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USA: Investigational new drug 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 antiinflammatory properties, without the traditional side effects associated with current nonsteroidal 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 antiinflammatory properties in animal studies. At least some of the analgesic and antiinflammatory 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 antiinflammatory 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: IACM-Bulletin 16.4.2000
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)

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