Coverage in the September issue of Journal of Clinical Investigation

Hanover, September 08, 2005: Figures from the World Health Organization are horrifying: 2 billion people are infected, each year 5 million new people contract tuberculosis (TB), 2 million die – and the figures are growing.

A German research group at the Max Planck Institute for Infection Biology in Berlin has succeeded in incorporating a new gene into the DNA of the world's standard tuberculosis vaccine BCG. As reported in the September issue of the Journal of Clinical Investigation (JCI), the new vaccine includes a pore-forming protein, which rips a hole into the macrophage membrane (phagocyte), thus revealing the BCG cells to the immune system. In preclinical trials, the researchers found that the new vaccine offers better protection against pulmonary tuberculosis and even against the feared clinical isolates of the Beijing type than the BCG vaccine used today.

Vakzine Projekt Management GmbH (VPM) has already at an early stage secured the global license for this highly promising vaccine candidate. VPM's corporate activities focus on managing the development of vaccines for which there is high medical need, as well as the commercialization of the results of development project. Dr. Leander Grode, VPM's Project Manager for the tuberculosis project, estimates the annual market potential for an improved TB vaccine at EUR 500 to 800 million. "An effective tuberculosis vaccine is highly interesting – not just for US and UK pharmaceutical companies. In particular companies from India, Korea or the former GUS states develop and sell tuberculosis drugs and are interested in new and better vaccines, as the silent disease, which at the end of the day is deadly, has been raging in these countries for years."

The company has been able to win a highly competent partner, BioProtect Research GmbH in Cuxhaven, for process development and manufacturing of study medication for preclinical and clinical trials taking into account so-called good manufacturing practice – the high quality standards set by the US FDA. Preclinical trials are scheduled to start in fall of 2005. The start of clinical phase I is scheduled for mid 2006. For clinical phase II, VPM aims to enter into strategic alliances with pharmaceuticals companies or find venture capital investors in order to secure financing and to accelerate development of the project, in Germany and abroad.

About VPM:
VPM (Vakzine Projekt Management GmbH, Hannover, www.vakzine-manager.de) organizes the preclinical and clinical development of vaccines and other immunologically active products on behalf of GBF (Gesellschaft für Biotechnologische Forschung, Braunschweig – German Biotechnology Research center) and is funded by BMBF (Bundesministerium für Bildung und Forschung – German Federal Ministry of Education and Research). VPM´s shareholders are the management, the non-profit foundation Deutsche Stiftung Impfstoffforschung (German Vaccine Foundation, Hannover) and the non-profit development association of the GBF, Braunschweig.

Contact:
Dr. Kay Baden Member of the Executive Board Kirchhoff Consult AG Ahrensburger Weg 2 22359 Hamburg Phone: ++49 (0)40 609 186 39 baden@kirchhoff.de