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 smoking cessation aids and reduce the number of lives lost due to tobacco smoking and nicotine addiction.”
According to the U.S. Surgeon General’s 2014 report1 “The Health Consequences of Smoking – 50 years of Progress”, there are more than 16 million Americans living with a disease caused by smoking and it is responsible for more than 480,000 deaths per year. The Report states that productivity losses from premature death exceed $150 billion per year and the annual costs of direct medical care of adults attributable to smoking are estimated to be over $130 billion.
Rick Stewart, Chairman and Chief Executive Officer of Achieve commented, “We are delighted that the NIH has provided assistance to Achieve in updating the non-clinical package for cytisine. We intend to file the IND in the second half of 2017. Phase 1 studies are expected to commence later in the year and a Phase 3 trial is expected to start in the first half of 2018.”
Two recent, large-scale clinical studies of cytisine, with favorable outcomes, have been successfully completed in over 2,000 patients. The TASC trial was a 740 patient, double-blind, placebo controlled trial conceived by Professor Robert West at University College London and funded by the U.K. National Prevention Research Initiative. The CASCAID trial was a 1,310 patient, single-blind, non-inferiority trial comparing cytisine to nicotine replacement therapy (NRT). The CASCAID trial was conceived by Dr. Natalie Walker, National Institute for Health Innovation, University of Auckland and funded by the H