ha-irinotecan phase 3 trial update , page-2

22 May 2012
ASX / MEDIA ANNOUNCEMENT
DSMB Recommends Continuation of Phase 3 Trial of HA-Irinotecan in
Colorectal Cancer
BRISBANE, Australia: May 22, 2012 – Alchemia Limited, (ASX – ACL) today announces that the independent Data Safety Monitoring Board (DSMB) responsible for reviewing the safety data of trial ACO002, the Phase 3, double blind, randomized, pivotal study of HA-Irinotecan in metastatic colorectal cancer (mCRC), recommended that the study should continue recruiting patients as planned.
The DSMB is an independent group of experts that review and evaluate accumulated study data for participant safety, study conduct and progress in a trial. Following a review, the DSMB will make recommendations concerning the continuation, modification, or termination of a trial. The DSMB considers study-specific data as well as relevant background knowledge about the disease, test agent, or patient population under study.
The DSMB reviewed data from 39 patients receiving either HA-Irinotecan or irinotecan delivered as part of the FOLFIRI regimen. The DSMB noted that no safety or efficacy concerns were identified. The DSMB review of data from the initial 20 patients was specified within the study protocol submitted to the US Food & Drug Administration (FDA) and European Medicines Agency (EMA).
"The DSMB's recommendation to continue our Phase 3 study of HA-Irinotecan is an important milestone in the progress of this pivotal trial," said Professor Tracey Brown, Chief Scientific Officer of Alchemia. "The expectation for this study, based on our prior clinical experience, is that HA-Irinotecan will provide improved clinical benefit to patients without increasing the burden of toxicity. While it is still early in the trial, the data presented to the DSMB is consistent with that expectation.”
Commenting on the trial, Alchemia’s CEO, Dr Pete Smith said: “We are very happy with the progress and management of this key trial. We are in the process of adding some additional sites in Australia and Eastern Europe to ensure that we complete recruitment and can deliver the top line results on schedule. This is to adjust for a higher than expected
number of patients not passing the selection criteria for the trial (screen failure rate), which is indicative of our robust design and stringent management of the trial. I want to thank the Alchemia clinical operations team, investigators, patients and the many others involved in the conduct of trial for their very significant efforts thus far.”
The ACO002 clinical study will recruit 390 irinotecan naïve 2nd or 3rd line metastatic colorectal cancer patients who will be randomized in a double blinded fashion to receive HA-Irinotecan or irinotecan delivered as part of the widely used FOLFIRI regimen (5-Fluourouracil, leucovorin and irinotecan). The primary endpoint of this trial is progression free survival (PFS) which will be assessed when 350 patients’ disease has progressed, estimated to occur in Q3 of calendar 2013. In a previous Phase 2 study, HA-Irinotecan provided a significant efficacy and clinical benefit to 2nd line colorectal cancer patients where the PFS period was more than doubled (5.2m vs 2.4m, p=0.014) when compared with the form of irinotecan that is currently used in the clinic.