GW Pharmaceuticals’ share price rose marginally in London yesterday after the company revealed positive preliminary results from a Phase III clinical trial with its cannibis-derived medicine, Sativex (tetrahydrocannabinol plus cannabidiol), in patients with severe cancer pain.
Dr Stephen Wright, GW’s research and development director, said: “Patients in this trial were suffering intense pain as a result of their cancer despite using currently available strong opioid treatments and therefore have a very high clinical need. The data from this important trial further demonstrates the broad potential of Sativex, not only in its initial Multiple Sclerosis and neuropathic pain markets, but also in cancer and potentially other types of chronic pain. These positive results suggest that Sativex may represent a valuable new treatment option for this group of patients.
GW, which has been stung by a string of setbacks to Sativex, also said that was expecting to hear a decision on from the UK regulatory agency on whether to approve the drug as a treatment for multiple sclerosis, within the next six months. The firm had originally expected a nod from UK regulators by the end of 2003 [[01/04/03e]] and submitted further efficacy, safety and quality information to the agency in July as part of a bid to address outstanding questions [[21/06/04f]]. However, late last year, the MHRA asked for an additional study be conducted to determine Sativex’ clinical relevance in treating in MS spasticity [[06/12/04e]]. GW received a so-called “qualifying notice” from Health Canada late last year, which is one of the last steps towards securing final approval [[21/12/04d]].