Alchemia's Cancer Treatment Shows Early Promise in Lung Cancer Trial

Alchemia, Brisbane, Australia (ASX: ACL): Alchemia’s lead cancer product from its HyACT? technology, HA-Irinotecan, was featured on Channel Seven News at 6pm yesterday in most regions, and was also featured on Sevens Sunrise program this morning (Wednesday 28 September) at 6.45am. The first two Small Cell Lung Cancer (SCLC) patients who received HA-Irinotecan have responded very rapidly to the first dose, experiencing substantial shrinkage of their tumours after only ten days. Both patients were treated as part of a Phase II clinical study conducted at Monash Cancer Centre.

The Principal Investigator of the trial Dr Vinod Ganju said: We are excited by these early responses to treatment, mostly because of the speed of the tumour regressions. Typically we would anticipate achieving a measurable response to therapy after one to two months of treatment but, in the case of the patients treated with HA-Irinotecan, we could measure tumour shrinkage in a matter of days.

Alchemia Oncology’s Chief Scientific Officer, Professor Tracey Brown described these early responses as “extremely encouraging” whilst emphasizing that the effectiveness of the treatment will need to be confirmed with further patient data. The rapidity of the responses is consistent with results from preclinical studies of HA-Irinotecan in lung cancer, she added.

The current study is examining the effectiveness of HA-Irinotecan, which utilises Alchemia’s patented HyACT? technology to target the anti-cancer drug irinotecan to the tumour. Patients are randomized to receive either HA-Irinotecan or irinotecan. The parameters that are being assessed include safety and measures of effectiveness such as Progression-Free Survival (PFS). In addition, the study will assess 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 platform works by delivering a higher concentration of the drug to the tumour and enhancing the uptake of the drug by cancer cells. It achieves this by targeting the drug to a specific protein, CD44, that is expressed at high levels by the cells in solid cancers such as breast, lung and colorectal. The technology has been shown to enhance the activity of a broad range of drugs across a number of preclinical models of different cancers. An earlier Phase II study in colorectal cancer with HA-Irinotecan showed a statistically significant improvement in progression free survival compared with irinotecan (20.8 vs 9.6 weeks, p=0.017). Recruitment to a pivotal Phase III study in colorectal cancer is expected to commence in 2011.

For further details of the Phase II investigator-sponsored trial with inclusion and exclusion criteria please see the press release from September 9 available on Alchemia’s website - www.alchemia.com.au

Trial sites:

Peninsula Oncology Centre in Frankston

Monash Cancer Centre, Southern Health, East Bentleigh

For further details about the trial please contact:

Peter Midolo MSc

Research Manager- Medical Oncology

Monash Medical Centre

865 Centre Rd

East Bentleigh 3165

T: 03 9928 8195

F: 03 9928 8543

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 Small Cell Lung Cancer (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 Companys first drug, fondaparinux (a generic version of GlaxoSmithKlines Arixtra?, a synthetic anticoagulant mainly used for the prevention of deep vein thrombosis), has been launched by Dr Reddys Laboratories in the USA. 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 anticancer drugs which demonstrate better efficacy. The lead product from the HyACT platform is HAIrinotecan for which a Phase III clinical trial has been prepared in metastatic colorectal cancer. Dosing of patients is expected to commence in 2011.

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