Category: Uncategorized
July 7, 2003

News Release: Celmed BioSciences, a subsidiary of Theratechnologies, completes Canadian Phase I/II clinical study for chronic myeloid leukemia (CML)

Celmed BioSciences, a subsidiary of Theratechnologies, (TSX:TH) that is engaged in the field of cell therapy, today announced positive safety results of a Canadian Phase I/II clinical trial regarding Theralux(TM) when used to treat patients with chronic myeloid leukemia (CML).

CML was chosen as a first indication for Theralux(TM) because of the presence of the Philadelphia chromosome (Ph+) in leukemia cells. This major chromosomal abnormality is an effective marker for the detection of cancer cells. The primary objective of this study was to determine the maximum tolerated purging intensity (MTPI). Secondary objectives were to evaluate possible toxicity of administering peripheral blood stem cells purged with Theralux(TM) (safety), as well as the efficacy of Theralux(TM) to eliminate CML cells (Ph+) in the graft.

The study established that at the MTPI, Theralux(TM) significantly reduced the absolute number of cancer cells (Ph+) in the graft, while preserving an adequate number of progenitor cells for sustained engraftment. The study also demonstrated that the Theralux(TM)-treated graft can be administered safely to the patient. Five levels of intensity have been studied in 15 CML patients who were unresponsive to currently available treatments and lacked a compatible donor. To date, 11 patients are still being monitored with an average of 30 months after Theralux(TM) treatment.

'These results indicate that Theralux(TM) purging of CML cells eliminated high levels of CML cells and allows complete and durable engraftment,'said Dr. Denis-Claude Roy, Lead Clinical Investigator of the study.

Approximately 12,000 new cases of CML were diagnosed in 2001 on a global basis. CML frequency increases gradually with age, with a median age at diagnosis of 53. Last April, the U.S. Food and Drug Administration (FDA) had granted orphan drug designation for Theralux(TM) when used to treat patients with chronic myeloid leukemia (CML).

'The positive results from this first Theralux(TM) study encourage us to accelerate the development of this innovative technology to eradicate cancer cells in autologous grafts,'said Dr. Andre de Villers, President and CEO of Celmed. 'We have reached a major milestone towards the approval of Theralux(TM) in Canada for the eradication of leukemic cells from the graft in CML,'added Dr. de Villers.

In addition to its evaluation in CML patients, Celmed's Theralux(TM) is also being evaluated in other medical indications. Celmed is currently conducting a Canadian clinical study in non-Hodgkin's lymphoma (NHL) patients and is also performing preclinical studies for the prevention of graft-versus- host disease (GvHD) in allogenic transplant patients. The Company is in the process of establishing a clinical program using Theralux(TM) for GvHD and plans to begin human clinical trials for this indication by the end of 2003 in Canada.

About the Canadian Phase I/II clinical study in chronic myeloid leukemia

(CML)

Five levels of intensity have been studied in 15 CML patients who were unresponsive to currently available treatments and lacked a compatible donor. To date, 11 patients are still being monitored with an average of 30 months after Theralux(TM) treatment.

About the Theralux(TM) system

An autologous transplantation is a procedure by which blood stem cells are withdrawn from the patient prior to the high dose chemotherapy regimen and given back to the patient, to rescue the immune system. Theralux(TM) was designed to purge cancer cells from the autologous graft prior to engraftment. With the Theralux(TM) system, a proprietary drug, TH9402, selectively enters the cancer cells of the graft. As a light source scans the graft, the cancerous cells containing TH9402 are killed, leaving only normal cells in the graft.

Additional information on the Theralux(TM) platform, clinical trials on CML and other indications, as well as current research is available on the Company's website: www.celmedbio.com .

About Celmed BioSciences

Celmed BioSciences, which has facilities in Montreal and Los Angeles, is a private company spun off by Theratechnologies (TSX:TH) in June 2001 to commercialize Theralux(TM) and products in the field of cancer and neurology. Theralux(TM) is being evaluated for use in patients with CML and NHL and to prevent GvHD. In addition to its Theralux(TM) program, the Company is evaluating adult neural stems cells for the treatment of Parkinson's disease.

About Theratechnologies

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 boasts a peptide portfolio 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 expands its peptide portfolio through its own proven 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'2002 Annual Report, which contains a more exhaustive analysis of risks and uncertainties.

For further information: Andre de Villers, MD, President and CEO, Celmed BioSciences Inc., (514) 336-7800; Diane Girard, Communications Coordinator, (514) 336-4886, ext. 611, dgirard(at)celmedbio.com

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