CytRx Corporation, a biopharmaceutical company specializing in oncology, announced progression in its clinical programme evaluating the preliminary efficacy and safety of its drug candidate bafetinib in three oncology indications. The company has enrolled its first patient in a phase-2 proof-of-concept trial in patients with high-risk B-cell chronic lymphocytic leukaemia (B-CLL), is reporting rapid advancement toward the initiation of a phase-2 proof-of-concept trial in advanced prostate cancer, and is on track to begin clinical evaluation later this year in glioblastoma multiforme, a common and aggressive type of primary brain tumour.

"These are very exciting times at CytRx as we make substantial progress in advancing the clinical development of bafetinib in a variety of oncology indications," said Steven A Kriegsman, CytRx president and CEO. "Patient enrolment is underway in the B-CLL trial, which we are now calling ENABLE, for Effectiveness iNAdvanced B-Cell Lymphocytic Leukaemia. Our oncology drug development team also is focused on gaining approvals for additional clinical sites for this trial as well as for our planned advanced prostate cancer trial to increase the enrolment rate and potentially shorten the time required for trial completion. We plan to keep investors apprised of our progress with the bafetinib clinical programme, as well as our clinical programmes with oncology drug candidates INNO-206 and tamibarotene, as we work toward our ultimate goal of building CytRx into a world-class oncology company."

In the ENABLE phase-2 proof-of-concept clinical trial with bafetinib in patients with B-CLL, the first patient has been enrolled at MD Anderson Cancer Center in Houston. CytRx is working toward opening additional clinical sites for the ENABLE trial, including a second prestigious site in the US and several sites in India. Activities are underway to gain approval from the Indian regulatory agency (DCGI) and respective site ethics committees.

CytRx is preparing to initiate its phase-2 trial with bafetinib in patients with metastatic hormone-refractory prostate cancer, which is now called the PROACT trialfor PROstate Advanced Cancer Treatment. The PROACT trial is expected to be initiated in a prominent clinical site in the US, as well as multiple clinical sites in India. The investigational new drug (IND) application for bafetinib and the PROACT clinical trial protocol have been submitted to the DCGI and the proposed clinical sites are working with their respective ethics committees to obtain site approvals.

"We are pleased with our progress with the bafetinib clinical programme, which will allow us to further evaluate its potential in the treatment of advanced-stage cancers," said CytRx chief medical officer Daniel Levitt. "Our optimism for this drug candidate is based on a key design differentiator - its pairing of Bcr-Abl inhibitor with a potent inhibitor of Lyn kinase, which is over expressed in many cancers. Potent, orally available bafetinib could improve survival and provide these patients with a better quality of life through its ability to reduce drug-related side effects compared with many approved oncology agents that are often quite toxic."

CytRx holds rights to bafetinib (formerly known as INNO-406) in all territories except Japan. Bafetinib is a potent, orally available, rationally designed, dual Bcr-Abl and Lyn kinase inhibitor, which was developed as a third-line treatment for patients with CML and certain forms of acute myeloid leukaemia (AML) that are refractory or intolerant of other approved treatments.

CytRx Corporation is a biopharmaceutical research and development oncology company engaged in the development of high-value human therapeutics.