Alkermes Inc. officials told analysts Monday that they started thesecond of three Phase II studies of a compound used to increase thepermeability of the blood-brain barrier.

Alkermes, of Cambridge, Mass., is developing RMP-7 (receptor-mediated permeabilizer) as a delivery vehicle. In these studies, it isbeing tested in conjunction with carboplatin to treat recurrent glioma,a type of primary brain tumor.

Both studies that have started are in Europe, and are expected toinvolve 40 to 60 patients each. The European studies will be open-label trials testing RMP-7 and carboplatin. One study will assess thecombination in patients who have undergone chemotherapytreatment. Those in the other study will not have had prior treatment.

A U.S. Phase II trial expected to begin in the next few months will becontrolled and double-blind comparing carboplatin and RMP-7 tocarboplatin alone, said Alkermes' CEO Richard Pops.

Pops said the company has demonstrated quantitative changes inblood-brain permeability. That, together with safety data alreadygathered, led the company to undertake the concurrent Phase IIstudies, he told BioWorld.

Endpoints in the European open-label studies are the response rate asmeasured by the change in tumor size on magnetic resonance imagingscanners, and assessments of clinical scores. The endpoint in the U.S.trial will be time to progression of disease.

Pops said the studies should be completed in about a year and a half.

RMP-7 is a peptide that has been shown to temporarily increase thepermeability of the blood-brain barrier and allow passage of smallmolecules into the brain. The company said RMP-7 acts by bindingto a cell surface receptor on brain endothelial cells, triggering a briefrelaxation of the tight cellular junctions.

"Now that we've shown it's safe and changes permeability, we'reactively discussing RMP-7 with pharmaceutical companies," Popssaid. "Our goal would be to have multiple partners."

Drugs that could be administered along with RMP-7 includechemotherapy drugs, such as carboplatin, and anti-infective drugsthat aren't being used effectively because of limited penetration ofthe blood-brain or blood-ocular barriers, the company said.

Alkermes' stock (NASDAQ:ALKS) closed unchanged Monday at$2.75 per share. n

-- Jim Shrine

(c) 1997 American Health Consultants. All rights reserved.