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FDA Grants Orphan Drug Designation to Theralux, Treatment for Chronic Myeloid Leukemia
MONTREAL, April 28 /PRNewswire-FirstCall/ -- Celmed BioSciences, a subsidiary of Theratechnologies (TSX:TH) which is engaged in the field of cell therapy, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Theralux™ when used to treat patients with chronic myeloid leukemia (CML). Theralux™ is Celmed's photodynamic therapy (PDT) technology being developed to destroy cancer cells in bone marrow or blood outside the body (ex vivo), using a proprietary drug, TH9402, which selectively kills cancer cells when exposed to light.
Orphan drug designation is granted to products that have the potential to treat life-threatening diseases that affect fewer than 200,000 patients in the United States. It gives the designated drug or biological product seven years of market exclusivity in the United States and also provides access to potential grant funding for clinical research and other cost savings.
Celmed is already conducting a Canadian pilot clinical study using Theralux™ in CML patients and expects to announce results of this trial in the course of 2003.
"Celmed's Theralux™ technology has the potential to improve the treatment of cancer patients suffering from certain forms of leukemia," said Dr. Andre de Villers, President and CEO of Celmed. "The orphan drug designation," added Dr. de Villers, "provides Celmed with an interesting opportunity to continue the clinical and commercial development of Theralux™."
In addition to its evaluation in CML patients, Celmed's Theralux™ core technology 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 prevention of graft- versus-host disease (GvHD). The Company is in the process of establishing a clinical program using Theralux™ for GvHD and plans to begin human clinical trials for this indication during 2003.
Additional information on the Theralux™ platform, clinical trials on CML and other indications, as well as current research is available on the Company's website: http://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™ and products in the field of cancer and neurology. Theralux™ is being evaluated for use in patients with CML and NHL and to prevent GvHD. In addition to its Theralux™ program, the Company is evaluating adult neural stems cells for the treatment of Parkinson's disease.
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 rich and well-balanced peptide portfolio at various stages of development for the treatment of catabolic disorders (loss of the body's synthesis and regeneration capacity), as well as osteoporosis and type II diabetes. In addition, Theratechnologies expands its peptide portfolio through innovative technologies.
This press release contains forward-looking statements, which reflect Celmed's current expectations regarding future development of Theralux™. 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.