Print: Australia's Alchemia Talks To USFD On HyCAMP

Australia's Alchemia Talks To USFD On HyCAMP

Alchemia Limited will begin 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, HyCAMP.

The final data from the randomized Phase II clinical trial in 80 patients with metastatic colorectal cancer treated with HyCAMP versus Camptosar shows:

HyCAMP 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 HyCAMP 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 HyCAMP.

Patients on HyCAMP 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 HyCAMP.

HyCAMP patients received less doses of anti-diarrheal medication than Camptosar patients.

Alchemia Chief Executive Officer, Dr Peter Smith said, "The Company's priority is now to identify the most expeditious path to make HyCAMP 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 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. There 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 of 76% in the HyCAMP arm versus 46% in the Camptosar arm are very consistent with the differences in the observed survival outcomes."