Connetics completes patient enrollment in Phase III atopic dermatitis trial.PALO ALTO, Calif.--(BW HealthWire)--March 24, 1997--Connetics Corp. (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 :CNCT) today announced that patient enrollment is complete in its Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of gamma interferon (Interferon gamma - 1b) for the treatment of severe atopic dermatitis, a chronic inflammatory skin disease which may result in significant morbidity and quality of life impairment. A total of 555 patients have been enrolled in the multicenter, double-blind, placebo-controlled study. As announced earlier today, Connetics is the new name for Connective Therapeutics Inc., subject to stockholder approval at the company's annual meeting in May 1997. "We are extremely pleased with the progress of this Phase III study and attribute the rapid patient accrual to investigator enthusiasm and the need for more effective therapies for this devastating disease," said W. Scott Harkonen, M.D., senior vice president of product development and operations at Connetics. "The trial is on schedule and we expect to report results from this study by year-end." In the atopic dermatitis trial, patients were 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. in three parallel groups, consisting of two active groups (50 microgram/m2 per day and 50 microgram/m2 every other day) and placebo. Primary endpoints include assessment of total clinical severity based upon erythema (redness of the skin), papulation (swelling) and excoriation excoriation /ex·co·ri·a·tion/ (eks-ko?re-a´shun) any superficial loss of substance, as that produced on the skin by scratching. (scratch marks) scores. Atopic dermatitis is a common inflammatory skin disease, which in its severe form can result in recurrent infections, hospitalization and physical disfigurement dis·fig·ure tr.v. dis·fig·ured, dis·fig·ur·ing, dis·fig·ures To mar or spoil the appearance or shape of; deform. [Middle English disfiguren, from Old French desfigurer . Recent market studies estimate that over 1.8 million individuals in the U.S. are afflicted with the disease, of whom approximately 10 percent suffer from the severe form. Current treatments provide only modest benefits and are associated with significant long-term side effects. Results from both placebo controlled and long-term Phase II trials of gamma interferon for the treatment of atopic dermatitis demonstrated statistically significant improvement in clinical scores of erythema and excoriation, and in global assessment of disease improvement. Side effects were minimal and no significant changes in the safety profile were apparent after two years of chronic use. Connetics Corp., known as Connective Therapeutics before the name change, is acquiring, developing and marketing products in the areas of rheumatology and dermatology. Ridura(R) (auranofin) is a treatment for rheumatoid arthritis that Connetics acquired from SmithKline Beecham. Several other products are under development: gamma interferon for the treatment of severe atopic dermatitis and keloids Keloids Definition Keloids are overgrowths of fibrous tissue or scars that can occur after an injury to the skin. These heavy scars are also called cheloid or hypertrophic scars. ; betamethasone betamethasone /be·ta·meth·a·sone/ (ba?tah-meth´ah-son) a synthetic glucocorticoid, the most active of the antiinflammatory steroids; used topically as the benzoate, dipropionate, or valerate salts as an antiinflammatory, topically or mousse for the treatment of scalp psoriasis and other scalp dermatoses; ConXn(TM) (relaxin re·lax·in n. A female hormone secreted by the corpus luteum that helps soften the cervix and relax the pelvic ligaments in childbirth. relaxin, n ) for the treatment of scleroderma scleroderma or progressive systemic sclerosis Chronic disease that hardens the skin and fixes it to underlying structures. Swelling and collagen buildup lead to loss of elasticity. The cause is unknown. and other fibrotic conditions; and TCR TCR T cell receptor. vaccines for the treatment of rheumatoid arthritis and multiple sclerosis. -0- Special Note: This news release contains forward-looking statements that involve risks and uncertainties that could cause actual results or events to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, without limitation, the unpredictability of clinical trials and the other factors mentioned in Connective's (also known as Connetics) Form 10-K Report for the year ended Dec. 31, 1996, under the heading "Additional Factors That May Affect Future Results." CONTACT: Connetics Corp., Palo Alto Cynthia Butitta, 415/843-2858 |
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