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Positive Final Data from HyCAMPTM Phase II Trial in Metastatic Colorectal Cancer |
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30 May 2007 |
Phase II results exceed expectations - Alchemia prepares for FDA talks on HyCAMP(TM)
SYDNEY, Australia | May 29, 2007 | Australian drug development company Alchemia Limited (ASX: ACL) will commence discussions with the US Food and Drug Administration (FDA) following the successful conclusion of the Phase II clinical trial of its metastatic colorectal cancer treatment, HyCAMPTM.
The final data from the randomized Phase II clinical trial in 80 patients with metastatic colorectal cancer treated with HyCAMPTM versus Camptosar® shows:
-- HyCAMPTM exerted superior anti-cancer activity with a significantly greater number of patients with observed tumour responses
-- A statistically significant increase in ‘time to treatment failure’ demonstrating that HyCAMPTM patients were able to stay on treatment longer due to reduced toxicity and increased efficacy
-- A significantly longer period (+116%) of ‘progression-free survival’ for patients receiving HyCAMPTM *
-- Patients on HyCAMPTM were able to receive therapy for a median of three times longer than those receiving Camptosar®*
-- A clinically significant trend towards longer overall survival for patients receiving HyCAMPTM
-- HyCAMPTM patients received less doses of anti-diarrheal medication than Camptosar® patients
* This data was announced to the ASX on April 26 2007
Alchemia Chief Executive Officer, Dr Peter Smith said, “The fact that we are seeing statistically significant improvements in efficacy end-points from such a small study is a reflection of the substantial increase in anti-tumour activity seen with HyCAMPTM. Generally, much larger studies would be required to show such effects. This data is an exceptional validation of our HyACTTM drug delivery technology platform and its application to the treatment of cancer patients.
The Company’s priority is now to identify the most expeditious path to make HyCAMPTM 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 HyCAMPTM 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 HyCAMPTM arm versus 46% in the Camptosar® 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 HyCAMPTM was able to deliver a higher concentration of irinotecan (Camptosar®) to tumours with reduced side-effects. The targeting of drug to the tumour, coupled with the ability of HyCAMPTM 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®.”
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 HyCAMPTM. This means that the HyACTTM technology is capable of generating multiple product and partnering opportunities.”
SOURCE: Alchemia Limited |
