Thursday April 6, 9:15 am Eastern Time
Company Press Release
SOURCE: BioTransplant Incorporated
BioTransplant Initiates Phase I/II Trial of
AlloMune(TM) Cancer System
CHARLESTOWN, Mass., April 6 /PRNewswire/ -- BioTransplant Incorporated (Nasdaq: BTRN - news) today announced
that enrollment and treatment has begun in a multi-center Phase I/II trial of the AlloMune(TM) Cancer System under an IND
for the treatment of therapy-refractory Hodgkin's and non-Hodgkin's lymphoma (NHL). The Company's AlloMune(TM)
Cancer System is being designed to re- educate the body's immune system to accept foreign cells with the potential to produce
powerful anti-tumor effects and minimize the occurrence of severe Graft-versus-Host disease (GvHD). GvHD is a serious
clinical syndrome caused when white blood cells from the donor bone marrow attack the tissue of the recipient.
The trial is built on the success of a prototype AlloMune(TM) System, which has been used at The Massachusetts General
Hospital (MGH) to treat end- stage lymphoma and leukemia patients. Clinical data presented at the Annual Meeting of the
American Society of Hematology demonstrated that treatment with the AlloMune prototype in 21 patients led to an overall
response rate of 67% (38% complete response, 29% partial response). The method, whereby patients are prepared for a bone
marrow or stem cell transplant with a combination of low-dose chemotherapy and antibodies against T cells, was published last
year in The Lancet. As compared to standard bone marrow transplantation, we believe that this approach may yield less
chemotherapy-related toxicity, potentially greater anti-tumor effects and a reduced incidence and severity of GvHD, an often
deadly complication of transplantation.
The Company also announced the composition of a Clinical Advisory Board to help guide its cancer program. Leading
clinicians comprise the membership of the Board, including: Barbara Bierer, M.D., Chief, Laboratory of Lymphocyte Biology,
National Heart, Lung and Blood Institute, and Professor of Pediatrics at Harvard Medical School; Bruce Chabner, M.D.,
Chief of Hematology-Oncology and Clinical Director of the Massachusetts General Hospital Cancer Center; Alex Fefer, M.D.,
Professor of Medicine, University of Washington School of Medicine; Thomas R. Spitzer, M.D., Director, Bone Marrow
Transplant Program, Deputy Chief of Hematology-Oncology, Associate Professor of Medicine, Harvard Medical School; and
Julie Vose, M.D., Professor, Internal Medicine, University of Nebraska Medical Center.
``We are very excited by our progress in advancing the AlloMune(TM) Cancer System toward the clinic, and are pleased by
the results we've seen to date,' said Elliot Lebowitz, Ph.D., President and CEO of BioTransplant. ``This Board is an important
part of our clinical initiative for the AlloMune(TM) Cancer System and our cancer program in general. We are delighted to
have the participation of this talented group to support this effort, and we look forward to the continuing success of our cancer
program this year.'
The AlloMune family of products is being designed to treat a broad range of medical conditions, including cancer, organ and
tissue transplantation, hematological disorders and autoimmune diseases. By harnessing the benefits of mixed chimerism, a state
in which the immune system of a transplant recipient blends with that of a donor, BioTransplant has been developing products
intended to induce long-term functional tolerance, increase the therapeutic benefit of bone marrow transplants and reduce or
eliminate the need for lifelong anti-rejection drugs. Previously, BioTransplant announced the issuance of two U.S. patents (no.
6006752 and no. 5876708) covering the induction of human tolerance (acceptance of foreign tissue as ``self') to grafts from
human and non-human donors through the creation of mixed chimerism. Methods for inducing tolerance include preparatory
conditioning regimens that do not require whole-body irradiation and that reduce the need for lifelong administration of
immunosuppressive drugs.
Using such an approach, MGH physicians have previously reported the successful treatment of a patient with both kidney
failure and multiple myeloma in the journal, Transplantation. After a double transplant of both bone marrow and a kidney from
her sister using an AlloMune prototype system, the patient currently has normal kidney function with no sign of GvHD. While
she received the anti-rejection drug, cyclosporine, immediately following the transplant, the immunosuppression was
discontinued on the 73rd day after the procedure. The myeloma remains at a nearly undetectable level at this time.
BioTransplant Incorporated utilizes these proprietary technologies in re- educating the body's immune responses to allow
functional 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
disease, for which current therapies are inadequate. BioTransplant's products 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, certain forward-looking statements about BioTransplant that
involve risks and uncertainties. Such statements reflect management's current views and are based on certain 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.
SOURCE: BioTransplant Incorporated |
