The Company's priority is now to identify the most expeditious path to make HyCAMP(TM) available to patients and, to that end, we will be liaising closely with the FDA and the EMEA (European Medicines Agency). Improvement in progression-free survival has been an acceptable end-point for the approval of several important cancer drugs and we believe that this study will substantially reduce the time to get HyCAMP(TM) to market."
The principal investigator of the Phase II clinical trial, Associate Professor Peter Gibbs said, "The differences in both time to treatment failure and progression-free survival are clinically meaningful and are differences that would lead to a change in clinical practice if these figures can be reproduced in a further study. The improved tumour control rates (76% in the HyCAMP(TM) arm versus 46% in the Camptosar(R) arm) are very consistent with the differences in the observed survival outcomes."
Associate Professor Tracey Brown, Alchemia's Head of Preclinical Research and inventor of the technology, added "Our preclinical data showed that HyCAMP(TM) was able to deliver a higher concentration of irinotecan (Camptosar(R)) to tumours with reduced side-effects. The targeting of drug to the tumour, coupled with the ability of HyCAMP(TM) to deliver more doses due to lower toxicity, has been successfully translated into man with a greater therapeutic benefit to patients in this Phase II trial compared with Camptosar(R)."
Dr Smith noted, "Commercially this result is very important for Alchemia. We have shown in preclinical studies that a broad range of anti-cancer drugs and antibodies can be targeted to different cancers with comparable therapeutic improvement to that seen with HyCAMP(TM). This means that the HyACT(TM) technology is capable of generating multiple product and partnering opportunities."