March 1, 2017
Ongoing IND-enabling Non-clinical Program to Support the Use of Cytisine in Smoking Cessation
Multiple Key Cytisine Development and Regulatory Milestones Expected in 2017
MILL VALLEY, Calif., BOTHELL, Wash. and VANCOUVER, British Columbia, March 1, 2017 /CNW/ — Achieve Life Science, Inc. (Achieve) and OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) (OncoGenex) today announced a strategic collaboration with the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH) to conduct non-clinical studies in support of an overall clinical development plan for cytisine as a smoking cessation treatment.
As part of the collaboration, Achieve is providing cytisine to the NIH to conduct a series of non-clinical studies required by the U.S. Food and Drug Administration (FDA) to support the submission of an Investigational New Drug (IND) application. The collaboration commenced in March 2015 and results of the initial study are expected in the second-quarter of 2017.
“Given the burden of smoking-related illnesses and existing preliminary data that indicates efficacy and safety, we consider cytisine to be a potential drug of public health importance,” said David Shurtleff, Ph.D., NCCIH Deputy Director. “We are hopeful that our research collaborations will lead to more smokin