Alchemia Limited (ASX:ACL), today announced the initiation of recruitment for 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.

This study will examine the effectiveness of HA-Irinotecan, which utilizes Alchemia’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. 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 (PFS). Alchemia will contribute the study drug, HA-Irinotecan, and will be responsible for the analysis of circulating tumour cells and cancer stem cells.

“This is a proof of concept trial for a very promising therapy,” said Principal investigator Dr. Vinod Ganju. “There are 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. This is also 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 tumor that are resistant to chemotherapy and which are believed to be responsible for treatment failure and tumor regrowth. Alchemia’s HyACT technology targets drugs to CD44, a protein target that is overexpressed in most cancers and 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.

“For a modest investment, this cutting edge trial is expected to yield important insights into the clinical and commercial value of our HyACT platform,” said Alchemia CEO, Peter Smith. “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.”

Alchemia is 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 (approval) of the drug in major markets, the end-points having been agreed with the US Food and Drug Administration and the European Medicines Agency. In a previous Phase II study in colorectal cancer, HA-Irinotecan reduced tumor progression by more than half compared to unformulated irinotecan.1

About Small Cell Lung Cancer

There are approximately 220,000 new cases of lung cancer in the US, accounting for around 15% of all new cancer diagnoses and 28% of cancer deaths. Of all lung cancer cases, 15-20% will be SCLC, which is particularly aggressive with median survival from diagnosis of 2-4 months without treatment. Overall, small cell carcinoma of the lung is associated with the poorest prognosis of all types of lung cancer; even with treatment 5-year survival is only 5%. SCLC responds well to chemotherapy but a cure is difficult to achieve because SCLC has a greater tendency to be widely disseminated by the time of diagnosis.

About Alchemia: Alchemia is a drug discovery and development Company founded on its chemistry expertise. The Company’s lead drug, fondaparinux (a generic version of GlaxoSmithKline’s Arixtra®, a synthetic anticoagulant mainly used for the prevention of deep vein thrombosis), was approved and launched in July 2011 in the U.S. by Alchemia’s marketing partner Dr Reddy’s Laboratories. Alchemia’s pipeline of assets is built on two platform technologies: HyACT® (targeted cancer delivery) and VAST® (drug discovery). The primary objective of the HyACT® technology is to develop a new generation of anti-cancer drugs which demonstrate better efficacy. The lead product from the HyACT® platform is HA-Irinotecan for which a Phase III clinical trial has been prepared in metastatic colorectal cancer. Dosing of patients is expected to commence in 2011.

1 Gibbs et al (2010) Hyaluronan-Irinotecan improves progression-free survival in 5-Fluorouracil refractory patients with metastatic colorectal cancer: a randomized Phase II trial. Cancer Chemother. Pharmacol. 2011 Jan; 67(1):153-63