Alchemia aims to report on mCRC trial in Q3
Alchemia (ASX:ACL) expects to report top-line results from its key phase III trial of HA-Irinotecan in metastatic colorectal cancer (mCRC) during the third quarter of 2014.
In a statement, CEO Thomas Liquard said the company is approaching the point where primary endpoint analysis will be conducted on the trial data.
“Based on the number of events accumulated to date and the progress the team is making on preparing the data for database lock, we expect to announce the phase III topline results before the end of Q3,” he said.
If the trial has a positive outcome, Alchemia will aim to file FDA and EMA submissions during the first half of next year. The company said it has had to push back the date of the anticipated filings due to the need to accommodate the drug product stability data package required for submission.
The first patient enrolled in the phase III HA-Irinotecan trial in December 2011 and recruitment of all 415 patients was completed by February last year. The data safety monitoring board overseeing the trial has cleared it to continue on four separate occasions.
Alchemia has also trialled HA-Irinotecan in small cell lung cancer and has partnered with Merck Serono to test the treatment in conjunction with Erbitux in mCRC.
Alchemia (ASX:ACL) shares were trading unchanged at $0.49 as of around 2 pm on Tuesday.
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