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Connective Therapeutics Announces Presentation of Results From Long-Term Gamma Interferon Therapy.


PALO ALTO, Calif.--(BUSINESS WIRE)--May 31, 1996--Connective Therapeutics, Inc. today announced the presentation of clinical results from long-term administration of gamma interferon in patients with severe atopic dermatitis Atopic Dermatitis Definition

Eczema is a general term used to describe a variety of conditions that cause an itchy, inflamed skin rash. Atopic dermatitis, a form of eczema, is a non-contagious disorder characterized by chronically inflamed skin and
.

The data, which support previous clinical safety and efficacy results, were presented by Seth R. Stevens, M.D. of the Department of Dermatology, University Hospitals of Cleveland University Hospitals is a major not-for-profit medical center in Cleveland, Ohio, United States. With 150 locations throughout northeast Ohio, it encompasses a network of hospitals, outpatient centers and primary care physicians.  and Case Western Reserve University, at the Clinical Dermatology 2000 Meeting being held in Vancouver.

The long-term maintenance data were generated in an open label Phase II study in atopic dermatitis patients who previously completed a 12-week, double-blind, placebo-controlled trial of gamma interferon. Twenty-four patients completed one year of therapy and 16 patients completed two years. Overall response, body surface area involvement, and clinical severity scores for erythema erythema (ĕr'əthē`mə), more or less diffuse redness of the skin due to concentration of an abnormally large amount of blood within the small vessels of the skin (hyperemia), as in burns.  (redness of the skin), edema edema (ĭdē`mə), abnormal accumulation of fluid in the body tissues or in the body cavities causing swelling or distention of the affected parts.  (swelling), pruritis (itching), excoriations (scratch marks), scaling and lichenification (accentuation of skin markings) were monitored at quarterly visits.

The results indicated that all parameters of clinical severity were statistically significantly improved following one- and two-year gamma interferon therapy. Total body surface area involvement at the beginning of the trial averaged 56 percent for those who completed one year of study and averaged 60 percent for those who completed two years. Following gamma interferon therapy, these values were reduced to 21 percent and 36 percent, respectively. Side effects were minimal and no significant changes in the safety profile were apparent after two years chronic use.

"Because atopic dermatitis is such a chronic disease, it is imperative that any proposed therapy have persistent efficacy, with an acceptable safety profile over years of use in order to be effective in treating this illness," said Dr. Stevens. "With no other systemic therapy currently available which meets these criteria, we are particularly excited about the data generated for gamma interferon in this trial."

Overall, these data are consistent with results published in the Journal of the American Academy of Dermatology The American Academy of Dermatology (AAD) is the largest organization of dermatologists in the world.

The Academy grants Fellowships and Associate Memberships, as well as Fellowships for Nonresidents (of the United States of America or Canada).
 from the 12-week, double-blind, placebo-controlled Phase II trial. In the study, patients who received gamma interferon experienced statistically significant improvement of overall disease severity, erythema, and excoriations/erosions compared to those patients who received placebo.

"We are pleased with the results from long-term administration of gamma interferon which confirm earlier efficacy results and demonstrate sustained disease improvement over time," said W. Scott Harkonen, M.D., senior vice president of Product Development and Operations at Connective. "These data support moving the product into advanced clinical testing in severe atopic dermatitis patients. We are tremendously excited about beginning our 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  in the near future."

Gamma interferon, a product Connective licensed from Genentech in 1995, is a protein involved in the regulation of the immune system. Because of its biological properties, Connective Therapeutics is initially developing gamma interferon for the treatment of 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.
. Genentech currently markets gamma interferon under the tradename Actimmune" (Interferon gamma - 1b) for the treatment of chronic granulomatous disease Chronic Granulomatous Disease Definition

Chronic granulomatous disease (CGD) is an inherited disorder in which white blood cells lose their ability to destroy certain bacteria and fungi.
 and is developing the product for other disease indications outside of Connective's licensed field.

Atopic dermatitis is a common inflammatory skin disease, which in its severe form, can result in 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
, potentially resulting in psychological trauma. Recent market studies estimate that over 1.8 million individuals in the U.S. are afflicted with the disease, of which more than 100,000 patients suffer from the severe form. Current treatments provide only modest benefits and are associated with significant long-term side effects. Connective Therapeutics, Inc., headquartered in Palo Alto, California “Palo Alto” redirects here. For other uses, see Palo Alto (disambiguation).
Palo Alto (IPA: /ˌpæloʊˈʔæltoʊ/, from Spanish: palo: "stick" and alto: "high", i.e.
, 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; 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 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 indications; and TCR TCR

T cell receptor.
 peptide vaccines for rheumatoid arthritis and multiple sclerosis. -0-

Note to Editors: 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 Inc.

Sylvia Wheeler, 415/843-2857
COPYRIGHT 1996 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:May 31, 1996
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