Alkermes Inc. said Monday that it has begun two separate Phase I/IIcombination trials of its proprietary drug delivery agent, Receptor-Mediated Permeabilizer 7 (RMP-7), used in combination with achemotherapeutic drug, carboplatin, in patients with advanced braintumor.In addition to safety, the trials will test methods of administration andthe efficacy of RMP-7 in overcoming the blood-brain barrier (BBB) indelivering a therapeutic agent to the brain.One trial, at the University of California, San Francisco, will useintravenous infusion as the administration method. The other newtrial, at the University of California, Los Angeles, will test intra-arterial methods. A third trial in the United Kingdom has alreadybegun that also uses the intravenous method.The combination trials follow six single-agent Phase I studies of RMP-7 in the U.S. A Phase I clinical trial of RMP-7 in 1992 failed todemonstrate that RMP-7 eased the passage of a radioactive markeracross the BBB. The Cambridge, Mass., company (NASDAQ:ALKS)attributed this to the limitations of the rubidium marker used.In the new trials, researchers will rely on magnetic resonance imagingto study the effectiveness of RMP-7 as a drug delivery mechanism,according to Donna LaVoie, Alkermes' director of corporatecommunications. LaVoie said the preliminary efficacy of RMP-7 inincreasing the penetration of an imaging agent in the treatment ofbrain tumors has already been demonstrated in a Phase I trial. _Philippa Maister
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