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news.Alchemia has randomized first patient in the pivotal Phase III clinical study of its lead cancer drug HA-Irinotecan.
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The 390-patient study will compare the safety and effectiveness of HA-Irinotecan with irinotecan in a double blind trial in second and third line metastatic colorectal cancer patients (mCRC).
The primary endpoint will be reached when 350 patients have experienced disease progression, anticipated to be achieved in third quarter of 2013.
The primary objective of this study is to demonstrate that HA-Irinotecan provides superior efficacy as indicated by an increased Progression-Free Survival (PFS) period.
HA-Irinotecan is a drug formulation that uses Alchemia’s HyACT technology to target the widely used chemotherapy drug irinotecan directly to cancer cells.
Alchemia Oncology chief scientific officer Tracey Brown said the trial is highly significant for the development of the HyACT technology.