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Presented: The Greenwich Biosciences Scientific Exhibit at the American Epilepsy Society Annual Meeting; Washington, DC; December 1– 5, 2017. History of Cannabidiol (CBD) and GW Clinical Trial Program To obtain a PDF of this poster • Scan the QR code or • Visit www.GWQRcodes.com/250706 Charges may apply. No personal information is stored. For further information please contact: [email protected] Potential CBD anticonvulsant mechanisms of action have yet to be confirmed in epilepsy. Cannabidiol is an investigational product and not approved for any indication in any country. 1981 Test CBD as anticonvulsant in humans (Petro et al) 1988 Specific THC- binding sites (cannabinoid receptor type, CB 1 ) in the rat brain identified (Howlett et al) 2005 GW Pharmaceuticals begins cannabinoids in epilepsy program in partnership with University of Reading 2010 GPR55 hypothesis (Pertwee et al) 2015 CBD does not directly bind, or activate, CB 1 or CB 2 receptors at concentrations relevant to its anticonvulsant actions (Ibeas Bih et al) Q2 2015 Phase 3 clinical trials in Lennox-Gastaut syndrome (LGS) and DS initiated Phase 1/2 synthetic CBD for treatment-resistant seizure disorders 2008 Adenosine hypothesis (Pertwee et al) 1982 Test CBD as anticonvulsant in humans (Zuardu et al) 1989 Clone CB 1 (Matsuda et al) 2007 GW Pharmaceuticals begins preclinical investigation of CBD antiseizure properties Q2 2014 Epidiolex state-sponsored expanded access program initiated Q4 2014 DS clinical trial initiated Q1 2016 GWPCARE1 (Phase 3 DS) completed Primary Endpoint Achieved Q2 2016 GWPCARE4 (Phase 3 LGS) completed Primary Endpoint Achieved GWPCARE6 (Phase 3 tuberous sclerosis complex [TSC]) study initiated Q3 2016 GWPCARE3 (Phase 3 LGS) completed Primary Endpoint Achieved 2001 TRPV1 hypothesis (Bisogno et al) 1940 Isolate CBD from cannabis (Adams et al) 1969 CBD synthesis absolute configuration (Petrzilka et al) 1992 Identify first endocannabinoid: AEA (Mechoulam et al) N H Q4 2013 FDA orphan designation for Epidiolex in Dravet syndrome (DS) 1998 GW Pharmaceuticals begins cannabis cultivation/ cannabinoid research 1899 CBN from cannabis resin (Wood et al) 1995 Identify second endocannabinoid: 2-AG (Mechoulam et al) 1900–1979 1980s 1990s 2000s Q1 2013 Physician- sponsored individual INDs established to treat SV and BJ with Epidiolex Q2 2013 Epidiolex physician-sponsored intermediate-size IND expanded access program initiated Q3 2013 “Weed” airs on CNN The CNN logo is a registered trademark of Cable News Network. Turner Broadcasting System, Inc. All Rights Reserved. 2010s Multiple mechanism of action hypotheses proposed Q2 2017 GWPCARE7 (Pilot infantile spasms [IS]) initiated Q4 2017 GWPCARE2 (Phase 3 DS) enrollment complete Q4 2012 Patient #1 treated by Dr. Cross with Epidiolex ® (compassionate use for intractable epilepsy)
