Alkermes Inc. on Monday filed its first investigational newdrug application with the Food and Drug Administration tobegin Phase I clinical trials of RMP-7, a compound designed toenable drugs to cross the blood-brain barrier (BBB).
RMP-7 (receptor-mediated permeability-7) is a syntheticpeptide developed by Cambridge, Mass.-based Alkermes thattransiently increases the permeability of the BBB. "We think itloosens the tight bonding or matrix between the endothelialcells that line the blood vessels, allowing small molecules toget through the matrix," said Richard Pops, president and chiefexecutive officer.
The trial will test safety in healthy patients. If successful,Alkermes plans a second Phase I trial of RMP-7 with aradionuclide imaging agent that normally doesn't cross theBBB. The company will measure the amount of agent reachingthe brain to help establish correct dosing levels of RMP-7.
The next step will be Phase I/II trials in AIDS patients withtoxoplasmosis or cryptococcal meningitis. Those trials willtest RMP-7 with an antibiotic such as clindamycin, an off-patent drug commonly used to treat toxoplasmosis.Clindamycin currently must be given in extremely high dosesto get sufficient drug across the BBB, causing gastrointestinaltoxicities, Pops said.
Alkermes also hopes to begin trials next year in patients withbrain tumors. Those tests would combine RMP-7 withcommonly used chemotherapeutic drugs such ascyclophosphamide, cisplatin and methotrexate, all of whichwould be off patent by the time Alkermes brings a product tomarket, Pops said.
Alkermes stock (NASDAQ:ALKS) closed at $14.50, up $1.25, onMonday. The company completed an initial public offering at$10 per share in July.
-- Karen Bernstein BioWorld Staff
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