Clinical Experience

Proof of Concept in Multiple Indications
Biothera Pharmaceuticals has demonstrated proof of concept and a favorable safety profile based on extensive clinical experience (>400 human subjects) in multiple clinical trials evaluating its oncology immunotherapeutic Imprime PGG.

Combination Phase 2 trials of Imprime PGG with monoclonal antibodies demonstrated efficacy signals across a range of advanced solid and hematological malignancies. These findings include increased response rates and enhanced progression-free survival (PFS) and overall survival (OS). Imprime PGG was well-tolerated and administered systemically, unlike other investigational PAMP (Pathogen Associated Molecular Patterning) drugs.

Clinical data also indicate that patients with certain levels of endogenous anti-beta glucan antibodies (ABA) had significant increases in PFS and OS. ABA is a potential biomarker for Imprime PGG activity.

 Indication Control Active Clinical Outcomes
Non-small Cell Lung Cancer (n=92) Bevacizumab (Avastin®), carboplatin/paclitaxel Imprime PGG + bevacizumab (Avastin), carboplatin/paclitaxel Imprime PGG + bevacizumab demonstrated improvements in overall response rate, PFS and OS compared to bevacizumab alone (p=NS)
Colorectal Cancer
(n=33)
NA Imprime PGG + cetuximab (Erbitux®) Imprime PGG and cetuximab induced responses independent of KRAS mutation status

Colorectal Cancer
(KRAS wild type) 
(n=217)

Cetuximab (Erbitux) Imprime PGG + cetuximab (Erbitux) Levels of endogenous ABA correlated with improved PFS and OS in patients receiving Imprime PGG and cetuximab (p=.0018)
Chronic Lymphocytic Leukemia
(n=20)
NA Imprime PGG + ritxumab (Ritxuan®) and alemtuzumab (Campath®) Imprime PGG combination therapy resulted in a 65% complete response rate, twice the rate of historical control in a similar population