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Clavis Pharma successfully completes clinical phase I study in haematology

13 Feb 2008 - Clavis Pharma announced that an important milestone has been reached in its haematology program with ELACYT(TM). The phase I part of the ongoing clinical phase I/II study within haematological cancers has been successfully completed. The maximal tolerated dose (MTD) has been determined and clinical activity has been reported. Defining the MTD is a prerequisite for embarking on the phase II part of the study. The Company is now in the process of confirming the dose and the optimal regimen to be used in the phase II part of the study where the efficacy of ELACYT will be evaluated. The phase II part is estimated to start when the dose and regimen has been decided by the international clinical expert group by the end of April 2008.
 
ELACYT is a novel cytotoxic agent, an analogue of cytarabine, a backbone of therapy in acute leukaemia. ELACYT is in development for the treatment of haematological cancers (blood cancers) as well as for solid tumours. In this ongoing phase I/II study 75 patients have been treated to date. Clavis Pharma reports that patients with haematological malignancies have tolerated ELACYT well at doses up to 2500 mg/m²/day both for 4 hour infusion and continuous infusion. The patient population in the phase II part are patients with late stage acute myeloid leukaemia (AML).
 
"ELACYT has shown a good safety profile for both regimens studied and the MTD was reached above the level where clinical activity was reported" says Tom Pike, CEO of Clavis Pharma. "We will soon open new sites for the phase II part and we are expecting the excellent recruitment to continue."
 
"We are pleasantly surprised that ELACYT has been better tolerated than anticipated when the study was initiated" says Bo Nilsson, CMO of Clavis Pharma. "The rapid patient enrolment is a sign of investigator enthusiasm, which is very encouraging for the company"