Austrianova Pivotal clinical trial gets go ahead from EMEA

Novel cell therapy for the treatment of pancreatic cancer to be tested in 200 patients

Vienna (PRWEB) September 19, 2004 -- The Viennese biotech company, Austrianova, has just moved one step closer to a pivotal clinical trial for pancreatic cancer. The Companys novel, cell based orphan medicinal product, NovaCaps® received a positive decision from the European Medicines Evaluation Agency (EMEA) during protocol assistance for the design of the pivotal clinical study, ensuring that data generated by the trial will be suitable for market authorization. We are very pleased with the outcome of the protocol assistance procedure. This represents a major step forward towards our goal of bringing a new therapy for pancreatic cancer to the market" said Brian Salmons, Managing Partner for Science and Technology, Austrianova.

The two armed phase III trial will be a randomised, multi-centre, international, open label clinical study evaluating the survival advantage for patients with inoperable pancreatic carcinoma pre-treated with encapsulated, cytochrome P450/2B1 expressing cells that locally convert ifosfamide into tumour toxic metabolites as compared to gemcitabine (Gemzar®), the current standard therapy. The trial is scheduled to commence in the second half of 2005 with around 200 patients from a number of European clinical centres being involved. Currently, Austrianova is developing the worldwide first production of this novel advanced cell therapy medicinal product required for these trials and for future marketing activities. In the coming months, Austrianova will select multiple clinical centres throughout Europe for the trial. If the endpoints are achieved, market authorization may be a reality in 2008.

About Austrianova
Austrianova is a biotech company located in Vienna, Austria. The Company was founded in December 2001 by Thomas Fischer, Walter H. Günzburg and Brian Salmons as a privately owned, independent, biotech company in Vienna, Austria. The company is located within the Research Institute for Virology and Biomedicine at the University of Veterinary Medicine in Vienna. As of September 2004, the Company, together with the Research Institute employs a staff of 66.

Austrianova's lead product, NovaCaps®, is a cell based therapy for the treatment of pancreatic cancer. This product was designated an Orphan Medicinal Product by the European Medicines Evaluation Agency at the end of June, 2003 (Orphan medicinal product EU/3/03/149; designation date 30/06/2003) as well as being the first of a new category of therapeutic i.e. an Advanced Therapy Medicinal Product. The company plans a pivotal clinical trial for this product to commence in 2005.

The Company also develops novel therapies for the treatment of other solid tumours. In addition, the company has a number of proprietary gene product delivery systems, many of which are based on retrovirus vectors. These unique vector systems are safer and more controllable than other systems and can be applied for use in gene therapy, biomolecule production and research.

About pancreatic cancer
Pancreatic cancer is a highly aggressive tumor which is often discovered quite late and grows extremely rapidly. The mean life expectancy is around six months from the time of diagnosis. The five year survival rate is less than 5% for pancreatic cancer (as compared to 62% for all cancers) according to the American Cancer Society. Approximately 45,000 new cases of pancreatic cancer occur each year in Europe.

Contact:
Brian Salmons, Managing Partner: Science and Technology
Thomas Fischer, Managing Partner: Finance and Adminjstration
Renate Moser, Business Development
Walter Tabotta, Clinical Trials
Tel. +43-1-25077-2601
www.austrianova.com
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