Connective Therapeutics Initiates Phase II Trial in Scleroderma.PALO ALTO, Calif.--(BUSINESS WIRE)--June 20, 1996--Connective Therapeutics, 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 : CNCT CNCT Connect CNCT Certified Network Computer Technician ) today announced that it has initiated a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of ConXn (recombinant human 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 H2) 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. . The primary objectives of the study are to evaluate the safety of administration of the product over 24 weeks, to confirm efficacy and to determine endpoints to be used in subsequent pivotal clinical studies. The multicenter, double-blind, placebo-controlled Phase II trial is expected to enroll a total of 60 patients with scleroderma, a serious, life-threatening connective tissue disorder. Patients in the trial will be 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. to receive ConXn at one of two dose levels (25 5ug/kg/day or 100 5ug/kg/day) or placebo, administered over a 24-week treatment period. The study is designed to evaluate the effects of ConXn on skin softening, joint mobility, quality of life and vital organ function. "Early data from previous studies suggest that ConXn is well-tolerated and may prove efficacious in alleviating some of the clinical symptoms experienced by scleroderma patients," said W. Scott Harkonen, M.D., senior vice president of Product Development and Operations at Connective. "In addition to initiating this trial, we intend to meet more clinical milestones by beginning additional late-stage trials with other products in our pipeline by year end." Last month, Connective announced results from Phase I testing of ConXn in thirty diffuse, systemic scleroderma patients. The data indicated that ConXn was well-tolerated. In addition, ten of 20 patients reported improvement in disease symptoms versus only two of ten receiving placebo during global assessments performed at the end of the study. Scleroderma is a serious connective tissue disease connective tissue disease Autoimmune disease, collagen-vascular disease Any of the diseases affecting connective tissues, with an autoimmune component, and immunologic/inflammatory defects Clinical Arthritis, connective tissue defects, endocarditis, myositis, in which the body produces excessive collagen that encases and hardens the skin and internal organs. Diffuse systemic scleroderma affects an estimated 60,000 patients in the United States, 80 percent of whom are women. In its most severe form, the disease is fatal in 50-70 percent of cases within five years. ConXn, a natural protein, has been shown to inhibit excessive connective tissue build-up by decreasing collagen production and enhancing collagen breakdown. In preclinical studies, ConXn demonstrated a dose-dependent ability to inhibit collagen accumulation in fibrosis models. Connective Therapeutics, Inc., headquartered in Palo Alto, Calif., is focused on the development of novel therapeutics for serious connective tissue disorders. The company has three products in development for six initial indications: gamma interferon for 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. ; relaxin for scleroderma and other fibrotic indications; and TCR TCR T cell receptor. peptide vaccines for rheumatoid arthritis and multiple sclerosis. 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, those mentioned in Connective's prospectus dated January 31, 1996 under the heading "Risk Factors" and in Connective's Report on Form 10-Q for the quarter ended March 31, 1996 under the heading "Additional Factors That May Affect Future Results." CONTACT: Connective Therapeutics Cynthia Butitta, 415/843-2858 |
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