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Alchemia`s Cancer Treatment Shows Early Promise In Trial

Alchemias Cancer Treatment Shows Early Promise in Lung Cancer Trial Alchemia, Brisbane, Australia ( ACL) Alchemias lead cancer product from its HyACT technology, HAIrinotecan, was featured on Channel Seven News at 6pm yesterday in most regions, and was also featured on Sevens Sunrise program this morning (Wednesday 28th September) at 6.45am. The first two Small Cell Lung Cancer (SCLC) patients who received HAIrinotecan 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 HAIrinotecan, we could measure tumour shrinkage in a matter of days. Alchemia Oncologys 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 HAIrinotecan in lung cancer, she added. The current study is examining the effectiveness of HAIrinotecan, which utilises Alchemias patented HyACT technology to target the anticancer drug irinotecan to the tumour. Patients are randomized to receive either HAIrinotecan or irinotecan.

The parameters that are being assessed include safety and measures of effectiveness such as ProgressionFree 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. Alchemias 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 HAIrinotecan showed a statistically significant improvement in progressionfree survival compared with irinotecan (20.8 vs 9.6 weeks, p0.017). Recruitment to a pivotal Phase III study in colorectal cancer is expected to commence in 2011. For further details of the Phase II investigatorsponsored trial with inclusion and exclusion criteria please see the press release from September 9 available on Alchemias website 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 1520% will be Small Cell Lung Cancer (SCLC) which is particularly aggressive with median survival from diagnosis of 24 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, 5year 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.

Alchemias 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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