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-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)
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.
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, that 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 (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: gsmith@tenxbiopharma.com
Source: TenX Biopharma, Inc.
CONTACT: Gardiner F.H. Smith, Chief Executive Officer, TenX
Biopharma,
Inc., +1-215-774-1176, gsmith@tenxbiopharma.com
Web Site: http://www.tenxbiopharma.com/
Posted: September 2010
