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news.Clavis Pharma has started recruiting patients to the Phase II part of its clinical Phase I/II study with Elacyt, within haematological cancers.
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The Phase II part commences after the completion of Phase I, which demonstrated a good safety profile, as well as clinical activity. The Phase II part will evaluate the efficacy and safety of Elacyt in patients with late stage acute myeloid leukemia (AML). Patients will be recruited at 16 major cancer centers in the US and Europe.
In this ongoing Phase I/II study 77 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 when administered as a short-lasting infusion and as continuous infusion. An international clinical expert group made the recommendation on dose and schedule based on Phase I data and the study will continue with Elacyt 2000 mg/m2/day administered by continuous infusion.
The centers recruiting in the Phase I part of the study were MD Anderson Cancer Centre, Houston, Duke University Hospital, Durham, and University of Texas Health Science Centre, San Antonio, all in the US and Institute Paoli Calmettes, Marseille, France. All four centers will continue into the Phase II part. Over the next weeks additional cancer centers will be opened for recruitment in New York and Cleveland (USA); Oslo (Norway); Paris, Toulouse and Lyon (France); Bologna and Rome (Italy); Berlin, Frankfurt and Munster (Germany); and Manchester (UK).
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 tumors.
Christian Melen, CEO of Clavis Pharma, said: “This Phase I/II study in haematological cancers has shown excellent recruitment from day one. We are looking forward to continue the study in Phase II together with an excellent and enthusiastic investigator team. Furthermore, we are pleased that we are now pursuing four individual indications in Phase II as part of our clinical development program for Elacyt.”