CANNAINVESTOR Magazine August 2016 - Page 70

*Phase 3 development programs:

Positive results in first Phase 3 Dravet syndrome trial

Positive results in first Phase 3 LGS trial

Data presentations expected at upcoming American Epilepsy Society Annual Meeting in December

Positive Dravet syndrome Pre-NDA meeting held with FDA

NDA on track for H1 2017 submission for both Dravet and LGS indications

Data from second LGS trial expected at end of Q3

Second Phase 3 Dravet syndrome trial ongoing

Phase 3 trial in TSC ongoing

Phase 3 trial in IS to commence in Q4 2016

*Positive results in first Phase 3 Dravet syndrome trial

*Positive results in first Phase 3 LGS trial

*Data presentations expected at upcoming American Epilepsy Society Annual Meeting in December

*Positive Dravet syndrome Pre-NDA meeting held with FDA

*NDA on track for H1 2017 submission for both Dravet and LGS indications

*Data from second LGS trial expected at end of Q3

*Second Phase 3 Dravet syndrome trial ongoing

*Phase 3 trial in TSC ongoing

*Phase 3 trial in IS to commence in Q4 2016

*Expanded access program and open label extension:

Over 1,000 patients now on Epidiolex treatment under Expanded Access Treatment INDs, U.S. State programs, and open label extension trial

*Over 1,000 patients now on Epidiolex treatment under Expanded Access Treatment INDs, U.S. State programs, and open label extension trial

*Advanced clinical programs in multiple cannabinoid pipeline product candidates:

*CBDV Phase 2 partial-onset epilepsy study in adults ongoing. Part A complete and Part B underway with data expected H1 2017

*CBDV pre-clinical research ongoing within field of autism spectrum disorders. Initial open-label clinical evaluation expected to commence in H2 2016, with Phase 2 trials expected to commence in H1 2017

*Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD Phase 1 clinical program expected to commence in Q4 2016

*Orphan Drug and Fast Track Designations granted from FDA and EMA

*THC:CBD Phase 1b/2a study for the treatment of Recurrent Glioblastoma Multiforme (GBM) fully enrolled with data expected in Q4 2016

*Sativex® Phase 2 study in children with spasticity due to cerebral palsy fully enrolled with data expected Q4 2016

*THCV Phase 2 study in type 2 diabetes completed, primary

endpoint not achieved

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