ATIS news:
Thursday August 26, 1:57 pm Eastern Time
Company Press Release
SOURCE: Advanced Tissue Sciences, Inc.
Data Indicate that Dermagraft Stimulates Blood Vessel Formation
LA JOLLA, Calif., Aug. 26 /PRNewswire/ -- Advanced Tissue Sciences, Inc. (Nasdaq: ATIS - news) announced that data were presented at The European Tissue Repair Society in Bordeaux, France, indicating that Dermagraft® stimulates new blood vessel formation, or angiogenesis, both in the laboratory and in diabetic foot ulcer patients. Adequate blood flow to damaged tissue is a vital part of the wound healing process. These studies are consistent with data previously reported by the Company investigating Dermagraft's role in wound healing and its potential for inducing new blood vessel formation.
Scientists and clinicians working in the Section of Vascular Medicine and Biology and the Diabetes Centre at University of Dundee Medical School, Scotland, presented, ''Blood Flow Changes in Diabetic Foot Ulcers Treated with Dermagraft.'' In their study they observed approximately a 75% increase (p<0.001) in blood flow at the base of diabetic foot ulcers treated for eight weeks with Dermagraft. Five of the seven wounds studied had healed by twelve weeks, and the other two had markedly reduced in size. The increase in blood flow was measured using laser Doppler imaging to study microvascular passage of blood at the base of the foot ulcers. The group indicated that the improvement in blood flow may reflect angiogenesis in the healing wound, possibly enhanced by a sustained and appropriate supply of angiogenic growth factors provided by Dermagraft.
Scientists from the Wound Healing Research Unit, University of Wales College of Medicine, Cardiff, presented data showing that human vascular endothelial cells co-cultured with Dermagraft increased the release of specific proteins believed to be important in angiogenesis. Vascular endothelial cells are cells which line the interior of blood vessels. Specifically, it was reported that Dermagraft significantly influenced the expression of VE (vascular endothelial) cadherin and beta catenin.
Dr. David Newton, Ph.D., Research Fellow in Vascular Medicine and Biology at University of Dundee Medical School, commented, ''Angiogenesis is a vital part of the wound healing process in diabetic foot ulcers and requires a finely balanced environment for success. An advantage of Dermagraft is that it may help maintain that balanced environment.'' Professor Keith Harding, MB, MRCGP, FRCS, Professor of Rehabilitation Medicine (Wound Healing) at Cardiff, added, ''In developing new technologies for the treatment of chronic wounds, it is important to understand their mechanism of action. The results from my own group and those in Dundee, taken together, may help explain in the laboratory, as well as in the patient, one crucial component of the potential benefit offered by Dermagraft.''
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® 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. The Company is also developing products for cardiovascular applications.
The discussion contained in this press release relating to research, development, or commercialization of the Company's products involves certain risks and uncertainties. In particular, the Company will need to successfully complete an additional controlled clinical trial for Dermagraft in the treatment of diabetic foot ulcers and submit a revised premarket approval application to the FDA prior to commercially marketing Dermagraft for that indication. The Company may not successfully complete the additional clinical trial, the clinical trial may not be completed within any specific timeframe, the data from the trial may not be statistically significant or otherwise consistent with the results of the Company's earlier pivotal trial. The Company may not obtain FDA or other regulatory approvals of Dermagraft or any other products at all or on a timely basis, scale up manufacturing processes, or successfully commercialize any such products. These and other risks are detailed in publicly available filings with the Securities and Exchange Commission such as the Company's Annual Report on Form 10-K for the year ended December 31, 1998 and the Company's most recent Registration Statement on Form S-3 filed on July 12, 1999, as amended. Actual results may differ materially from those currently anticipated as a result of such risks.
SOURCE: Advanced Tissue Sciences, Inc.
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