GT Biopharma Announces Eighth Patient Begins Treatment Of GTB-3550

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[{"type":"text","content":"BEVERLY HILLS, Calif., Jan. 12, 2021 /PRNewswire/ -- GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company's proprietary NK cell engager (TriKE™) technology platform is pleased to announce the continuation of enrollment with patient 8 in its GTB-3550 clinical trial following the conclusion of a 30-day Covid-19 related pause in enrolling patients in all clinical trials currently being conducted at the University of Minnesota's Masonic Cancer Center.\nPatients with CD33+ malignancies (primary induction failure or relapsed AML with failure of one reinduction attempt or high-risk MDS progressed on two lines of therapy) age 18 and older are eligible to participate in the GTB-3550 TriKE™ clinical trial (NCT03214666). The primary endpoint of the Study is to identify the maximum tolerated dose (MTD) of GTB-3550 TriKE. Correlative objectives include the number, phenotype, activation status and function of NK cells and T cells.\nGTB-3550 TriKE™ Demonstrates Clinical Benefit in Patients and 61.7% Reduction in Cancer Burden in patient 7\nThe GTB-3550 TriKE™ clinical trial commenced patient enrollment in February 2020 for the treatment of relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS). To date, seven patients have been enrolled in the clinical trial; two patients treated at 5 mcg/kg/day, two patients treated at 10 mcg/kg/day, two patients at 25 mcg/kg/day, and one patient treated at 50 mcg/kg/day. All seven patients have completed therapy. The results to date have been positive and the company continues to expand the enrollment.\nClinical Benefit Achieved and Reduction in Cancer Burden in HR-MDS Patient\nA high-risk myelodysplastic syndromes (HR-MDS) patient had failed hypomethylating agent and Luspatercept therapies prior to being treated with GTB-3550 at 50mcg/kg/day (three consecutive 96-hour continuous infusions). The patient achieved bone marrow blast level reduction from 12% before GTB-3550 therapy to 4.6% post GTB-3550 therapy determined by morphological assessment (61.7% reduction in cancer cells), and had stable hematologic parameters including normal platelet counts throughout therapy. Following this single course of GTB-3550 therapy and the significant reduction in bone marrow blast levels, the patient demonstrate...

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