On October 13, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting significant unmet needs in the treatment of tumors and viruses, reported additional preliminary data from the Phase 1 clinical trial of its immuno-stimulating STAT3 inhibitor, WP1066, in patients with glioblastoma (GBM) (Press release, Moleculin, OCT 13, 2020, View Source [SID1234568385]). This supports the progression of the trial to the fourth and final dose escalation cohort. Three patients have completed treatment in the third cohort at a dose level of 8 mg/kg with no adverse events related to WP1066 and the study will now proceed to the next higher dose of 16 mg/kg.
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Walter Klemp, Chairman and CEO of Moleculin, stated, "On the heels of our recent positive announcement regarding the progress of the pediatric brain tumor trial of WP1066, we are pleased to also report on the progress of the adult GBM clinical trial for the same drug candidate. The trial in adults has been important in leading the way to establishing a safe and tolerable human dose level for what we believe is a first-in-class compound that crosses the blood-brain barrier and is being developed for the treatment of central nervous system malignancies. In animal models, WP1066 has been shown to stimulate immune responses that successfully modulate oncogenic transcriptional activity in tumor cells and repress their ability to drive tumor growth.
Mr. Klemp continued: "In addition to providing valuable pharmacokinetic data, this trial also creates the foundation for future studies in WP1066, including another investigator-initiated study, which is currently being proposed to examine the combination of WP1066 with radiation for the treatment of GBM. This next clinical trial is being proposed as a result of recent discoveries presented in a peer-reviewed article published in Clinical Cancer Research (Clin Cancer Res June 30 2020 DOI:10.1158/1078-0432.CCR-19-4092), which reported findings that Moleculin’s STAT3 inhibitor, WP1066, used in combination with traditional whole brain radiation therapy, resulted in long-term survivors and enhanced median survival time relative to monotherapy in mice with implanted human brain tumors."
Mr. Klemp concluded, "In keeping with our established clinical trial reporting policies, we look forward to updating investors on the continued progress of this trial once this final cohort is completed."