BioTransplant Announces CE Mark Authorization for Second Eligix HDM Cell Separation Product for the Treatment of Cancer
- Only Commercially Available Product in Europe for the Removal of CD8+ Cells from DLI -
CHARLESTOWN, Mass., Sept. 26 /PRNewswire/ -- BioTransplant Incorporated (Nasdaq: BTRN - news) announced today that it 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(TM) 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, Ph.D., 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. 1998 May 15; 91, 10: 3671-80) 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 to 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.
BioTransplant is also targeting the use of the Eligix Cell Separation products as a component of the AlloMune(TM) 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 non-transplant approaches by potentially reducing the deadly risks of relapse and graft versus host disease, while maintaining an anti-leukemia effect.
BioTransplant Incorporated utilizes its proprietary technologies under development to re-educate the body's immune responses to allow tolerance of foreign cells, tissues and organs. Based on this technology, the Company is developing a portfolio of products for application in a range of medical conditions, including treatment of cancer and autoimmune diseases, organ and tissue transplantation, for which current therapies are inadequate. BioTransplant's products under development are intended to increase the therapeutic benefit of bone marrow transplants, reduce or eliminate the need for lifelong immunosuppressive therapy, and induce long-term functional transplantation tolerance in humans.
Any statements in this press release about future expectations, plans and prospects for BioTransplant, including but not limited to statements regarding the market penetration and potential benefits of BioTransplant's Eligix TCell- DLI Cell Separation Device, and other statements containing the words ``believes,'' ``anticipates,'' ``plans,'' ``expects,'' ``will,'' and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those currently anticipated as a result of a number of important factors. Important factors that could cause future results to differ materially from such forward-looking statements include, but are not limited to: BioTransplant's ability to secure additional funding for its operations and research and development programs; BioTransplant's ability to successfully discover, develop and commercialize its products, obtain required regulatory approvals in a timely fashion, and overcome other difficulties inherent in developing pharmaceuticals and procedures for transplantation; the risk that BioTransplant's and Eligix' businesses will not be integrated successfully or that the anticipated benefits of the merger will not be realized; BioTransplant's ability to obtain and enforce the patent protection required for its products; uncertainties as to the extent of future government regulation of the transplantation business; and BioTransplant's ability to maintain collaborations and distribution agreements with third parties. For a detailed discussion of these and other factors, see the section entitled ``Business - Factors Which May Affect Results'' in BioTransplant's current annual report on Form 10-K, as filed with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this news release. While BioTransplant may elect to update these forward- looking statements in the future, BioTransplant specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing BioTransplant's views or estimates as of any date subsequent to the date of this news release.
Contact: BioTransplant Incorporated
Elliot Lebowitz
CEO
617-241-5200
biotransplant.com
Noonan/Russo Communications, Inc.
Prateek Patnaik (Media), x273
David Walsey (Investor), x230
212-696-4455
noonanrusso.com
SOURCE: BioTransplant Incorporated |
