Advancell reports CLL drug Acadra positive phase I/IIa results

Acadra is an investigational, intravenous, small molecule that is transformed to its monophosphate active form (ZMP) once present within cells.

It selectively induces apoptosis to B-cell leukemic cells with a mechanism of action independent of p53 status, a departure from drugs currently used in CLL.

Encouraging non-clinical results in Multiple Myeloma (MM), Mantle Cell Lymphoma (MCL) and other lymphoproliferative disorders were also reported.

Results demonstrated a synergism of Acadra in combination with current treatment in these indications.

The study results found Acadra to have an acceptable safety and tolerability profile in doses which induce reduction in the leukemic tumor burden.

Some patients in part I showed reversible asymptomatic hyperuricaemia which significantly reduced in incidence when mandatory prophylactic allopurinol in subsequent cohorts was introduced.

Acadra did not induce myelosuppression at any of the doses tested. No Grade 3 or 4 adverse events occurred at the OBD or below.
No Grade 5 events occurred during the study.

Acadra was in-licensed by Advancell from the University of Barcelona and co-developed with Protherics (BTG) until November 2009, when the Spanish biotech licensed-back its rights from BTG.

Acadra patent co-author and lead of the clinical development programs Clara Campas said the efficacy observed with Acadra is of particular interest because there is a clear unmet clinical need in patients who become resistant to standard therapies; particularly in those who have alterations in the p53 gene.