Alchemia Recruits First Patient to Pivotal Phase III Clinical Trial of HA-Irinotecan in Metastatic Colorectal Cancer

BRISBANE, AUSTRALIA--(Marketwire - January 04, 2012) - (ASX: ACL) -- Alchemia Limited is pleased to announce that the first patient in the pivotal Phase III clinical study of its lead cancer drug, HA-Irinotecan, was randomized on Dec 30, 2011 and has now received their first cycle of treatment.

HA-Irinotecan is a novel drug formulation that uses Alchemia's HyACT technology to target the widely used chemotherapy drug irinotecan directly to cancer cells. The 390-patient Phase III study will compare the safety and effectiveness of HA-Irinotecan with irinotecan in a double blind trial in second and third line metastatic colorectal cancer patients (mCRC) when administered as part of the FOLFIRI regimen, a combination chemotherapy regimen that includes folinic acid, fluorouracil, and irinotecan. The primary objective of this study is to demonstrate that HA-Irinotecan provides superior efficacy as indicated by an increased Progression-Free Survival (PFS) period.

This pivotal Phase III trial is being conducted at 55 sites in Australia, Eastern and Western Europe. Of these, 27 sites are actively recruiting and it is anticipated that the remainder will initiate recruitment in the first quarter of 2012. It will take around 12 months to recruit the required 390 patients. The primary endpoint will be reached when 350 patients have experienced disease progression, anticipated to be achieved in Q3 2013.

"Investigators are very enthusiastic to recruit to this study as previous clinical experience with HA-Irinotecan has demonstrated it to be a very effective drug in delaying the growth of tumors in patients with colorectal cancer who had failed other treatment regimens," said Principal Investigator, Associate Professor Peter Gibbs. "We are excited by the tumor-targeting abilities of HA-Irinotecan and we hope that it will be successful in providing a significant clinical benefit to cancer patients. Importantly this benefit is likely to be seen with no increase in treatment side effects and even the possibility of reduced toxicity."

HA-Irinotecan is a new formulation of irinotecan which targets the drug to the tumor and increases its uptake into cancer cells. This occurs through a well established receptor-based mechanism. A Phase II trial of HA-Irinotecan in metastatic colorectal cancer showed a statistically significant increase in PFS compared with irinotecan (5.2 months vs 2.4 months, p=0.017) with no increase in toxicity. After consultation with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), both regulatory agencies indicated that the successful completion of this single pivotal Phase III trial may be sufficient for registration in both the US and Europe.

"This trial is highly significant for the development of the HyACT technology," said Professor Tracey Brown, Chief Scientific Officer of Alchemia Oncology. "Following a successful Phase II result, this will provide the final proof that Alchemia's proprietary drug delivery platform is able to improve the efficacy of currently used anti-cancer agents by converting them from a non-specific therapy into a more effective tumor-targeted treatment. We hope that this will provide a significant clinical benefit to cancer patients."

About HA-Irinotecan/HyACT

HyACT is a platform technology that enables the targeted delivery of cancer drugs to tumor cells. HyACT targets a receptor called CD44 which is known to be present at high levels in the majority of cancer types but, importantly, not in non-diseased tissue. CD44 over expression is associated with more aggressive, metastatic tumors and is also a marker for cancer stem cells which are believed to be responsible for treatment failure. HA-Irinotecan is clinically the most advanced product using the HyACT technology and preclinical and clinical evidence suggests that HyACT may be able to enhance the activity of a broad range of cancer drugs without increasing their toxicity. HA-Irinotecan is currently in a Phase II study in Small Cell Lung Cancer.

About the trial -- for more details about the trial including the inclusion/exclusion criteria please see www.clinicaltrials.gov. Identifier: NCT01290783

About Alchemia: Alchemia is a drug discovery and development company founded on its chemistry expertise. The Company's first marketed drug is fondaparinux (a generic version of GlaxoSmithKline's Arixtra®, a synthetic anticoagulant mainly used for the prevention of deep vein thrombosis) launched in 2011 by Dr Reddy's Laboratories in the US. 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.