GW now occupies a world leading position in cannabinoid science. The Company has developed a proprietary and validated cannabinoid technology platform and formed constructive collaborations with leading international scientists, universities and institutions in the field.
In addition to this expanding research network, GW also supports clinicians who approach the Company in seeking to explore the potential of cannabinoids in the clinic through investigator initiated studies. GW’s extensive research continues to yield highly promising data and new intellectual property across a range of therapeutic areas and provides GW with the potential to develop and license several new cannabinoid drug candidates in the coming years.
GW’s understanding of the pure and applied pharmacology of new cannabinoids continues to be illuminated under the direction of two of the world’s most eminent cannabinoid scientists, Professor Roger Pertwee at the University of Aberdeen and Professor Vincenzo di Marzo at Institute of Biomolecular Chemistry of the National Research Council, Naples.
Selected GW cannabinoids have shown anti-convulsant effects across a range of in vitro and in vivo models of epilepsy. A lead candidate has been identified, supported by strong intellectual property, and additional confirmatory pre-clinical tests are under way prior to progression into clinical trials. In particular, GW cannabinoids have shown the ability to treat seizures in models of epilepsy with significantly fewer side effects than existing anti-epileptic drugs.
GW’s pipeline in the field of epilepsy includes the following two product candidates:
A liquid formulation of pure plant-derived Cannabidiol (CBD) , as a treatment for various orphan pediatric epilepsy syndromes, for which FDA has granted Orphan Drug Designation in the treatment of Dravet syndrome and Lennox-Gastaut syndrome and Fast Track designation for Dravet syndrome; and
Which features Cannabidivarin (CBDV) as the primary cannabinoid and which has shown antiepileptic properties across a range of pre-clinical models of epilepsy. GW has advanced CBDV into a Phase 2 study of 130 patients with epilepsy. CBDV strongly suppressed seizures in six different experimental models commonly used in epilepsy treatment. Phase 1 study completed in 66 healthy subjects, CBDV tolerated even at the highest tested dose and no serious or severe adverse events, nor any withdrawals due to AEs.
GW embarked on a programme of three Phase IIa clinical trials to evaluate a range of GW cannabinoids as treatments for features of Type 2 diabetes and metabolic syndrome. GWP42004, which features Tetrahydrocannabivarin (THCV) as the primary cannabinoid, produced desirable effects in fasting plasma glucose, fasting insulin, beta cell function, adiponectin, systolic blood pressure and inflammatory cytokines. The studies were designed with lipids as the primary endpoint and as such the patients recruited had normal HbA1c levels (deviations of which are the usual gold standard for diabetes trials). Therefore GW are now planning a larger placebo controlled Phase 2 dose ranging trial of GWP42004 in patients with uncontrolled HbA1c levels, which is expected to start in the first half of 2014, to evaluate its efficacy as an oral anti-diabetic medicine.
GW’s clinical study programme seeks to build upon pre‑clinical data demonstrating the desirable effects of GW cannabinoids on plasma insulin, leptin and adiponectin levels. In addition, these results have shown a reduction in total cholesterol with an increase in the proportion of HDL (good) cholesterol. GW cannabinoids have also shown the ability to reduce liver fat levels in animal models of hepatic steatosis. Recent findings include the observation in a rodent model of diabetes that cannabinoids are able to protect the insulin‑producing cells of pancreatic islets cells.
GW have shown that GWP42003, which features Cannabidiol (CBD) as its primary cannabinoid, has anti inflammatory properties in a number of accepted animal models of inflammation, notably of the gut and the joints. In addition, we have shown the capacity of GWP42003 to inhibit the production in tissues of chemical mediators of inflammation, such as Tumor Necrosis Factor alpha, or TNFα. In particular, we have demonstrated efficacy in the treatment of UC in standard in vivo models.
GW have initiated a 62 patient Phase 2a trial to investigate the efficacy and safety of GWP42003 compared with placebo for the treatment of UC in patients refractory to 5 ASA. This trial is due to report results in the first half of 2014.
Several GW cannabinoids have shown anti-inflammatory properties in a number of models of inflammation, notably of the gut and the joints, and have the capacity to inhibit the production in tissues of chemical mediators of inflammation. In addition to the first clinical study in ulcerative colitis, GW is conducting pre-clinical research exploring the effect of cannabinoids on various models of airways inflammation, including chronic cough, and inflammatory skin diseases.
GW cannabinoids have been shown to be orally active in the treatment of cancer and not only has a dose response been shown in the pre-clinical work, but also tumour response has been shown to be positively associated with tissue levels of cannabinoid. Results of key research in glioblastoma multiforme and in breast cancer have been published in high status journals. Work now focuses on defining the optimum cannabinoid candidate and tumour type for initial clinical studies.
GW commenced a Phase 1b/2a clinical trial for the treatment of Recurrent Glioblastoma Multiforme (GBM). This study follows several years of pre-clinical research conducted by GW in the field of glioma which has demonstrated that cannabinoids inhibit the viability of glioma cells both in vitro and in vivo via apoptosis or programmed cell death, may also affect angiogenesis, and have demonstrated tumor growth-inhibiting action and an improvement in the therapeutic efficacy of temozolomide, a standard treatment for glioma.
Pre-clinical research findings suggest that a range of psychiatric conditions, including schizophrenia, anxiety and depression are promising targets for cannabinoid medicines. More recently, a report demonstrates that the cannabinoid, cannabidiol (CBD), is as effective as standard anti-psychotic drugs in ameliorating the positive symptoms of schizophrenia whilst showing superior effects with regards to the negative symptoms.
Of particular interest is emerging evidence which suggests that CBD, possibly in combination with other cannabinoids, may have potential utility in schizophrenia not only as an anti-psychotic, but also in the alleviation of the metabolic and inflammatory abnormalities associated with the disease. GW has started a Phase IIa trial to investigate this further.