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Alchemia Announces First Patient Enrolled in Investigator-Led Phase II Trial of HA-Irinotecan and Erbitux ("CHIME" Trial)

BRISBANE, AUSTRALIA -- (Marketwired) -- 06/20/14 -- Alchemia Limited (ASX: ACL), a drug discovery and development company, today announced that the first patient has been enrolled into the new clinical trial of HA-Irinotecan and Erbitux® (cetuximab); the CHIME trial. This clinical trial is being conducted as an Investigator-Sponsored trial and is jointly supported by Alchemia and Merck Serono SA (Merck Serono). The trial is being led by principal investigator, Associate Professor Peter Gibbs (Walter and Eliza Hall, Royal Melbourne Hospital and Western Hospital, Australia).

"The commencement of this clinical trial achieves another milestone in the clinical development of HA-Irinotecan as this study will be the first use of a HyACT drug within an antibody-containing regimen, which is the current and future standard of care for cancer patients," commented Dr Tracey Brown, Alchemia's Chief Scientific Officer.

The primary objective of this study is to evaluate the safety of Alchemia's lead HyACT drug, HA-Irinotecan, as part of the FOLFIRI treatment regimen, in combination with Erbitux. The CHIME trial will enrol approximately 50 patients who are candidates for second-line treatment of metastatic colorectal cancer (mCRC) and it will take place at six to ten sites around Australia. The trial is scheduled to run for approximately 24 months.

"We are very pleased to have the first patient enrolled. Due to the potential therapeutic benefit that HA-Irinotecan can add to cancer patients, we expect steady enrolment to this study," said Associate Professor Gibbs, the Principal Investigator for the CHIME trial. "The goal of this trial is to demonstrate that HA-Irinotecan, when administered as part of the FOLFIRI regimen, is well tolerated when used in combination with Erbitux which is a current standard of care in the treatment of metastatic colorectal cancer patients."

Alchemia's lead asset HA-Irinotecan is in a pivotal Phase III clinical trial for the treatment of metastatic colorectal cancer. Colorectal cancer is one of the most common cancers in the world, with over 1.2 million new cases diagnosed annually1 and is the second leading cause of cancer deaths in the US, claiming more than 50,000 lives each year2. In November 2013, the Company announced that the Data Safety Monitoring Board (DSMB) concluded a scheduled review of patient experience and safety in the Company's ongoing pivotal Phase III clinical trial of HA-Irinotecan in metastatic colorectal cancer. The trial continues to treat patients safely, thus permitting the Company to continue the trial to its completion.

1 WHO, IARC GLOBOCAN, Cancer Incidence and Mortality Worldwide in 2008 at http://globocan.iarc.fr/. Accessed February 21, 2014
2 http://www.cancer.gov/cancertopics/pdq/prevention/colorectal/HealthProfessional/page3. Accessed February 21, 2014.

About Alchemia Limited
Alchemia is a drug discovery and development company marketing FDA approved fondaparinux, an injectible antithrombotic in the US, as well as other major markets via partner Dr. Reddy's Laboratories. The Company is also developing a late stage oncology product pipeline with multiple ongoing trials through its proprietary HyACT drug delivery platform, which targets anti-cancer drugs to solid tumours. Lead asset HA-Irinotecan is in a pivotal Phase III clinical trial for the treatment of metastatic colorectal cancer. HA-Irinotecan is also in two Phase II investigator-sponsored trials, one of which (the CHIME study) is in collaboration with Merck Serono combining HA-Irinotecan, as part of the FOLFIRI regimen, with Erbitux® (cetuximab). Alchemia is also exploring additional small molecule drug discovery targets via an internal discovery platform VAST, based on the Company's deep chemistry expertise. The VAST technology is being developed in collaboration with leading academic institutions and is partnered with AstraZeneca AB.

Erbitux® is a trademark of Merck KGaA, Darmstad, Germany.

PI - https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-01421-3

CMI - https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-CMI-01424-3

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