Alchemia teams with Merck Serono for cancer trial

Alchemia (ASX:ACL) and Merck Serono have agreed to collaborate on a clinical trial of the chemotherapy drug HA-Irinotecan in metastatic colorectal cancer (mCRC).

The companies will jointly arrange a phase II clinical trial of Alchemia’s HA-Irinotecan in combination with Merck Serono’s therapeutic antibody Erbitux (cetuximab).

The trial will involve around 45 patients who are candidates for second-line treatment of mCRC. It will be conducted across 6-10 Australian sites and run for around 24 months. Patient enrolment is expected to commence in Q3.

HA-Irinotecan is a formulation of chemotherapy drug irinotecan with hyaluronic acid. It is produced using Alchemia’s HyACT platform.

“This clinical collaboration provides external validation and recognition of the potential for HA-Irinotecan to replace irinotecan in current mCRC treatment regimens when used in combination with the antibody Erbitux,” Alchemia CSO Dr Tracey Brown said.

Separately, Alchemia blamed seasonal buying patterns and heightened competition for a quarter-on-quarter decline in net sales of anticoagulant generic fondaparinux by marketing partner Dr Reddy’s Laboratories.

Dr Reddy’s net sales of generic fondaparinux fell to US$8.8 million in the March quarter and from US$12.3 million a quarter earlier.

Alchemia’s share will be US$1.85 million once its quarterly contribution to the US$10 million investment in improving fondaparinux production is deducted.

Alchemia said sales volumes had been significantly lower in January and February due to the seasonal factors but returned to form in March at slightly weaker prices.

Finally, the data safety monitoring board (DSMB) overseeing Alchemia’s own phase III HA-Irinotecan trial has, for a third time, recommended that the trial continue.

The DSMB made the recommendation based on a review of the clinical data being generated from the trial, including safety data from 408 mCRC patients.

Brown said that based on the progress so far, the trial is on track to reach its primary endpoint in 1H13.

Alchemia shares were trading 3.95% lower at $0.365 as of around 1.30 pm on Wednesday.