Healthcare Industry News: Diabetic Foot Ulcer
News Release - April 25, 2006
Ortec Completes Patient Enrollment for Confirmatory Trial Evaluating OrCel(R) in Healing Venous Leg UlcersNEW YORK, April 25 (HSMN NewsFeed) -- Ortec International, Inc. (OTC Bulletin Board: ORTN ), a company focused on development and commercialization of products applicable to regenerative medicine and stem cell therapy, today announced that it has completed patient enrollment of a trial designed to confirm the superiority of cryopreserved OrCelŪ in the healing of difficult to heal venous leg ulcers in comparison to the standard of care therapy.
Upon completion of the 12-week treatment phase for the last patient enrolled, the data of this trial will be analyzed. As described in our clinical trial protocol approved by the Food and Drug Administration (FDA), the primary endpoint efficacy data of the 61 patients enrolled in this trial are intended to be integrated with results of 61 patients from our pivotal trial. The combined results will be analyzed and reported using a Bayesian statistical approach.
The trial is being conducted at ten clinical sites located throughout the United States. As previously announced, the confirmatory trial is being conducted at the recommendation of the FDA to confirm Ortec's pivotal trial results. The primary efficacy endpoint is investigator assessment of 100% wound closure within 12 weeks.
The efficacy data from the 12-week pivotal trial previously submitted as part of Ortec's PMA and which will be integrated with the data of the current trial showed that in typical venous ulcers (those ulcers being evaluated in the current trial), 59% of the OrCelŪ treated patients achieved wound closure versus 36% of the patients who received the standard of care treatment (p=0.034), as well as a statistically significant differential in the rate of healing (p<0.0001).
Ron Lipstein, Vice Chairman and CEO of Ortec, commenting on the completion of patient enrollment, said, "Now that we have enrolled all the required patients, we look forward to completing the 12-week treatment phase and at that time being able to analyze the combined clinical results and, thereafter, submit our PMA supplement to the FDA."
About Ortec International, Inc.
Ortec International, Inc. (ORTN) is a company focused on advancing regenerative medicine and stem cell therapy through the development and commercialization of innovative products by combining advanced cell technology and advanced biomaterials. Ortec's lead product is OrCelŪ (Bilayered Cellular Matrix). Ortec's current focus is the application of OrCelŪ to heal chronic and acute wounds, such as venous leg ulcers and Diabetic Foot Ulcers. OrCelŪ is composed of a collagen sponge seeded with allogeneic epidermal and dermal cells. These cells secrete growth factors and cytokines normally found in acute human wounds and are believed to have a beneficial role in promoting tissue repair.
A pivotal clinical trial evaluating a cryopreserved version of OrCelŪ in the treatment of venous leg ulcers has been completed and a Pre Market Approval (PMA) application has been filed. Ortec has recently completed patient enrollment in a confirmatory trial and the data from this trial is expected to be integrated with the results of the pivotal clinical trial and submitted as a clinical supplement to its PMA filing. Ortec has already obtained FDA approvals for use of a non-frozen version of OrCelŪ in the treatment of Epidermolysis Bullosa and donor sites in burn patients. In addition, the FDA has granted Ortec approval to initiate a pivotal (Phase III) trial evaluating OrCelŪ for the treatment of Diabetic Foot Ulcers.
Ortec recently acquired two fibrin derived advanced biomaterial technologies, Fibrin Micro Beads (FMB's) and Haptides(TM). FBM's have the potential to play a significant role in advancing stem cell therapy, having demonstrated the ability to efficiently recover adult stem cells and allow for their growth, proliferation, and potential reimplantation into the patient. Haptides(TM) utilize proprietary synthetic peptides that mimic the mechanism of cell attachment to fibrin. These peptides have demonstrated the ability to significantly enhance cell attraction and attachment, providing the potential to use Haptides(TM) in the development of product opportunities applicable to the cosmetic tissue augmentation, wound healing, orthopedics, and drug delivery markets.
For more information, visit Ortec's website at http://www.ortecinternational.com .
This news release may contain "forward-looking statements" for the purposes of the United States Securities and Exchange Commission's "safe harbor" provisions under the Private Securities Litigation Reform Act of 1995 and Rule 3B-6 under The Exchange Act. Without limitation, statements regarding expected FDA approvals, clinical trial results, product performance, expectations with respect to sales, gross margins, research and development expenditures, earnings per share, capital expenditures, collaborations, or other expansion opportunities would be "forward-looking statements." These statements may be identified by words such as "expects," "anticipates," "intends," "estimates," "believes" or similar expressions in connection with any discussion of future financial and operating performance. The forward- looking statements contained herein involve risks and uncertainties that may cause results to differ materially from the Company's expectations, including, but not limited to, global economic trends, competitive pricing or product developments, government legislation and/or regulations, technology, manufacturing, legal and patent issues, suppliers, capital availability, personnel changes, cancellation or delays in renewal of contracts, and lack of suitable raw materials or packaging materials. Investors are cautioned to review risk factors in the Company's filings with the United States Securities and Exchange Commission.
Source: Ortec International
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