Emergent initiates Phase Ib/II chronic lymphocytic leukemia study

January 31, 2011

BlankEmergent initiates Phase Ib/II chronic lymphocytic leukemia study

Posted on: Wed, 26 Jan 2011 08:36:07 EST

Jan 26, 2011 (Datamonitor via COMTEX) –

Emergent BioSolutions Inc., a biopharmaceutical company, has announced the

initiation of a Phase Ib/II study of TRU-016 for chronic lymphocytic leukemia,

or CLL.

TRU-016 is a CD37-directed Small Modular ImmunoPharmaceutical (SMIP) protein

therapeutic in development for the treatment of B-cell malignancies. TRU-016 is

being developed in collaboration with Abbott.

The open-label, multi-center, active-controlled study is expected to enroll up

to 114 bendamustine-naive patients with a confirmed diagnosis of relapsed CLL

and who have failed up to three previous treatments. The Phase Ib portion of the

study will determine a safe and tolerable dose of TRU-016 in combination with

bendamustine in up to 14 patients with relapsed CLL. The primary endpoint for

the Phase Ib portion is the incidence of dose-limiting toxicities.

The Phase II portion of the study will evaluate the safety and efficacy of

TRU-016 in combination with bendamustine compared with standalone bendamustine

treatment in a total of 100 randomized patients. The primary endpoint for the

Phase II portion of the study is an overall response rate as defined by 2008

International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria.

Secondary endpoints include complete and partial response rates as defined by

the 1996 National Cancer Institute (NCI) criteria, progression-free survival,

duration of response, and improvement in quality of life and disease symptoms.

The pharmacokinetics and pharmacodynamics of TRU-016 will be studied in both

phases of the study.

" Given the strong TRU-016 preclinical combination data, and the positive

clinical results from the single agent dose escalation study, we believe human

clinical evaluation of TRU-016 in combination with bendamustine could yield

meaningful results, " said Dr W. , chief scientific officer at

Emergent BioSolutions. " The dose escalation study in CLL continues to

demonstrate that TRU-016 is well tolerated and clinically active and we look

forward to Phase I combination data from this study, as well as the planned

Phase I combination study for follicular Non-Hodgkin's Lymphoma. "

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