CITY OF INDUSTRY, Calif., Feb. 23, 2005 (PRIMEZONE) -- U.S. BioDefense (OTCBB:UBDE) is pleased to announce today that it has signed a 90 day option to license European Patent Application No. 02743434.9, and U.S. patent application 10/483,190 entitled "Liver cell progenitor and use for the treatment of liver disease" and related foreign applications with UCL BioMedica Plc., a wholly owned subsidiary of University College London.
U.S. BioDefense will evaluate the hepatic stem cell sorting and enrichment technology, which can be applied to gene therapy and liver re-population technology, and will release more detailed information about the Hepatic Stem Cell technology and potential applications, including gene therapy and re-population in patients with liver disease, immediately after finalizing its evaluation and successful exercise of its option agreement by end of the 2nd Quarter of 2005.
CEO David Chin stated that, "We are pleased to announce to shareholders that the company has entered into an evaluation agreement for the hepatic stem cell sorting and enrichment technology. Currently, researchers are testing a new procedure in which they repopulate the liver with healthy cells for patients with liver disease, especially, acute liver failure. 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."
Patients with acute liver failure, who are those most exposed to shortage of donor organs, may particularly benefit from liver cell transplantation. Data obtained from the European Liver Transplant Registry, show that in the period from 1988 to 1998, 2,615 patients were transplanted for acute liver failure (10% of the total number of patients transplanted in the same period).
The concept of liver regeneration in human adult livers has been revolutionized in the last decades with the discovery of a hepatic stem cell compartment which is able to regenerate hepatocytes and biliary epithelial cells after hepatic injury. Phenotypic and functional characterization of liver cell precursors have therefore become major priorities in the fields of tissue engineering, liver support technology and gene therapy.
The object of the present invention is to establish a system to isolate and expand stem cells which may be used for therapeutic liver re-population in patients with liver disease. It is furthermore our belief that access to autologous or allogeneic hepatic stem cells would allow the development of an "artificial liver".
U.S. BioDefense also recently signed an option license agreement with a major university and is now evaluating 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. 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.
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, 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. The company has published its open source 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).
About University College London
Founded in 1826, University College London (UCL; http://www.ucl.ac.uk) is the Sunday Times University of the Year 2004 and the fourth-ranked U.K. University in the top 500 world universities for 2004 league table produced by the Shanghai Jiao Tong University.
About UCL BioMedica Plc
UCL BioMedica Plc (www.uclbiomedica.com) has been created through the merger of UCL Ventures and Freemedic Plc. UCL Biomedica aims to generate income and create capital value for UCL through the commercial exploitation of the bioscience research base at UCL and its associated Institutes. The company represents the integration of two highly successful technology transfer offices. Founded in 1989, UCL Ventures was established to form the link between academia and industry for the development of scientifically and commercially valuable technologies arising from UCL. UCL Ventures returned over pounds Sterling 15 million to UCL. Freemedic was established in 1993 to commercialize the intellectual property and other rights and opportunities arising primarily from the Royal Free Campus of UCL's Medical School. Freemedic's profits since 1996, all of which have been donated to UCL and utilized for investment in the Royal Free Campus, have exceeded pounds Sterling 15 million.
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.