CytRx Corp. (CYTR) Monday said a phase II proof-of-concept study of bafetinib showed clinical activity in patients with relapsed or refractory B-cell chronic lymphocytic leukemia or B-CLL. CytRx has also determined the dose for moving into any future clinical trials in combination with a cytotoxic agent or monoclonal antibody.
Bafetinib, a Lyn kinase inhibitor, targets a member of the B-cell receptor activation pathway in a manner similar to inhibitors of other tyrosine kinases developed for B-CLL.
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 U.S. each year. Patients with high-risk B-CLL have a median overall survival of one to five years.
The 18 late-stage B-CLL patients enrolled in the ENABLE trial had been treated with and failed between one and six therapies. Patients were treated with orally administered bafetinib twice daily. Of the 12 evaluable patients, CytRx reported that six achieved 30 percent or greater shrinkage of the lymph node and spleen. Four of the 12 patients had stable disease.
The company said no serious adverse events were observed at the dose of 240 mg twice daily, the dose likely to be used in any future clinical trials for chronic lymphocytic leukemia.
CytRx holds rights to bafetinib (formerly known as INNO-406) in all territories except Japan. Bafetinib was originated by Kyoto, Japan-based Nippon Shinyaku Co. Ltd.
In November 2008, CytRx announced that bafetinib demonstrated clinical responses in patients with CML in an international, open-label Phase 1 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 dasatinib and nilotinib.
CytRx's chief medical officer Daniel Levitt, said," Bafetinib is 25 to 55 times more potent than the protein-tyrosine kinase inhibitor imatinib against certain BCR-ABL-positive leukemia cell lines and is a potent inhibitor of Lyn kinase, which is over expressed in many imatinib-resistant leukemia cells."
Bafetinib has been granted Orphan Drug Status for the treatment of Ph+ CML by the U.S. Food and Drug Administration. The drug has also received a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency for the status for treatment of CML.
CytRx president and CEO Steven Kriegsman said," We are currently in discussions with potential partners to further advance bafetinib's clinical development as we focus our clinical efforts on our other two promising drug candidates, INNO-206 and tamibarotene."
CYTR is currently trading at $0.31, down $0.02 or 6.06%, on a volume of 1.5 million shares, on the Nasdaq. Over the past year, the stock traded in a range of $0.27 -$1.11, with three-month average volume of 0.8 million shares.
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