CytRx Announces the Completion of Enrollment in Its Global Phase 2b Clinical Trial of Aldoxorubicin in Patients with Second-Line Small Cell Lung Cancer

LOS ANGELES, Sept. 7, 2016 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that it has reached its enrollment target of 132 patients for the company's global Phase 2b clinical trial of aldoxorubicin in patients with previously treated small cell lung cancer (SCLC).  The Phase 2b study is a randomized, comparative trial being conducted at 41 sites in the United States, Hungary and Spain. 

"Patients with metastatic small cell lung cancer who have relapsed or are refractory to first-line chemotherapy have few treatment options," said Steven A. Kriegsman, Chairman and CEO of CytRx. "Aldoxorubicin represents a potential new therapy to combat this aggressive form of cancer.  The Phase 2b trial uses a lower dose of aldoxorubicin than our Phase 3 trial in soft tissue sarcoma, which may improve the tolerability and potentially allow patients to stay on treatment longer.  We look forward to reporting the trial results once they are available."

Because of the unmet medical need for patients with second-line SCLC, if the global Phase 2b clinical trial results are positive, CytRx intends to meet with the U.S. FDA to discuss the regulatory pathway for the submission of a New Drug Application for aldoxorubicin in this patient population.

Trial Design

The multicenter, randomized, open-label, global Phase 2b clinical trial enrolled 132 patients with metastatic SCLC who either did not respond to, or who progressed following treatment with one systemic therapy. Trial patients were randomized 1:1 to be treated with aldoxorubicin at a dose of 230mg/m2 (170mg/m2 of doxorubicin equivalents) or standard dose topotecan. The primary endpoint of the study is progression-free survival, and secondary endpoints include overall survival, response rates and safety.

About Small Cell Lung Cancer

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 American Cancer Society, more than 33,000 new cases will be diagnosed in the USA in 2016.  GlobalData estimates the 2016 incidence of SCLC in Europe and Asia to be greater than 32,000 and 175,000, respectively.

About Aldoxorubicin

Aldoxorubicin is a rationally-engineered cytotoxic which combines doxorubicin, a widely used chemotherapeutic agent, with a novel linker molecule that binds directly and specifically to circulating albumin, the most abundant protein in the bloodstream.  Protein-hungry tumors concentrate albumin, which facilitates 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. Typically, doxorubicin is delivered systemically and is highly toxic, which limits dosing 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. Using this acid-sensitive linker technology, aldoxorubicin delivers greater doses of doxorubicin (3 ½ to 4 times). To date, 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. Aldoxorubicin is the first-ever single agent to show superiority over doxorubicin in a randomized, global Phase 2b clinical trial in first-line STS. 

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, its improved version of the widely used chemotherapeutic agent doxorubicin, and DK049, a novel drug conjugate which is expected to enter clinical trials in 2017.  CytRx is also expanding its pipeline of oncology candidates at its laboratory facilities in Freiburg, Germany, through its LADR™ (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx's expertise in albumin biology and linker technology for the development of a new class of anti-cancer therapies.

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 testing of aldoxorubicin and preclinical testing of its LADR™ linker technology platform, the outcome, timing or results of CytRx's clinical testing of aldoxorubicin, the risk that any future pre-clinical or human testing of compounds based on the LADR™ technology platform might not show efficacy or reduced side effects of those compounds,, 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 2 and Phase 3 clinical development of aldoxorubicin for SCLC and STS, respectively, and the preclinical and clinical development of compounds based on the LADR™ technology platform, 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.

Company Contact:

CytRx CorporationDavid J. HaenVice President, Business Development and Investor Relations(310) 826-5648, ext. 304[email protected]

Investor Relations:Alexander Capital, LP(855) 288-ALEX (2539)[email protected]

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SOURCE CytRx Corporation