Immutep S A's ImmuFact IMP321 has moved into Phase I/II clinical trials. ImmuFact IMP321 is a potent natural human T cell immunostimulatory factor designed to amplify the T cell immune response in therapeutic vaccines.
The two randomised single-blind escalating-dose Phase I/II studies are designed to show first, safety and tolerability, and second, to assess the T cell immune response. Studies are being conducted in healthy individuals with ImmuFact IMP321 alone and combined with antigens. Two well-defined standard types of antigens are being used: soluble influenza virus antigens and the particulate hepatitis B surface antigen. Immutep and its partners will use the resulting data in the development of therapeutic vaccines against cancer and infectious diseases.
The company has set up an immunomonitoring facility to measure a wide range of immune response parameters. The trials will be completed in 2005.
The clinical study is being carried out at Aster-Cephac, a contract research organisation in Paris, France.
The cGMP batch of IMP321 was produced by Henogen S.A. (Gosselies, Belgium) in Chinese hamster ovary (CHO) cells.
For more information, visit www.immutep.com
