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Biotech / Medical : Biotransplant(BTRN) -- Ignore unavailable to you. Want to Upgrade?

To: Arthur Radley who wrote (1092)	11/9/2001 7:43:59 PM
From: Arthur Radley	Respond to of 1475

Allogeneic Transplantation October 31, 2001 3:17pm BioTransplant Inc. (BTRN) has received European Community authorization to affix the CE Mark to its second HDM (high density microparticle) product, signifying regulatory approval to market the device in Europe. This product, the Eligix TCell-DLI Cell Separation System, is intended for ex vivo use for patients receiving a donor leukocyte infusion (DLI) following allogeneic transplantation to augment immune response against malignancies. BioTransplant will receive an additional milestone payment from its distribution partner, Gambro, for obtaining CE mark authorization for its Eligix TCell-DLI product based on the terms of the recently announced distribution agreement. "We believe that the TCell-DLI Cell Separation System has the potential to bring significant benefits to a large cancer patient population. With the help of Gambro, we hope to rapidly make this product widely available in Europe," commented Elliot Lebowitz, PhD, CEO of BioTransplant. "We are also committed to bring forward other Eligix products that are currently under development to address the unmet needs of a wide range of cancer patients." The TCell-DLI Cell Separation System is an ex vivo system for removal of CD8 & & + & & cells from donor leukocyte infusions. According to published literature (Alyea et al. Blood May 15, 1998;91(10):3671-3680) CD8-depleted donor leukocyte infusions are effective in inducing complete remissions in patients with some hematologic cancers, with a lower incidence of graft versus host disease as compared with unmanipulated DLI. The Eligix TCell-DLI Cell Separation product is now the only commercially available product in Europe for this important indication. This certification will enable BioTransplant, through its Gambro BCT distribution alliance, to market Eligix TCell-DLI Cell Separation products in member countries of the European Community. Advertisement: Explore Within This Space BioTransplant is also targeting the use of the Eligix Cell Separation products as a component of the AlloMune System, which, along with its proprietary monoclonal antibody MEDI-507, is being developed as a complete approach to increase the safety and efficacy of immune modulation and transplantation for cancer and other life threatening diseases. There are approximately 16,000 allogeneic transplants worldwide for the treatment of hematological and solid cancers, a number that has been growing steadily in the past years. BioTransplant estimates that allogeneic bone marrow transplantation for cancer accounts for over $1 billion in healthcare expenditures worldwide each year. With its TCell-DLI product, the company hopes to further enhance allogeneic bone marrow transplant outcomes versus those obtainable using nontransplant approaches by potentially reducing the deadly risks of relapse and graft versus host disease, while maintaining an antileukemia effect. This article was prepared by Cancer Weekly editors from staff and other reports.