Boston Life Sciences Inc., is proposing a Phase III trial ofTherafectin to give the carbohydrate compound anotherchance at showing its effectiveness against rheumatoidarthritis.

The Waltham, Mass., company got the compound when itmerged with the drug's original developer, GreenwichPharmaceuticals Inc., last June. Therafectin was deemednot approvable in January 1994 by an FDA advisorycommittee, several months after the agency had sentGreenwich a "not approvable" letter for the drug.

The drug's rejection was based on data from four studies,RA-9 through RA-12, the first three of which had fourclinical endpoints: swollen joints, painful joints,physician assessment and patient assessment. A fifthendpoint was improvement in three of the four areas.

Boston Life said its wants to replicate the RA-9 study,which by itself was statistically significant. In that trial 41percent of 98 Therafectin patients improved in all fourvariables compared to 21 percent of 103 placebo patients.In RA-10, 36 percent of 206 drug patients improvedcompared to 30 percent of 105 placebo patients.

Marc Lanser, chief scientific officer of Boston Life, saidthe company is proposing that the new trial have stricterentry criteria than RA-10, which included patients thatdid not have sufficiently active disease. While the druggroup's response was similar to that seen in RA-9, thehigh placebo responses led to lack of significance.

"To minimize the placebo response we want to get moreactive patients," Lanser said. "The consensus from thelast advisory committee meeting was that if RA-9 couldbe replicated it would predispose them towardrecommending approval of the drug."

Boston Life is proposing a 200-patient study at 10 U.S.centers. The treatment is expected to involve 2 grams ofdrug given three times per day for 20 weeks.

Greenwich's second drug candidate, another syntheticmonosaccharide, failed to show efficacy against in aPhase II rheumatoid arthritis study released in May 1994.Greenwich then laid off most of its work force and scaledback development before its "reverse merger" withBoston Life.

"We spent months before and since the merger goingthrough the data," said George Eldridge, vice president,corporate development and finance for Boston Life."Their previous interaction with the FDA indicated that,from the FDA's perspective, Greenwich had not providedsufficient information for approval. They did not have thecapital to provide that information.

"We have the ability to continue and try to answer thosequestions," Eldridge said. "One of the ways to satisfytheir request for additional information is through thistrial." n

-- Jim Shrine

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