Connetics completes patient enrollment in three separate clinical trials; rapid pace of enrollment is achieved.PALO ALTO, Calif.--(BW HealthWire)--May 12, 1997--Connetics Corporation (formerly 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) announced today that patient enrollment is complete for three clinical trials, including 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 scalp psoriasis, gamma interferon for 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. and a therapeutic vaccine for multiple sclerosis. Data from these trials are expected in the fourth quarter of 1997. "Each of these trials was enrolled very rapidly, indicating investigator and patient enthusiasm for these therapies," said W. Scott Harkonen, M.D., senior vice president, product development and operations, for Connetics Corporation. The betamethasone mousse 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. , multicenter, Phase III trial enrolled 190 patients with scalp psoriasis in less than one month. Scalp psoriasis affects approximately three million Americans, with over 1.2 million patients in treatment at any one time. This novel foam formulation has been designed to achieve rapid and targeted penetration of betamethasone to the disease site. If the Phase III trial is successful, the Company plans to submit a New Drug Application for betamethasone mousse to the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) in 1998. The Company has also completed enrollment of a 40-patient placebo-controlled, randomized, multicenter 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 gamma interferon in keloids, fibrotic growths, which affects approximately 3 million Americans, that result from an abnormal healing response in the skin. The trial is designed to evaluate the effectiveness of intralesional gamma interferon treatment to prevent the recurrence of 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. lesions following surgical excision. As previously announced, enrollment has also been completed for a Phase III trial with gamma interferon for the treatment of atopic dermatitis. Data from this trial are expected by the end of the year. The T-cell receptor (TCR TCR T cell receptor. ) vaccine multicenter Phase I/II clinical trial enrolled 100 patients with multiple sclerosis to evaluate safety and immunogenicity. The vaccine is being developed to elicit a heightened immune response against the pathogenic T-cells believed to cause multiple sclerosis. "Connetics has now completed enrollment of our major clinical trials -- two Phase III and three Phase II -- and our goal is to complete all of these trials and announcing results before year end," said Thomas G. Wiggans, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Connetics. 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. Ridaura (auranofin) is a treatment for rheumatoid arthritis that Connetics acquired from SmithKline Beecham. Several 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 (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 and other fibrotic conditions; and TCR vaccines for the treatment of rheumatoid arthritis and multiple sclerosis. In March 1997, the Company's board of directors approved a change in the Company's name to "Connetics Corporation," which is subject to approval by the Company's stockholders at its annual meeting on May 14, 1997. -0- Special Note: The third and seventh 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 and risks associated with product development. These and other factors are discussed in more depth in Connective's (also known as Connetics) Form 10-K for the year ended December 31, 1996 under the heading "Additional Factors That May Affect Future Results." CONTACT: Connetics Corporation Cynthia M. Butitta, 415/843-2800 or Burns-NY Reagan Codner (IR), 212/505-1919 or Burns-SF Audra Nass (Media), 415/352-6262 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion