IACM-Bulletin of December 9, 2007

Science USA — Clinical study with the cannabis extract Sativex started in the USA

According to a press release by GW Pharmaceuticals the British company and its Japanese partner Otsuka Pharmaceutical began a phase III study of its cannabis spray Sativex pain-relief medicine for cancer patients. The five-week trial of 336 patients will test whether the drug reduces the pain of patients with advanced cancel who do not respond to opiates. The principal investigator of this study is Dr. Russell K. Portenoy, Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City. The study will be conductet in approximately 40 centers primarily in the US. The primary objective of the study is to evaluate the potential role and dose of Sativex in these patients as an adjunct to their pre-existing pain medications.

GW Pharmaceuticals plans to report first findings from the study next year and expects to receive U.S. regulatory approval in 2011. Otsuka has exclusive rights to develop and market Sativex in the U.S. GW Pharmaceuticals estimates, that as much as 40 percent of cancer patients have severe enough pain to warrant a treatment with opiates. Sativex is already approved in Canada for pain relief from advanced cancer and multiple sclerosis.

More at:

http://www.gwpharm.com/

http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aTIBTT0uLsV8

(Sources: Press release by GW Pharmaceuticals of 26 November 2007, Bloomberg News of 26 November 2007)

USA — New Mexico wants to establish a system for the distribution and manufacture of medical cannabis

Patients, caregivers or private entities could get licenses from the state Department of Health to provide cannabis under New Mexico's medical cannabis program, according to proposed regulations released by the department. The proposed rules would establish a regulated system for the licensure, distribution and manufacture of medical cannabis.

The department plans to publish the rules later this month. A public hearing will be held in Santa Fe on 14 January.

The state law that took effect this summer allows the use of cannabis for pain or other symptoms of debilitating illnesses such as cancer, glaucoma, epilepsy, multiple sclerosis, HIV-AIDS and spinal cord injury. Since the law took effect on 1 July, the department has certified 74 patients as eligible to possess cannabis. That protects the individuals from state prosecution, but leaves them to find their own supply of cannabis potentially growing it themselves or obtaining it from friends or drug dealers. Under the proposed rules, the department would provide for several different kinds of licensed producers, including a qualified patient, a caregiver, a state-owned or operated facility or a private entity. New Mexico was the 12th state to legalize cannabis for certain medical uses, but it is the only one where the law calls for state-licensed production and distribution of the drug.

(Source: Associated Press of 4 December 2007)

News in brief

USA — California and Colorado

Courts in California and Colorado ordered the police to return seized cannabis from patients who were allowed to use the drug under state laws. The police argued that the possession of cannabis was illegal under federal law. The judges argued that enforcement of federal drug laws did not supersede the state’s allowance of cannabis for medicinal purposes. (Sources: New York Times of 30 November 2007, Coloradoan of 4 December 2007)

USA — Irvin Rosenfeld

On 20 November 2007 it was 25 years that Irvin Rosenfeld, who is suffering from a rare bone disease, was allowed by the federal government to use cannabis. He is the longest living of the federal government's medical cannabis recipients. Once there were 13 in the exclusive club. There are only five left. No new participants have been allowed since 1992, but those in the program still are supplied cannabis grown at the University of Mississippi and rolled into cigarettes in North Carolina. Rosenfeld was the second person in the USA to get a federal license to smoke cannabis. The first, Robert Randall, a glaucoma and later an AIDS patient, died in 2001. (Source: Virginian-Pilot of 3 December 2007)

Science — Sativex

On 3 December GW Pharmaceuticals announced that it has started a new phase III trial of its cannabis extract Sativex in spasticity of multiple sclerosis patients. This trial is designed to provide the basis for regulatory approval of Sativex in the indication of MS spasticity in Europe. The study aims to report results towards the end of 2008. The objective of the study is to satisfy the regulator's outstanding requirement for clarification related to the magnitude of the treatment effect of Sativex in "responders" (those patients that respond to a treatment with Sativex). (Source: Press release by GW Pharmaceuticals of 3 December 2007)

Science — HIV/AIDS

The synthetic cannabinoid WIN55,212-2 was shown to suppress the replication of the HI virus in cultures of certain brain cells and this effect was mediated by the CB2 receptor. (Source: Rock RB, et al. J Neuroimmune Pharmacol 2007;2(2):178-83)

Science — Multiple sclerosis

British researcher demonstrated in animal models of multiple sclerosis that cannabinoids were neuroprotective and immunosuppressive, which could slow disease progression. However, only the neuroprotective effects were achieved at doses low enough to be relevant in treatment of humans. Immunosuppressive effects were only achieved at high doses. (Source: Croxford JL, et al. J Neuroimmunol. 2007 Nov 23 [Electronic publication ahead of print])

Science — Cannabis dependence

In a Danish study with 36 subjects seeking treatment for cannabis dependence the participants were followed for an average of 26 months after treatment. It was noted that the intensity of withdrawal symptoms during treatment did not predict the probability of relapse during follow-up. (Source: Arendt M, et al. Am J Addict 2007;16(6):461-7.)