MENLO PARK, Calif., Oct. 1, 2012 /PRNewswire/ -- Coyote Pharmaceuticals, Inc., an emerging biopharmaceutical company focused on orphan and neurodegenerative diseases, today announced that it is moving forward with a "dual-track" clinical program for its lead compound, CNS-102, for treating Amyotrophic Lateral Sclerosis (ALS) and Alzheimer's disease (AD). The first phase of the clinical program, targeting ALS, is set to commence in 2013.
"Neurodegenerative disorders, including ALS, Alzheimer's disease and Parkinson's disease, are at once a tremendous opportunity and a considerable challenge because the precise causes of these diseases are not yet fully understood," commented Hiroaki Serizawa, Ph.D., president, CEO & co-founder of Coyote Pharmaceuticals. "However, a growing body of research suggests that cellular networks vital to maintaining homeostasis may hold a key to managing, and perhaps reversing, the conditions. Our lead therapeutic candidate, CNS-102, is designed to increase the expression of natural heat shock proteins, which are capable of repairing the aggregated protein structures known to be key indicators of AD and ALS."
CNS-102 is an orally bioavailable small molecule inducer of heat shock protein gene expression. In pre-clinical animal models of neurodegenerative disease, CNS-102 significantly improved animal behaviors and protected neurons from damage, compared to controls. CNS-102 was also proven safe and well tolerated in these preliminary studies. Based on these results and the results of research of CNS-102's less potent predecessor compound, CNS-101, the Company is planning to commence a clinical program for CNS-102 in 2013. The program will focus initially on ALS, utilizing the safety data from the previous studies to support an IND filing with the FDA.
Dr. Serizawa continued, "ALS, also known as Lou Gehrig's disease, impacts a relatively small number of individuals, but its devastating effects and high mortality have spurred a worldwide effort toward finding a cure. We have decided to take on this challenge and we look forward to leveraging the benefits afforded to orphan indications to rapidly advance the program and apply the findings to our broader neurodegenerative disease pipeline, most notably AD."
To support Coyote's clinical strategy and operations, the company recently named Merit E. Cudkowicz, MD, MSc as a clinical development advisor. As the Julianne Dorn Professor of Neurology at Massachusetts General Hospital, at Harvard Medical School, Dr. Cudkowicz's research and clinical activities are dedicated to the study and treatment of patients with neurodegenerative disorders, in particular ALS. Dr. Cudkowicz directs the Mass General ALS clinic and the Neurological Clinical Research Institute (NCRI), and is one of the founders and co-directors of the Northeast ALS Consortium (NEALS), a group of 92 clinical sites in the United States and Canada dedicated to performing collaborative academic led clinical trials in ALS.
In addition to Dr. Cudkowicz, Coyote has assembled a seasoned group of business and scientific advisors:
- Patricia Ann Walicke, M.D., Ph.D. – Clinical Development. Prior to working with Coyote, Pat served as Chief Medical Officer and Vice President of Clinical Affairs with OXiGENE, Inc.
- Linda Pullan, Ph.D. – Business Development. Linda was the former Head of Oncology and Hematology Licensing at Amgen
- Bill Boyle, Ph.D. – Corporate Development. Previously, Bill was the President, Chief Scientific Officer and Founder of AnaptysBio, and prior to that the Director of Discovery Research at Amgen
- Michelle Greer, Ed.M. – Human Resources. Most recently, Michelle was Vice President, Human Resources at Skystream Networks, and before she served as Global Infrastructure Group Human Resources Director with Agilent Technologies
- Timothy Gray, CPA – Finance. Tim is the former Director of Revenue and Reimbursement for the Lucile Packard Children's Hospital at Stanford
- Obsidiana Abril-Horpel, Ph.D. – Research and Development. Obsidiana is the Chief Executive Officer of Optim Sciences, experts in process development optimization and CMC
Dr. Serizawa concluded, "Coyote is on the cusp of advancing what we believe could be groundbreaking technology that eventually could be used to treat a host of orphan and neurodegenerative diseases. I greatly look forward to working with our expanded business and scientific teams to bring this vision to fruition."
About Coyote Pharmaceuticals:
Coyote Pharmaceuticals, Inc. is an emerging biopharmaceutical company focused on treating orphan and neurodegenerative diseases through the modulation of cellular networks vital to maintaining homeostasis. The company's lead drug candidate, CNS-102, is being developed initially to treat Amyotrophic Lateral Sclerosis (ALS) and Alzheimer's disease (AD). The orally bioavailable small molecule therapeutic is designed to activate gene expression of a family of proteins involved in regulating cellular homeostasis known as heat shock proteins. These natural proteins are capable of repairing aggregated protein structures, which are known indicators of AD and ALS. For more information on Coyote visit http://www.coyotepharma.com.
SOURCE Coyote Pharmaceuticals, Inc.