Clavis Pharma ASA provides an update on recruitment into and timelines for its Phase III CLAVELA trial in patients with late-stage acute myeloid leukemia.
To date, 234 patients have been recruited into the trial at centers in Europe, Australia and North America.
The Company now expects CLAVELA to be fully recruited (approximately 380 patients) during the second half of 2012, versus earlier guidance of the second quarter of 2012.
This timeline delay versus previous guidance is owing to a temporary shortage of elacytarabine as a result of factory-wide quality issues at Ben Venue Laboratories (BVL), Ohio, USA, the current manufacturer of elacytarabine.
BVL is unable to release two final batches of elacytarabine until the investigation at its Ohio facility has been completed. Clavis Pharma has now been informed that these batches cannot be released for clinical use until later in the first quarter of 2012.
The investigations at BVL concern the quality systems for the manufacturing plant in general and are not related to elacytarabine.
Clavis Pharma is tightly managing its remaining supplies to ensure that existing patients receive uninterrupted supplies of elacytarabine and to continue limited recruitment until the next batch is available for use.
Clavis Pharma is committed to completing CLAVELA as fast as possible to the highest clinical and regulatory standards and in close cooperation with relevant regulatory bodies.
In 2011, Clavis Pharma signed an agreement with Baxter Oncology GmbH (Germany) as a second contract manufacturer for elacytarabine, with the intent to transfer manufacturing in the first quarter 2012.
The companies have been working closely for some time to facilitate a smooth switchover so that patients on the CLAVELA trial will receive drug manufactured by Baxter in the second quarter 2012.
CP-4126 (also known as CO-101), which has been licensed to Clovis Oncology (Clovis) is not affected by this manufacturing issue.
CP-4126 has never been manufactured by BVL and Clovis is already utilizing two manufacturers for its clinical trials and potential commercial supply.
In addition, Clovis has sufficient supply on hand of both CP-4126 and the active control arm (gemcitabine) to complete its pivotal LEAP trial in metastatic pancreatic cancer.
Clovis continues to expect to complete enrollment in the 360-patient LEAP trial at the end of the first quarter of 2012 and anticipates top line results from the LEAP trial in fourth quarter of 2012.
Olav Hellebø, Clavis Pharma CEO, commented: “The speed of recruitment into CLAVELA has been as planned and we are disappointed that the issues at BVL are now slowing down this progress. We are working closely with BVL and Baxter so that we can resume full-speed recruitment as quickly as possible and we now expect to complete the recruitment in this important study during the second half of 2012 and to have data available in the first quarter of 2013.”