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A Cambridge UK-based medical technology company has started a critical trial of its cannabis-based Sativex® treatment for pain in advanced cancer patients.
GW Pharmaceuticals' Phase III clinical trial holds the key to approval in this indication by the FDA in America. GW will also use the data for future regulatory applications in Europe and around the world.
Japanese pharma giant Otsuka, which has licensed the US commercialisation rights to the product, is funding the entire programme.
The new trials embrace what GW calls "two pivotal 380 patient Phase III cancer pain studies" and says both are proceeding on track. The company expects to complete recruitment around the end of 2013.
Dr Stephen Wright, GW's R & D director, said: "This clinical development programme, being performed in partnership with Otsuka, is the largest ever undertaken by GW.
"With significant numbers of patients with advanced cancer around the world suffering pain in spite of treatment with opioid therapy, Sativex has the potential to meet a very significant unmet need."
AIM-listed GW has posted an interim pre-tax loss of £4.1m — in line with expectations — for the six months to March 31. That compares to a £3.1m profit last time.
Total revenue of £11.1m was down from £16.6m this time last year but the company received a further £9.8m milestone payment this month that will be recognised in H2.
The company has £26.2m in cash and short term deposits — only slightly down from the £28.3m it held at the end of H1 2011.
Chairman Geoffrey Guy reported strong commercial progress right across GW's product portfolio.
News Hawk- TruthSeekr420 420 MAGAZINE
Source: biusinessweekly.co.uk
Author: Kate Sweeney
Contact: Company Contacts | Business Weekly | Technology | Biotechnology | Business news | Cambridge and the East of England
Website: Cannabis-based medicine in cancer trial | Business Weekly | Technology | Biotechnology | Business news | Cambridge and the East of England
GW Pharmaceuticals' Phase III clinical trial holds the key to approval in this indication by the FDA in America. GW will also use the data for future regulatory applications in Europe and around the world.
Japanese pharma giant Otsuka, which has licensed the US commercialisation rights to the product, is funding the entire programme.
The new trials embrace what GW calls "two pivotal 380 patient Phase III cancer pain studies" and says both are proceeding on track. The company expects to complete recruitment around the end of 2013.
Dr Stephen Wright, GW's R & D director, said: "This clinical development programme, being performed in partnership with Otsuka, is the largest ever undertaken by GW.
"With significant numbers of patients with advanced cancer around the world suffering pain in spite of treatment with opioid therapy, Sativex has the potential to meet a very significant unmet need."
AIM-listed GW has posted an interim pre-tax loss of £4.1m — in line with expectations — for the six months to March 31. That compares to a £3.1m profit last time.
Total revenue of £11.1m was down from £16.6m this time last year but the company received a further £9.8m milestone payment this month that will be recognised in H2.
The company has £26.2m in cash and short term deposits — only slightly down from the £28.3m it held at the end of H1 2011.
Chairman Geoffrey Guy reported strong commercial progress right across GW's product portfolio.
News Hawk- TruthSeekr420 420 MAGAZINE
Source: biusinessweekly.co.uk
Author: Kate Sweeney
Contact: Company Contacts | Business Weekly | Technology | Biotechnology | Business news | Cambridge and the East of England
Website: Cannabis-based medicine in cancer trial | Business Weekly | Technology | Biotechnology | Business news | Cambridge and the East of England
