CHR2797 (Tosedostat) is a first-in-class, once daily, orally active aminopeptidase inhibitor which has been shown to halt cell growth or cause apoptosis (cell death) in a large number of cancer cell lines without having any impact on normal cells.
CHR2797 (Tosedostat) has successfully completed a number of pre-clinical studies that demonstrated proof-of-concept.
Chroma undertook Phase I and II clinical studies and in December 2008 announced positive data from a Phase II study in the treatment of patients with haematological malignancies. Final results from the OPAL Phase II study were announced in December 2011 which demonstrated a significant response rate in elderly patients with relapsed or refractory acute myeloid leukaemia (AML).
In March 2011 Chroma signed a licensing deal for North, Central and South America with Cell Therapeutics, Inc. (CTI) who intend to progress CHR2797 (Tosedostat). In June 2012, CTI initiated a Phase II study for elderly patients with newly-diagnosed AML or high-risk myelodysplastic syndrome (MDS), with positive data being announced in June 2015. Results showed the combination of CHR2797 (Tosedostat) with low dose cytarabine/ Ara-C resulted in an overall response rate of 54% in elderly patients with AML, with 45% of patients achieving durable complete responses. CTI have confirmed they are continuing to advance the development of CHR2797 including the potential for a Phase III registration study in primary AML or AML that evolves from MDS.