Thursday, March 30, 2006
Alzheimer's Disease Drug Trials To Start
Humanetics Corporation and Mount Sinai School of Medicine to Begin Clinical Trials of New Alzheimer's Compound; FDA Clears the Way with Approval of Investigational New Drug (IND) Application
MINNEAPOLIS--(BUSINESS WIRE)--March 30, 2006--In an announcement today, Humanetics Corporation said that the Food & Drug Administration (FDA) has approved the start of human trials for Humanetics' promising new oral compound, NIC5-15, aimed at combating Alzheimer's disease.
Based on the Investigational New Drug Application (IND) submitted to FDA for NIC5-15, Mount Sinai School of Medicine (MSSM) will proceed immediately with Phase I and Phase II studies in a population of early stage Alzheimer's disease patients. The studies will be conducted at Mount Sinai in New York and at the Bronx VA Medical Center. According to Giulio Maria Pasinetti, M.D., Ph.D. of Mount Sinai's Department of Psychiatry and the clinical trials' principal investigator, "the studies will measure safety, dosing, efficacy and biomarkers for Alzheimer's disease."
"We are pleased that FDA has approved the start of clinical trials for NIC5-15," stated Ronald Zenk, President and CEO of Humanetics. "NIC5-15 represents the potential for a new class of compounds focused on modifying the disease itself by slowing or preventing its progression," he said.
Humanetics and Mount Sinai School of Medicine Working Collaboratively
In December 2005, Humanetics entered into two agreements with Mount Sinai School of Medicine connected to the development of NIC5-15. The first is a clinical research agreement related to this announcement, which allows investigators at Mount Sinai to study Alzheimer's patients to assess if NIC5-15 is well tolerated and to compare doses with respect to tolerability and clinical efficacy. The second--an exclusive licensing agreement--provides Humanetics with exclusive rights under pending patents to commercialize products containing NIC5-15.
In the earlier pre-clinical studies and animal models, NIC5-15 was found to be effective in preventing the formation or slowing the progression of beta amyloid plaques, which are believed to be a cause of Alzheimer's disease. In animal models specifically, moderate doses of the compound improved cognitive function in mice with Alzheimer's type neuropathology and memory impairment.
Discovery and development of NIC5-15 for Alzheimer's disease has been under the direction of Dr. Pasinetti who added that "NIC5-15 was chosen to move into human trials because of its selectivity, safety and potency--making it an ideal agent for long-term prophylactic administration in this population."
About Mount Sinai School of Medicine
Located in Manhattan, Mount Sinai School of Medicine is internationally recognized for ground-breaking clinical and basic-science research, and innovative approaches to medical education. Through the Mount Sinai Graduate School of Biological Sciences, Mount Sinai trains biomedical researchers with an emphasis on the rapid translation of discoveries of basic research into new techniques for fighting disease. One indication of Mount Sinai's leadership in scientific investigation is its receipt during fiscal year 2004 of $153.2 million. Mount Sinai now ranks 25th among the nation's medical schools in receipt of research support from NIH. Mount Sinai School of Medicine also is known for unique educational programs such as the Humanities in Medicine program, which creates opportunities for liberal arts students to pursue medical school, and instructional innovations like The Morchand Center, the nation's largest program teaching students and physicians with "standardized patients" to become not only highly skilled, but compassionate caregivers. Long dedicated to improving its community, the School extends its boundaries to work with East Harlem and surrounding communities to provide access to health care and educational programs to at risk populations.
Located in Manhattan, Mount Sinai School of Medicine is internationally recognized for ground-breaking clinical and basic-science research, and innovative approaches to medical education. Through the Mount Sinai Graduate School of Biological Sciences, Mount Sinai trains biomedical researchers with an emphasis on the rapid translation of discoveries of basic research into new techniques for fighting disease. One indication of Mount Sinai's leadership in scientific investigation is its receipt during fiscal year 2004 of $153.2 million. Mount Sinai now ranks 25th among the nation's medical schools in receipt of research support from NIH. Mount Sinai School of Medicine also is known for unique educational programs such as the Humanities in Medicine program, which creates opportunities for liberal arts students to pursue medical school, and instructional innovations like The Morchand Center, the nation's largest program teaching students and physicians with "standardized patients" to become not only highly skilled, but compassionate caregivers. Long dedicated to improving its community, the School extends its boundaries to work with East Harlem and surrounding communities to provide access to health care and educational programs to at risk populations.
About Humanetics Corporation
Humanetics is a privately-held specialty pharmaceutical company headquartered in Minneapolis, Minnesota. The Company is focused on the rapid discovery, development and commercialization of orally-administered bioactive compounds for prevention and treatment of diseases in categories with urgent and unmet needs. The Company has several proprietary compounds in preclinical and/or clinical stages of development in the areas of Alzheimer's disease, bioterrorism and obesity. For further information, visit: http://www.humaneticscorp.com.
Humanetics is a privately-held specialty pharmaceutical company headquartered in Minneapolis, Minnesota. The Company is focused on the rapid discovery, development and commercialization of orally-administered bioactive compounds for prevention and treatment of diseases in categories with urgent and unmet needs. The Company has several proprietary compounds in preclinical and/or clinical stages of development in the areas of Alzheimer's disease, bioterrorism and obesity. For further information, visit: http://www.humaneticscorp.com.
This Press Release contains discussion of certain expectations regarding Humanetics' future performance. These forward-looking statements are based on the Company's current views and assumptions. Actual results could differ materially from these current expectations and projections, and from historical performance.
Contacts
Latitude
Pam Pettinella, 952-404-1853
pam@latitude-c.com
¶ 1:37 PM Latitude
Pam Pettinella, 952-404-1853
pam@latitude-c.com
