Alchemia has announced an update regarding the pivotal Phase III clinical study of its anti-cancer drug, HA-Irinotecan, which is currently being used to treat patients with 2nd/3rd line metastatic colorectal cancer (mCRC).
HA-Irinotecan is a drug formulation of irinotecan that uses the company's HyACT technology to target the widely used chemotherapy drug irinotecan directly to cancer cells.
HyACT technology enables the targeted delivery of cancer drugs to tumour cells, and has been shown to improve the activity of a range of cancer drugs without increasing their toxicity.
The 390-patient double-blinded Phase III study is designed to compare the effectiveness and safety of HA-Irinotecan with irinotecan when administered as part of the standard Folfiri regimen which is commonly used to treat mCRC patients who have failed at least one previous line of therapy.
The study's primary objective is to demonstrate that HA-Irinotecan shows superior efficacy as indicated by an increased period of Progression-Free Survival (PFS), and the secondary objectives include time to progression (TTP), time-to-treatment-failure (TTF) and overall survival (OS).
To-date only 53 patients have been recruited, and it is expected to take around 12 months to recruit all the patients.
The data from the initial 20 patients is being collected and will be assessed by the trial's independent Data Safety and Monitoring board (DSMB).
Alchemia CEO Peter Smith said the company is pleased to have recruited the safety cohort and expect to have a response from the DSMB in the coming weeks.
"We will continue to closely manage this important trial to ensure our target for recruitment is met. We believe HA-Irinotecan and, in due course, other HyACT drugs, have the potential to radically improve the existing standard of care for cancer patients," Smith added.
The Phase II trial of HA-Irinotecan in metastatic colorectal cancer showed a considerable increase in PFS compared with irinotecan with no increase in toxicity.