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CytRx Corporation : Major Milestone Achieved in CytRx's Phase 2b Global Clinical Trial with Tamibarotene as a First-Line Treatment for Non-Small-Cell Lung Cancer

06/25/2012 | 08:35am EDT

Independent Data Safety Monitoring Board recommends continuation of Phase 2b trial

Trial data expected in 2013

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, today announced the recommendation by the Data Safety Monitoring Board (DSMB) to continue with the global Phase 2b clinical trial with tamibarotene in combination with chemotherapeutical agents as a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC). The DSMB's pre-scheduled review of Phase 2b trial data collected as of May 31, 2012 showed no significant difference in drug-related severe or serious adverse events reported by trial patients between those treated with tamibarotene and those treated with placebo. The DSMB is an independent group of oncologists and biostatisticians who monitor the safety and efficacy of the Phase 2b trial.

"We've achieved a key milestone in advancing the late-stage clinical development of tamibarotene in a significant oncology indication that claims more lives than breast, prostate and ovarian cancer combined," said CytRx CEO Steven A. Kriegsman. "We expect to report data from the global Phase 2b clinical trial in 2013. There is no question that effective treatment of metastatic NSCLC is a major unmet medical need and that tamibarotene in this indication could represent an important market opportunity for CytRx and our shareholders."

One hundred forty (140) evaluable patients with advanced NSCLC are being enrolled at 25 clinical sites in the U.S., Mexico, Europe and India in the double-blind, placebo-controlled Phase 2b trial. Trial patients are treated with paclitaxel plus carboplatin and either tamibarotene or placebo. The primary objective of this trial is to determine the objective response rate (complete and partial responses) and progression-free survival. Secondarily, the trial will evaluate overall survival, quality-of-life and examine the pharmacokinetics of tamibarotene in this population, among other measures.

"We are optimistic about tamibarotene's prospects in advanced NSCLC based on clinical data indicating a statistically significant improvement in these patients when all-trans retinoic acid (ATRA) was combined with paclitaxel and cisplatin," said Daniel Levitt, MD, Ph.D., CytRx's Chief Medical Officer. "Tamibarotene appears to be 10-times more potent than ATRA and was designed to avoid several of the toxic side effects of ATRA by selectively binding to specific molecular receptors. The DSMB's recommendation to move forward with Phase 2b testing indicates that there are no significant safety issues seen thus far when tamibarotene is used with potent chemotherapy agents, even in patients with advanced disease."

A clinical trial conducted by Arrieta (the principal investigator for CytRx's clinical trial) et al. and published in the peer-reviewed Journal of Clinical Oncology (June 17, 2010) compared ATRA added to a regimen of paclitaxel plus cisplatin to a regimen of paclitaxel plus cisplatin alone as a treatment for patients with advanced NSCLC. The group administered ATRA plus the chemotherapeutic agents showed improved response rates of 55.8% versus 25.4%, and increased progression-free survival of 8.9 months versus 6.0 months. Median overall survival was increased from 9.5 months to 23.5 months when ATRA was added to the above chemotherapy regimen, representing a 14-month median extension of life.

Non-Small-Cell Lung Cancer

This year more than 226,000 new cases of lung cancer will occur in the U.S. and more than 1.5 million worldwide. Deaths due to lung cancer account for the majority of cancer-related deaths (160,000 in the U.S., 1.4 million worldwide) and the five-year survival ranges between 8-15%. NSCLC accounts for 85-90% of all lung cancers.

About Tamibarotene

Tamibarotene is an orally available, rationally designed, synthetic retinoid compound. CytRx also is conducting a Phase 2 clinical trial with tamibarotene as a treatment for acute promyelocytic leukemia (APL). CytRx holds the North American and European rights to certain tamibarotene intellectual property for the treatment of NSCLC and APL, and retains an option to expand its licenses for the use of tamibarotene in other fields in oncology.

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 to discuss a potential Phase 3 pivotal trial as a third-line therapy for soft tissue sarcomas in the second half of 2012. 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 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 or uncertainties related to the outcome, timing and results of CytRx's planned Phase 2b clinical trial for tamibarotene as a treatment for NSCLC, uncertainties regarding regulatory approvals for current and future clinical testing of tamibarotene and the scope of the clinical testing that may eventually be required by regulatory authorities for tamibarotene, the significant time and expense that will be incurred in developing any of the potential commercial applications for tamibarotene, including for NSCLC, the risk that any future human testing of tamibarotene for NSCLC might not produce results similar to those seen with ATRA, risks related to CytRx's ability to manufacture its drug candidates, including tamibarotene, 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 tamibarotene, 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.

Investor Relations
Legend Securities, Inc.
Thomas Wagner
800-385-5790 x152
718-233-2600 x152

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Managers and Directors
Steven A. Kriegsman Chairman & Chief Executive Officer
John Y. Caloz Chief Financial Officer, Treasurer & Senior VP
Louis J. Ignarro Lead Independent Director
Joel Caldwell Independent Director
Cristina Newman Secretary
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