CytRx to Present Global Phase 3 Aldoxorubicin Clinical Data in Patients with Soft Tissue Sarcomas at the 2017 American Society of Clinical Oncology Annual Meeting

LOS ANGELES, May 17, 2017 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced the presentation of two abstracts at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2017 in Chicago.  The first is an oral presentation featuring updated and more detailed results from the Company's global Phase 3 clinical trial evaluating aldoxorubicin versus investigator's choice in patients with relapsed and refractory soft tissue sarcomas (STS).  The other is a poster presentation describing updated data from an ongoing Phase 1/2 clinical trial combining aldoxorubicin with ifosfamide/mesna (I-M) in first- and second-line STS.

"In addition to the significantly prolonged progression-free survival achieved by both North American and L-sarcoma patients, the data presented at ASCO this year demonstrate that, unlike any other drugs in this class, aldoxorubicin can be dosed continuously with minimal to no cardiotoxicity," commented Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, California, and Principal Investigator for the Phase 3 trial.  "Another distinct advantage is its ability to be administered to patients who have already been treated with doxorubicin.  Taken together, these findings support aldoxorubicin's potential as a superior anthracycline treatment for patients suffering with these highly complex and difficult to treat types of cancer."

Daniel Levitt, M.D., Ph.D., Chief Operating Officer and Chief Medical Officer of CytRx, commented, "The data from both of these important clinical trials evaluating aldoxorubicin in sarcomas, along with our several other completed clinical and preclinical studies, will form the basis of our planned New Drug Application submission to the U.S. Food and Drug Administration, and we are pleased to share these more mature and detailed results in this peer-reviewed forum with the medical and scientific communities."

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
Summary:  This multicenter, randomized, open-label Phase 3 trial enrolled 433 patients at 79 sites.  The data summarized here are as of August 2016.  In patients with leiomyosarcoma and liposarcoma (n=246), aldoxorubicin demonstrated median progression-free survival (PFS) of 5.32 months, compared to a median PFS of 2.96 months for investigator's choice therapy, a statistically significant improvement of 2.36 months (p=0.007; hazard ratio (HR)=0.62, 95% CI 0.44-0.88), representing a 38% reduction in the risk of tumor progression.  In patients treated in North America plus Australia (n=312), aldoxorubicin demonstrated a median PFS of 4.21 months, compared to a median PFS of 2.96 months for investigator's choice therapy, a statistically significant improvement of 1.25 months (p=0.023, HR=0.71, 95% CI 0.53-0.96).  In the overall intent to treat (ITT) trial population (n=433), aldoxorubicin performed better than investigator's choice demonstrating a median PFS of 4.11 months, compared to a median PFS of 2.96 months for investigator's choice therapy, narrowly missing statistical significance (p=0.087; HR=0.81, 95% CI 0.64-1.03).  All responses in this study were determined by an independent, blinded central lab assessment of scans.

Key safety findings included that aldoxorubicin caused no clinically significant cardiac, renal, or hepatic toxicities.  Aldoxorubicin administered at 350mg/m² per cycle showed no cardiotoxicity up to 40 cycles.  Importantly, left ventricular ejection fraction (LVEF) below 50% of expected values were reported in 4.2% of patients treated with aldoxorubicin, compared to 19.1% for patients receiving investigator's choice.  Additionally, ≥20% decreases in LVEF from baseline were reported in 3.8% of patients treated with aldoxorubicin, compared to 8.5% for patients receiving investigator's choice.  For the global trial population, the most commonly reported (≥10%) Grade ≥3 adverse events were neutropenia, anemia, febrile neutropenia, stomatitis and decreased white blood cell count, and were manageable with standard supportive care.  The non-cardiac Grade ≥3 adverse events associated with aldoxorubicin were similar to doxorubicin despite exposure up to 3-4 times the standard doxorubicin dose.

Updated data relating to the trials other secondary endpoints, including objective response rate (ORR), disease control rate (DCR), overall survival, and other safety parameters were in line with what has previously been reported by CytRx and will be included in the oral presentation being given at ASCO 2017.

Following conclusion of Dr. Chawla's presentation, a PDF copy of the oral presentation slides will be available at http://cytrx.com/investors/presentations.

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
Summary:  This ongoing open-label Phase 1/2 clinical trial is designed to assess the preliminary safety and activity of aldoxorubicin plus I-M as a first- or second-line treatment in patients with STS.  Patients were administered 1 of 2 dose levels of aldoxorubicin (170mg/m² or 250mg/m² [125mg/m² or 185mg/m² doxorubicin equivalent]) on Day 1, then I-M (1g/m² of each per day) was administered for up to 14 days as a continuous infusion.  Chemotherapy cycles were repeated at 28 day intervals, but I-M was limited to a maximum of 6 cycles to avoid cumulative bone marrow toxicity.  Aldoxorubicin was continued per investigator decision in either responding or stable disease (SD) patients.  Patients were followed for tumor response by CT scans and echocardiogram for cardiac toxicity every 8 weeks along with standard labs.

Of the 44 evaluable patients as of May 10, 2017, 16 patients (36%) achieved a partial response (PR), 25 patients (57%) achieved SD, with 20 patients (45%) achieving SD for ≥4 months, for an overall disease control rate (DCR) of 82% (PR+SD≥4).  Twenty-two of 44 (50%) patients received at least 6 cycles of aldoxorubicin (>1,300 mg/m² cumulative doxorubicin equivalent).  As of the data cutoff date, the median PFS had not been reached.  The most commonly reported Grade ≥3 adverse event (AEs; >20%) were neutropenia and anemia.  Reported serious adverse events (SAEs) included febrile neutropenia (14%, n=6), anemia (5%, n=2), thrombocytopenia (2%, n=1), stomatitis (2%, n=1) and pyrexia (2%, n=1).  No clinically significant cardiotoxicity has been observed and no patients had a clinically significant decrease in LVEF or QTc prolongation, despite administration of median cumulative doses of doxorubicin equivalents of 1364-1965mg/m².  No treatment related deaths occurred.  These results support the thesis that aldoxorubicin can be administered safely and for prolonged periods with continuous infusion I-M and achieves high response rates and SD, with substantial tumor necrosis.  Based on these results, the decision was made to stop further aldoxorubicin dose escalation and continue to enroll only in the 250mg/m² cohort.

Following conclusion of the poster presentation, a PDF copy of the poster will be available at http://cytrx.com/investors/presentations.

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 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 and uncertainties relating to the preparation and submission of an NDA for aldoxorubicin for the treatment of STS and FDA acceptance and review of any NDA, the risk that CytRx may be unsuccessful in obtaining FDA approval or, if approval is obtained, in commercializing aldoxorubicin in the United States or elsewhere, and other 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 Corporation
David J. Haen
Vice President, Business Development and Investor Relations
(310) 826-5648, ext 304
[email protected]

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SOURCE CytRx Corporation

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