Alkermes Inc. presented results of its Phase I clinical trial onRMP-7 at the Second U.S.-Japan Symposium on Drug DeliverySystems in Maui, Hawaii.
The trial of the compound, a synthetic peptide designed toincrease the permeability of the blood-brain-barrier (BBB) forimproved delivery of drugs to the brain, was conducted inpatients with malignant glioma.
William Graney, vice president of medical affairs at Alkermesof Cambridge, Mass., presented data indicating that thecompound, RMP-7, is safe in this patient population.
In the study, patients received one of five ascending doses ofRMP-7 intravenously. All doses were well-tolerated and therewere no severe adverse effects.
Additionally, three of of the five patients (60 percent) havingbrain tumors that could be imaged by contrast-enhancedmagnetic resonance imaging indicated greater volume ofdistribution of contrast agent following administration of RMP-7.
Based on the results of this trial and other completed Phase Ison RMP-7, Alkermes (NASDAQ:ALKS) has submitted twoprotocols to the FDA to begin combined Phase I/II trials ofRMP-7 in combination with carboplatin, an approvedchemotherapeutic drug. Alkermes intends to file a similarapplication for trials in the United Kingdom.
-- Jennifer Van Brunt Senior Editor
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