Alchemia progresses with colorectal cancer trial

Alchemia (ASX:ACL) has enrolled the 390th patient for its phase III trial of HA-Irinotecan in metastatic colorectal cancer and expects to reach the primary endpoint in early 2014.

Alchemia (ASX:ACL) has hit its recruitment quota for a phase III trial of its chemotherapy drug HA-Irinotecan in metastatic colorectal cancer.

The company made its goal of recruiting 390 patients for the trial by 31 January 2013 - around a year since the study commenced.

Alchemia executive chairman Dr Mel Bridges said the recruitment milestone had been “completed on time and within budget”.

The double-blind trial is being conducted across 76 sites in Australia, Eastern and Western Europe. Its purpose is to compare the effectiveness of  HA-Irinotecan - a version of the chemotherapy produced using Alchemia’s HyACT cancer drug platform - with irinotecan alone.

Patients are being given either HA-Irinotecan or irinotecan as part of the standard FOLFIRI chemotherapy regimen. The main objective is an increase in progression-free survival of at least six weeks.

The primary endpoint will be reached when 350 patients have experienced disease progression. Alchemia said that based on historic data, it had initially expected this endpoint to be reached in 2H13.

But preliminary trial data indicates that the subjects are continuing treatment for longer than anticipated before experiencing disease progression. The company now expects the end point to be reached in early 2014.

The independent data safety board monitoring the trial gave Alchemia approval to continue the trial in November.

Alchemia was late last year forced to call off a plan to spin off its oncology business into a standalone company, citing a lack of interest from potential investors, particularly in the US where the new company was to be listed.

Alchemia (ASX:ACL) was trading unchanged at 32c as of around 2:30 pm on Monday. The shares have lost over 40% of their value since the oncology spin-off was shelved.