LA JOLLA, Calif., Aug. 5 /PRNewswire/ -- Advanced Tissue Sciences, Inc.
(Nasdaq: ATIS) reported today the U.S. Food and Drug Administration (FDA) has
granted approval of its application for an Investigational Device Exemption
(IDE) for an additional clinical trial of its Dermagraft(R) human dermal
replacement product for the treatment of diabetic foot ulcers. Based on the
clinical plan, additional data as requested by the FDA to support a premarket
approval (PMA) application for Dermagraft could be available for submission as
early as twelve months after trial initiation, assuming such data are
consistent with the previous PMA submission for Dermagraft. The Company also
stated the selection and qualification of clinical centers was close to
completion and that patient enrollment would begin immediately following
institutional approvals of the study.
"The Company worked closely with the FDA in developing the protocol and
statistical plan that were submitted in the IDE," said Gail K. Naughton,
Ph.D., President and Chief Operating Officer of Advanced Tissue Sciences, Inc.
"The trial is to include up to thirty centers and provides for an interim
analysis of the data after the enrollment of 180 patients (90 per arm). If
the healing rates shown in the interim analysis are equivalent to the results
of the earlier pivotal trial, we estimate that a PMA application could be
submitted to the FDA within twelve months of trial initiation."
Dr. Naughton added, "Structuring the trial with an interim analysis allows
us the flexibility to stop the trial based on the interim analysis or, if
necessary, to go forward and promptly complete the entire trial. We believe
this additional trial, taken together with a Treatment IDE as recommended by
the FDA, will further strengthen the clinical support for Dermagraft and, if
successful, will serve to expeditiously bring our second product to the U.S.
market."
Kenneth R. Heilbrunn, M.D., Executive Director, Clinical Research, noted,
"The study will have the same primary endpoint -- complete wound closure by
twelve weeks -- used in the previously conducted pivotal trial. Unlike the
previous trial, thirty-two week follow-up will not be required. An interim
analysis will be performed after the first 180 patients have completed the
trial. Showing statistical significance on an intent-to-treat basis at the
interim analysis would allow us to submit an application for approval at that
time and stop further study enrollment. Otherwise, as specified in the IDE,
the trial will continue until 330 patients (165 per arm) have been enrolled."
The Company has estimated that, if necessary, data from all 330 patients could
be available for submission to the FDA approximately eighteen months after
trial initiation.
As previously announced, the FDA requested the additional controlled
clinical trial be completed in support of the Company's PMA application for
Dermagraft in the treatment of diabetic foot ulcers. The PMA application was
based on the results, retrospectively identified, of a subset of patients in a
controlled pivotal clinical trial who had received Dermagraft within a
specified therapeutic range. In January 1998, an FDA advisory panel
recommended approval of Dermagraft with the condition that the Company perform
a post-marketing study to confirm efficacy and provide physician training.
Nonetheless, the FDA concluded the PMA application was not approvable without
supportive data from an additional clinical trial.
Dr. Naughton further reported, "With the approval of the clinical trial
plan, we now intend to pursue an application for a Treatment IDE for
Dermagraft in the treatment of diabetic foot ulcers as suggested by FDA.
Approval of the Treatment IDE would give us the opportunity to provide
Dermagraft to leading physicians and patients in need while we gather the
prospective data requested by the FDA." A Treatment IDE is a regulatory
provision for devices that permits companies to make available promising new
products under an agreed clinical protocol to patients with serious diseases
for which there is no satisfactory alternative.
Advanced Tissue Sciences 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, 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 matters discussed in this press release involve risks and
uncertainties. In particular, the Company will need to successfully complete
an additional controlled clinical trial of Dermagraft in the treatment of
diabetic foot ulcers and submit a revised premarket approval application to
the FDA. No assurance can be given that the Company will successfully
complete the additional clinical trial, the clinical trial will be completed
within any specific timeframe, that the data from the trial will be
statistically significant or otherwise consistent with the results of the
Company's earlier pivotal trial or that the Company will obtain FDA or other
regulatory approvals of Dermagraft (or that any such approvals will be
obtained on a timely basis). In addition, there can be no assurance the
Company can successfully scale up manufacturing processes, launch its products
within reasonable timeframes, obtain reimbursement for, or successfully
commercialize any such products. These and other risks are detailed in the
Company's publicly available filings with the Securities and Exchange
Commission including the Company's Annual Report on Form 10-K for the year
ended December 31, 1997. Actual results may differ materially from those
currently anticipated as a result of such risks.
SOURCE Advanced Tissue Sciences, Inc.
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Company News On-Call: http://www.prnewswire.com or
fax, 800-758-5804, ext. 532975
CONTACT:
Jack D. Strube, Executive Director, Finance,
619-450-5802, both of Advanced Tissue Sciences, Inc.
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