Alchemia updates Phase III Trial timeline

THE ROADHOUSE PHARMACY: Alchemia Limited (ASX: ACL) announced it expects to report the top-line results from a Phase III trial of HA-Irinotecan in metastatic colorectal cancer (mCRC) before the end of the third quarter of 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,” Alchemia CEO Thomas Liquard said in the company’s announcement to the Australian Securities Exchange.

“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 and is the second leading cause of cancer deaths in the US, claiming more than 50,000 lives each year.

“Alchemia with its HyACT technology are entering an exciting phase with the pending completion of the pivotal HA-Irinotecan Phase III clinical trial,” the trial’s principal investigator Dr. Peter Gibbs said.

“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, Alchemia said FDA and EMA submissions are expected to occur in the first half of 2015.

The company previously announced a potential regulatory filing timeframe of 4Q CY 2014-1Q CY 2015.

Alchemia explained the adjustment in filing timelines is driven primarily by the need to accommodate the drug-product stability data package needed for submission.

Website: www.alchemia.com.au