Here's one for you AND Rick. On the subject of "cannabis stocks," I haven't followed GWPH. One that got away, it seemed. But I came across pointers to research suggesting MOA for CBD (not sure if Rick is interested in drugs that don't hit CB1 or CB2, though) in some forms of epilepsy is becoming a bit more clear, and that this is a potential positive catalyst for GWPH. There seems to be evidence that increased inhibitory neurotransmission helps reduce convulsions. One paper from last year from GWPH itself pointed to inhibition of GPR55 by CBD as the mechanism for achieving that. Recently, another paper from UW suggests the same, in particular with respect to Dravet's Syndrome. Some P3s have already been done, and been successful, BUT, upcoming drug-drug interaction study and a second P3 in Dravet's read out soon, & could be catalysts.
I started this post a few days ago, but have been busy. Yesterday, AES abstracts came out, and there is indeed good news in the form of good data for CBD as a single agent in these indications:
>>
GW Pharmaceuticals and U.S. Subsidiary Greenwich Biosciences to Present Epidiolex(R) (cannabidiol) Data and Educational Programs at the American Epilepsy Society Annual Meeting
7:00 am ET November 21, 2017 (Globe Newswire) Print
GW Pharmaceuticals plc (Nasdaq:GWPH) ("GW," "the Company" or "the Group"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its US subsidiary Greenwich Biosciences, announced today that new results from completed Phase 3 trials of Epidiolex (cannabidiol or CBD) in Lennox-Gastaut syndrome (LGS) and Dravet syndrome, along with other supportive data, will be presented at the American Epilepsy Society (AES) Annual Meeting, December 1-5, 2017, in Washington D.C.
Abstracts released today include the following highlights:
-- Responder analyses from pooled Phase 3 data of LGS patients on/off clobazam
-- Data from two expanded access sites in patients on/off clobazam
-- Long-term maintenance treatment effect and safety in the open label extension study and the expanded access program
-- Exposure-response analysis of CBD in Phase 3 LGS studies
"We continue to see a robust flow of data from the Epidiolex clinical program and look forward to sharing these new data with the epilepsy community at AES. Importantly, data in the abstracts show long-term maintenance of safety and efficacy, as well as that patients on Epidiolex who achieved clinically meaningful responses did so regardless of concomitant clobazam therapy," said Justin Gover, GW's Chief Executive Officer. "Having recently completed our New Drug Application submission to the FDA, we are now focused on the goal of gaining approval for Epidiolex in mid-2018 and making this much-needed, first-in-class medicine available to the patients who need it."
The Epidiolex-related presentations at AES will include more than 20 posters from the Phase 3 pivotal trials, reports from the Expanded Access Program, as well as additional Phase I and pre-clinical studies of CBD. GW/Greenwich will also host a scientific pavilion where additional scientific updates, legal and regulatory perspectives, and other related data will be presented. Company-sponsored activities will be conducted under the Greenwich Biosciences, Inc. name.
Highlights:
Drug-drug interaction data:
Cannabidiol (CBD) Treatment Responders Analysis in Patients with Lennox-Gastaut Syndrome (LGS) On and Off Clobazam (CLB) - Thiele et al (Poster #1.436, Poster Session 1, Saturday, December 2, 2017)
Efficacy of Cannabidiol in Patients with Refractory Epilepsy Relative to Concomitant Use of Clobazam - Bruno et al (Poster #3.181, Poster Session 3, Monday, December 4, 2017)
Presence of Clobazam does not affect Seizure Frequency and Severity in Patients Taking a Pharmaceutical Formulation of Cannabidiol (CBD) - Gaston et al (Poster #2.319, Poster Session 2, Sunday, December 3, 2017)
Bidirectional Drug-drug Interaction with coadministration of Cannabidiol and Clobazam in a Phase 1 Healthy Volunteer Trial - Sommerville et al (Poster #1.433, Poster Session 1, Saturday, December 2, 2017)
CBD Exposure-response
Exposure-Response Analysis of CBD Oral Solution for the Treatment of LGS - Morrison et al (Poster #2.281, Poster Session 2, Sunday, December 3, 2017)
Long-term Epidiolex data:
Maintenance of Long-Term Safety and Efficacy of Cannabidiol (CBD) Treatment in Dravet Syndrome (DS): Results of the Open-Label Extension (OLE) Trial (GWPCARE 5) - Devinsky et al (Poster #: 1.289, Poster Session 1, Saturday, December 2, 2017)
Maintained Safety and Efficacy of CBD in a Long-Term Open-Label Trial in Patients with LGS (GWPCARE 5) - Marsh et al (Poster #2.271. Poster Session 2, Sunday, December 3, 2017)
Long-Term Effectiveness and Safety of Cannabidiol in Children and Adults with Treatment-resistant Lennox-Gastaut Syndrome or Dravet Syndrome - Laux et al (Poster #1.434 Poster Session 1, Saturday, December 2, 2017)
Long-term Efficacy and Safety of Cannabidiol (CBD) in Children and Adults with Treatmentâ?'Resistant Epilepsies (TRE) - Bebin et al (Poster #2.427; Poster Session 2, Sunday, December 3, 2017)
Pooled Phase 3 LGS Data:
CBD Significantly Reduces Drop Seizure Frequency in LGS: Pooled Efficacy and Safety Results from 2 Randomized, Controlled Trials - Patel et al (Poster #1.291, Poster Session 1, Saturday, December 2, 2017)
CBD Treatment Effect and Adverse Events by Time in Patients with LGS: Pooled Results from 2 Trials - Privitera et al (Poster #2.279; Poster Session 2, Sunday, December 3, 2017)
Burden of Illness Data:
Poster Session 1, Saturday, December 2, 2017
-- The Direct Cost Burden of Illness of Dravet Syndrome in the US - Chez et al (Poster #1.314)
-- The Direct Cost Burden of Illness of LGS in the US - Montouris et al (Poster #1.315)
Pre-Clinical and Phase I Results:
Poster Session 1, Saturday, December 2, 2017
-- The human metabolite of cannabidiol, 7-hydroxy cannabidiol, but not 7-carboxy cannabidiol, is anticonvulsant in the maximal electroshock seizure threshold test (MEST) in mouse - Whalley et al (Poster #1.435)
-- Antiseizure properties of CBD are attenuated in the absence of TRPV1 receptors - Jones et al (Poster #1.022)
-- A role of GPR55 in the anti-epileptic properties of CBD - Bazelot et al (Poster #1.029)
Poster Session 2, Sunday, December 3, 2017
-- CBD improves the welfare and survival of Dravet syndrome mice - Petra et al (Poster #2.263)
-- Single Therapeutic and Supratherapeutic Doses of CBD Do Not Significantly Impact Heart Rate (HR) Corrected QT Interval (QTc) - VanLandingham et al (Poster #2.280)
Expanded Access Program:
More than a dozen posters from the Expanded Access Program covering varying aspects of the use of Epidiolex in children and adults will be presented during sessions on Saturday, Sunday and Monday.
Scientific Exhibit:
Advancing Cannabidiol: GWPCARE Phase III Trials and Long-term Results
Monday, December 4
8:00 - 11:00 AM EST
Salon B, Street Level
The company will host a satellite exhibit providing meeting attendees with a comprehensive overview of the Epidiolex development program, including the data presented in the AES poster sessions and the following additional topics (authors will be on hand):
-- GW Pipeline
-- History of Cannabidiol (CBD) and GW Clinical Trial Program
-- Ongoing GWPCARE Phase III Trials
-- Assessment of the Abuse Potential of Cannabidiol (CBD) in Recreational Polydrug Users: A Randomized, Double-blind, Controlled Trial
-- Pharmacokinetics and Safety Evaluation of Cannabidiol (CBD) in Subjects With Hepatic or Renal Impairment: Results of Two Phase I Trials
-- Cannabidiol improves seizures and epilepsy associated co-morbidities in rats
GW Pharmaceuticals Innovation Pavilion: Presentations on Continuum of Care and Cannabinoid Science
Saturday, December 2
12:00pm - 6:00pm EST
Pavilion D
12:00pm-1:00pm Nurses Hour w/light lunch Alice Mead, JD Demystifying the legal landscape of cannabinoids Patricia Bruno, RN, BSN, MGH Cannabinoid Experiences and learnings 2:30pm - 3:30pm Syndrome Identification and Continuum of Care Elizabeth Thiele, MD, PhD Ian Miller, MD 1:15pm-1:45pm Demystifying the legal landscape of cannabinoids Alice Mead, JD and 4:00pm - 4:30pm 1:45pm-2:15pm Cannabinoid Preclinical Science Ben Whalley, PhD and 4:30pm-5:00pm About Epidiolex (cannabidiol)
Epidiolex, GW's lead cannabinoid product candidate is a pharmaceutical formulation of purified cannabidiol (CBD), which is in development for the treatment of several rare childhood-onset epilepsy disorders. GW has submitted a New Drug Application with the FDA for Epidiolex as adjunctive treatment for seizures associated with LGS and Dravet syndrome with an expected approval and launch in 2018. To date, GW has received Orphan Drug Designation from the FDA for Epidiolex for the treatment of Dravet syndrome, LGS, TSC and IS. Additionally, GW has received Fast Track Designation from the FDA for the treatment of Dravet syndrome and conditional grant of rare pediatric disease designation by FDA. The Company has also received Orphan Designation from the European Medicines Agency, or EMA, for Epidiolex for the treatment of LGS and Dravet syndrome. GW is currently evaluating additional clinical development programs in other orphan seizure disorders including Phase 3 trials in Tuberous Sclerosis Complex and Infantile Spasms.
About GW Pharmaceuticals plc and Greenwich Biosciences
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW, along with its U.S. subsidiary Greenwich Biosciences, is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex (cannabidiol), for which GW has submitted an NDA to the FDA for the adjunctive treatment of LGS and Dravet syndrome. The Company continues to evaluate Epidiolex in additional epilepsy conditions and currently has ongoing clinical trials in Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world's first plant-derived cannabinoid prescription drug, Sativex(R) (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the United States. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioblastoma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.<<
snip
Good for about 8% pop (and there was some anticipation yesterday). Still could be room to run? Another good call by Alfredo Fontanini.
Cheers, Tuck |
