Carrington Labs Announces Second Phase III Pivotal Trial In Ulcerative Colitis.IRVING, Texas--(BUSINESS WIRE)--June 6, 1996--Carrington Laboratories, Inc., (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CARN), announces plans to initiate a second Phase III pivotal trial of Aliminase(TM) (CARN 1000) in patients with ulcerative colitis ulcerative colitis Inflammation of the colon, especially of its mucous membranes. The inflamed membranes develop patches of tiny ulcers, and the diarrhea contains blood and mucus. . Two pivotal trials are required prior to the submission of data to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for any new drug. This decision was based on the planned interim analysis of an on-going double-blind controlled trial controlled trial Clinical research A clinical study in which one group of participants receives an experimental drug while the other receives either a placebo or an approved–'gold standard' therapy. See Blinding, Double-blinded. comparing a placebo with three dosages of Aliminase(TM) in 288 patients at 35 test centers across the United States. According to the protocol, the analysis involved statistical comparisons of the four treatment groups that did not involve breaking the double- blind code. David Shand, M.D., Ph.D., Carrington executive vice president of research and development, stated, "While the final outcome of any on-going trial cannot be predicted with certainty, based on my clinical experience, I am sufficiently encouraged by these interim results to recommend proceeding with a second Phase III pivotal trial in ulcerative colitis." Carlton E. Turner, Ph.D., D.Sc., Carrington 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. , said, "We are delighted to accept Dr. Shand's recommendation to proceed with a second Phase III pivotal trial of Aliminase(TM) in ulcerative colitis. This continues to validate our faith in the clinical usefulness of therapeutics developed using our complex carbohydrate complex carbohydrate n. A polysaccharide consisting of a chain of glucose molecules; starch. technology." Carrington Laboratories, Inc., is an emerging research-based pharmaceutical and medical device company engaged in developing complex carbohydrate-based therapeutics and oral technology products, and in manufacturing and marketing products for the management of wounds. Carrington currently has more than 40 products on the market and will launch several new wound care products this summer and fall. CONTACT: Carrington Laboratories Inc. Investor Contact Line, 800/471-8817 or Blackmore & Co. Jim Blackmore, APR APR See: Annual Percentage Rate , 214/988-3736 |
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