TenX Biopharma Publishes Data on Phase II Peripheral T-Cell Lymphoma Trial
PHILADELPHIA, Sept. 14 /PRNewswire/ — TenX Biopharma, Inc. announced today that data from a Phase II trial of zanolimumab (HuMax-CD4Ã‚®) 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) n=9, PTCL-not otherwise specified (NOS) n=7, anaplastic large cell lymphoma (ALCL) n=4 and enteropathy type T-cell lymphoma n=1) were treated in a single-arm multi-center study, with 12 weekly intravenous infusions of zanolimumab, 980 mg. Seventeen of the patients had advanced stage disease (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.
HuMax-CD4Ã‚® (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, that zanolimumab targets and depletes.
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 (CO:GEN). 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.
Gardiner F.H. Smith, Chief Executive Officer, TenX Contact: Biopharma, Inc. P: 215-774-1176 E: email@example.com
SOURCE TenX Biopharma, Inc.