Orsay, October 16, 2008 - Immutep S.A. announced that the FDA, after review of the Investigational New Drug Application (IND), has allowed the administration of IMP321 in cancer patients in a Phase I trial conducted by Dr. William G. Hawkins at the Washington University School of Medicine in Saint Louis (MO).IMP321 is a first-in-class immunopotentiator that agonizes MHC class II molecules thereby stimulating antigen-presenting cells (APC), such as dendritic cells and monocytes, leading to markedly improved cytotoxic CD8 T cells responses against tumours in patients with metastatic kidney or breast cancer. More than 500 s.c. injections have been administered to date at doses up to 30 mg.
The phase I study is an open-label, two-arm, dose escalation trial in advanced pancreatic cancer treated by first-line gemcitabine alone or associated with increasing doses of IMP321. Investigators will assess the safety and tolerability of this new chemo-immunotherapy combination protocol. The other points to be studied include IMP321's pharmacokinetics, pharmacodynamics and immunogenicity, as well as the exploration of the molecule's mechanism of action. IMP321 will be given s.c. q14 for a 6-month period the day after gemcitabine injection, with an option for additional months of therapy if disease improvement or stabilization is observed. The first two dose levels will be 3 and 6.5 mg followed by 13 and 26 mg if safety at higher doses is confirmed. At least 27 patients are expected to be enrolled...
...Immutep S.A.
Immutep S.A. is a biopharmaceutical company developing immunostimulatory factors for the treatment of cancer and chronic infectious diseases and immunomodulatory therapeutic antibodies for the treatment of cancer or autoimmune disease. The Company's technologies are based on the LAG-3 immune control mechanism that mediates T cell immune responses... Immutep's Press Release -
