MONTREAL, Dec. 10 /PRNewswire-FirstCall/ -- Celmed BioSciences, a subsidiary of Theratechnologies (TSX:TH), announced today that it has signed a collaboration agreement with the National Heart, Lung and Blood Institute (NHLBI) and the National Institutes of Health (NIH) Clinical Center in Bethesda, MD. The agreement involves preclinical research in human cells using Celmed's photodynamic (PDT) Theralux(TM) device, for the treatment of graft- versus-host disease (GvHD), a major life-threatening side effect associated with allogeneic transplants (from a donor). Celmed's PDT-based approach is aimed at specifically eliminating the T lymphocytes that cause GvHD following an allogeneic transplant while keeping the antileukemic effect of the graft.
"We are very pleased that an institution as prominent as the NIH and its world-renowned researchers/clinicians are collaborating with us to find a treatment for GvHD," said Dr. Andre de Villers, President and CEO of Celmed. "We are already preparing the clinical stage for Theralux(TM) in GvHD as we plan to initiate a Canadian clinical study soon. These GvHD studies, combined with our ongoing study in non-Hodgkin's lymphoma, clearly demonstrate that our Theralux(TM) PDT device is a versatile platform, capable of treating a broad range of indications," he added.
The objective of the collaboration announced today is to develop, evaluate and optimize a clinical-scale method for ex vivo selective photodepletion of host-reactive donor T lymphocytes using Celmed's proprietary drug, TH9402, and photodynamic purging and to test the safety and efficacy of selectively depleted (SD) allografts in a Phase l/ll clinical trial of allogeneic peripheral blood stem cell transplantation (SCT). Dr. John Barrett, Chief of the Stem Cell Transplant Program, Clinical Hematology Branch of the NIH, an authority on stem cell transplants, has gathered an experienced team comprising Scott R. Solomon, M.D., Stem Cell Transplant Program, Clinical Hematology Branch, NHLBI and Elizabeth J. Read, M.D., Chief, Cell Processing Section, Department of Transfusion Medicine (DTM), Clinical Center.
About the use of the Theralux(TM) system to purge tumor cells in
An autologous transplantation is a procedure through which blood stem cells are withdrawn from the patient prior to a high dose chemotherapy regimen and subsequently given back (engrafted) to the patient to rescue blood cells and the immune system. Celmed's proprietary Theralux(TM) device is designed to specifically purge cancer cells contaminating the blood stem cells prior to engraftment. With the Theralux(TM) system, a proprietary drug, TH9402, selectively enters the cancer cells of the graft. As a light source is applied to the graft, the cancerous cells containing TH9402 are killed, leaving only normal cells in the graft behind.
About the use of the Theralux(TM) system to prevent GvHD after allogeneic
Allogeneic SCT from an HLA-matched family donor is the treatment of choice for a wide range of blood cancers resistant to standard chemotherapies. Unfortunately only 25-30% of patients are able to find a related matched donor. For the others, transplantation from a matched unrelated or mismatched related donor is possible but associated with higher risks. Allogeneic SCT has a major side effect known as GvHD, a life threatening condition in which organs of the patient are destroyed by the newly formed immune system.
Celmed has broadened the application of Theralux(TM) to the purging of alloreactive immune cells that cause GvHD. Theralux(TM) was designed to selectively eliminate GvHD-causing immune cells while sparing the majority of normal immune cells, providing a new means of preventing GvHD in patients requiring allogeneic transplantation. Exciting pre-clinical results have been published by Drs. Denis?Claude Roy of Maisonneuve-Rosemont Hospital and Nelson J. Chao of Duke University. Additional information on the Theralux(TM) platform, clinical trials on GvHD and other indications, as well as current research is available on the Company's website: http://www.celmedbio.com/ .
About Celmed BioSciences
Celmed BioSciences, a private company spun off by Theratechnologies in 2001, targets niche applications in oncology and neurology. Headquartered in Montreal with research facilities in Canada and the United States, Celmed develops cell-based therapies for the treatment of hematological, immune and neurodegenerative disorders.
Theratechnologies (TSX:TH) is a Canadian biotechnology company engaged in the discovery and development of therapeutic products in the field of endocrinology and metabolism. The Company has and is developing a portfolio of peptides at various stages of development for the treatment of catabolic (loss of the body's synthesis and regeneration capacity) and metabolic disorders, as well as osteoporosis and type II diabetes. In addition, Theratechnologies is expanding its peptide portfolio through proven, proprietary technologies.
This press release contains forward-looking statements, which reflect Celmed's current expectations regarding future development of the Theralux(TM) system. Such statements inherently involve numerous risks and uncertainties, including the availability of funds and resources to pursue preclinical and clinical projects, the successful and timely completion of clinical studies, and the granting of the necessary approvals by the regulatory authorities. Actual future results may differ materially from the anticipated results expressed in the forward-looking statements contained in this press release. Investors are cautioned against placing undue importance on this forward-looking information and should consult Theratechnologies' 2002 Annual Report, which contains a more exhaustive analysis of risks and uncertainties.
CELMED BIOSCIENCES INC.