PR from 2004...sound familar?
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 Company�s 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.
