pain relief (read on)
Posted: Thu Jan 24, 2002 5:37 pm
16th January 2002
GW Expands Phase Three Clinical Trials Programme
of Cannabis-Based Medicine Into Cancer Pain
GW Pharmaceuticals plc, the company developing a portfolio of non-smoked cannabis-based prescription medicines, announces that it has expanded its Phase Three clinical trials programme into cancer pain. This Phase Three trial is the first large-scale trial of its kind and will examine the effectiveness of a cannabis-based medicine in treating pain associated with cancer.
Cancer pain represents the second key target market for GW's programme of developing cannabis-based medicines for a range of medical conditions. The Institute of Medicine in the United States has reported that some of the most encouraging clinical data on the effects of cannabis on chronic pain are from studies of cancer pain .
Over 100 patients, who have terminal cancer and are experiencing pain that is not responding adequately to current therapy, will take part in the double-blind, placebo-controlled study at more than 20 centres around the UK. The cannabis-based medicine is being administered by means of a sublingual (under-the-tongue) spray.
Dr Geoffrey Guy, Executive Chairman of GW, commented, "This is a significant milestone for GW, and - we hope - for sufferers from cancer pain. Cannabis-based medicine has the potential to provide considerable advantages over current medications to cancer patients. The potential market is very significant since approximately 40 per cent of cancer sufferers at present have unmet needs in pain suppression."
The new cancer trial is part of a significant expansion of GW's pivotal regulatory clinical trials programme which will continue throughout the coming months. GW is already conducting a Phase Three trial in Multiple Sclerosis patients. Recruitment for this trial is proceeding on track with 135 patients screened, of which 62 are already enrolled. Up to a further 35 patients may become eligible for entry in the coming weeks.
As part of its clinical trials expansion, GW has commenced further clinical studies including a Phase Three randomised placebo-controlled trial in brachial plexus injury, a severe form of nerve-damage pain. (This injury commonly results from motorcycle accidents and follows a wrenching of the arm and traumatic disruption of nerve connections leading to extreme pain.)
The aim of each of GW's clinical programmes is to prepare data for Product Licence Approval by the Medicines Control Agency. Phase Three of the trials programme is the final stage in preparing for an application to be made for a Product Licence Approval.
New positive data from GW's Phase Two clinical trials in Multiple Sclerosis and Spinal Cord Injury is provided in the preliminary results announced separately today. This encouraging data shows significant improvements in a range of symptoms.
Institute of Medicine, Division of Neuroscience and Behavioral Health, Janet E. Joy, Stanley J. Watson, Jr., and John A. Benson, Jr., "Marijuana and Medicine: Assessing the Science Base"
GW Expands Phase Three Clinical Trials Programme
of Cannabis-Based Medicine Into Cancer Pain
GW Pharmaceuticals plc, the company developing a portfolio of non-smoked cannabis-based prescription medicines, announces that it has expanded its Phase Three clinical trials programme into cancer pain. This Phase Three trial is the first large-scale trial of its kind and will examine the effectiveness of a cannabis-based medicine in treating pain associated with cancer.
Cancer pain represents the second key target market for GW's programme of developing cannabis-based medicines for a range of medical conditions. The Institute of Medicine in the United States has reported that some of the most encouraging clinical data on the effects of cannabis on chronic pain are from studies of cancer pain .
Over 100 patients, who have terminal cancer and are experiencing pain that is not responding adequately to current therapy, will take part in the double-blind, placebo-controlled study at more than 20 centres around the UK. The cannabis-based medicine is being administered by means of a sublingual (under-the-tongue) spray.
Dr Geoffrey Guy, Executive Chairman of GW, commented, "This is a significant milestone for GW, and - we hope - for sufferers from cancer pain. Cannabis-based medicine has the potential to provide considerable advantages over current medications to cancer patients. The potential market is very significant since approximately 40 per cent of cancer sufferers at present have unmet needs in pain suppression."
The new cancer trial is part of a significant expansion of GW's pivotal regulatory clinical trials programme which will continue throughout the coming months. GW is already conducting a Phase Three trial in Multiple Sclerosis patients. Recruitment for this trial is proceeding on track with 135 patients screened, of which 62 are already enrolled. Up to a further 35 patients may become eligible for entry in the coming weeks.
As part of its clinical trials expansion, GW has commenced further clinical studies including a Phase Three randomised placebo-controlled trial in brachial plexus injury, a severe form of nerve-damage pain. (This injury commonly results from motorcycle accidents and follows a wrenching of the arm and traumatic disruption of nerve connections leading to extreme pain.)
The aim of each of GW's clinical programmes is to prepare data for Product Licence Approval by the Medicines Control Agency. Phase Three of the trials programme is the final stage in preparing for an application to be made for a Product Licence Approval.
New positive data from GW's Phase Two clinical trials in Multiple Sclerosis and Spinal Cord Injury is provided in the preliminary results announced separately today. This encouraging data shows significant improvements in a range of symptoms.
Institute of Medicine, Division of Neuroscience and Behavioral Health, Janet E. Joy, Stanley J. Watson, Jr., and John A. Benson, Jr., "Marijuana and Medicine: Assessing the Science Base"