TenX Biopharma announced that it has re-initiated enrollment in the pivotal Phase III clinical trial assessing zanolimumab treatment for cutaneous T-cell lymphoma (CTCL) patients
PHILADELPHIA, PA, USA | September 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 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.
SOURCE: TenX
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TenX Biopharma announced that it has re-initiated enrollment in the pivotal Phase III clinical trial assessing zanolimumab treatment for cutaneous T-cell lymphoma (CTCL) patients
PHILADELPHIA, PA, USA | September 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 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.
SOURCE: TenX
Post Views: 113
