Alchemia cleared to continue HA-Irinotecan trial

Alchemia (ASX:ACL) has been given the go-ahead to continue with its phase III trial of chemotherapy candidate HA-Irinotecan in metastatic colorectal cancer.

The data safety monitoring board (DSMB) overseeing the trial has reviewed safety data from all 390 patients enrolled in the study and uncovered no evidence of safety concerns.

This marks the fourth time the DSMB has recommended the trial continue. For example, the DSMB gave a positive recommendation in May 2012 after reviewing data from the first 39 patients and again in November 2012 once data from the first 220 patients were available.

But it marks the first time the board has had access to patient data from all 390 participants. Alchemia hit its recruitment target for the trial in February this year.

The multicentre double-blind trial is evaluating the efficacy of HA-Irinotecan as part of the standard FOLFIRI chemotherapy regimen. Patients have been randomised to receive either standard irinotecan or Alchemia’s hyaluronic acid infused formulation.

Alchemia also announced that its share of the profits on sales of the generic fondaparinux anticoagulant it produces for marketing partner Dr Reddy’s Laboratories was $3 million during the September quarter.

This is before the company’s quarterly contribution to the US$10 million ($10.9 million) Alchemia and Dr Reddy’s have invested to improve the fondaparinux production process.

In September last year, Alchemia and Dr Reddy’s agreed to split the costs of the investment 50:50. Alchemia’s contribution is being deducted from its profit share at the rate of US$500,000 a quarter.

Alchemia (ASX:ACL) shares were trading 0.84% lower at $0.59 as of around 1 pm on Friday.