IACM-Bulletin of September 3, 2006

Science — New phase III trials of GW Pharmaceuticals in Europe and North America, including for this first time in the USA

It is expected that phase III clinical trials with Sativex, a cannabis extract produced by the British company GW Pharmaceuticals, will begin in the United States later this year. GW was supported by the consulting firm Apjohn Group, hired by GW in early 2005 to help bring the drug closer to clinical trials in the US. Current trials are targeted at patients with advanced cancer whose pain has not been relieved by opioid medications like morphine, according to GW.

On 9 August GW Pharmaceuticals announced also the start of a second phase III trial in people with multiple sclerosis suffering from central neuropathic pain. The first patient has been enrolled in the study conducted in the UK, Canada, France, Spain and the Czech Republic. This study is a placebo-controlled study of Sativex in 218 patients with central neuropathic pain due to MS, who have achieved inadequate pain relief with existing therapies. Promising results of an earlier phase III study of Sativex in neuropathic pain due to MS have already been published in the journal Neurology.

More information:

http://www.mlive.com/business/kzgazette/index.ssf?/base/business-3/1156652675255420.xml&coll=7

http://www.gwpharm.com

(Sources: Kalamazoo Gazette of 27 August 2006, GW Pharmaceuticals of 9 August 2006)

USA — Judge orders changes in official explanation of cannabis measure in South Dakota

A judge told South Dakota officials on 25 August to make substantial changes in the language that will appear on the November ballot to explain a proposal that would legalize the use of cannabis for medical purposes. Voters in November will decide whether to legalize cannabis for people who have certain medical conditions such as cancer, AIDS or chronic pain. The ballot will be explained by Attorney General Larry Long.

Judge Max Gors gave Long the option of either using a new explanation written by the judge or making substantial changes to the explanation Long had written. Several statements appeared to be biased, the judge said. "The whole impression leads one to believe that the attorney general wants voters to reject the initiative," Gors wrote. Among others the Attorney General had stated several times that even if state voters approve the measure the medical use of cannabis will remain illegal under federal law.

More information: http://cache.trafficmp.com/tmpad/content/vendare/uproar/1205/720X300-J-intro_20051215172322.htm

(Source: Associated Press of 25 August 2006)

News in brief

Science — Cannabinor

On 10 August Pharmos Corporation announced that it has commenced a second phase II clinical study of cannabinor for the treatment of pain. This placebo-controlled trial will test for analgesic activity and the safety of intravenous cannabinor in healthy subjects experiencing experimental pain induced by capsaicin, a compound of red hot chili pepper. It will take place at the University College of London. The Company also noted that patient enrolment continues in its separate phase II clinical trial of cannabinor as a treatment for pain in third molar dental extraction. Cannabinor is a synthetic cannabinoid that selectively binds to the CB2 receptor.

More information:

http://www.biospace.com/news_story.aspx?StoryID=27123&full=1

http://www.pharmoscorp.com/development/cannabinor.html

(Sources: Biospace.com of 10 August 2006, www.pharmoscorp.com)

Canada/USA — Renee Boje

Renee Boje is finally free. In 1998, Boje faced a potential 10-year federal sentence for her minor involvement in the cultivation of medical cannabis in California. Boje fled from the US to Canada on the advice of her lawyer. She failed to receive refugee status in Canada. Under the terms of an agreement between Boje and federal prosecutors, Boje pled guilty to minor cannabis possession. On 14 August she was sentenced by a Californian judge to one-year probation.

More information: http://www.cannabisculture.com/articles/4803.html.

(Source: Cannabis Culture of 22 August 2006)

Science — THC-cyclodextrin complex

A complex formed by THC and a beta-cyclodextrin, a circular sugar compound, increased the solubility of THC in water by four orders of magnitude. A maximum THC concentration of about 14 mg/ml was reached. The complex was stable for at least eight weeks. (Source: Hazekamp A, Verpoorte R. Eur J Pharm Sci 2006 Jul 6; [Electronic publication ahead of print])

Science — Ajulemic acid

In cell experiments, the synthetic cannabinoid ajulemic acid (CT3, IP751) was shown to inhibit the secretion of a protein (metalloproteinase) that is known to facilitate cartilage degradation and bone erosion in patients with inflammatory arthritis. Researchers conclude that "these results suggest that AjA may be useful for treatment of patients with rheumatoid arthritis and osteoarthritis." (Source: Johnson DR, et al., J Cell Biochem. 2006 Aug 22; [Electronic publication ahead of print])

Science — Stomach and bowel

In a placebo-controlled study with 30 healthy subjects researchers of the Mayo Clinic in Rochester investigated the effects of THC on the transit of food through stomach and bowel. Subjects received three doses of 5 mg THC or placebo on the first day of the study. Gastric emptying was slowed by THC and in males fasting volume of the stomach was greater in those receiving THC compared to placebo. No significant effects were observed for transit of food in the bowel. (Source: Esfandyari T, et al. Neurogastroenterol Motil 2006;18(9):831-8)

Science — Saliva secretion

Both CB1 and CB2 receptors are located in salivary glands. Their activation by cannabinoids causes a decrease in saliva secretion. (Source: Prestifilippo JP, et al. Exp Biol Med (Maywood) 2006;231(8):1421-9)