LA JOLLA, Calif., July 28 /PRNewswire/ -- Advanced Tissue Sciences, Inc.
(Nasdaq: ATIS), announced today the issuance of a U.S. patent covering three
dimensional tissue products made with genetically modified cells for gene
therapy applications. Under the technology described in the patent
(U.S. Patent No. 5,785,964), genetically modified tissues can be grown on a
biocompatible scaffold using genetically engineered stromal cells, genetically
engineered parenchymal cells or both. The patent comprises both product and
method of use claims, and is the first to issue in a series of patents filed
by Advanced Tissue Sciences in the area of gene therapy. Genetically modified
tissue products may provide a safe, unique delivery vehicle for therapeutic
proteins. The patent is not restricted to the use of any specific gene
product, vector, promoter or regulator. Advanced Tissue Sciences intends to
seek strategic alliances with corporate partners to commercialize this
technology.
This patent is an extension of Advanced Tissue Sciences' broad core patent
covering the growth of three dimensional tissue products grown on a
biocompatible scaffold. As with the Company's core technology, genetically
modified cells would be seeded onto a biocompatible scaffold, allowed to
attach, grow and divide, depositing matrix proteins and forming into a three
dimensional tissue capable of secreting therapeutic proteins to correct a
disease. Advanced Tissue Sciences' genetically engineered tissues may provide
a unique delivery vehicle to the gene therapy industry for such indications as
hemophilia (Factor VIII), short stature (growth hormone), anemia
(erythropoietin), cancer or cardiovascular disease.
"Tissue engineering may provide a safe and effective means of delivering
therapeutic proteins to patients using state of the art gene therapy
techniques," said David Horwitz, M.D., Ph.D., Senior Vice President of
Technology at Advanced Tissue Sciences. "Delivering genes in three
dimensional tissue may allow long-term expression in vivo by providing an
environment for the cells that is more similar to that found in the body.
Obtaining long-term expression is one of the key technical hurdles that the
gene therapy industry is facing today."
Since 1990, over 300 clinical protocols have been initiated worldwide
using currently available gene therapy techniques. Although gene therapy has
been recognized as a revolutionary way to treat disease, progress has been
slow due to the many challenges associated with gene delivery and in obtaining
long-term expression in vivo (inside the body). Research to date utilizing
the newly-patented approach has shown expression of the genetically engineered
protein for up to 150 days in vivo.
"We are very pleased with this broad patent relating to genetically
modified tissue products using a three dimensional scaffold," said Gail K.
Naughton, Ph.D., President and Chief Operating Officer of Advanced Tissue
Sciences. "We believe it could represent an important alternative to current
in vivo and ex vivo gene therapy approaches by providing off-the-shelf
products that can deliver therapeutic proteins in a controlled manner."
Advanced Tissue Sciences, Inc. is a tissue engineering company utilizing
its proprietary core technology to develop and manufacture human tissue
products for tissue repair and transplantation. The Company currently has two
products on the market, Dermagraft-TC(R), a temporary covering for full and
partial-thickness burns, and Dermagraft(R), a living, permanent dermal
replacement for the treatment of diabetic foot ulcers (currently available in
Canada and the United Kingdom). The Company is pursuing the worldwide
commercialization of Dermagraft through a fifty-fifty joint venture with Smith
& Nephew plc. The joint venture includes the worldwide development and
marketing of Dermagraft and Dermagraft-TC, and future product developments for
diabetic, venous and pressure ulcers, burns and other skin wounds. Advanced
Tissue Sciences has retained rights to market Dermagraft-TC for burns in the
United States. In addition to Dermagraft and Dermagraft-TC, the Company is
also developing products for cartilage and cardiovascular applications.
The discussion contained in this press release relating to the development
and commercialization of products involves risks and uncertainties. No
assurance can be given that the patents referred to in this release or any
other patents of Advanced Tissue Sciences will afford protection against
competitors with similar technologies or processes, that any such patents will
not be infringed upon or designed around by others, that the Company will be
successful in developing products based on such technology, seeking alliances
with corporate partners to commercialize such technology, completing clinical
trials, obtaining regulatory approvals of any such products (or that any such
approvals will be obtained in a timely basis), scale up manufacturing
processes, or otherwise commercializing or significantly penetrating the
market for any of its products. These and other risks are detailed in the
Company's publicly available filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K. Actual results may
differ materially from those currently anticipated as a result of such risks.
SOURCE Advanced Tissue Sciences, Inc.
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fax, 800-758-5804, ext. 532975
CONTACT:
Jack Strube, Executive Director, Finance,
619-450-5802, or Dawn Applegate, Ph.D, Senior Manager, Medical
Affairs, 619-450-5724, both of Advanced Tissue Sciences, Inc.
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