Alkermes expands RMP-7 brain tumor clinical trials.CAMBRIDGE, Mass.--(BUSINESS WIRE)--March 28, 1996--Alkermes, Inc. (Nasdaq: ALKS ALKS Alkermes, Inc. (stock symbol) ) today announced the initiation of 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(Tm) 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 tumors. The Phase II study is being initiated following the successful completion of a first Phase I/II (safety) clinical trial and the dose escalation phase of a second Phase I/II clinical trial in brain tumor patients. The Phase II clinical trial will be conducted at eight medical centers in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . 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. RMP-7 is also being tested when administered intravenously, in three multi-center Phase II clinical trials with carboplatin. These studies commenced in 1995 and patient accrual in all three trials is expected to be completed in the first half of 1996. "We are now conducting multi-center Phase II clinical trials of RMP-7 and carboplatin administered by both the intravenous and intra-arterial routes," said Richard F. Pops, Chief Executive Officer of Alkermes. "Over 18 medical centers in the U.S. and over 20 centers in Europe will be involved in RMP-7 clinical trials in brain tumor. By conducting such a broad clinical program, we believe that we increase the probability of demonstrating RMP-7's utility in improving the efficacy of chemotherapy in brain tumors." 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(Tm). 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 of the most valuable drug delivery opportunities: (1) controlled, sustained release Sustained-release (SR), extended-release (ER, XR, or XL), time-release or timed-release, controlled-release (CR), or continuous-release (CR or Contin of injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. 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, Massachusetts headquarters, Alkermes operates a manufacturing facility in Ohio and a medical affairs office in Cambridge, England. CONTACT: Richard F. Pops Chief Executive Officer Alkermes, Inc. (617) 494-0171 or Press Relations: Thomas A. Pearson Pearson Communications (610) 995-9730 or Investor Relations Investor relations The process by which the corporation communicates with its investors. : Reagan Codner Burns McClellan (212) 505-1919 |
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