Wednesday August 5, 9:05 am Eastern Time
Company Press Release
Ortec to Begin Donor Site and Venous Ulcer Trials
NEW YORK--(BW HealthWire)--Aug. 5, 1998--Ortec International, Inc. (NASDAQ:ORTC - news) announced today that it will begin to enroll
patients in its venous ulcer clinical trial in September. Enrollment of patients is subject to approval by the IRB(Internal Review Board) of the
clinical sites and such approvals are expected to be received shortly.
This pilot trial will enroll up to 40 patients at three clinical sites and these patients will be followed for six months after wound closure. Ortec
expects to complete patient enrollment by the first quarter of 1999. Subject to FDA approval, Ortec intends to initiate patient enrollment in a
pivotal trial by the first quarter of 2000.
During the course of the initial 40 patient study, Ortec will focus on refining its clinical end points and trial design to achieve a well characterized
patient group so that the clinical data generated during the pivotal study will clearly demonstrate clinical efficacy with statistical significance and
cost effectiveness in comparison to standard therapies.
Steven Katz, Ph.D., CEO of Ortec, commenting on the commencement of the venous ulcer trial said, ''Taking the time before implementing
pivotal trials to do things correctly, to ensure quality data and deliver a user friendly, cost effective product will distinguish Ortec and avoid the
potential difficulties which have occurred with similar products in the PMA process and the marketplace.'' Commenting further, he said, ''It's
quite gratifying that Ortec has reached the significant milestone of initiating a clinical trial for venous ulcers. Venous ulcers, by any measure,
represent a significant patient population with unmet medical needs. Ortec is executing a clinical trial strategy which will position CCS as the
therapy of choice in the treatment of venous ulcers.''
Ortec also announced progress regarding its donor site wound trial. In December 1997, Ortec was granted allowance to initiate a pilot trial in
donor sites, however, patients were not enrolled. Management contemplated, based on previous experience with CCS used on donor sites in
Epidermoloysis Bullosa(EB) patients, to apply for a pivotal study. Management has now elected to, in fact, pursue the pilot trial.
The decision to pursue a pilot study was made so that clinical data generated will have the highest probability of supporting product approval,
ensuring rapid market adoption and supporting reimbursement of CCS.
Ortec expects to start enrolling patients in the donor site trial at a new clinical site, subject to the site's IRB approval, during August. The pilot
study is expected to include eight patients who are planned to be followed for one month post application.
Ortec expects, subject to FDA approval, to initiate a pivotal donor site wound trial during the first quarter of 1999. The pivotal study is expected
to include five clinical sites and be completed by the fourth quarter of 1999, which would allow Ortec to submit its PMA by the second quarter of
2000, which is in line with Ortec's previously projected product launch date.
Regarding the donor site wound trial, Dr. Katz said, ''Effective treatment and closure of donor site wounds is critical in a wide range of patients
and Ortec believes, based on previous experience of CCS on donor site wounds, that CCS will play a leading role in addressing the medical
needs of this significant patient population.''
Ortec International is a biotechnology company involved in the development of proprietary and patented technology to stimulate the repair and
regeneration of human tissues, such as skin. Ortec's technology consists of a patented biologically active dressing(CCS) consisting of a
bioengineered bovine collagen matrix seeded with epidermal and dermal cells. Ortec believes that CCS may have wide commercial
applications for the treatment of venous and diabetic skin ulcers, serious skin diseases, such as Epidermolysis Bullosa(EB), burns, as well as
for reconstructive and cosmetic surgeries.
Certain statements made in this press release which express the ''belief'', ''anticipation'' or ''expectation'', as well as other statements which
are not historical fact, and statements relating to the clinical trials and their results, design, features, functionality and performance insofar as
they may apply prospectively, are forward-looking statements within the meaning and pursuant to the Safe Harbor Provisions of the Securities
Litigation Reform Act of 1995 and involve risks and uncertainties. The Company's actual results may differ significantly from the results
discussed in this release or in other forward-looking statements presented by management. Factors that might cause such a difference include
but are not limited to, development by the Company's competitors of new technologies or products that are more effective than the Company's,
risks of failure of clinical trials, dependence on and retention of key personnel, protection of proprietary technology, compliance with U.S. Food
and Drug Administration regulations, continued availability of raw material for the Company's products, availability of product liability insurance
in the event of commercialization of the Company's products, ability to effect transition from pilot-scale manufacturing to large-scale commercial
production of products, uncertainty as to the availability of additional capital on acceptable terms, if at all, and the demand for the Company's
products, if and when commercially available.
Contact:
Ortec International, Inc., New York
Ron Lipstein, 212/740-6999
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