Atlantic Technology Ventures, Inc. Initiates a Phase II Pilot Human Efficacy Trial of CT-3 for Chronic Neuropathic Pain.Business Editors NEW YORK--(BUSINESS WIRE)--May 2, 2002 Atlantic Technology Ventures, Inc. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). : ATLC.OB- news) has received approval from the German Federal Institute for Drugs and Medical Devices to initiate a phase II pilot clinical trial evaluating the safety, efficacy and dosing of its proprietary CT-3 compound in cases of chronic neuropathic pain. This trial will be a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, placebo-controlled, escalating dose crossover trial of CT-3 in 21 patients, and will be conducted at the University of Hannover Medical School The Hannover Medical School (abbreviated MHH in German), founded in 1965, is one of the world's leading university medical centres in Germany. The research and patient care set national and international standards. in Hannover, Germany. Atlantic will begin enrolling patients into the study immediately. "We are very excited about initiating our first phase II pilot efficacy trial of CT-3," said Fred Zotos, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Atlantic. "A successful clinical showing of human efficacy will be a significant milestone in the development of CT-3, and should generate strong interest among potential clinical and commercial development partners to sub-license the compound." Neuropathic pain is a condition resulting from damage to peripheral nerves, pain receptors, or to the central nervous system. This type of pain typically occurs in patients with peripheral neuropathy caused by diabetes, AIDS, or from an unknown cause (idiopathic) and postherpetic pain. It is typified by hyperalgesia hyperalgesia /hy·per·al·ge·sia/ (-al-je´ze-ah) abnormally increased pain sense.hyperalge´sic hy·per·al·ge·sia n. Extreme sensitivity to pain. (excessive sensitivity to painful stimuli) and allodynia (pain resulting from touch stimuli that would normally not be painful and by aberrant, painful sensations in the absence of touch stimuli). Over 130 million Americans suffer from chronic pain, with worldwide prescription sales of analgesic/anti-inflammatory drugs exceeding $9 billion. Many currently available therapies for neuropathic pain have proven ineffective, and it appears patients may be under-treated due to lack of therapeutic options. "For this reason", states Michael Ferrari, Vice President of Business Development of Atlantic, "there currently exists a dire need for effective alternatives with minimal side effects for the treatment of chronic neuropathic pain." Both anecdotal evidence of cannabinoids Cannabinoids The chemical compounds that are the active principles in marijuana. Mentioned in: Marijuana in general, and preclinical studies of CT-3 in particular point to its efficacy for treating neuropathic pain. For thousands of years, cannabinoids have been known to have a pain-inhibiting effect without any definite clarification of the mode of action. CT-3 has undergone testing in an animal model designed to test for hyperalgesia and allodynia. Rats were given an injection of platelet activating factor (PAF PAF platelet activating factor. PAF abbr. platelet-aggregating factor PAF platelet activating factor. ) into a hindpaw to produce local irritation and inflammation of nervous tissue. The changes in pain sensitivity were assessed by determining the threshold for pain induced by mechanical pressure. The injections of PAF induced allodynia (decreased pain threshold), which was fully reversed by CT-3. In fact, CT-3 not only reversed alloydinia produced by PAF, it produced analgesia evidenced by a significant increase in the threshold beyond the normal level. This demonstration of CT-3's anti-allodynic and anti-hyperalgesic effects suggested that it might be an efficacious treatment for neuropathic pain. About CT-3 CT-3 is a chirally pure, patented synthetic carboxylic car·box·yl n. The univalent radical, COOH, the functional group characteristic of all organic acids. [carb(o)- + ox(y)- + -yl. derivative of tetrahydrocannabinol tetrahydrocannabinol /tet·ra·hy·dro·can·nab·i·nol/ (THC) (-hi?dro-kah-nab´i-nol) the active principle of cannabis, occurring in two isomeric forms, both considered psychomimetically active. (THC-7C). It is a new chemical entity specifically designed to have increased analgesic and anti-inflammatory properties and reduced psychotropic activity compared to the THC THC tetrahydrocannabinol. THC n. Tetrahydrocannabinol; a compound that is obtained from cannabis or is made synthetically; it is the primary intoxicant in marijuana and hashish. parent. Pre-clinical animal studies have shown that CT-3 demonstrates analgesic/anti-inflammatory properties at microgram microgram /mi·cro·gram/ (µg) (mi´kro-gram) one millionth (10-6) of a gram. mi·cro·gram n. Abbr. doses without central nervous system or gastrointestinal side effects. About Atlantic Technology Ventures, Inc. Atlantic is engaged in the development of biomedical and pharmaceutical products and related technologies. Atlantic's strategy is to identify nascent medical products and technologies that have the potential to address unmet market needs, rapidly develop these through a definitive proof-of-principle, then partner, license or sell them to realize significant revenue. Atlantic currently has ownership interest in Avantix (formerly known as "Catarex"), a surgical device for cataract removal, and CT-3, a synthetic cannabinoid cannabinoid /can·nab·i·noid/ (kah-nab´i-noid) any of the principles of Cannabis, including tetrahydrocannabinol, cannabinol, and cannabidiol. can·nab·i·noid n. derivative for treating pain and inflammation. Safe Harbor Statement Cautionary statement under the "safe harbor" provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 from other manufacturers of related 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. |
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