DSMB clears Alchemia to continue cancer trial
Thursday, 08 November, 2012
Alchemia (ASX:ACL) has been given the nod to continue its phase III trial of HA-Irinotecan in metastatic colorectal cancer.
The independent data safety monitoring board reviewing the safety data of the study has recommended that the trial continue recruiting patients as planned.
This is the second time the board has met to go over the data, and approved the continuation of the trial.
Data from 220 patients in the randomised, double-blind trial were made available to the DSMB for review. The trial is targeting recruitment of 390 irinotecan naïve, second or third line metastatic colorectal cancer patients.
HA-Irinotecan is a combination of chemotherapeutic irinotecan with hyaluronic acid, produced with Alchemia's HyACT platform.
During the trial, each patient is being randomised to receive either HA-Irinotecan or vanilla irinotecan, as part of the popular FLOLFIRI (5-Fluourouracil, leucovirin and irinotecan) chemotherapy regimen.
The primary endpoint is progression-free survival, which will be assessed when 350 patients have experienced disease progression, which is expected for the second half of 2013.
Alchemia is preparing to spin off its oncology business including the HyACT platform into the standalone Audeo Oncology.
The company has won over shareholder and court approval for a plan to conduct an IPO on the Nasdaq exchange for the spun-off company by the end of the year.
Alchemia (ASX:ACL) shares were trading 1.82% lower at 54c as of 3pm on Thursday.
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