Theratechnologies inc.
TSX : TH

Theratechnologies inc.

March 28, 2006 08:31 ET

University of Washington to Conduct Clinical Trial with Theratechnologies' TH9507: NIH Providing US $2.6 Million to Finance the Project

MONTREAL, QUEBEC--(CCNMatthews - March 28, 2006) - (TSX:TH) The University of Washington in Seattle, with support from the National Institutes of Health (NIH), is conducting a clinical trial investigating the effects of Theratechnologies' TH9507 on cognitive function in healthy older adults and older adults with mild cognitive impairment.

Dr. Michael V. Vitiello, Professor at the Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, is the principal investigator for the study, entitled SMART (Somatotrophics, Memory, and Aging Research Trial). "We have previously studied the effects of GRF, also known as GHRH (growth hormone releasing hormone), on cognitive function in healthy older men and women (mean age: 68 plus or minus 0.7 years old) with promising results," Dr. Vitiello explained. "We found that daily treatments of GHRH in this population resulted in significantly improved cognitive function when compared to placebo, particularly on tests involving problem solving, psychomotor processing speed, and working memory. The data also suggest that such treatment might partially ameliorate cognitive declines in individuals with impaired cognitive function, i.e.; mild cognitive impairment (MCI) and Alzheimer's disease (AD) (1). The SMART study is designed to follow up on these findings but this time using TH9507, a stabilized analog of GRF. We will also be testing for its effects in MCI patients for the first time," Dr. Vitiello explained.

The SMART project is the subject of an investigator-sponsored Investigational New Drug Application (IND) in the United States. SMART is being funded by a US $2.6 million grant from the NIH through its member-agency, the National Institute on Aging. An expected 160 male and female subjects between the ages of 55 and 80 years old will be enrolled in this randomized, double blind, placebo-controlled clinical trial. Theratechnologies is supplying the test-drug, TH9507, which is a stabilized analog of human growth hormone releasing factor (GRF).

"Our corporate priority is the rapid development of TH9507 in HIV-associated lipodystrophy and this is where we are putting most of our resources," stated Yves Rosconi, President and Chief Executive Officer of Theratechnologies. "However, we are pleased to provide TH9507 for innovative research initiatives like the SMART project. Through this investigator-initiated study, TH9507 will become better characterized in a new therapeutic area while we continue to pursue our priority indications in house," he added.

Mild Cognitive Impairment

Mild Cognitive Impairment (MCI) denotes cognitive impairments that do not meet diagnostic criteria for dementia but exceed or differ in characteristics from those found as a general feature of aging. MCI is associated with increased likelihood of progressive cognitive decline to a diagnosis of dementia within a few years. Interest in MCI derives from the hope that early detection of what is likely to be pre-clinical a stage of Alzheimer's disease will eventually be treatable, and prevent, or at least delay, progression to clinical dementia.

(1) Vitiello MV, et al. GHRH Treatment Improves Cognitive Function in Healthy Older Adults. Neurobiology of Aging 27 (2006) 318-323.

About UW Medicine

UW Medicine includes the University of Washington School of Medicine, UW Medical Center, the management of Harborview Medical Center, UW Medicine Neighborhood Clinics, and the UW's involvement in the Seattle Cancer Care Alliance. UW Medicine has major academic and service affiliations with Children's Hospital and Regional Medical Center, the Fred Hutchinson Cancer Research Center, and the Veteran's Affairs Medical Centers in Seattle and Boise. Consistently among the top five recipients of federal funding for biomedical research, the School of Medicine has among its more than 1,700 regular faculty, five Nobel Laureates, 26 members of the National Academy of Sciences, and 26 members of the Institute of Medicine. For more information about UW Medicine, visit www.uwmedicine.org .

About the National Institute on Aging

The National Institute on Aging is one of 27 Institutes and Centers that constitute the National Institutes of Health. The NIA leads Federal efforts to support and conduct basic, clinical, epidemiological, behavioral, and social research on aging and the special needs of older people.

About Theratechnologies

Theratechnologies (TSX:TH) is a Canadian biopharmaceutical company that discovers or acquires innovative drug candidates in order to develop them and bring them to market. The Company targets unmet medical needs in attractive specialty markets where it can retain full or partial commercial rights for its products. Its most advanced program is TH9507, now in Phase 3 clinical trials for a major metabolic complication known as HIV-associated lipodystrophy. The Company also has other promising projects at earlier stages of development.

Contact Information

  • Theratechnologies
    Yves Rosconi
    President and Chief Executive Officer
    (514) 336-4804, ext. 221
    yrosconi@theratech.com
    or
    Theratechnologies
    Tobie Trudel
    Director, Investor Relations and Communications
    (514) 336-4804, ext. 229
    ttrudel@theratech.com