The DSMB overseeing Alchemia's (ASX:ACL) phase III trial of HA-Irinotecan in metastatic colorectal cancer has recommended that recruitment continue.
Dylan Bushell-Embling (Australian Life Scientist)23 May, 2012 15:07Comments.
The safety board monitoring Alchemia's (ASX:ACL) phase III trial of its HA-Irinotecan anticancer product in metastatic colorectal cancer has recommended that the trial continue recruiting patients.
The Data Safety Monitoring Board (DSMB) reviewing the safety data of the trial has given a clean bill to the initial results from the first 39 patients, finding no safety or efficacy concerns.
The DSMB is an independent group of experts tasked with reviewing study data for participant safety, study conduct and trial progress.
Alchemia's phase III trial is a double-blind, randomised study. Patients are receiving doses of either HA-Irinotecan or irinotecan.
HA-Irinotecan combines chemotherapeutic drug irinotecan – marketed as Camptosar by Pfizer – with hyaluronic acid. It is produced using Alchemia's HyACT production technology.
A phase II clinical trial comparing the efficacy of HA-irinotecan versus Camptosar indicates that Alchemia's version can produce a superior anti-cancer effect. Progression-free survival rates more than doubled for the HA-irinotecan patients.
This latest study will eventually involve 390 irinotecan-naive second or third line metastatic colorectal patients. Patients are receiving either HA-Irinotecan or irinotecan as part of the FOLFIRI chemotherapy regimen. FOLFIRI consists of 5-Fluourouracil, leucovorin and irinotecan.
Progression free survival is the primary endpoint, which will be assessed when 350 patients' cancer has progressed.
Data from the trial will be used to support applications with the US FDA and the European Medicines Agency.
Colorectal cancer is the third most common form of cancer diagnosed in the US, An estimated 143,000 patients will be diagnosed with some form of colorectal cancer in 2012, and approximately 51,000 patients will die from the disease.
Alchemia is planning to spin off its oncology division into standalone entity Alchemia Oncology, if shareholders approve the split. The new entity would remain 100% owned by Alchemia shareholders.
The side of the business that will not be spun off will stay responsible for Alchemia's anticoagulant product, generic fondaparinux, which is gaining market share in the US.
Alchemia (ASX:ACL) shares gained 4.44% on Tuesday, the day the DSMB's decision was announced, but had pared most of these gains by around 1:30pm on Wednesday.
ACL Price at posting:
47.0¢ Sentiment: LT Buy Disclosure: Held
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