LA JOLLA, Calif., Aug. 25 /PRNewswire/ -- Advanced Tissue Sciences, Inc.
(Nasdaq: ATIS) and Smith & Nephew plc (NYSE: SNN) reported that statistical
significance was reached for the primary endpoint in their additional clinical
trial of Dermagraft(R) for the treatment of diabetic foot ulcers and that a
Pre-Market Approval (PMA) application has been submitted to the U.S. Food and
Drug Administration (FDA). The data demonstrated that in difficult-to-heal
chronic ulcers, with duration greater than six weeks at the time of screening,
Dermagraft healed significantly more ulcers than the control treatment
(p-value = 0.023).
"We are pleased to report that statistical significance has been reached
in this clinical trial," said Gail K. Naughton, Ph.D., President and Chief
Operating Officer of Advanced Tissue Sciences, Inc. "In addition to data from
this trial, positive feedback from clinicians using the product in
international markets where it is commercially available continues to support
our belief that Dermagraft will provide patients in the United States with an
important alternative to current treatment options."
Dermagraft was applied weekly until the ulcer healed, or up to a maximum
of eight applications. In all other respects, Dermagraft patients and control
patients received the same treatment. Data demonstrating statistical
significance was based on an intent-to-treat analysis of patients with ulcer
duration of greater than six weeks at the time of screening, as specified in
the amended statistical plan.
In the clinical trial, Dermagraft demonstrated significantly improved
healing over conventional treatment. For the primary endpoint of complete
wound closure by twelve weeks, 30% of patients treated with Dermagraft healed
(39/130) compared to 18% of patients receiving control treatment (21/115).
These results, from patients with difficult-to-heal ulcers, were achieved in a
study designed to simulate a real world treatment environment as closely as
possible. While investigators encouraged patients to stay off their feet as
much as they could, the study allowed patients to be ambulatory during
Secondary endpoint data demonstrated that Dermagraft patients also
achieved complete wound closure significantly faster than control patients,
and experienced a significantly higher percentage of wound closure by week
twelve than control patients. Data from the clinical trial will be presented
at an upcoming clinical symposium.
"Diabetic foot ulcers represent a tremendously difficult medical problem
for both patients and the health care system," said Jason R. Hanft, D.P.M.,
FACFAS, Director of the Diabetes Care Center Foot Clinic, South Miami
Hospital. "The trial has demonstrated that Dermagraft can provide patients
with chronic ulcers the opportunity for faster healing even in a real life
setting where strict compliance with non-weight bearing regimens isn't always
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, plc. 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. In addition, the Company is developing
products for cardiovascular applications. For more information on Advanced
Tissue Sciences visit our web site at www.advancedtissue.com.
Smith & Nephew is a global medical device company employing 10,000 people
with operations in 36 countries and established sales in 90 countries. Smith
& Nephew markets technically innovative products principally in the areas of
orthopedics, endoscopy, and wound management to deliver cost effective
solutions, significant physician advantages and real patient benefits. With
the introduction early this year of the Collagenase enzymatic debriding
product, Smith & Nephew is now ranked number one in the global wound
The discussions contained in this press release that are not strictly
historical may be "forward-looking" statements which involve risks and
uncertainties. The Company cannot predict with any certainty that the FDA
will accept its PMA application filing, or that the FDA will ever approve any
such application, or approve it on a timely basis. In addition, if approved,
there can be no assurance that the Company can manufacture commercial
quantities of Dermagraft at a reasonable cost, launch its products within
indicated timeframes, successfully commercialize or significantly penetrate
the market or that it will obtain adequate reimbursement for its products.
These and other risks are detailed in publicly available filings with the
Securities & Exchange Commission including but without limitation to Advanced
Tissue Sciences' Quarterly Report on Form 10-Q for the quarter ended June 30,
2000. 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.