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| |  Phase II Clinical Trial of Gamma Interferon in Keloids PALO ALTO, Calif.-- Jan. 22, 1997-- Connective Therapeutics Inc. (NASDAQ:CNCT) announced today that it has initiated a Phase II clinical trial of gamma interferon in keloids, fibrotic growths that result from an abnormal healing response in the skin. Keloids are the second indication for the product. Connective also is currently evaluating gamma interferon in a Phase III clinical trial for the treatment of atopic dermatitis. "We strategically in-licensed gamma interferon with knowledge of its expanded potential and clinical history as an anti-fibrotic," said W. Scott Harkonen, M.D., senior vice president of Product Development and Operations at Connective. "We are excited to advance the development of gamma interferon in keloids and hope to confirm earlier clinical observations of its potential use in this indication." The placebo-controlled, multicenter, randomized Phase II study of 40 patients is designed to evaluate effectiveness of intralesional gamma interferon therapy to prevent the recurrence of keloid lesions following surgical excision. The study will involve two parallel groups to compare gamma interferon against placebo. Keloids are fibrotic growths that result from excessive collagen formation (or an abnormal healing response) in the skin of susceptible individuals. They generally appear as large, red, elevated scars which extend beyond the original scar boundaries and are often painful. The incidence of keloid formation is higher in individuals with darker skin, and the tendency to form keloids appears to be inheritable. Approximately 3 million people in the United States, predominantly of black and Hispanic ethnicities, are estimated to be affected by keloids. Current therapies for the disease are plagued with high recurrence rates and can often result in suboptimal cosmetic outcomes. Two earlier clinical trials provided preliminary evidence of the potential of gamma interferon in the treatment of keloids. One study involved nine patients with keloids or hypertrophic scars. Response to intralesional gamma interferon treatment (injections directly into a keloid lesion) was evident in four patients with lesion size reductions of 50 percent, as well as in the five remaining patients who experienced a 20-40 percent decrease in lesion size. One additional patient in this study was treated with keloid excision prior to intralesional gamma interferon therapy. This patient had no sign of keloid recurrence at 18 weeks. A separate, controlled study had similar results with six of eight evaluable patients experiencing significant reduction in size of keloid lesions compared to placebo treated lesions. Also in this study, a patient was treated with keloid excision prior to intralesional gamma interferon therapy. This patient showed improvement in the gamma interferon treated lesion at one year follow up, while the placebo-treated lesion showed complete recurrence. Gamma interferon is a protein involved in the regulation of the immune system and also has demonstrated an ability to potently down regulate collagen synthesis in a dose-dependent manner. Because of its biological properties and established clinical data, Connective Therapeutics is initially developing gamma interferon for the treatment of atopic dermatitis and keloids. Connective Therapeutics Inc., headquartered in Palo Alto, is focused on the acquisition, development and marketing of products in the areas of rheumatology and dermatology. Ridaura(R) (auranofin), a treatment for rheumatoid arthritis that Connective recently acquired from SmithKline Beecham, is currently being marketed by SmithKline Beecham. Several other products are under development: gamma interferon for the treatment of atopic dermatitis and keloids; betamethasone mousse for the treatment of scalp psoriasis and other scalp dermatoses; ConXn(TM) for the treatment of scleroderma and other fibrotic conditions; and TCR vaccines for the treatment of rheumatoid arthritis and multiple sclerosis. Special Note: This news release contains forward-looking statements, such as Dr. Harkonen's quote, 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 prospectus dated Jan. 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."
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