LA JOLLA, Calif., Dec., 21 /PRNewswire/ -- Advanced Tissue Sciences, Inc. (Nasdaq: ATIS) and Smith & Nephew plc (NYSE: SNN) today announced the results of a planned interim analysis of data from a clinical trial of Dermagraft(R) in the treatment of diabetic foot ulcers. These data showed that, although statistical significance was not achieved at the interim analysis, Dermagraft was healing more ulcers than the control treatment at twelve weeks for all patients and healed approximately twice as many ulcers as the control treatment in diabetic foot ulcers having a duration of greater than six weeks. The interim analysis has been presented to the Food and Drug Administration (FDA) and further discussions are planned, particularly on how a strong interaction between ulcer duration and healing (p value = 0.017) should be considered in the clinical trial. These interim data are based on an intent-to-treat analysis. Specifically, the results for the endpoint of complete healing at twelve weeks were as follows: Complete Interim Interim Healing at Intent-to-Treat Intent-to-Treat 12 weeks Dermagraft Control % N % N p-value Patients with ulcers > 6 weeks* 28% 20/72 14% 10/71 0.035 All Patients 30% 27/90 23% 21/92 0.176 * At time of screening; minimum ulcer duration >8 weeks at time of treatment initiation. Gail K. Naughton, Ph.D., President and Chief Operating Officer, stated, "We are particularly encouraged that Dermagraft healed twice as many ulcers as the control group for patients with ulcers greater than six weeks duration, and four times as many ulcers as the control group for patients with ulcers approximately six months in duration. We believe this trial has included a more difficult-to-heal patient population than in our previous diabetic foot ulcer studies as evidenced by the low number of healed ulcers in the control group." As previously reported, the FDA had requested an additional controlled clinical trial be completed for Dermagraft in the treatment of diabetic foot ulcers. In January 1998, an FDA advisory panel in support of an earlier Pre-Market Approval (PMA) application, recommended approval of Dermagraft with the conditions that the Company perform a post-marketing study to confirm efficacy and provide physician training. The FDA subsequently concluded that the PMA application was not approvable without supportive data from an additional clinical trial. Advanced Tissue Sciences is a tissue engineering company utilizing its proprietary core technology to develop and manufacture human-based tissue products for tissue repair and transplantation. The Company has two joint ventures with Smith & Nephew. The first covers the application of Advanced Tissue Sciences' tissue engineering technology for skin wounds and includes Dermagraft(R) for the treatment of diabetic foot ulcers, TransCyte(TM) for the temporary covering of second and third-degree burns and future developments for venous ulcers, pressure ulcers, burns and other non-aesthetic wound care treatments. The second joint venture is developing tissue-engineered orthopedic cartilage, initially focusing on the repair of cartilage in knee joints. The Company also has a strategic alliance with Inamed Corporation for the development and marketing of several of Advanced Tissue Sciences' human-based, tissue-engineered products for aesthetic and certain reconstructive applications. In addition, the Company is developing products for cardiovascular applications. Smith & Nephew is a leading worldwide medical device company with a highly successful track record in developing, manufacturing and marketing a wide variety of innovative and technologically advanced tissue repair products, primarily in the areas of bone, joints, skin and other soft tissue. Smith & Nephew have extensive marketing and distribution capabilities, with an established sales force in more than 90 countries. The discussions contained in this press release that are not strictly historical may be "forward-looking" statements which involve risks and uncertainties. The statistical results reported in this release are based on an interim data analysis of a controlled clinical trial. These results are not necessarily indicative of the results which might be obtained following completion of the full trial. Further, the Company cannot predict with any certainty potential outcomes of its discussions with the FDA which could include limiting subsequent enrollment to patients with ulcer duration in excess of six or more weeks upon entering the screening period, increasing the total number of patients to be enrolled, or analysis of data from this trial in conjunction with data from previous clinical trials of Dermagraft in diabetic foot ulcers, among others. No assurances can be given that the statistical results reported in this release will not be modified, the Company will successfully complete this additional controlled clinical trial of Dermagraft in the treatment of diabetic foot ulcers, the clinical trial will be completed within any specific timeframe, the data from the trial will be statistically significant or otherwise consistent with the results of the Company's earlier clinical trials or that the Company will obtain FDA approval (or that such approval will be obtained on a timely basis). In addition, there can be no assurance that the Company can manufacture commercial quantities of Dermagraft at a reasonable cost, launch its products within indicated timeframes, or successfully commercialize or significantly penetrate the market for any of its products. These and other risks are detailed in the Company's publicly available filings with the Securities & Exchange Commission such as Advanced Tissue Sciences' Annual Report on Form 10-K for the year ended December 31, 1998 and its most recent Registration Statement on Form S-3 filed on July 12, 1999, as amended. The Company undertakes no obligation to release publicly the results of any revision to these forward-looking statements to reflect events or circumstances arising after the date hereof.
SOURCE Advanced Tissue Sciences, Inc.