GW Pharmaceuticals plc, the company developing a portfolio of prescription medicines derived from cannabis, today announces the first release of preliminary safety and efficacy data from its Phase One and Two clinical trial
W also announces that, following detailed submissions to the Medicines Control Agency ("MCA") on patient progress in its trials covering 20 patient-years of data, the MCA has approved the extended use of its cannabis-based medicines (both THC and CBD containing materials) from 12 months to 24 months treatment.
GW presented its first data to the American Academy of Pain Management in Arlington, Virginia, USA on Friday 7 September. The data relates to the effects of different formulations of cannabis-based medicines and placebo on patients suffering principally from Multiple Sclerosis or Spinal Cord Injury. The highlights are as follows:
Active treatments provide superior benefit to placebo in key outcomes (pain, overall symptom relief, sleep duration).
The data shows clear trends which support the clinical improvements experienced by patients whose conditions have been considered intractable in the face of standard therapy. In some cases, the improvements have been sufficient to transform lives.
Of the first 53 patients entering the studies in three centres, two remain in the acute phase of the study and 44 have completed this phase. Of these, 41 sustained a sufficiently beneficial response for them to opt to continue on active treatment long term.
The studies have generated over 20 patient-years of treatment. Adverse events have been predictable and generally well tolerated.
By careful self-titration (dose adjustment), most patients are able to separate the thresholds for symptom relief and intoxication.
Analysis of dosage levels over extended periods shows no evidence of tolerance, thereby avoiding the requirement for patients to progressively increase their dose.
Commenting on the data, Dr Philip Robson, Medical Director, said, "This is the most comprehensive evaluation of cannabis-based medicines so far undertaken in patients suffering from multiple sclerosis and spinal cord injury. We are seeing definite trends indicating the superiority of active treatment over placebo. I have seen at first hand in the Oxford trial the very real clinical benefits that cannabis-based medicines can provide for these seriously ill patients. These encouraging early results fully justify the expansion of the clinical research programme into larger scale Phase Three pivotal trials. This Phase Three programme is now well underway.
"The data also suggest an excellent safety profile for these medicines and I welcome the MCA's decision to allow patients to extend their maintenance treatment into a second year."
Dr Geoffrey Guy, Executive Chairman, commented, "Our clinical trials programme is moving ahead in a most satisfactory manner. We remain confident of being able to present data on quality, safety, and efficacy to the UK regulatory authorities in 2003, and - subject to approval - bring the first cannabis-based prescription medicine to market in early 2004."
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