MONTREAL, April 29 /PRNewswire-FirstCall/ -- Celmed BioSciences, a subsidiary of Theratechnologies (TSX:TH), active in the field of oncology, today announced the interim results, of an ongoing open-label clinical study using its ex vivo photodynamic therapy, Theralux(TM), for patients with non- Hodgkin's lymphoma (NHL). The results show that Theralux(TM), a non-invasive process used outside the body (ex vivo) to treat disorders affecting the blood and bone marrow, was able to completely eradicate cancer cells from autologous stem cell grafts in 88 percent of patients.
The objective of the present study was to determine the safety of the Theralux(TM) process and whether the process could eliminate lymphoma cells from a contaminated graft below detectable levels in at least 50 percent of patients. Fourteen patients have been enrolled in the trial to date. They all had histologically confirmed NHL with a documented molecular rearrangement (Bcl2) in the peripheral blood or bone marrow cells that could be detected at levels as low as 5 cells per million. The efficacy of Theralux(TM) to purge lymphoma cells from contaminated grafts to below detectable levels was 88 percent (7 out of 8) in fully evaluable patients. Another analysis with all available patients showed that 77 percent (10 out of 13) patients received grafts without detectable levels of cancer cells after the Theralux(TM) therapy. The remaining 3 patients received grafts where greater than 85 percent of cancer cells were eliminated. Data from one patient was not available at the time of the analysis.
Following autologous stem cell transplantation, successful engraftment was reported in all 14 patients suggesting that Theralux(TM) did not affect the viability of precursor and progenitor cells that allow engraftment. Thirteen of the patients are still alive, and 9 patients are disease-free survivors with clinical remissions up to 39 months. Based on these positive results, Celmed plans to accelerate the completion of the study.
"Purging cancer cells from autologous stem cell grafts is currently used to reduce the possibility of cancer relapse, but new methodologies need to be developed to improve the efficacy of purging - this data suggests that the Theralux(TM) process is a most promising candidate for this application," said Dr. Denis Claude Roy, Hematologist and Director, Cellular Therapy Laboratory at Maisonneuve-Rosemont Hospital in Montreal and principal investigator of the study. "These interim results suggest that Theralux(TM) is able to target and eliminate cancer cells without compromising engraftment," Dr. Roy added.
"These positive results represent the first of several important milestones expected from Celmed over the next 12 to 18 months, including the start of additional clinical trials expanding the applications of Theralux(TM)," commented Dr. Andre de Villers, President and Chief Executive Officer of Celmed. "We are also building key relationships with both the medical and business communities to add further value to the Theralux(TM) technology platform. In addition, Celmed is in excellent financial position to carry out its intensified development activities," he added.
About non-Hodgkin's lymphoma
Non-Hodgkin's lymphoma is one of several cancers originating in the lymphatic system. It occurs when a lymphocyte, a white blood cell, undergoes a malignant change and begins to multiply, eventually crowding out healthy cells and creating tumors that enlarge lymph nodes. According to the US National Cancer Institute, over 50,000 people develop non-Hodgkin's lymphoma every year in the US (140,000 worldwide), while approximately 25,000 die of this disease annually. Treatment for this disease includes chemotherapy and radiation, monoclonal antibody-based treatments and both allogeneic and autologous stem cell transplantation coupled with high-dose chemotherapy. Autologous stem cell transplantation with high-dose chemotherapy is often recommended for certain types of relapsed NHL. In these cases, the stem cells in the graft are often contaminated by the patient's own cancer cells and would be reinfused into the patient if they are not first purged from the graft.
About the Theralux(TM) platform
The Theralux(TM) process consists of a photosensitive drug and a device designed to eliminate certain unwanted cells. The drug, TH9402, is Celmed's proprietary product that is preferentially retained in cancer cells and activated T cells. When TH9402 is administered to a stem cell graft, it enters and is retained in the cancerous cells and T cells, but not the stem cells, progenitors and precursors. When the cells are exposed to visible light using Celmed's device, the drug undergoes photodynamic activation leading to elimination of the unwanted cells. The process is conducted ex vivo (outside the body), thus minimizing side effects and toxicity. Once the blood sample has been purged of the unwanted cells, it is reinfused into the patient who meanwhile has undergone high-dose chemotherapy. In addition to its program in NHL, the Company is in the process of establishing a clinical program using Theralux(TM) for two other applications: the prevention of graft-versus-host disease (GvHD) and the treatment of autoimmune diseases and GvHD by extracorporal photochemotherapy (ECP).
About Celmed BioSciences
Celmed BioSciences is a private Canadian biopharmaceutical company in the field of oncology. Spun off by Theratechnologies in 2001, the Company develops photodynamic-based therapies using its proprietary technology Theralux(TM). Celmed has reached several key milestones of its accelerated clinical and preclinical program for Theralux(TM) which is currently being evaluated in three therapeutic areas: the prevention of graft-versus-host disease (GvHD), the purge of cancerous cells in non-Hodgkin's lymphoma (NHL) and the treatment of autoimmune diseases and GvHD by extracorporal photochemotherapy (ECP).
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
Theralux(TM). 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
authorizations 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' 2003 Annual Report,
which contains a more exhaustive analysis of risks and uncertainties.
CELMED BIOSCIENCES INC.
CONTACT: Mark E. Kaufmann, Chief Operating Officer and Vice President,Corporate Development, Celmed BioSciences, (514) 336-4886; Dr. PierreCaudrelier, Vice President, Clinical Research, Celmed BioSciences,(514) 336-4886; Contact : Diane Girard, Communications Coordinator, CelmedBioSciences, (514) 336-4886, ext. 611, Cell: (514) 912-0904