PHILADELPHIA, Sept. 7 /PRNewswire/ -- 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 therapy (n=70). Patients receive a dose of 14 mg/ kg as weekly infusions for 12 weeks. Key endpoints include objective response, complete response, clinical complete response, partial response or stable disease by physician's global assessment across the trial period. Stage 1, a dose-ranging study (n=22), was completed to determine the optimum dose for Stage 2.
TenX Biopharma expects a final data collection date for primary outcome measures to occur in early 2011.
About Zanolimumab
HuMax-CD4® (Zanolimumab) is a fully human monoclonal anti-CD4 antibody for the targeted treatment of T-cell lymphomas, including cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). Over 90% of CTCL patients express malignant CD4+ T cells, which zanolimumab targets and depletes.
About TenX
TenX Biopharma, Inc., is a biopharmaceutical company focused on late stage development and commercialization of novel monoclonal antibody-based cancer therapies. TenX Biopharma acquired global rights to zanolimumab across disease indications in February, 2010 from Genmab. For more information visit www.tenxbiopharma.com.
This press release contains forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. TenX does not undertake any obligation to update or revise forward looking statements in this press release nor to confirm such statements in relation to actual results, unless required by law.
Contact: | Gardiner F.H. Smith, Chief Executive Officer, TenX Biopharma, Inc. | |
SOURCE TenX Biopharma, Inc.
