News: INDA for CT-3
Monday April 3, 9:04 am Eastern Time
Company Press Release
SOURCE: Atlantic Technology Ventures, Inc.
Atlantic Technology Ventures Submits U.S. Food & Drug Administration Investigational New Drug (IND) Application for CT-3
Company Moves Ahead Towards Developing Next Generation of Analgesic and Anti-Inflammatory Drugs with Concurrent Phase I Studies in Europe
NEW YORK, April 3 /PRNewswire/ -- Atlantic Technology Ventures, Inc. (Nasdaq: ATLC - news), a company engaged in developing and commercializing a diverse portfolio of patented technologies, announced today 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 nonsteroidal anti- inflammatory drugs.
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.
``It is expected 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,' said Dr. A. Joseph Rudick, President of Atlantic. ``We are moving ahead to demonstrate that this promising new drug may be more beneficial to people than Celebrex or Vioxx.'
Atlantic is developing CT-3, a patented synthetic derivative of tetrahydrocannabinol (THC-11-oic acid), as an alternative to nonsteroidal anti-inflammatory drugs (NSAIDs). 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. 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 the laboratory to maximize the medical properties of THC without producing any undesirable psychoactive properties,' said Dr. Rudick. ``CT-3 is the first of a series of cannabinoid acids to be developed for clinical use. Other naturally occurring compounds of this class have been tested in humans and found to not have psychoactive properties,' 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.
SOURCE: Atlantic Technology Ventures, Inc.
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