Seven years ago, Jordan Tang, Ph.D., led a team of scientists at OMRF that identified and cloned the enzyme believed to cause Alzheimer’s disease, then created an inhibitor to halt the enzyme’s action. Today, a biopharmaceutical company announced that it has begun human clinical trials of an Alzheimer’s drug based on Tang’s discoveries.
CoMentis, Inc., which is headquarted in South San Francisco and also has research operations in Oklahoma City, has initiated a Phase I clinical trial of an experimental drug known as CTS-21166. The drug is being developed as a disease-modifying treatment for Alzheimer’s disease and has exhibited excellent efficacy, selectivity, brain penetration and pharmacologic activity in pre-clinical trials.
“This is probably the biggest thrill a scientist can have, to see that his work is on its way to treat and help people,” said Tang, who holds the J.G. Puterbaugh Chair in Medical Research at OMRF. “Researchers live for experiences like these, because they’re so few and far between.”
The trial will involve 48 healthy volunteers and will study the safety of CTS-21166, as well as the body’s ability to tolerate, absorb and metabolize the drug. The trial will be conducted at a single site in Salt Lake City, Utah.
Study subjects will intravenously receive one of several different doses or placebo. The company expects to begin generating human clinical data by the end of 2007 and to begin Phase II studies in Alzheimer’s patients in 2008.
“This is a significant achievement for CoMentis and for Alzheimer’s disease drug development,” said W. Scott Harkonen, M.D., President and CEO of CoMentis. “CTS-21166 is an entirely new approach to the treatment of Alzheimer’s disease because it is a disease-modifying agent targeting beta-secretase, a critical enzyme involved in the pathogenesis of Alzheimer’s disease, and it has the potential to become the first-in-class therapeutic agent.”
The drug’s roots date back to Tang’s groundbreaking discovery in 2000 of beta-secretase, a cutting enzyme thought to play a key role in the development of Alzheimer’s disease. Tang, along with fellow OMRF researchers Gerald Koelsch, Ph.D., and Lin Hong, Ph.D., published those findings in the Proceedings of the National Academy of Sciences.
Tang collaborated with Arun Ghosh, Ph.D., now a professor at Purdue University, to create an inhibitor to halt the enzyme’s cutting action. For the past seven years, Tang and Ghosh have worked with scientists at CoMentis to transform that discovery into CTS-21166, the drug that now has begun clinical trials.
“Teamwork got us where we are today,” Tang said. “There’s still a long road ahead, but this is the most exciting target today for intervening against Alzheimer’s disease. If we could block the activity of this enzyme, we could drastically reduce the impact of Alzheimer’s disease.”
About Alzheimer’s Disease
Alzheimer’s disease is a neurological disorder characterized by slow, progressive memory loss due to the gradual death of brain cells. According to the Alzheimer’s Association, the disease affects more than 4.5 million Americans, including 62,000 Oklahomans and nearly half the U.S. population over the age of 85.
Chartered in 1946, OMRF (www.omrf.org) is an independent, nonprofit biomedical research institute dedicated to understanding and developing more effective treatments for human disease. Its scientists focus on such critical research areas as Alzheimer’s disease, cancer, lupus and cardiovascular disease. OMRF’s scientists, who include a member of the National Academy of Sciences and a Howard Hughes Medical Institute investigator, hold more than 500 U.S. and international patents.