Connetics Announces Phase III Results of Gamma Interferon for Atopic Dermatitis.PALO ALTO, Calif.--(BW HealthWire)--Aug. 27, 1997--Connetics Corporation (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) announced today that based on the results of a 555 patient Phase III trial, it has suspended plans to submit a Biological License Application (BLA) for gamma interferon for the treatment of atopic dermatitis. The Company, which has one product on the market and three compounds in late-stage clinical trials, stated analysis of the study did not show an acceptable therapeutic response with respect to the primary clinical endpoint -- a composite clinical severity index 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). "Naturally, we are disappointed with these results, but this program was conducted quickly and efficiently to evaluate gamma interferon's viability as a therapeutic option for atopic dermatitis," stated Thomas G. Wiggans, president and chief executive officer of Connetics. "We are committed to meeting our objectives with our late-stage programs, including the evaluation of the Phase II gamma interferon keloid keloid /ke·loid/ (ke´loid) a sharply elevated, irregularly shaped, progressively enlarging scar due to excessive collagen formation in the dermis during connective tissue repair. trial." Connetics has recently reported positive clinical results on two of its product candidates, including Phase III data on a novel mousse formulation of 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 for the treatment of psoriasis, for which the Company expects to file a new Drug Application in the first quarter of 1998. In addition, Connetics reported positive Phase II results on 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 scleroderma, a life-threatening condition that affects over 300,000 Americans and for which there is currently no marketed treatment available. Connetics Corporation, 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 acquisition, development and marketing of products in the areas of rheumatology and dermatology. The Company currently markets Ridaura(R) (auranofin), a treatment for rheumatoid arthritis, acquired from SmithKline Beecham. Several products are under development: betamethasone mousse for the treatment of scalp psoriasis and other dermatoses; gamma interferon for the treatment of 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. ; ConXn(TM) (relaxin) for the treatment of scleroderma and other fibrotic conditions; and TCR TCR T cell receptor. vaccines for the treatment of rheumatoid arthritis and multiple sclerosis. -0- Special Note: The second and third paragraphs of this news release contain 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, potential delays in filing its planned NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any , and risks associated with product development. These and other factors are discussed in more depth in Connetics' Form 10-K for the year ended December 31, 1996 under the heading "Additional Factors That May Affect Future Results." CONTACT: Connetics Corp. Cynthia M. Butitta, 650/843-2800 or Burns McClellan Audra Nass, 650/352-6262 Reagan Codner, 212/213-0006 |
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