Monday May 15, 9:31 am Eastern Time
Company Press Release
SOURCE: BioTransplant, Incorporated
BioTransplant and the Massachusetts General
Hospital Announce Preliminary Results with a Novel, Less Toxic
Treatment for Lymphoma and Leukemia
CHARLESTOWN, Mass., May 15 /PRNewswire/ -- BioTransplant, Incorporated (Nasdaq: BTRN - news) and the
Massachusetts General Hospital (MGH) today announced preliminary results of a trial using BioTransplant's proprietary
MEDI-507 humanized monoclonal antibody, in a prototype of the Company's AlloMune(TM) Cancer System. In six patients
with blood or bone marrow cancers who received mismatched bone marrow transplants, MEDI-507 led to the establishment
of a partially blended immune system, with no graft-versus-host disease (GvHD) in four patients. Study results were presented
at Transplant 2000, the annual meeting of the combined American Society of Transplant Surgeons and American Society of
Transplant Physicians today in Chicago by Steven Alexander, M.D. a researcher at the MGH Transplant Biology Research
Center (TBRC). Dr. Alexander will receive an Upjohn Young Investigator's Award at Transplant 2000 for this research.
The six patients treated with the AlloMune(TM) Cancer prototype system, incorporating MEDI-507, had received bone
marrow transplants from donors with two or three HLA mismatches out of a possible six. Despite the possible powerful
anti-tumor effects of such mismatched transplants, they have historically been unable to be executed without severe and/or fatal
GvHD. The six patients had either acute myelogenous leukemia (AML) or non-Hodgkins lymphoma that had not responded to
all previous treatment regimens including chemotherapy, radiation and/or autologous bone marrow transplantation.
The goal of the treatment was to produce a condition of ``mixed chimerism'' in which an immune system containing elements of
both donor and recipient cells is created. The donor's transplanted cells do not attack the patients', and the patient, in turn,
recognizes them as ``self''. Previously, 13 patients were similarly treated with an earlier AlloMune(TM) Cancer system
prototype using anti-thymocyte globulin (ATGAMR) and bone marrow in patients with one or two HLA antigen mismatches,
yet 77% of these patients demonstrated GvHD following treatment. The current result incorporating MEDI-507, reduced
GvHD despite greater mismatching, and is thus a marked improvement over previous efforts. The attainment of chimerism
without GvHD would allow for subsequent donor-lymphocyte infusion (DLI), the most potent anti-tumor component of the
process. In previous MGH studies, patients who underwent DLI had high response rates for their underlying malignancies. The
overall strategy is based on the results of animal studies from the laboratory of Megan Sykes, MD, of the MGH TBRC, a
co-author of Alexander's study. The Company is currently enrolling patients in an initial multicenter Phase I/II clinical trial under
an IND.
Thomas Spitzer, M.D., Director, Bone Marrow Transplant Program and Deputy Chief of Hematology-Oncology at the
Massachusetts General Hospital, said, ``I have been very impressed with this approach and believe that it represents the future
in non-myeloablative transplant strategies.''
``We are pleased with the exciting results of the MGH trial and we are also encouraged about the initial results of the
company's multicenter clinical trial, which together reflect our continuing commitment to and focus on the company's cancer
program,'' said Elliot Lebowitz, Ph.D., president and CEO of BioTransplant.
BioTransplant's clinical program in cancer is building on the success of the MGH Bone Marrow Transplant Program, directed
by Spitzer, which has employed a similar approach to treat end-stage lymphoma and leukemia patients. Clinical data presented
by MGH investigators at the December, 1999 American Society of Hematology meeting demonstrated that a similar treatment
strategy in 21 patients with matched transplants led to an overall response rate of 67% (38% complete response; 29% partial
response). Using this method, the patient is prepared for bone marrow transplantation with low-dose chemotherapy and anti-T
cell antibodies. This approach, the so-called ``mini-transplant'' approach is less toxic to the patient and has provided important
anti-tumor effects.
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 designed to
treat a range of medical conditions, including organ and tissue transplantation, 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 document includes forward-looking statements based on management's current expectations. Factors that could cause
future results to differ materially from such forward-looking statements include, but are not limited to: the Company's ability to
secure the substantial additional funding required for its operations and research and development programs; the Company'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; the
company's ability to obtain and enforce the patent protection required for its transplantation business; and the Company's ability
to maintain collaborations with third parties, as well as the timing and content of decisions made by the US Food and Drug
Administration. For a detailed discussion of these and other factors, see the Company's Annual Report on Form 10-K as filed
with the Securities and Exchange Commission.
Contact: Elliot Lebowitz, Ph.D., President and CEO, 617-241-5200; or Susan McGreevey, 617-724-2764, both of
BioTransplant, Inc., or Investor - Patricia Dimond, Ph.D., ext., 245, or Media - Prateek Patnaik, ext., 273, both of
Noonan/Russo Communications, for, 212-696-4455.
SOURCE: BioTransplant, Incorporated |
