BioTransplant Reports Massachusetts General Hospital Study Showing Clinical Progress in Cancer Therapy and End-Stage Renal Disease
ORLANDO, Fla., Dec. 10 /PRNewswire/ -- BioTransplant Incorporated (Nasdaq: BTRN - news) today announced new developments in cancer therapy being presented by its collaborators at Massachusetts General Hospital (MGH) at the 43rd Annual Meeting of the American Society for Hematology (ASH) from December 7-11, 2001 in Orlando, Florida. Significantly, a mild course of chemotherapy including in some cases MEDI-507, BioTransplant's proprietary T-cell depleting monoclonal antibody, followed by bone marrow transplantation was found to positively effect the treatment of Large B-cell Lymphoma (L-BCL) in patients. These investigations were led by Thomas Spitzer, M.D., Director of the Bone Marrow Transplant Program at the Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School and Megan Sykes, M.D., Head, Bone Marrow Transplantation Section, Transplantation Biology Research Center, Massachusetts General Hospital and Professor of Surgery and Medicine at Harvard Medical School.
Patients with advanced chemotherapy refractory L-BCL normally have a poor prognosis with only a remote possibility of survival following conventional, harsh chemotherapeutic regimens. In this pilot trial, twenty patients with advanced L-BCL were treated. Eight of nineteen evaluable patients achieved a response (5 complete response, 3 partial response) including 3 of 10 HLA matched patients and 5 of 10 HLA mismatched patients. Of these 20, five patients are alive and progression-free 13 to 52 months after transplant.
In further studies, sixty-nine patients with a variety of refractory hematologic malignancies were transplanted using a similar mild non-myeloablative regimen including in-vivo T cell depletion. Forty-six of these patients received a bone marrow transplant from an HLA matched donor and twenty-three received an HLA mismatched donor transplant. Thirty five percent of patients who maintained long-term full or partial donor chimerism achieved a complete anti-tumor response or complete remission. Even among 20 patients who subsequently lost chimerism, four patients, all with refractory NHL developed complete anti-tumor responses. Two of these patients relapsed at 6 and 8 months post-transplant while the other two remain in complete remission more than two years after the transplant.
Dr. Spitzer commented, ``I am very encouraged by the response rate among patients with chemorefractory hematologic malignancies. The early results of our non-myeloablative transplants are highly promising and demonstrate a curative potential for this treatment among patients with no other viable treatment options.''
The continuing success of a double transplant (bone marrow and kidney) procedure to treat multiple myeloma and end-stage renal disease will also be presented. Two patients who were suffering from renal failure secondary to refractory myeloma were treated with a mild non-ablative regimen in preparation for bone marrow transplantation including in-vivo T cell depletion. Each patient also received a kidney transplant from their HLA-matched bone marrow donor immediately before the marrow was infused. Both patients have experienced remission of multiple myeloma. Each patient has normal renal function at one year and 34 months respectively despite the withdrawal of immunosuppressive medication by Day 77 following transplant. This procedure represents the first successful demonstration of allograft tolerance and was developed at the Bone Marrow and Kidney Transplantation Units at the Massachusetts General Hospital.
Elliot Lebowitz, CEO of BioTransplant said, ``We are encouraged by pilot studies supporting the potential of the AlloMune System, which includes the T cell depleting MEDI-507 antibody, for the treatment of refractory hematological cancers and end stage renal disease.''
The AlloMune(TM) family of products is 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.
The Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $200 million and major research centers in AIDS, the neurosciences, cardiovascular research, cancer, cutaneous biology, transplantation biology and photomedicine. In 1994, the MGH joined with Brigham and Women's Hospital to form Partners HealthCare System, an integrated health care delivery system comprising the two academic medical centers, specialty and community hospitals, a network of physician groups and non-acute and home health services.
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 release and additional information on BioTransplant is available on the Web at biotransplant.com |
