CytRx To Conduct Phase 2 Clinical Trial With Bafetinib In B-cell Chronic Lymphocytic Leukemia

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Blood / Hematology;  Clinical Trials / Drug Trials;  Cancer / Oncology
Article Date: 14 Jan 2010 - 21:00 PDT

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CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company specializing in oncology, today announced plans to initiate a Phase 2 proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib (formerly known as INNO-406) in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL).

CytRx President and CEO Steven A. Kriegsman, stated, "We believe bafetinib is a cutting-edge treatment that could be efficacious in a wide range of hematological cancers. Our objective is to evaluate results from this trial, and if successful, quickly progress into later-stage clinical trials either internally or with partners. An effective treatment could result in a multi-billion dollar oncology product for CytRx."

In the planned Phase 2 trial, approximately 20 patients who have failed treatment with first-line agents will be administered daily oral doses of bafetinib. Patients will be monitored for clinical response, time to disease progression and cancer progression-free survival. Based on trial results, CytRx plans to conduct a larger comparative trial to further determine efficacy of this agent.

Leukemias are cancers of the white blood cells. B-CLL involves an abnormal and malignant proliferation of a particular subtype of white blood cells known as a B cell. B cells originate in the bone marrow, develop in the lymph nodes and normally fight infection. In B-CLL, the DNA of a B cell is damaged, making it unable to fight infection. Additionally, these damaged B cells proliferate and accumulate in the bone marrow and blood, where they crowd out healthy blood cells.

"We are optimistic that our dual protein kinase inhibitor bafetinib will demonstrate efficacy in patients with high-risk B-CLL who have failed other therapies and have few viable treatment options," said CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D. "Bafetinib has shown significant activity in blocking B-CLL cell proliferation in vitro and caused increased cancer cell death. Additionally, bafetinib has demonstrated anti-tumor activity in patients with chronic myelogenous leukemia, who have failed first- and second-line therapy with other kinase inhibitors."

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 in the high-risk B-CLL have a median overall survival of one to five years.

About Bafetinib

Bafetinib is a potent, orally available, rationally designed, dual Bcr-Abl and Lyn-kinase inhibitor, which is currently being planned as a third-line treatment for patients with chronic myeloid leukemia (CML) or certain forms of acute myeloid leukemia (AML) that are refractory or intolerant of other approved treatments. In November 2008, CytRx announced that bafetinib demonstrated clinical responses in patients with CML in an international Phase I dose-ranging clinical trial conducted in patients with CML and other leukemias that have a certain mutation called the Philadelphia Chromosome (Ph+) and are intolerant of or resistant to Gleevec and, in some cases, second-line tyrosine kinase inhibitors such as dasatiniband nilotinib). INNO-406 has been granted Orphan Drug Status for the treatment of Philadelphia chromosome-positive (Ph+) CML by the FDA.

Source
CytRx Corporation

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