Therapeutic Areas

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.

GW’s early stage research in diabetes/metabolic disease and inflammatory conditions is funded in-house and research in the field of CNS and oncology is funded by Otsuka under a global research collaboration agreement.

In-House Funded Research

The principal areas of GW’s investment are in diabetes/metabolic disease and inflammatory conditions. GW is selectively investing its resources to advance this part of the cannabinoid pipeline with a view to signing new out-licensing agreements in due course.

Diabetes/Metabolic Disease

GW has 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

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.

Inflammation

GW will commence a Phase IIa study in the inflammatory diseases area in early 2012. This study will investigate CBD extract in the treatment of ulcerative colitis

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 such as TNFα. 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.

Otsuka Funded Research

GW’s research activities in the earlier stage pipeline are supported by income from the global cannabinoid research collaboration with Otsuka. This collaboration was originally signed in July 2007 with a three year term, and was extended for a further three years to June 2013. Under this agreement, Otsuka funds GW’s research into a range of cannabinoids as potential new drug candidates in the field of CNS disorders and oncology. To date, Otsuka’s total investment in GW’s research activities under this collaboration exceeds £15m.

Oncology

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.

Epilepsy

GW’s epilepsy research takes place at the centre of excellence at the University of Reading, to which scientists from Otsuka have also been seconded

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.

Psychiatric Illness

Pre-clinical research findings suggest that a range of psychiatric conditions, including schizophrenia, anxiety and depression are promising targets for cannabinoid medicines

GW is currently investigating the potential of cannabinoids as treatments for psychiatric disorders in collaboration with Otsuka. Of particular interest is emerging evidence which suggests that the cannabinoid, cannabidiol (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.