Anthony J. Cataldo, GT Biopharma s Chairman and Chief Executive Officer, commented: It is exciting to announce the addition of a second clinical trial site for our Phase I/II program of our novel GTB-3550 TriKE™ program. With this progress, we are closer to bringing our disruptive and target-directed NK cell engager approach to patients in need. We are grateful to the valiant patients and their families, as we continue to progress this initial indication trial of our first-in-class NK cell protein biologic cancer therapy.
GTB-3550 TriKE™ is being evaluated in patients age 18 and older with CD33+ malignancies (primary induction failure or relapsed acute myeloid leukemia [AML] with failure of one reinduction attempt, or high-risk myelodysplastic syndromes [MDS] progressed on two lines of therapy). The primary endpoint is to identify the maximum tolerated dose and safety of GTB-3550 TriKE™ therapy. Correlative objectives include the number, phenotype, activation status and func
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BEVERLY HILLS, Calif., March 4, 2021 /PRNewswire/ GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage biopharmaceutical company focused on the development and commercialization of its disruptive, target-directed Natural Killer (NK) cell engager immunotherapy protein biologic platform technology: TriKE™ for cancer and infectious diseases, today announced the addition of a new clinical trial site for its ongoing GTB-3550 TriKE™ multicenter Phase I/II trial (ClinicalTrials.gov NCT03214666). The University of Wisconsin – Madison Carbone Cancer Center will serve as the second site for this program, with Kalyan Vara Ganesh Nadiminti M.D., UW Assistant Professor in Hematology, Oncology and Palliative Care, serving as lead investigator. Dr. Nadiminti will be working closely with Jeffery S. Miller, M.D., GT Biopharma s Consulting Chief Medical Officer and developer of TriKE™ and the trial design, and Erica Warlick, M.D., Principal Investigato