Alchemia and Merck Serono collaborate on HA-Irinotecan with Erbitux

Australian drug developer Alchemia (ASX: ACL) and Merck Serono, a subsidiary of Germany’s Merck KGaA (MRK: DE) have agreed to collaborate by supporting the initiation of a new clinical trial of HA-Irinotecan which will be conducted by principal investigator associate Professor Peter Gibbs. Financial terms were not disclosed.

The collaboration begins with an investigator-led Phase II clinical trial of Alchemia’s HA-Irinotecan in combination with Merck Serono’s leading therapeutic antibody Erbitux (cetuximab), for patients with metastatic colorectal cancer (mCRC). Initial patient enrolment is expected by third-quarter 2013. Around 45 patients, who are candidates for second-line treatment of mCRC, are to be enrolled at six to ten sites around Australia with the trial scheduled to run for about 24 months.

If Alchemia’s current HA-Irinotecan Phase III clinical trial (NCT01290783) is successful, and the drug obtains health authority approval for use in irinotecan-containing chemotherapy regimens, there is the possibility that HA-Irinotecan will progressively replace the current form of irinotecan used by oncologists. According to current treatment guidelines, 50%-60% of mCRC patients should be considered for treatment with chemotherapeutic drugs, such as irinotecan, in combination with Erbitux. The Phase II study led by Dr Gibbs is intended to generate data supporting the clinical use of HA-Irinotecan with Erbitux in the treatment of mCRC. Specifically, this study will primarily evaluate the safety of Alchemia’s HyACT drug, HA-Irinotecan, as part of the FOLFIRI treatment regimen, in combination with Erbitux.