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Alchemia (ASX: ACL) announces Initiation of P2 trial in Small Cell Lung Cancer

ASX: ACL is about to initiate recruitment to a 390 patient pivotal P3 study of HA-Irinotecan in metastatic colorectal (bowel) cancer.


In a previous P2 study in colorectal cancer, HA-Irinotecan reduced tumor progression by more than half compared to un-formulated irinotecan.

  • This study will examine the effectiveness of HA-Irinotecan, which utilizes ACL’s patented HyACT^® technology to target the anti-cancer drug irinotecan to the tumor. The trial will recruit a total of 40 patients. Patients will be randomised to receive either HA-Irinotecan or irinotecan. 2 patients have received their 1st doses of therapy;
  •  This investigator sponsored trial is being conducted at Monash Cancer Centre, Southern Health and Peninsula Oncology Centre in Melbourne,Victoria;
  • The primary endpoint will be tumor stem cell burden during and at the conclusion of the study. On the safety side, the trial will measure the incidence of grade 3 and 4 toxicity. Secondary endpoints include Progression-Free Survival (NYSE:PFS).

The Bottom Line: There is few treatment options for patients with small cell lung cancer and, based on the previous experience with HA-Irinotecan in colorectal cancer. This is a proof of concept trial for a very promising therapy. This is also the 1st 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 tumor that are resistant to chemotherapy and which are believed to be responsible for treatment failure and tumor re-growth. ACL’s HyACT technology targets drugs to CD44, a protein target that is over-expressed in most cancers and on cancer stem cells. Data presented by ACL showed that drugs formulated using the HyACT platform showed up to a 40 fold increase in potency against cancer stem cell populations.