Monday, October 03, 2016 4:44:36 PM
“We recently commenced a Phase 1 study with our film product. The study is currently ongoing. The objective of that study is to demonstrate that first, the IntelGenx oral film product creates therapeutically effective blood levels of Montelukast. Secondly, we want to demonstrate that Montelukast, when administered via our film crosses the blood brain barrier, which is important for the treatment of Alzheimer's and related diseases. We expect results of that Phase 1 trial to be available in September. Upon successful completion of that study, we plan to conduct a Phase 2a, a proof-of-concept study. The study will likely involve 24 patients. The duration will be approximately six months. Cost will be less than $500,000. We expect enrollment of this study to commence in or around January of 2017, of course, and so therefore, we expect the study to be completed and results to be available late Q3 of 2017 or probably early Q4 of next year.
Upon successful completion of that study, we will go out and try to attract a major pharmaceutical company to complete the development. We have had initial discussions with a number of major players and we have seen significant interest in the opportunity. However, we purposely want to wait until the completion of the proof-of-concept study, until we commence serious negotiations for a development and commercialization agreement.”
http://s2.q4cdn.com/790425727/files/doc_financials/2016/final-081116-intelgenx-q2-2016-financial-results-47950179-v.3.pdf
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