On June 28, 2018 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported 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) (Press release, CytRx, JUN 28, 2018, View Source [SID1234527501]). 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 2018and the second trial, for patients with advanced squamous cell carcinoma, commenced in February 2018.
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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.