A Phase I clinical trial of ImmuFact IMP321 in pancreatic cancer has started at Washington University in Saint Louis (MO)

Immutep S.A. announced today the first administration of IMP321 in pancreatic 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 stimulates antigen-presenting cells (APC), such as dendritic cells and monocytes, leading to markedly improved cytotoxic CD8 T cells responses against tumours in patients. The pancreatic cancer trial follows the promising results obtained in metastatic breast cancer with a similar chemo-immunotherapy protocol.

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 (3, 6.5, 13 and 26 mg). Investigators will assess the safety and tolerability of this new chemo-immunotherapy combination. The other points to be studied include IMP321's pharmacokinetics, pharmacodynamics, immunogenicity, a preliminary assessment of anti-tumour activity 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 administration, with an option for additional months of therapy if disease improvement or stabilisation is observed. Approximately 33 patients are expected to be enrolled.

Published 04/2009 by admin@immutep.com