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Advancell Announces Promising Phase I/IIa Results with Acadra(R) in CLL

2/15/2011 10:30:19 AM

BARCELONA, Spain, February 15th, 2011. ADVANCELL, an emerging biopharmaceutical company, today announced positive results from a Phase I/IIa clinical study conducted with Acadra® in Chronic Lymphocytic Leukemia (CLL) patients resistant/refractory to current therapies. The company also announced promising non-clinical in vivo results with Acadra® in Multiple Myeloma (MM), Mantle Cell Lymphoma (MCL) and other lymphoproliferative disorders. Synergism of Acadra® in combination with current treatment in these indications has been demonstrated.

The Phase I/IIa multi-center dose-escalation study was designed to assess the safety, efficacy and pharmacokinetics of Acadra® in CLL patients with refractory or relapsed disease.

The results of this study demonstrated that Acadra® has an acceptable safety and tolerability profile at doses that induce reduction in the leukemic tumor burden. The study patient population included patients with relapsed or refractory CLL who had received a minimum of one prior line of treatment including either a fludarabine or an alkylator-based regimen (median number of prior treatments was 5). The study was conducted in two parts and enrolled twenty-four patients in cohorts of 3 patients each.

In part I, Acadra® was administered as a single dose with the aim to find the Optimal Biological dose (OBD), defined as the dose of Acadra® that generated the maximum exposure to the active metabolite ZMP with no Dose Limiting Toxicities (DLTs). Acadra® 315 mg/kg was the dose limiting toxicity (DLT) dose with one patient having a DLT of Tumour Lysis Syndrome that resolved with appropriate treatment. Saturation of the metabolism of Acadra® to ZMP occurred at 210 mg/kg. Thus, the OBD was declared as 210 mg/kg and this was the dose used for multiple Acadra® administrations in part IIa of the study. In part II, patients received up to 5 doses of Acadra®.

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