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CytRx Initiates Global Phase 2b Clinical Trial of Aldoxorubicin for the Treatment of Relapsed/Refractory Small Cell Lung Cancer
Date:9/30/2014

LOS ANGELES, Sept. 30, 2014 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced the initiation of a global Phase 2b clinical trial evaluating aldoxorubicin compared to topotecan in subjects with extensive-stage small cell lung cancer (SCLC) who have relapsed or were refractory to prior chemotherapy. Aldoxorubicin is CytRx's modified version of the widely-used chemotherapeutic agent, doxorubicin. CytRx has received Orphan Drug Designation for the treatment of SCLC from the U.S. Food and Drug Administration (FDA).

"The significant toxicities associated with topotecan, the only approved chemotherapy for the treatment of second-line SCLC, prevent many patients from even finishing one course of treatment, translating to poor response and overall survival rates," said Dr. Daniel Levitt, Executive Vice President and Chief Medical Officer of CytRx.  "Based on its mechanism of action, data observed in a broad range of tumor types, and compelling Phase 1 pharmacokinetic data in metastatic, treatment relapsed or refractory solid tumors, aldoxorubicin may offer patients an improved tolerability profile together with significant improvements in clinically meaningful efficacy measures in this indication. Our previous data in relapsed or refractory solid tumor patients indicates that the dose of aldoxorubicin being administered to these patients is well tolerated and without any treatment-limiting side effects.  Up to 21 cycles (4.8 grams/m2) have been given to one patient with small cell lung cancer with minimal side effects and good anti-tumor activity."

The open-label Phase 2b clinical trial is expected to enroll approximately 132 patients (1:1 randomization) with extensive-stage SCLC who have relapsed or were refractory to prior chemotherapy. Patients will receive either aldoxorubicin or topotecan.  The primary endpoint is progression-free survival (PFS) and the secondary endpoints are overall survival (OS), overall response rates (partial and complete) and the safety of aldoxorubicin compared to topotecan in this population.  Enrollment is expected to be completed in 2015 and PFS data are anticipated by mid-2016.  The study is expected to involve approximately 40 clinical trial sites in the U.S., Spain, Italy and Hungary.

"Initiation of this global clinical trial builds on our substantial experience evaluating aldoxorubicin in soft tissue sarcomas (STS), glioblastoma multiforme and Karposi's sarcoma, and reflects our strategy to leverage the broad potential of aldoxorubicin into a variety of solid tumor and hematological indications, " said CytRx CEO Steven A. Kriegsman.  "We are particularly interested in the potential of aldoxorubin in small cell lung cancer, as this tumor type typically is more sensitive to chemotherapy than STS."

In 2013, CytRx presented results from its Phase 1b clinical trial evaluating the pharmacokinetics and safety of aldoxorubicin in patients with metastatic solid tumors who have either relapsed or not responded to treatment with standard therapies, demonstrating a prolonged duration of treatment with aldoxorubicin.  In that trial, treatment with aldoxorubicin extended to 21 cycles (a cycle is 21 days) in a patient with small cell lung cancer as well as to over 10 cycles in several other patients.

Aldoxorubicin is also currently being studied in a pivotal global Phase 3 clinical trial evaluating the efficacy and safety of aldoxorubicin as a second-line treatment for patients with STS under a Special Protocol Assessment with the FDA. CytRx is also evaluating aldoxorubicin in two Phase 2 clinical trials, one in patients with late-stage glioblastoma (GBM) and the other in HIV-related Kaposi's sarcoma, and a Phase 1b trial in combination with ifosfamide in patients with STS.

About SCLC

An estimated 1.6 million new cases of lung cancer are diagnosed worldwide each year.  In the Western world, approximately 13-15% of cases are SCLC, a deadly form of lung cancer associated with tobacco use.  The five year survival rate is less than 7%, in part because an estimated 70% of patients have extensive disease at diagnosis.  According to the National Cancer Institute, more than 30,000 new cases will be diagnosed in the USA in 2014.  The estimated 2014 SCLC incidences for Europe and Asia are over 58,000 and 136,000, respectively.  

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 1/2 to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx has initiated under a special protocol assessment a pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy, and recently announced that it has received approval from the FDA to continue dosing patients with aldoxorubicin until disease progression in that clinical trial. CytRx has initiated a Phase 2 clinical trial in HIV-related Kaposi's sarcoma, a Phase 2 clinical trial in patients with late-stage glioblastoma (brain cancer), a Phase 2b clinical trial in patients with SCLC, and a Phase 1b trial in combination with ifosfamide in patients with soft tissue sarcoma. CytRx has completed a global Phase 2b clinical trial with aldoxorubicin as a first-line therapy for STS, a Phase 1b/2 clinical trial primarily in the same indication, a Phase 1b clinical trial of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. CytRx plans to expand its pipeline of oncology candidates at its laboratory facilities in Freiburg, Germany, based on novel linker technologies that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. 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 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, risks related to lawsuits that have been brought against the Company and its officers and/or directors for alleged violations of the securities laws, 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:
Argot Partners
Michelle Carroll
212.600.1902
michelle@argotpartners.com

Media:
Argot Partners
Eliza Schleifstein
973.361.1546
eliza@argotpartners.com

Company Contact:
CytRx Corporation
David J. Haen
Vice President, Business Development and Investor Relations
310-826-5648, x304
dhaen@cytrx.com


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SOURCE CytRx Corporation
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