Actinium Pharmaceuticals is set to begin a new Phase I trial to evaluate Actimab-A in combination with CLAG-M for treating patients with relapsed or refractory acute myeloid leukaemia (AML).

The dose-escalation trial will be carried out at Medical College of Wisconsin in the US by principal investigator Dr Ehab Atallah.

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Actinium’s Actimab-A drug is currently being developed as part of the company’s CD33 programme.

It is an antibody radio-conjugate (ARC) that features the CD33 targeting antibody lintuzumab and actinium-225, an alpha-emitting radioisotope.

CLAG-M is a salvage chemotherapy regimen featuring cladribine, cytarabine, and filgrastim with mitoxantrone for patients suffering from relapsed or refractory AML.

“Actimab-A is ideally suited to be studied in combination with other therapeutic modalities such as CLAG-M given its potency and minimal extramedullary toxicities.”

Actinium chief medical officer Dr Mark Berger said: “Relapsed and refractory AML patients unfortunately have limited treatment options that have little clinical benefit for patients.

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“Actimab-A is ideally suited to be studied in combination with other therapeutic modalities like CLAG-M given its potency and minimal extramedullary toxicities.

“We are optimistic that this novel combination will demonstrate Actimab-A’ s key strengths through higher response rates, a greater number of patients successfully receiving a bone marrow transplant and ultimately, survival.”

Actinium is currently examining Actimab-Aina Phase ll clinical trial in patients who are newly diagnosed with AML and are over the age of 60 and are ineligible for intense chemotherapy.

Patient enrolment for the trial is scheduled to end in the first half of this year andtop line data results are expected by the second half of this year.