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CytRx Corporation (CYTR) Ditches Lung Cancer Drug After Phase 2 Trial Failure



5/8/2013 10:48:49 AM

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CytRx Provides Update on Clinical Programs

LOS ANGELES--(BUSINESS WIRE)--CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that it will focus on the clinical development of aldoxorubicin and expansion of its oncology pipeline based on its proprietary linker platform technology, following the recommendation of an independent Data Safety Monitoring Committee (DSMC) to discontinue the Phase 2b clinical trial with tamibarotene as a first-line treatment for patients with advanced non-small-cell lung cancer. The recommendation was based on an interim analysis indicating that patients treated with tamibarotene were unlikely to show improved progression-free survival over treatment with approved chemotherapeutic agents. No safety concerns were raised.

Earlier this week, CytRx announced that the independent DSMC for its Phase 2b clinical trial with aldoxorubicin as a first-line treatment for patients with advanced soft tissue sarcoma found no significant safety issues and recommended that the trial should be continued to completion. The Company expects to report results from the Phase 2b clinical trial in the second half of 2013.

“This is an eventful time as we expect to announce data from three clinical trials with aldoxorubicin this year and are making preparations to begin our first pivotal Phase 3 clinical trial with aldoxorubicin,” said Steven A. Kriegsman, CytRx President and CEO. “We see significant opportunities ahead with potential from multiple drug candidates addressing numerous oncology indications. Aldoxorubicin is its own pipeline with demonstrated efficacy in human tumor models of breast, ovarian, lung and pancreatic cancers and renal cell carcinoma (kidney cancer). Our linker platform can be combined with virtually any chemotherapeutic agent and is designed to improve concentration of drug at the site of tumors.

“We are disappointed by the outcome of the tamibarotene trial for our Company, but more importantly for patients. The trial was well-conducted but the DSMC judged that it would not be able to successfully meet its primary endpoint. We will continue to make tamibarotene available on a compassionate use basis for patients with acute promyelocytic leukemia,” he added.

Update on Aldoxorubicin Development

CytRx is preparing to initiate a global, open-label, randomized pivotal Phase 3 clinical trial comparing treatment with aldoxorubicin with approved chemotherapeutic agents for patients with soft tissue sarcoma who have relapsed or were refractory following prior treatment with chemotherapy. A Special Protocol Assessment (SPA) has been granted by the U.S. Food and Drug Administration (FDA) for the pivotal Phase 3 trial. The SPA indicates that the FDA deems the results from a single Phase 3 clinical trial as acceptable to support the regulatory approval, with final marketing approval dependent on the results of the trial and other accomplishments.

In addition to results from the Phase 2b clinical trial with aldoxorubicin, CytRx expects to report data from two additional clinical trials with aldoxorubicin in 2013, both in the second quarter. The first is a Phase 1b clinical trial in patients with advanced solid tumors to determine the maximum tolerated dose (MTD) of a combination of aldoxorubicin and doxorubicin. The clinical trial will continue with the combination aldoxorubicin and doxorubicin administered at the MTD to an expanded group of patients with chondrosarcomas or chordomas to determine safety and preliminary efficacy in these normally chemotherapy-insensitive malignancies. The purpose of this trial is to extend the Company’s patent portfolio and potentially increase market penetration with aldoxorubicin for the treatment of patients with solid tumors. The Company also expects to report pharmacokinetic results from an open-label, single-center Phase 1b clinical trial in patient with metastatic solid tumors.

Novel Linker Platform Technology

CytRx is evaluating drug candidates developed with a novel linker platform technology that has demonstrated affinity to couple with chemotherapeutic agents and concentrate drug at the site of tumors. The linker technology works by attaching a drug to its pH-sensitive, albumin-binding chemical linker. Following intravenous administration, the two-part drug rapidly develops a chemical bond with circulating albumin, the most abundant amino acid in blood. Albumin concentrates at the tumor site and drug is released in high concentrations into the tumor due to the lower pH level of the tumor.

“This linker technology is designed to address the limitations of many chemotherapeutic agents,” said CytRx Executive Vice President and Chief Medical Officer Daniel Levitt, MD, Ph.D. “Systemic delivery of these toxic agents adversely affects normal organs. Additionally, efficacy is often not optimized due to the inability to safely deliver sufficient amounts of these toxic chemotherapeutic agents to tumor sites. The tumor-targeting linker technology harnesses the body’s own albumin to concentrate drug at the tumor site, which appears to allow for greater amounts of drug to be safely administered in each chemotherapy cycle and for additional cycles of drug to be administered with reduced side effects.”

CytRx is evaluating the linker technology with a platinum-based chemotherapeutic agent in preclinical testing, targeting ovarian cancer and small cell lung cancer for the clinic, as well as a combination of the linker with lactosaminated albumin (LSA), which has shown the ability in preclinical testing to target and destroy tumors in the liver.

CytRx holds certain exclusive worldwide rights to the linker technology, which was developed by Felix Kratz, Ph.D., Department of Medical Oncology, Clinical Research, at the Tumor Biology Center in Freiburg, Germany.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline is focused on the clinical development of its tumor-targeting doxorubicin conjugate aldoxorubicin (formerly known as INNO-206). 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, and has initiated a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors. The Company is initiating a Phase 3 pivotal trial under a special protocol assessment (SPA) with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx is expanding its pipeline of oncology candidates based on its proprietary linker platform technology that can be utilized with multiple chemotherapeutic agents and could allow for greater concentration of drug at tumor sites. The Company also has rights to two additional drug candidates, tamibarotene and bafetinib. 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, and is evaluating further development of tamibarotene. For more information about CytRx Corporation, visit www.cytrx.com.

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 risks relating to the outcome, timing and results of CytRx's clinical trials, the risk that any future human testing of aldoxorubicin, the Company’s linker technology and other drug candidates might not produce results similar to those seen in past human or animal testing, risks related to CytRx's ability to manufacture its drug candidates 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 the Phase 3 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.

Contacts

Investor Relations
Legend Securities, Inc.
Thomas Wagner
800-385-5790 x152
718-233-2600 x152
twagner@legendsecuritiesinc.com
or
CytRx Corporation
David Haen
Vice President, Business Development
(310) 826-5648 x304
dhaen@cytrx.com

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