Alchemia completes recruitment for colorectal cancer trial

Alchemia (ASX:ACL) has reached the recruitment target for a Phase III trial of HA-Irinotecan, a modified chemotherapy treatment for metastatic colorectal cancer.

The international trial involves 76 sites across Australia and Europe. Although the original recruitment target for the trial was 390 patients, enthusiasm for the trial by investigators and patients has resulted in an additional 25 patients being enrolled in four weeks.

The final number of 415 patients includes 71 patients who are enrolled in a trial substudy. Patients are given the option of taking part in the substudy, which is looking at the pharmacokinetics and toxicity to further confirm the safety of HA-Irinotecan.

This randomised double-blind trial will compare the effectiveness of HA-Irinotecan with irinotecan. Irinotecan is currently used to treat patients with colorectal cancer as part of the standard FOLFIRI (irinotecan, 5-fluorouracil and leucorvorin) chemotherapy regimen. HA-Irinotecan is a modified form of this chemotherapy drug produced using Alchemia’s HyACT cancer drug platform. Patients will be given HA-Irinotecan or irinotecan along with 5-fluorouracil and leucorvorin.

The results of a Phase II trial of HA-Irinotecan in patients with metastatic colorectal cancer compared with irinotecan showed a significant increase in progression-free survival and no increased toxicity.

Alchemia said that the rapid recruitment of these additional patients supports the Phase III trial reaching an endpoint in 2014. The primary endpoint of the trial is an increase in progression-free survival of at least six weeks.

Trial data available to date indicates that patients are continuing on treatment for longer than anticipated before experiencing disease progression.

The company expects the trial endpoint will be reached in the first half of 2014.

Alchemia (ASX:ACL) shares were trading at 32c as of around 3 pm on Monday.