Clinical Trials

ImmuFact® IMP321

Eight clinical trials are completed, ongoing or planned for 2008. The corresponding protocols are termed P001 to P008. The monotherapy or chemo-immunotherapy trials are to provide therapeutic efficacy proof-of-concept in man in indications with very large potential markets. The adjuvant trials where a low-dose IMP321 is mixed with antigens before injection are designed to establish IMP321 as the gold standard T cell adjuvant for therapeutic vaccines. 

Overall, more than 500 s.c. injections of IMP321 have been administered since 2005 and the product has a good local and systemic tolerability profile.

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Monotherapy:

P003: IMP321 in metastatic kidney cancer (21 patients, Paris) completed:
http://clinicaltrials.gov/ct/gui/show/NCT00351949?order=2).

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Chemo-Immunotherapy:

P005: IMP321 in metastatic breast cancer (16 patients, Paris) recruiting:
http://clinicaltrials.gov/ct/gui/show/NCT00349934?order=1).

P008: IMP321 in advanced pancreatic cancer (in preparation, Saint-Louis, USA)




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Vaccine Adjuvant:

P001: IMP321 alone or with influenza Ag (60 healthy volunteers, Paris) completed:
http://www.clinicaltrials.gov/ct/show/NCT00354263?order=1).

P002: IMP321 + HBsAg (48 healthy volunteers, Paris) completed:
http://www.clinicaltrials.gov/ct/show/NCT00354861?order=3).

P006: IMP321 + 8 melanoma peptides in disease-free melanoma (28 patients, Brussels) recruiting:
http://clinicaltrials.gov/ct/show/NCT00365937?order=3).

P007: IMP321 + a melanoma peptide in metastatic melanoma treated by lymphoablative chemotherapy and lympho-reconstitution (9 patients, Lausanne, recruiting).