ALKERMES ANNOUNCES INTERIM RESULTS OF PHASE 1B TRIAL
ALKERMES ANNOUNCES INTERIM RESULTS OF PHASE 1B TRIAL CAMBRIDGE, Mass., Aug. 18 /PRNewswire/ -- Alkermes, Inc.
(NASDAQ: ALKS) today announced interim results of a Phase 1b safety trial of RMP-7. The study was designed to investigate the safety of a range of single doses of RMP-7 administered to healthy volunteers. In addition, volunteers were given a radioactive tracer and Positron Emission Tomography (PET) was used to attempt to quantitate changes in blood-brain barrier permeability to that tracer.
Interim results in the study confirm the findings in the company's first Phase I trial completed in June 1992, which indicate a range of tolerable doses of RMP-7. No changes in blood-brain barrier permeability to the radioactive tracer were noted in any of the subjects tested. "We are pleased that RMP-7 continues to show a consistent tolerability profile in subjects studied to date. We were hoping to see changes in blood-brain barrier permeability through the PET imaging technique, but the lack of quantifiable increases in blood-brain barrier permeability to this particular radioactive tracer to date in no way changes our development schedule for the compound. From the time that we designed the trial, we have been aware of the limitations of the PET imaging component and included it with the hope that it could provide supplemental data that could aid in our designing future studies," said Richard F. Pops, CEO. As previously announced, the company expects to commence a third Phase I trial in volunteers with RMP-7 later this month and expects to begin a Phase I/II study in patients at the end of 1992. Alkermes is developing RMP-7 as an agent to increase the permeability of the blood-brain barrier on behalf of Alkermes Clinical Partners, L.P. Alkermes, Inc. is a neuropharmaceutical company founded in 1987 that is focused on the development and commercialization of therapeutic and diagnostic products for the treatment of diseases and disorders of the central nervous system. -0- 8/18/92 /CONTACT: Richard F. Pops, president and CEO of Alkermes, 617-494-0171, or Thomas A. Pearson of Pearson Communications, 215-644-4420, for Alkermes/ (ALKS) CO: Alkermes Inc. ST: Massachusetts IN: MTC SU: PDT
CH -- NE008 -- 0926 08/18/92 11:49 EDT
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|Date:||Aug 18, 1992|
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