CytRx to Present Aldoxorubicin Clinical Trial Data in Patients with Soft Tissue Sarcomas at the 2017 American Society of Clinical Oncology Annual Meeting (ASCO)

Global Phase 3 Clinical Trial Results Selected for Oral Presentation

 

LOS ANGELES, April 21, 2017 -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that an abstract describing results from its global Phase 3 clinical trial evaluating aldoxorubicin versus investigators' choice in patients with relapsed and refractory soft tissue sarcomas (STS) has been selected for an oral presentation at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2017 in Chicago. 

 

In addition, updated data from the Company's ongoing Phase 1/2 clinical trial combining aldoxorubicin with ifosfamide/mesna in patients with first-line soft tissue sarcomas has also been selected for a poster presentation.  

 

"We look forward to presenting the more detailed and updated global Phase 3 results to the medical community at ASCO this year," said Daniel Levitt, M.D., Ph.D., Chief Operating Officer and Chief Medical Officer of CytRx.  "The Phase 3 trial and the combination trial of aldoxorubicin with ifosfamide continue to build on our prior studies showing the utility of aldoxorubicin as a treatment for patients with STS.  These trials, together with our other clinical and pre-clinical studies of aldoxorubicin, will support our planned New Drug Application submission."

 

Details for the presentations at ASCO 2017:

 

Oral Presentation

 

Title: Phase III study of aldoxorubicin vs investigators' choice as treatment for relapsed/refractory soft tissue sarcomas

Presenter:Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, and Principal Investigator

Abstract #: 11000

Session Title: Oral Abstract Session: Sarcoma

Location: S100bc

Date and Time: Friday, June 2, 2017; 3:00pm-6:00pm CT

 

Poster Presentation

 

Title: Administration of aldoxorubicin and 14 days continuous infusion of ifosfamide/Mesna in metastatic or locally advanced sarcomas.

Presenter:Frederick C. Eilber, M.D., Director of the UCLA Sarcoma Translational Research Program within the Jonsson Comprehensive Cancer Center 

Abstract #: 11051

Session Title: Poster Session: Sarcoma

Location: Hall A

Poster board#: 374

Date and Time:  Sunday, June 4, 2017; 8:00am-11:30am CT

 

About Soft Tissue Sarcoma

 

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue.  It can arise anywhere in the body at any age.  STS remains a high unmet medical need because of the difficulty in treating the more than 50 types of this aggressive cancer.  According to the American Cancer Society, in 2016 more than 12,300 new cases were diagnosed in the U.S. and approximately 5,000 Americans died from this disease.  In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

 

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 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. 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 6,500 mg/m2 of doxorubicin equivalents. Aldoxorubicin is the first-ever single agent to show superiority over doxorubicin in a randomized 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.  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. Such statements are not promises or guarantees, and involve numerous risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements.  These risks include: risks relating to the outcome, timing and results of CytRx's clinical testing of aldoxorubicin and the timing and outcome of the planned NDA submission for aldoxorubicin for the treatment of STS; and the other risks and uncertainties described in CytRx's Annual Report on Form 10-K for the year ended December 31, 2016 filed with the Securities and Exchange Commission. 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 Corporation

David J. Haen

Vice President, Business Development and Investor Relations

(310) 826-5648, ext 304

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Investor Relations Contact:

Argot Partners

Michelle Carroll

(212) 600-1902

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