Alchemia kicks off phase II lung cancer trial

Brisbane-based Alchemia announced today it is starting recruitment for a phase II clinical study of its lead cancer drug HA-Irinotecan in Small Cell Lung Cancer (SCLC) to be held at Monash Cancer Centre, Southern Health and Peninsula Oncology Centre in Melbourne.

The study will examine the effectiveness of HA-Irinotecan, which is based on Alchemia’s HyACT technology to target the anti-cancer drug irinotecan to the tumour. Patients will be randomised to receive either HA-Irinotecan or irinotecan.

The parameters that will be assessed include safety and measures of efficacy such as Progression-Free Survival (PFS). In addition, the study will measure the impact of the treatments on circulating tumour cells (the number of cancer cells detected in the blood) and certain cell populations such as cancer stem cells in the tumour.

Alchemia’s HyACT technology targets drugs to CD44, a protein target that is overexpressed in most cancers and, importantly, on cancer stem cells.

Data presented by Alchemia at the American Association of Cancer Research meeting last year showed that drugs formulated using the HyACT platform showed up to a 40-fold increase in potency against cancer stem cell populations.

In the current study, cancer stem cells will be quantified in biopsies of tumour tissue obtained from patients at the start, during and at the end of treatment.

Two patients have already received their first doses of the experimental therapy.

Alchemia is also about to initiate recruitment to a 390 patient pivotal phase III study of HA-Irinotecan in metastatic colorectal (bowel) cancer. This study will be used for registration of the drug in major markets, the end-points having been agreed with the U.S. Food and Drug Administration and the European Medicines Agency.