Data from Phase II trial of zanolimumab in PTCL published in British Journal of Haematology

Sep 14 2010

TenX Biopharma, Inc. announced today that data from a Phase II trial of zanolimumab (HuMax-CD4®) in peripheral T-cell Lymphoma (PTCL) were published in the British Journal of Haematology (Sep 2010: 150(5):565-73). The Hx-CD4-109 trial was designed to evaluate the safety and efficacy of zanolimumab in patients who have relapsed or refractory non-cutaneous peripheral T-cell lymphoma.  

Twenty-one adult patients with relapsed or refractory CD4+ PTCL of non-cutaneous type (angioimmunoblastic T-cell lymphoma (AITL)>Ann Arbor stages III-IV).

Objective tumor responses were obtained in 5 of 21 patients (24%) with two complete responses unconfirmed (CRu) and three partial responses (PR). One of the CRus lasted more than 252 days. Responses were obtained in the different PTCL entities: AITL (n = 3), ALCL (n = 1) and PTCL-NOS (n = 1).

The authors concluded that, in general, zanolimumab was well tolerated with no major toxicity reported. Zanolimumab at a dose of 980 mg weekly demonstrated clinical activity and an acceptable safety profile in this poor-prognosis population, suggesting that the potential benefit of combining zanolimumab with standard chemotherapy in the treatment of PTCL should be investigated.

"We believe these data to be very promising and look forward to the results of our ongoing trials. We remain confident that, with further research, zanolimumab will play a significant role in the future treatment of a variety of T-cell lymphomas," said Gardiner Smith, CEO of TenX Biopharma.