CytRx Initiates Phase 1b Clinical Trial with Combination of Aldoxorubicin (INNO-206) and Doxorubicin in Patients with Advanced Solid Tumors

LOS ANGELES, Jul 25, 2012 (BUSINESS WIRE) -- CytRx Corporation CYTR +19.47%  , a biopharmaceutical company specializing in oncology, today announced the initiation of a Phase 1b clinical trial to determine the maximum tolerated dose and to evaluate preliminary efficacy of aldoxorubicin (formerly INNO-206) administered in combination with the commonly used chemotherapeutic agent doxorubicin in patients with advanced solid tumors who have failed other therapies. Aldoxorubicin is a tumor-targeting conjugate of doxorubicin.

"Recent trials conducted by Dr. Felix Kratz of the Tumor Biology Institute in Freiburg, Germany using animal models of human tumors showed that the combination of aldoxorubicin and free doxorubicin administered at 50% each of their respective maximum tolerated dose provided complete and prolonged remissions in ovarian and pancreatic cancers with minimal weight loss compared with each drug administered individually at its maximum tolerated dose," said Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, Calif. "Given these favorable results, the combination of aldoxorubicin plus doxorubicin warrants further evaluation as a treatment for patients with solid tumors."

The single-center Phase 1b clinical trial will be conducted under the direction of Dr. Chawla and will enroll up to 24 patients. Doxorubicin will be administered at 50% of its maximum tolerated dose in combination with escalating doses of aldoxorubicin to determine the maximum tolerated dose of the combination of these two drugs in this patient population.

In June, CytRx reported results for a Phase 1b/2 clinical trial indicating that aldoxorubicin administered at its maximum tolerated dose showed clinical benefit (defined as partial response and stable disease of more than four months following up to eight cycles of treatment) in 10 of 13 (77%) evaluable patients with relapsed or refractory soft tissue sarcoma. All patients in the Phase 1b/2 trial had either not responded to or relapsed after treatment with between one and three prior chemotherapy regimens. Based on the results of this trial CytRx plans to meet with the FDA in the second half of 2012 to discuss a potential Phase 3 pivotal trial as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy.

"We are delighted that such a distinguished sarcoma expert as Dr. Chawla has agreed to serve as principal investigator for yet another trial with aldoxorubicin," said CytRx CEO Steven A. Kriegsman. "Dr. Chawla led our Phase 1b/2 clinical trial with aldoxorubicin in patients with advanced solid tumors and presented clinical results from this trial at the American Society of Clinical Oncology (ASCO) conference last month. He also is leading our global Phase 2b clinical trial designed to compare aldoxorubicin head-to-head with doxorubicin as a first-line treatment for patients with advanced soft tissue sarcoma. Enrollment completion and data analysis are expected for this trial in 2013."

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: aldoxorubicin (formerly known as INNO-206), tamibarotene and bafetinib. With its tumor-targeted doxorubicin conjugate aldoxorubicin, CytRx has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication, recently initiated a Phase 2 trial for patients with advanced pancreatic ductual adenocarcinomas, and plans to meet with the FDA in the second half of 2012 to discuss a potential Phase 3 pivotal trial as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx's pipeline also includes tamibarotene, which it is testing in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer, and which is in a Phase 2 clinical trial as a treatment for acute promyelocytic leukemia (APL). The Company completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about the Company, visit .

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including the risk that any human testing of aldoxorubicin in combination with doxorubicin as a therapy for cancer, including the Phase 1b maximum tolerated dose study described in this press release, might not produce positive results or results similar to those seen in preclinical studies, risks and uncertainties related to the outcome, timing and results of CytRx's other ongoing and planned clinical trials with aldoxorubicin, the risk that aldoxorubicin alone, or in combination with free doxorubicin, might not show greater efficacy than doxorubicin alone notwithstanding the administration of higher doses than the standard of care, the risk that additional longer-term dosing of aldoxorubicin might cause adverse events not seen to date, uncertainties regarding whether aldoxorubicin effectively targets doxorubicin to tumors, uncertainties regarding regulatory approvals for current and future clinical testing of aldoxorubicin and the scope of the clinical testing that may eventually be required by regulatory authorities for aldoxorubicin, the significant time and expense that will be incurred in developing any of the potential commercial applications for aldoxorubicin, including for soft tissue sarcomas, risks related to CytRx's ability to manufacture its drug candidates, including aldoxorubicin, in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including any future clinical development of aldoxorubicin, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE: CytRx Corporation