IACM-Bulletin of April 16, 2000

Science UK — Clinical trial with Cannabis approved by the MCA

A clinical trial of a cannabis-based medicine has been given the go-ahead by the Medicines Control Agency (MCA), it was disclosed on 14 April. Junior Health Minister Gisela Stuart said the trial would look at the use of the drug to treat multiple sclerosis and other neurological disorders.

"If a marketing authorization were to be issued by the MCA, we would seek to modify the current Misuse of Drugs Act controls on the use of cannabis," Ms Stuart said.

The company running the trials, GW Pharmaceuticals, believes them to be the first of their kind in the world. They will start shortly at the Pain Relief Clinic at the James Paget Hospital, Great Yarmouth, in eastern England, under the supervision of Dr. William Notcutt.

Patients will take different formulations of cannabis-based medicines using devices that spray them under the tongue and allow them to be absorbed directly into the bloodstream. About 2,000 patients will take part in the trial, details of which can be found on the Web site www.medicinal-cannabis.org.

(Sources: PA News of 6 and 15 April 2000)

Economy USA — Investigational new drug (IND) application for CT3

Atlantic Technology Ventures announced on 3 April that it has filed an investigational new drug (IND) application with the United States Food and Drug Administration and is seeking approval to begin clinical trials for CT-3 (chemical name: ajulemic acid), a patented compound that the company believes will have significant analgesic and anti-inflammatory properties, without the traditional side effects associated with current non-steroidal anti- inflammatory drugs.

CT-3 is a synthetic derivative of the main non-psychoactive metabolite (THC-11-oic acid) of THC or dronabinol, the main psychoactive compound of cannabis. THC-11-oic acid has analgesic and anti-inflammatory properties in animal studies. At least some of the analgesic and anti-inflammatory effects of Cannabis may be due to the acid metabolites of THC.

Extensive animal studies have shown that CT-3 is equipotent to morphine and demonstrates analgesic and anti-inflammatory properties at microgram doses without central nervous system, respiratory depressive or gastrointestinal side effects.

The company also announced that it has signed a contract with Aster Clinical Research Center in Paris, France, to conduct the first scientific testing for CT-3 in Europe. This phase I clinical trial will begin in France in May 2000. Atlantic expects this parallel advancement pathway will shorten the development time and get CT-3 to market faster.

(Sources: PR Newswire of 3 April 2000; Burstein SH: The therapeutic potential of ajulemic acid (CT3). In: Grotenhermen F, Russo E (eds): Cannabis and Cannabinoids: Pharmacology, Toxicology, and Therapeutic Potential. New York: Haworth Press, 2000, in press)

USA — Clinical conference on Cannabis therapeutics

On 7 and 8 April the First National Clinical Conference on Cannabis Therapeutics was held at the Iowa State University IMU, sponsored by the UI Colleges of Nursing and Medicine, along with Patients Out of Time.

An estimated 80 people, health-care professionals, lawyers and patients, used the conference as an opportunity to discuss the uses and variations of marijuana. Melanie Dreher, the dean of the nursing school, who helped to organize the conference, said attendance at the conference was fairly high, considering the subject. It was broadcast live via satellite to sites in Arkansas, Colorado, Oregon, Virginia and Canada.

Conference Co-chairwoman Mary Lynn Mathre said she hopes people were able to see the issue of medical marijuana use from a different perspective after listening to the various presentations. "We're not trying to say it has no problems or that it works for everyone," she said.

People such as George McMahon, one of eight people in the United States who not only has federal government permission to smoke marijuana for medical reasons, and Scott Imler, president of the Los Angeles Cannabis Resource Center, are hopeful the UI conference contributes to public discussion and allows people to talk about using marijuana for medical purposes more openly.

(Sources: COMTEX-Newswire of 10 April 2000, The Gazette of 9 April 2000)

News in brief

Europa/Deutschland

At the 2nd International Congress of Homoeopathy for chronic diseases near Stuttgart the participants claimed the medical approval of homoeopathic preparations of Cannabis. The use of this remedy was juristically hindered, despite Cannabis was no longer chemically provable in this diluteness, Dr. Walter Koester said on 7 April. Koester is the first professor for homoeopathy in Europe at the University of Sevilla (Spain). About 800 physicians and healers participated in the meeting that continued until 9 April (Source: Stuttgarter Nachrichten of 8 April 2000)