CITY OF INDUSTRY, Calif., Jan. 25, 2005 (PRIMEZONE) -- U.S. BioDefense (OTCBB:UBDF) is pleased to announce today that it has signed an option license agreement with a major university and will now evaluate an adult stem cell sorting and enrichment technology, which can be applied to gene therapy and bioengineered skin technology, which is a $1 billion market today according to sources. More detailed information about the Adult Stem Cell technology and potential applications, including gene therapy and engineering tissue grafts, will be released immediately after finalizing its evaluation and successful exercise of its option agreement by June 2005.
CEO David Chin stated that, "We are pleased to announce to shareholders that the company has entered into an evaluation agreement for this adult stem cell sorting and enrichment technology. Currently, researchers at a major university are testing a new procedure in which they use the technology and can take a tiny piece of a person's mouth lining, grow it into a dollar-bill sized piece of tissue and graft that expanded piece into the donor's mouth to heal a wound. There is also an expanded interested in potentially modifying the approach to infuse the piece of tissue with gene therapy compounds, meaning the implanted tissue might help a person with such chronic or systemic illnesses like diabetes or hemophilia."
According to a recent published article, a team of doctors at a major university are currently working with five patients to treat small mouth wounds with the grafts. These five patients are part of a proof of concept study for the Food and Drug Administration. That is the precursor to moving into the trials that inform an FDA decision to approve a new medical treatment. Following successful completion of the preliminary trial, researchers plans to seek FDA approval for a larger clinical trial involving 50 patients. The researchers are collaborating with a scientist and surgeon who already have seen success with the method in about 80 patients in Japan. This research is supported in part by a $1.25 million grant from the National Institute of Dental and Craniofacial Research, part of the National Institutes of Health.
Many types of people have trouble with mouth wounds that do not heal well on their own-patients going through cancer chemotherapy, for example, or people with diabetes. Those who have been involved in accidents are candidates, as well. Existing treatments include taking a skin graft from a site such as a leg and stitching it into the mouth. Skin works for covering the wound, but is not as pliable as the mucosal lining of the mouth, and if it is too thick, it might even grow hair inside the mouth. A large skin graft also leaves the patient in pain with lengthy healing time.
Tissue engineering has many advantages, including a smaller donor site that heals faster and a graft that is mucosal cells, more like the mouth lining, not skin. After a short healing period, the patient feels mouth lining as it is supposed to feel. Eventually, researchers hope to see the treatment used not only for small mouth wounds but for major reconstructive surgery where the patient cannot physically donate enough tissue for repairs.
About U.S. BioDefense, Inc.
U.S. BioDefense is a Department of Defense central contractor that researches, develops, and commercializes leading-edge biotechnology. U.S. BioDefense recently announced that it had filed its Small Business Innovation Research (SBIR) Grant proposal Number C051-117-0060 with the Department of Defense Chemical Biological Defense Agency in response to SBIR (dodsbir.net) Topic number CBD05-117 'Stem Cell Technology And Autologous Bioengineered Skin For The Treatment of Cutaneous Vesicant Injury'. U.S. BioDefense recently sponsored the Project T2 Technology Transfer Conference, the nation's leading showcase of new university technologies, being hosted at the Wilshire Grand Hotel in Los Angeles, CA. Other sponsors (http://www.projectt2.org/sponsors.htm) include Southern California Edison, Latham & Watkins, Morrison & Foerster, PricewaterhouseCoopers, Canadian Consulate General, and Genzyme. U.S. BioDefense, Inc. recently entered into a Commercial Evaluation License Agreement with the National Institutes of Health (NIH). The biotechnology is related to a method for universal inactivation of viruses, parasites and tumor cells. These inactivated agents can be used as vaccines against the diseases caused by such viruses, parasites and tumor cells. Hence, the immunogenic of the agent as a whole is maintained and can be safely used for vaccination without the threat of infection. U.S. BioDefense, Inc. intends to conduct laboratory experiments under this Agreement to evaluate the suitability for commercial development. Furthermore, U.S. BioDefense, Inc. has agreed to provide the facilities, personnel, and expertise to evaluate the commercial applications. NIH's bioterrorism the company has now set the deadline of February 1st for publishing its white paper on Stem Cell technology transfer, analyzing California University and industry participants intellectual property resources including ViaCell (Nasdaq:VIAC), Geron (Nasdaq:GERN), Aastrom Biosciences (Nasdaq:ASTM), and StemCells, Inc. (Nasdaq:STEM).
Safe Harbor Statement Forward-Looking Statements
Included in this release are certain "forward-looking" statements, involving risks and uncertainties, which are covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the U.S. BioDefense's financial performance. Such statements are based on management's current expectations and are subject to certain factors, risks and uncertainties that may cause actual results, events and performance to differ materially from those referred to or implied by such statements. In addition, actual future results may differ materially from those anticipated, depending on a variety of factors, including continued maintenance of favorable license arrangements, success of market research identifying new product opportunities, successful introduction of new products, continued product innovation, the success of enhancements to the U.S. BioDefense's brand image, sales and earnings growth, ability to attract and retain key personnel, and general economic conditions affecting consumer spending, including uncertainties relating to global political conditions, such as terrorism. Information with respect to important factors that should be considered is contained in the U.S. BioDefense's Annual Report on Form 10-K as filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The U.S. BioDefense does not intend to update any of the forward-looking statements after the date of this release to conform these statements to actual results or to changes in its expectations, except as may be required by law.