HA-Irinotecan in patients with metastatic colorectal cancer

Alchemia’s most advanced anticancer product is HA-Irinotecan in Phase III for patients with mCRC using the HyACT® technology platform, it is a combination of the chemotherapeutic drug, irinotecan and hyaluronic acid (HA).

In May 2007 Alchemia reported significant results from an Australian Phase II clinical trial. On average, HA-Irinotecan enabled cancer patients to receive three times more therapy which resulted in better tumour responses.  Statistically, HA-Irinotecan significantly increased the time it took for tumours to grow, otherwise known as the progression free survival (PFS) by 116%.

Now Alchemia is conducting a global pivotal Phase III study (see details below).

HA Irinotecan global pivotal Phase III trial in mCRC

Title:  Randomized double-blind Phase III trial of FOLF(HA)iri vs FOLFIRI for second or third line therapy in irinotecan-naïve patients with metastatic colorectal cancer.
Sites/Location:  76 sites in Australia, UK, Russia, Ukraine, Serbia, Poland & Bulgaria
Study design:  2 arms, 1:1 randomized, double-blinded, multi-centre study
Patients:  second or third line
Prior treatment:  Irinotecan-naïve
Control arm:  FOLFIRI
Test arm:  FOLF(HA)iri where irinotecan is administered as HA-Irinotecan Solution for Infusion
Primary endpoint:  Progression Free Survival (PFS)

Alchemia's Phase III trial missed primary endpoint - data is currently under review.

Alchemia's Phase III trial is being run under an FDA Investigational New Drug (IND) Application. Dr Peter Gibbs MD based at the Royal Melbourne Hospital (Australia) is the principal investigator for the global trial. For further information on the Phase III trial please visit the following clinical trials website at clinicaltrials.gov and search for Identifier: NCT01290783.