CytRx Reports Further Positive Interim Data From Global Phase 2b Clinical Trial With Aldoxorubicin Versus Doxorubicin As First-Line Therapy In Advanced Soft Tissue Sarcomas

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announces further positive clinical data from a multi-site global Phase 2b study comparing the Company’s aldoxorubicin as a first-line treatment for advanced soft tissue sarcomas (STS) versus the widely used chemotherapeutic agent doxorubicin. The data is contained in a poster presented today at the 18 th Annual Connective Tissue Oncology Society Meeting at the Sheraton New York Times Square Hotel and includes additional information captured between September 27 and October 16, 2013. The study is still ongoing, and as of October 16, 2013, 47 patients remained active in the clinical trial (36 on aldoxorubicin and 11 on doxorubicin). CytRx expects to report top-line progression-free survival results for the global Phase 2b clinical trial in December 2013.

In this trial 123 patients age 18-80 years with histologically confirmed metastatic, locally advanced or unresectable soft tissue sarcomas were randomized 2:1 to receive 350 mg/m 2 aldoxorubicin (260 mg/m 2 doxorubicin equivalents) IV or 75 mg/m 2 doxorubicin IV every three weeks for up to six cycles.

According to the findings presented in the poster, aldoxorubicin can be administered at doses greater than 3 1/2 x the standard doxorubicin dose with similar or fewer systemic side effects. A significantly higher percentage of patients receiving aldoxorubicin are still active, have received at least 4 or 6 cycles of treatment and have a greater number of tumor responses and stable disease.

Among the findings presented today, patients in the trial treated with aldoxorubicin had a higher Overall Response Rate (ORR) (22%) compared with those treated with doxorubicin (0%) (p=0.004). In addition, a lower percentage of patients treated with aldoxorubicin (32%) showed progressive disease compared with patients treated with doxorubicin (50%) at the time of analysis.

A higher percentage of aldoxorubicin patients completed four cycles of treatment compared with doxorubicin patients (59 vs. 22, respectively) and six cycles of treatment (45 vs. 14, respectively). A similar percentage of aldoxorubicin patients (15%) and doxorubicin patients (16%) experienced neutropenic fever, and a higher percentage of doxorubicin patients (22%) had decreased cardiac output compared with aldoxorubicin patients (11%), as measured by a 15% decrease in left ventricular ejection fraction. No patient treated with aldoxorubicin had ejection fractions below 50% of their institutional norm versus 9.4% of patients that had received doxorubicin. Most importantly, there was no clinically significant reduction in cardiac function in the aldoxorubicin patients despite receiving 3 ½ times the standard dose of doxorubicin.

The poster also reported 24 serious adverse events (SAEs) associated with aldoxorubicin therapy versus 6 SAEs in patients receiving doxorubicin. All SAEs resolved and did not require treatment discontinuation. One treatment-related death in a patient treated with doxorubicin was reported.

“We are very pleased with the continued clinical findings from our global Phase 2b trial with aldoxorubicin as a first-line treatment in advanced soft tissue sarcomas, and the strength of the data presented today reinforces our belief that the linker technology platform can be applied to a broad range of cancer treatments,” said CytRx President and CEO Steven A. Kriegsman. "We look forward to advancing our aldoxorubicin second-line program into a Phase 3 pivotal trial in the first quarter of 2014 as well as evaluating aldoxorubicin as treatment for malignant glioblastoma (brain cancer) and HIV-related Kaposi’s sarcoma.”

STS is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. There are more than 30 types of STS, and according to the National Cancer Institute more than 11,410 new cases are diagnosed each year in the U.S., with 4,390 deaths. According to the Annals of Oncology, incidence of STS in Europe is approximately 4 out of every 100,000 people.

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 500 mg/m 2. 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 of doxorubicin to be administered in a greater number of drug cycles 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 g/m 2.

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 is conducting a global Phase 2b clinical trial with aldoxorubicin as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors, and has completed a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. CytRx plans to initiate under a special protocol assessment a potential pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx also is initiating Phase 2 clinical trials with aldoxorubicin in patients with late-stage glioblastoma (brain cancer) and AIDS-related Kaposi’s sarcoma. CytRx plans to expand its pipeline of oncology candidates based on a linker platform technology that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib. CytRx 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 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, including the conclusion of the Phase 2b clinical testing of aldoxorubicin as a first-line treatment in patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy, might not produce objective response results similar to the preliminary data described in this press release, or might not correlate with the trial’s primary endpoint of progression-free survival, 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.

Copyright Business Wire 2010

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