Md., Mass. firms seek approval for tests MedImmune working on drug to suppress transplant rejection

April 16, 1997|By M. William Salganik | M. William Salganik,SUN STAFF

MedImmune Inc., a Gaithersburg biotechnology company, and BioTrans-plant of Charlestown, Mass., announced at a London conference yesterday that they have applied to the U.S. Food and Drug Administration for permission to begin clinical trials of MEDI-507.

The drug has potential applications in preventing the body from rejecting organ transplants and in treating autoimmune diseases, such as rheumatoid arthritis, in which an immune system fights a body's own organs.

MedImmune and Bio-Trans-plant already are testing BTI-322, a version of MEDI-507 developed from rat antibodies. By re-engineering BTI-322 to match human gene sequences, the companies hope to develop a drug as safe and effective as BTI-322 appears to be, but which humans can tolerate in more sustained doses, said Julie M. Adamou, a MedImmune spokeswoman.

Elliot Lebowitz, chief executive officer of BioTrans-plant, announced the application at a life sciences conference in London.

BioTransplant and MedImmune have been working together to develop BTI-322 and variations on it.

Adamou said the application to the FDA is for "Phase 1" testing, which examines the safety and properties of the drug but not its effectiveness, in a small number of human subjects, typically fewer than 50.

The size and location of the trial have not been announced.

From the beginning of Phase 1 testing, it typically takes four to six years, if the experiments are successful at each step, to get a drug to market, Adamou said.

MedImmune currently markets two drug products and has six potential products in various stages of trials.

MedImmune shares closed yesterday at $14, down 50 cents.

Pub Date: 4/16/97

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