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Positive Phase I/II AlloMune results for end-stage lymphoma reported
Mass. | Friday, December 28, 2001, 08:00 Hrs  [IST]

BioTransplant Incorporated announced that a Phase I/II trial utilizing its proprietary AlloMune System demonstrated encouraging anti-tumor results in a majority of patients afflicted with end-stage refractory lymphoma. AlloMune utilizes BioTransplant's proprietary antibody MEDI-507, in combination with (non-myeloablative) allogeneic bone marrow transplantation.

The current trial was a multi-center, company-sponsored trial including only patients who were deemed to have no alternative therapeutic options following failure to respond to chemotherapy, and in some cases, radiation and autologous bone marrow transplantation. Incremental modifications to AlloMune system prototypes have led to increasing success in the treatment of refractory blood cancers, not only in terms of response rates, but also in terms of bone marrow engraftment and reduction in graft-versus-host-disease, the most severe complication of allogeneic bone marrow transplantation.

"We are pleased to have positive results in this trial for patients who have exhausted all other treatment options and to report, for the first time, our company-sponsored Phase I/II data with AlloMune as a step toward FDA approval of the AlloMune System," said Dr. Elliot Lebowitz, CEO of BioTransplant. "We expect to implement further modifications to the system, specifically the introduction of the TCell HDM device, which we expect will enhance these results by potentially further reducing the risk of graft-versus-host disease. We continue to move forward toward our goal of a pivotal AlloMune System trial in 2002."

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