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.
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http://www.prnewswire.com/comp/532975.html or fax,
800-758-5804, ext. 532975
CONTACT:
Jana Stoudemire, Senior Director, Corporate
Communications of Advanced Tissue Sciences, Inc., 858-713-7802
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