University of Washington to Conduct Clinical Trial with Theratechnologies' TH9507: NIH Providing US $2.6 Million to Finance the Project.MONTREAL -- (TSX:TH) The University of Washington in Seattle, with support from the National Institutes of Health (NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. ), 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 mild cognitive impairment (MCI), n memory loss generally associated with aging; does not affect normal independent functioning of an individual. . 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 GHRH Growth hormone regulatory hormone (growth hormone releasing hormone Growth-hormone-releasing hormone (GHRH), also known as growth-hormone-releasing factor (GRF or GHRF) or somatocrinin, is a 44-amino acid peptide hormone produced in the arcuate nucleus of the hypothalamus. ), 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 psychomotor /psy·cho·mo·tor/ (si?ko-mo´ter) pertaining to motor effects of cerebral or psychic activity. psy·cho·mo·tor adj. 1. 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 (1) (Media Control Interface) A high-level programming interface from Microsoft and IBM for controlling multimedia devices. It provides commands and functions to open, play and close the device. (2) (Microwave Communications Inc. ) 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 itseffects 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 The National Institute on Aging is a division of the U.S. National Institutes of Health, located in Bethesda, Maryland. Formed in 1974, NIA's mission is to improve the health and well-being of older Americans through research. It is the primary U.S. . An expected 160 male and female subjects between the ages of 55 and 80 years old will be enrolled in this randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double blind, placebo-controlled clinical trial.Theratechnologies is supplying the test-drug, TH9507, which is a stabilized analog of human growth hormone human growth hormone (HGH): see 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 Neurobiology Study of the development and function of the nervous system, with emphasis on how nerve cells generate and control behavior. The major goal of neurobiology is to explain at the molecular level how nerve cells differentiate and develop their of Aging 27 (2006) 318-323. About UW Medicine UW Medicine includes the University of Washington School of Medicine The University of Washington School of Medicine (UWSOM) is a public medical school located in Seattle, Washington. It is a graduate school affiliated with the University of Washington, and is the only medical school in the states of Washington, Wyoming, Alaska, and Idaho. , UW Medical Center, the management of Harborview Medical Center Harborview Medical Center, located on Seattle's First Hill, is the public hospital of King County, Washington and is managed by the University of Washington. It was founded in 1877 as King County Hospital, a six-bed welfare hospital in a two-story south Seattle building. , 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 This list includes approximately 2,000 current (not past) members and 350 foreign associates of the United States National Academy of Sciences, each of whom is affiliated with one of 31 disciplinary sections. Each person's name, primary institution, and election year are given. , 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. Theratechnologies inc. (TSX:TH) |
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