CytRx Initiates Phase 2 Clinical Trial with Bafetinib in B-cell Chronic Lymphocytic Leukemia

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BlankCytRx Initiates Phase 2 Clinical Trial with Bafetinib in B-cell Chronic

Lymphocytic Leukemia

–Commences patient enrollment in first of six proof-of-concept trials planned

for 2010–

–Marks major achievement in transition to building a significant oncology

franchise–

May 28, 2010 01:03 PM Eastern Daylight Time

LOS ANGELES--(EON: Enhanced Online News)--CytRx Corporation (NASDAQ: CYTR), a

biopharmaceutical company specializing in oncology, today announced initiation

of a Phase 2 proof-of-concept clinical trial to evaluate the preliminary

efficacy and safety of its oncology drug candidate bafetinib in patients with

high-risk B-cell chronic lymphocytic leukemia (B-CLL).

“This is the first of six Phase 2 proof-of-concept clinical trials we plan to

initiate this year with our promising oncology candidates bafetinib and INNO-206

and, importantly, marks a major milestone in our evolution as an oncology

company”

“This is the first of six Phase 2 proof-of-concept clinical trials we plan to

initiate this year with our promising oncology candidates bafetinib and INNO-206

and, importantly, marks a major milestone in our evolution as an oncology

company,” said CytRx President and CEO A. Kriegsman. “Our strategy is to

conduct small proof-of-concept studies and, based on the success of these

trials, further determine efficacy by quickly moving into larger comparative

trials either using our internal resources or with partners. This strategy

reflects our goals of rapidly advancing our oncology pipeline toward

commercialization and enhancing shareholder value.”

In this Phase 2 proof-of-concept clinical trial, high-risk B-CLL patients who

have failed treatment with first-line agents will self-administer oral doses of

bafetinib twice daily. The bafetinib dose used in this trial is based on the

highest tolerated dose in a Phase 1 study led by the University of Texas MD

Cancer Center in Houston. Patients will be monitored for clinical

response, time to disease progression and cancer progression-free survival.

Enrollment is expected to be completed in 12 to 14 months, with potential

interim data announcements periodically.

“We are cleared to begin recruiting patients for this trial at the MD

Cancer Center in Houston,” said CytRx Chief Medical Officer Levitt, MD,

Ph.D. “Patients with advanced-stage, high-risk B-CLL may benefit from

bafetinib’s dual protein kinase inhibition mechanism and, more specifically,

from its ability to inhibit Lyn kinase – an enzyme that is over-expressed in

certain cancers including B-CLL. Bafetinib has shown significant activity in

blocking B-CLL proliferation in vitro and has demonstrated anti-tumor activity

in patients with chronic myelogenous leukemia, who have failed first- and

second-line therapy with the approved bcr/abl kinase inhibitors, Gleevec®,

Sprycel® and Tasigna®. We also are preparing to commence Phase 2 clinical

testing with bafetinib in glioblastoma multiforme – a common and aggressive type

of primary brain tumor – and advanced hormone-refractory prostate cancer.”

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