More from Dr. Byrd on PCI-32765

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http://www.eurekalert.org/pub_releases/2011-06/osum-nea060311.php

Ohio State University Medical Center

Novel experimental agent is highly active in CLL patients, interim study shows

COLUMBUS, Ohio – An interim analysis of a phase II clinical trial indicates that

a novel experimental agent for chronic lymphocytic leukemia (CLL) is highly

active and well tolerated both in patients who are undergoing treatment for the

first time and those who have relapsed and are resistant to other therapy.

The agent, called PCI-32765, is the first drug designed to target Bruton's

tyrosine kinase, whose function is essential for CLL-cell survival and

proliferation.

Study leader Dr. C. Byrd, director of the division of hematology at Ohio

State University Comprehensive Cancer Center – Arthur G. Cancer Hospital

and J. Solove Research Institute (OSUCCC – ) presented the findings

June 5 at the 2011 American Society of Clinical Oncology annual meeting in

Chicago

The analysis involved the first 21 cases in the untreated-patient group and the

first 27 individuals in the relapsed/refractory-patient group. One patient in

each group had a complete remission, and 13 patients (62 percent) in the

previously untreated group and 12 patients (44 percent) in the relapsed group

had partial remissions.

" We are excited about these early findings because they suggest that PCI-32765

is a highly active oral therapeutic that produces a high rate of durable

remissions – the remissions last months on end – with acceptable toxicity in

relapsed and refractory CLL, " Byrd says.

" It is exciting to see a drug that was shown to be active in the laboratory

translate to clinical benefit for CLL patients, " says researcher Dr. Amy

, assistant professor of medicine at the OSUCCC – . co-led

the pre-clinical CLL work at Ohio State with Byrd and now coordinates several

correlative studies for this clinical trial.

Byrd stresses that the patients show several benefits of the treatment, such as

higher platelet counts and hemoglobin levels, and that many report that they

feel dramatically better overall with less fatigue, factors that are difficult

to measure and report as a number.

" These responses last for many months in part because patients are willing to

remain on the drug since the side effects are very tolerable, " he notes.

The ongoing phase II clinical trial involves 78 patients with previously

untreated or relapsed and refractory CLL or small lymphocytic leukemia. The

previously untreated patients were all age 65 or older; individuals in the

relapsed group all had two or more earlier treatments followed by recurrent

disease.

" These are early findings, so patients with partial remissions could improve to

complete remissions with further observation, " Byrd says. " Usually patients with

highly resistant and refractory CLL would have progressed and possibly died by

this time, but 85 percent remain on PCI-32765 and continue to improve. "