: Alkermes, Inc., Cambridge Richard F. Pops, 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 Clarence Swearngan, Jr., 212/505-1919 |
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