Sep 7 2010
TenX Biopharma, Inc. announced today that it has re-initiated enrollment in the pivotal Phase III clinical trial assessing zanolimumab treatment for cutaneous T-cell lymphoma (CTCL) patients (ClinicalTrials.gov identifier: NCT00127881). The trial enrollment was suspended in October 2008 while Genmab (CO:GEN) was seeking a out-license agreement to further develop the compound. TenX Biopharma acquired global rights to zanolimumab in February, 2010 from Genmab.
Stage 2 of the pivotal, Phase III trial is an open-label, single arm study in patients with mycosis fungoides (stage IB-IVB), or Sezary Syndrome, who are refractory or intolerant to treatment with Targretin and one other standard therapys global assessment across the trial period.
TenX Biopharma expects a final data collection date for primary outcome measures to occur in early 2011.