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Alchemia Limited (ASX:ACL) Initiation Of Phase 2 Trial In Small Cell Lung Cancer

Alchemia Announces Initiation Of Phase II Trial In Small Cell Lung Cancer

Alchemia Limited, Brisbane, Australia (ASX:ACL), is pleased to announce the opening of recruitment to a Phase II clinical study of its lead cancer drug HA Irinotecan in Small Cell Lung Cancer (SCLC). Two patients have received their first doses of therapy. This investigator sponsored trial is being conducted at Monash Cancer Centre, Southern Health and Peninsula Oncology Centre in Melbourne, Victoria. The principal investigator is Dr Vinod Ganju. The trial will recruit 40 patients.

This study will examine the effectiveness of HA Irinotecan, which utilises Alchemia's patented 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.

Medical oncologist at Monash Cancer Centre Dr Vinod Ganju, said: "This is a very exciting trial of a very promising therapy. There are very few treatment options for patients with small cell lung cancer and, based on the previous experience with HA Irinotecan in colorectal cancer, we hope to see improved patient outcomes in this trial. It is also interesting from a scientific point of view being the first trial to directly examine the impact of a therapy on lung cancer stem cells."

Cancer stem cells are a small population of cells within the tumour that are resistant to chemotherapy and which are believed to be responsible for treatment failure and tumour regrowth. 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.

Professor Tracey Brown, Chief Scientific Officer of Alchemia Oncology said: "This unique trial will greatly assist the development of the HyACT technology. We are anticipating valuable insights into the mechanism of action of the platform as well as providing further data on the improved effectiveness of HA Irinotecan in another cancer. The field of cancer stem cell research is of great interest to the pharmaceutical industry and has the potential to deliver breakthrough treatments. Data from this trial will be extremely useful in our partnering discussions."

Alchemia will contribute the study drug, HA Irinotecan, and will be responsible for the analysis of circulating tumour cells and cancer stem cells. Commenting on the trial, Alchemia CEO Pete Smith added: "For a modest investment this cutting edge trial is expected to yield important insights into the clinical and commercial value of our HyACT platform. This is in keeping with our strategy of exploring the utility of this flexible technology whilst focusing Alchemia's financial resources on the planned pivotal Phase III study."
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