PHARMACYCLICS has announced it is beginning treatment on patients in a Phase I dose-escalation study to evaluate the safety and tolerability of PCI-32765.
PCI-32765 a selective inhibitor of Bruton's tyrosine kinase, or Btk is beginning clinical testing as a potential treatment for patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL).
Pharmacyclics says PCI-32765 is the first Btk selective inhibitor to be tested in humans.
Additionally, Pharmacyclics says Bruton's tyrosine kinase is disrupted in the human disease X-linked agammaglobulenemia (XLA). Patients with XLA are devoid of mature B-lymphocytes and immunoglobulins in the bloodstream, but are otherwise healthy.
XLA provides strong clinical rationale for development of a novel therapeutic drug targeting Btk for safe inhibition of B-cell mediated diseases.
The researchers say the Phase 1 study will be evaluating the safety and pharmacokinetics of PCI-32765 in patients with refractory B-cell non-Hodgkin's lymphoma at Stanford University, MD Anderson Cancer Center and the University of Chicago using a 28-day dose-escalation design.
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