Data Show Aldoxorubicin, Alone or in Combination with Ifosfamide, Lacks Cardiotoxicity with Doxorubicin Equivalent Doses Beyond 1000 mg/m2
LOS ANGELES, June 7, 2018 /PRNewswire/ -- CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today highlighted clinical data from partner NantCell’s poster presentation on June 2, 2018 at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting, in Chicago. The data clearly demonstrates the lack of cardiac toxicity associated with treatment with aldoxorubicin. These results were obtained from two clinical trials of aldoxorubicin, a rationally-engineered cytotoxic which employs a linker bound to albumin to deliver doxorubicin directly into the tumor.
Fifty-two patients from a Phase 1/2 study of aldoxorubicin and ifosfamide/mesna, and a Phase 3 study using aldoxorubicin alone were evaluated. Data from a global Phase 2 (INNO-206-P2-STS-01) and Phase 3 (P3-STS-01) clinical study of doxorubicin versus aldoxorubicin was also reviewed. Cardiac function was evaluated by echocardiogram at regular intervals. The median cumulative dose of aldoxorubicin was 2,800 mg/m2 (range 1,500-9,000 mg/m2), equivalent to 2,080 mg/m2 (range 1,115-6,687 mg/m2) of doxorubicin. Results from the study showed that no patient developed any sign or symptom of clinical congestive heart failure. Ventricular ejection fractions ranged from 45-74% baseline, and 50-77% at the end of treatment, with the median being 60% both at the beginning and at the end of treatment.
“Doxorubicin’s use in treating sarcomas has always been limited due to its known cardiotoxicity profile,” said Sant Chawla M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica and Principal Investigator for both studies. “The data presented this year at ASCO show that aldoxorubicin can be administered safely alone, or with continuous infusion of ifosfamide/mesna, without causing cardiotoxicity. Importantly, no clinically significant cardiac problems were observed with median cumulative dose of aldoxorubicin of 2,800 mg/m2, which is equivalent to 2,080 mg/m2 of doxorubicin. These results continue to build upon the growing body of safety data for aldoxorubicin.”
CytRx out-licensed global development, manufacturing, and commercialization rights for aldoxorubicin to NantCell, Inc., a private subsidiary of NantWorks, LLC, in July 2017.
About ASCO
The American Society of Clinical Oncology Annual Meeting is one of the largest and most influential conferences in the field. It is an international gathering that brings together more than 40,000 oncology professionals, thought leaders, patient advocates and the general public to present cutting-edge treatment modalities, discuss new therapies, and debate ongoing controversies. The 2018 meeting will take place in Chicago, June 1 through June 5. ASCO provides conference attendees with a variety of perspectives on treatment through debates, tumor boards, presentations of abstracts, and Meet the Professor sessions. New in 2018, the conference will feature ASCO Voices, a thought-provoking one-hour session devoted to the presentation of 7-minute long talks that convey the speaker’s ideas and passion, without incorporating slides, data or figures of any kind.
About CytRx Corporation
CytRx Corporation (Nasdaq: CYTR) is a biopharmaceutical company with expertise in discovering and developing new therapeutics to treat patients with cancer. CytRx’s wholly owned subsidiary, Centurion BioPharma Corporation, is focused on advancing a portfolio of novel, anti-cancer drug candidates that employ its LADR™ (Linker Activated Drug Release) technology, a discovery engine designed to leverage the Company’s expertise in albumin biology and linker technology for the development of a new class of potential breakthrough anti-cancer therapies. A critical element of the LADR™ platform is its ability to bind anti-cancer molecules to albumin, the most ubiquitous protein in human blood plasma, and then to release the highly potent cytotoxic payload at the tumor site. This technology allows for the delivery of higher doses of drug directly to the tumor, while avoiding much of the off-target toxicity observed with the parent molecules. CytRx’s most advanced drug conjugate, aldoxorubicin, is an improved version of the widely used anti-cancer drug doxorubicin and has been out-licensed to NantCell, Inc.
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 ability of NantCell, Inc., to obtain regulatory approval for its products that use aldoxorubicin; the ability of NantCell, Inc., to manufacture and commercialize products or therapies that use aldoxorubicin; the amount, if any, of future milestone and royalty payments that we may receive from NantCell, Inc.; Centurion BioPharma Corporation’s ability to develop new ultra-high potency drug candidates based on its LADR™ technology platform; our ability to attract potential licensees; 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.
Investor Relations Contact:
Argot Partners
Michelle Carroll
(212) 600-1902
cytrx@argotpartners.com
SOURCE CytRx Corporation
