BRISBANE, AUSTRALIA--(Marketwired - June 05, 2014) - Alchemia Limited (ASX: ACL), a drug discovery and development company, announced today that they expect to report the top-line results from the pivotal Phase III trial of HA-Irinotecan in metastatic colorectal cancer (mCRC) before the end of 3Q CY 2014.
"Based on the number of events accumulated to date and the progress the team is making on preparing the data for database lock, we expect to announce the Phase III top line results before the end of 3Q CY 2014," says Thomas Liquard, CEO of Alchemia. "We are excited to be approaching the period when the primary endpoint analysis will be conducted on our HA-Irinotecan Phase III trial, and we look forward to communicating the results of this pivotal trial to the community at the earliest opportunity."
The HA-Irinotecan Phase III trial in patients with metastatic colorectal cancer, randomized its first patient in December 2011 and recruited the last patient in February 2013. A total of 415 patients were enrolled. The trial has successfully completed four safety reviews by the data safety monitoring board (DSMB). Colorectal cancer is one of the most common cancers in the world, with over 1.2 million new cases diagnosed annually(1) and is the second leading cause of cancer deaths in the US, claiming more than 50,000 lives each year(2). More than $7.5B is spent annually on colorectal cancer drug treatments across the major markets (US, EU and Japan)(3).
"Alchemia with its HyACT technology are entering an exciting phase with the pending completion of the pivotal HA-Irinotecan Phase III clinical trial," commented Dr. Peter Gibbs, the trial's principal investigator. "I have a great deal of respect for the Alchemia clinical team, and if successful, HA-Irinotecan has the potential to become the standard-of-care in metastatic colorectal cancer. I look forward to the opportunity to work with Alchemia on educating the oncology community about the value of HA-Irinotecan and CD44-targeted drug delivery."
Assuming a positive outcome of the primary endpoint analysis, the FDA and EMA submissions are expected to occur in 1H 2015. The company previously announced a potential regulatory filing timeframe of 4Q CY 2014 - 1Q CY 2015. The adjustment in filing timelines is driven primarily by the need to accommodate the drug-product stability data package needed for submission.
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 is in collaboration with Merck Serono combining HA-Irinotecan 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.
(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.
(3) Decision Resources, 2012