AstraZeneca and
Pharmacyclics, Inc. PCYC today announced that they have entered into
a clinical trial collaboration to evaluate novel combination therapies
targeting a number of hematologic cancers.
The collaboration will explore separate combinations of two different
AstraZeneca investigational PI3 kinase pathway inhibitors in combination with
IMBRUVICA^® (ibrutinib), Pharmacyclics' oral Bruton's tyrosine kinase
inhibitor, for the treatment of patients with relapsed or refractory Diffuse
Large B-cell Lymphomas. Preclinical evidence suggests that the combination of
IMBRUVICA with these investigational medicines may enhance their effects.
Under the terms of the agreement, AstraZeneca and Pharmacyclics will
collaborate on a non-exclusive basis and multiple studies may be considered
and conducted. The studies will be led by AstraZeneca.
The Phase I element of each study is expected to establish a recommended safe
and tolerable dose and schedule for the combination, and the Phase IIa element
will assess its safety and efficacy in an expanded patient population. The
financial terms of the agreement have not been disclosed. The results of the
clinical studies will be used to determine whether further clinical
development of the different combinations is warranted.
Susan Galbraith, Head of AstraZeneca's Oncology Innovative Medicines Unit
said, "There is a clear and significant unmet need in the treatment of
hematologic malignancies, an area of increasing focus for AstraZeneca. Our
partnership with Pharmacyclics will allow us to explore new and potentially
potent treatment combinations, which could have a positive impact on patient
outcomes."
"We are optimistic that combining our oral once-per-day IMBRUVICA with other
agents has the potential to enhance efficacy and duration across the landscape
of hematologic cancers," said Bob Duggan, Chairman & CEO, Pharmacyclics.
IMBRUVICA is being developed and commercialized jointly by Pharmacyclics and
Janssen Biotech, Inc.
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