IACM-Bulletin of July 19, 2009

Science — Clinical phase III study with the cannabis extract Cannador successful in multiple sclerosis

A clinical study with the standardized cannabis extract Cannador was recently completed in 279 patients with multiple sclerosis suffering from muscle stiffness under the guidance of Dr John Zajicek, professor at the Peninsula Medical School, Plymouth/UK. The study met its primary objective to show superiority of Cannador over placebo in the treatment of muscle stiffness. The cannabis extract was also superior to placebo with regard to secondary efficacy parameters such as pain, muscle spasms, quality of sleep, and questionnaires on severity of spasticity and overall disability due to multiple sclerosis.

The study, which has been conducted in 22 centres in the UK, was sponsored by the Society for Clinical Research, Germany, and the pharmaceutical company Weleda, Switzerland. It was a randomized, double-blind, placebo-controlled, phase III study, in which 143 patients received the encapsulated cannabis extract and 134 a placebo. Each capsule of Cannador contained 2.5 mg THC (dronabinol) and about 1.25 mg CBD (cannabidiol). Patients received the extract or the placebo for 12 weeks, of which the first two weeks were used to find the individual dose of each patient.

This article with preliminary information is based on the clinical study report and was written in cooperation with the sponsors. Detailed results will be presented at a conference in Duesseldorf (ECTRIMS) in September and reported in an IACM-Bulletin thereafter.

(Source: Personal communication by the Institute for Clinical Research, Berlin)

News in brief

UK — GW Pharmaceuticals

The British company GW Pharmaceuticals received commercial manufacturing licence for its cannabis extract Sativex. A new GW facility is initially able to produce quantities of Sativex sufficient to treat 25,000 patients per year. In May, GW filed a regulatory submission for Sativex for the treatment of spasticity due to multiple sclerosis in the UK and Spain under the European decentralised procedure. It is expected that an outcome of the regulatory submission will be known towards the end of 2009 / early 2010. (Source: Press release by GW Pharmaceuticals of 16 July 2009)

USA — New Hampshire

Governor John Lynch vetoed a bill on 10 July that would have made New Hampshire the 14th state to legalize cannabis use by severely ill people. Members of the Senate and House of Representatives had made extensive changes to the bill in hopes of getting consent of Lynch, who had been critical from the start. But the governor said that the bill still has too many defects. The bill passed the House of Representatives 232-108 last month and the Senate 14-10. To override the veto the bill needs two-thirds of votes in both houses. If the veto is overridden, the bill would establish three non-profit centres to dispense up to 2 ounces (about 57 grams) of cannabis every 10 days to severely ill patients whose doctors approve the drug's use. (Source: Associated Press of 10 July 2009)

USA — California

A bill to tax and regulate cannabis in California like alcohol would generate nearly 1.4 billion US-Dollars (about 1 billion Euros) in revenue for the state, according to an official analysis released by tax officials on 15 July. The bill introduced by Tom Ammiano, member of the state House of Representatives, in February would allow adults 21 and older to legally possess, grow and sell cannabis. Ammiano has promoted the bill as a way to help overcome the state's budget problems. (Source: Associated Press of 15 July 2009)

Science — Fibrosis

According to cell research of scientists of the University of Siena, Italy, a synthetic cannabinoid (WIN55,212-2) showed anti-fibrotic activity in scleroderma fibroblasts. Both CB1 and CB2 receptors were increased in these fibroblasts compared to healthy fibroblasts. Researchers concluded that cannabinoids possibly represent "a new class of agents targeting fibrosis diseases." (Source: Garcia-Gonzalez E, et al. Rheumatology (Oxford) 2009 Jul 9. [Electronic publication ahead of print])

Science — Liver cirrhosis

According to research at the Hadassah-Hebrew University in Jerusalem with an animal model of liver cirrhosis and brain damage due to liver cirrhosis the natural cannabinoid CBD improved cognitive and motor function, which were impaired by the disease. (Source: Magen I, et al. J Hepatol 2009 May 27. [Electronic publication ahead of print])

Science — Acetaminophen

According to researchers from India acetaminophen (Paracetamol) produced anxiety reducing effects and these effects are mediated probably by the endocannabinoid system. (Source: Umathe SN, et al. Prog Neuropsychopharmacol Biol Psychiatry 2009 Jul 3. [Electronic publication ahead of print])