LOS ANGELES, June 28, 2018 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today highlighted that aldoxorubicin licensee NantCell, Inc., a private subsidiary of NantWorks, LLC, has dosed the first patient in the Phase 1b portion of a Phase 1b/2 clinical trial for patients with triple negative breast cancer (TNBC). This is the third trial conducted by NantCell which will investigate aldoxorubicin combined with immunotherapy or high-affinity natural killer (haNK) cell therapy in certain high unmet need cancer indications. The first trial in pancreatic cancer patients commenced in January 2018 and the second trial, for patients with advanced squamous cell carcinoma, commenced in February 2018.
Eric Curtis, CytRx's President and Chief Operating Officer stated, "The initiation of this third clinical trial speaks to NantCell's commitment to investigating aldoxorubicin in combination with their proprietary haNK cell therapy and working to identify effective treatment alternatives for women challenged by TNBC, an aggressive, difficult to treat type of breast cancer."
The trial titled "QUILT-3.067 NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy," (NCT03387085) is a single-center, open-label, Phase 1b/2 clinical trial designed to evaluate the safety and efficacy of several combination therapies, including combinations with aldoxorubicin, in subjects with TNBC who have progressed on or after standard of care therapies. This trial is expected to enroll approximately 79 patients. The primary endpoint for the Phase 1b portion of the trial is safety and the primary endpoint for the Phase 2 portion of the trial is objective response rate (ORR) by RECIST.
About Triple Negative Breast Cancer
Triple-negative breast cancer (TNBC) is a particularly aggressive form of cancer whose cells do not have estrogen, progesterone, or receptors of the HER2 protein. According to the National Institutes of Health, it is estimated that between 10 and 20 percent of breast cancer patients are diagnosed with TNBC and approximately 170,000 cases of TNBC have been reported annually worldwide, with higher rates among women under 50 years old and women of African American or Hispanic background. The disease may also be associated with inherited mutations in the BRCA1 gene.
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 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. CytRx's website is www.cytrx.com
About Centurion BioPharma Corporation
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 Centurion'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. The website is www.centurionbiopharma.com
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.
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