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FDA Approves Testing of Synthethic Derivative of Mj

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May 12,00
Clinical trials might begin in the United States
Source: PRNewswire
Atlantic Technology Ventures, Inc. a company
engaged in developing and commercializing a
diverse portfolio of patented technologies,
announced today that the United States Food and
Drug Administration (FDA) has approved an
investigational new drug (IND) application to begin clinical trials for CT-3, an analgesic and anti-inflammatory drug that is a synthetic derivative of tetrahydrocannabinol (THC), the
active ingredient in marijuana.
The company also announced that Aster Clinical Research Center in Paris, France, will conduct the first scientific testing for CT-3 in Europe. This phase 1 clinical trial involves human volunteers and will begin in France this month.
"The FDA approval opens up the possibility for clinical trials to begin in the United States," said Dr. A. Joseph Rudick, President of Atlantic. "The agency scrutinized our work and found that it met their high standards. Our animal studies have strongly demonstrated CT-3's likelihood for successful administration in people."
Atlantic is developing CT-3, a patented synthetic derivative of carboxylic tetrahydrocannabinol (THC-7C), as an alternative to nonsteroidal anti-inflammatory drugs (NSAIDs). Preliminary
cellular and animal studies have shown that CT-3
demonstrates analgesic and anti-inflammatory properties at microgram doses without central nervous system or gastrointestinal side effects. This makes the compound an attractive development candidate as an analgesic and anti-inflammatory agent with the potential to overcome the major side effects of current anti-inflammatory drugs.
"CT-3 was designed in a laboratory to maximize the medical properties of marijuana without producing any undesirable psychoactive properties," said Dr. Rudick. "CT-3 is the first of a series of carboxylic acid compounds based on the chemical
structure of marijuana, to be developed for clinical use. Other compounds of this class have been tested in humans and found to not have psychoactive properties. We believe that CT-3 will
offer relief from pain and inflammation equal to or better than medicines presently on the market, but without their side effects," added Dr. Rudick.
The most commonly prescribed analgesic and
anti-inflammatory drugs for the long-term treatment of arthritis are NSAIDs such as aspirin, ibuprofen and indomethacin. Although reasonably effective, if taken chronically, NSAIDs can cause side effects, including an increased risk of ulcer formation and gastrointestinal bleeding.
It has been estimated that 24 percent of all patients undergoing chronic NSAID therapy develop some degree of ulceration. Despite these complications, worldwide prescription sales of NSAIDs exceeded $6 billion in 1994.
Atlantic plans to develop oral and parenteral formulations of the compound for pain and inflammation associated with a variety of disease states.

Safe Harbor Statement:
Cautionary statement under the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995: This press
release contains certain forward-looking statements that relate to future scientific, business and financial performance. These
statements are only predictions and are subject to a number of risks and uncertainties that may cause the actual events or results to differ from those discussed or implied in these statements. These risks and uncertainties include competition
form other manufacturers of cataract-extraction technologies, the unavailability of any necessary intellectual property rights possessed by third parties, and certain of those risks described
in Atlantic's most recent report on Form 10-KSB with the Securities and Exchange Commission.

Contact: Vito A. Turso, 212-981-5156, or Michael Paluszek, 212-981-5149, both of Dan Klores Associates, Inc., for Atlantic Technology Ventures, Inc.

Atlantic Technology Venture's CT-3 Shows Fewer Side Effects For Next Generation Of Analgesic & Anti-Inflammatory Drugs:

New York/PRNewswire/
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