CytRx commences Phase 2 clinical trial of bafetinib for high-risk B-cell chronic lymphocytic leukemia

May 29 2010

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," said CytRx President and CEO Steven 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 Anderson 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 Anderson Cancer Center in Houston," said CytRx Chief Medical Officer Daniel 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."

Leukemias are cancers of the while blood cells. B-CLL involves an abnormal and malignant proliferation of a particular subtype of white blood cells known as B cells, which originate in the bone marrow, migrate to the lymph nodes and spleen, and normally fight infection by producing antibodies. In B-CLL, the DNA of a B cell is damaged, causing a single damaged B cell to proliferate and accumulate in the bone marrow and blood, crowding out healthy blood cells.

B-CLL is the most common form of leukemia in adults in Western countries. More than 17,000 new cases of B-CLL are reported in the United States each year; however up to an estimated 40% of cases may not be reported due to under-diagnosis and lack of placement in cancer registries. Virtually all patients are older than 55 years at presentation, with an average age of 70 years. Patients with high-risk B-CLL who have failed other therapies have a median overall survival of one to five years.