BioTransplant Presents Positive Safety Data for BTI-322 Monoclonal Antibody in Adult Liver Transplant Patients
CHARLESTOWN, Mass., Aug. 29 /PRNewswire/ -- BioTransplant Incorporated (Nasdaq: BTRN) and its collaborators from the Liver Transplant Program at St. Luc University Hospital in Brussels today announced the results of a phase I/II study demonstrating that adding the company's BTI-322 monoclonal antibody to a commonly used immunosuppressive therapy, including Prograf(R) (tacrolimus), reduced the incidence of rejection in human liver transplantation in the immediate post-operative period by 70% compared to Prograf(R) protocol alone.
The study, "One Year Results of Tacrolimus (TAC) and Anti-CD2 Antibody (BTI-322) In Adult Liver Transplantation," was presented today at the International Congress of the Transplantation Society, Rome, Italy, by Jan Lerut, MD. The results of this 40-patient prospective randomized study build on Dr. Lerut's previous work with BTI-322 and further demonstrate the antibody's potential safety and efficacy in treating adult liver transplant recipients.
"Patients receiving BTI-322 in addition to the Prograf(R) regimen showed a significantly lower incidence of histological rejections despite lower Prograf(R) dosing," noted Dr. Lerut. "The combined use of these therapies appears to be safe in liver transplantation and there were no additional side effects due to the addition of BTI-322. Decreasing the initial dosing of immunosuppressive drugs may be possible by adding early treatment with BTI-322."
BTI-322 is a murine monoclonal antibody discovered at the Catholic University of Louvain, Belgium. It has been tested extensively with encouraging preclinical and clinical results in kidney transplantation and Graft versus Host Disease (GvHD). MEDI-507, a humanized version of BTI-322, is being developed by MedImmune in collaboration with BioTransplant. MEDI-507 is currently in Phase II clinical trials for treatment of GvHD, a frequent and often fatal outcome of bone marrow transplantation. GvHD occurs when donor cells in a bone marrow transplant attack the tissue of the recipient. MEDI-507 is also being evaluated for treatment of psoriasis.
BioTransplant, Incorporated utilizes its proprietary technologies 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 organ and tissue transplantation, and treatment of cancer and autoimmune diseases, for which current therapies are inadequate. BioTransplant's products under development are intended to induce long-term functional transplantation tolerance in humans, increase the therapeutic benefit of bone marrow transplants, and reduce or eliminate the need for lifelong immunosuppressive therapy.
This announcement contains, in addition to historical information, forward-looking statements about BioTransplant that involve risks and uncertainties, such as statements regarding the potential safety and efficacy of the Company's BTI-322 product for treating liver transplantation patients. Such statements reflect management's current views and are based on assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors. 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 the substantial additional funding required 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 organ transplantation; BioTransplant's ability to obtain and enforce the patent protection required for its products; uncertainties to the extent of future government regulation of the transplantation business; and BioTransplant's ability to maintain collaborations with third parties. For a detailed discussion of these and other factors, see the section titled "Business Factors Which May Affect Results" in BioTransplant's current annual report on Form 10-K, as filed with the Securities and Exchange Commission.
Contact: Elliot Lebowitz, Ph.D., President and CEO of BioTransplant
Incorporated, 617-241-5200; or Investor - Patricia Dimond, Ph.D., ext. 245, or
Media - Prateek Patnaik, ext. 273, both of Noonan/Russo Communications,
212-696-4455, for BioTransplant Incorporated.
SOURCE BioTransplant Incorporated |
