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news.Australian drug development company Alchemia will commence discussions with the FDA following the successful conclusion of the phase II clinical trial of its metastatic colorectal cancer treatment, HyCAMP.
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The final data from the randomized phase II clinical trial in 80 patients with metastatic colorectal cancer treated with HyCAMP versus Pfizer’s Camptosar, showed that HyCAMP exerted superior anticancer activity, with a significantly greater number of patients with observed tumor responses.
The data also highlighted a statistically significant increase in time to treatment failure, demonstrating that HyCAMP patients were able to stay on treatment longer due to reduced toxicity and increased efficacy. A longer period (+116%) of progression-free survival for patients receiving HyCAMP was also recorded, as well as a clinically significant trend towards longer overall survival for patients receiving HyCAMP.
Alchemia CEO, 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-tumor activity seen with HyCAMP. Generally, much larger studies would be required to show such effects. This data is a validation of our HyACT drug delivery technology platform and its application to the treatment of cancer patients.”
The company is now planning to identify the most expeditious path to make HyCAMP available to patients and, to that end, 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 to market,” stated Dr Smith.
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 tumor control rates (76% in the HyCAMP arm versus 46% in the Camptosar arm) are very consistent with the differences in the observed survival outcomes.”