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Nanopharmaceutics and Northwestern University initiate Phase I Adaptive Dose Escalation Clinical Study for Recurrent Glioblastoma Patients with Oral Triapine® and Temozolomide (TMZ)

Wednesday, May 15, 2024

Nanopharmaceutics, Inc. (OTC:TGRP), a pharmaceutical company focusing on clinical development, has initiated a Phase I clinical trial in collaboration with the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. This trial, titled "A Phase 1 Adaptive Dose Escalation With Dose Expansion Study of Triapine in Combination With Temozolomide (TMZ) for Patients With Recurrent Glioblastoma" (ClinicalTrials.gov Identifier: NCT06410248), aims to determine the recommended phase 2 dose (RP2D) for Triapine® when used alongside temozolomide (TMZ) in patients with recurrent glioblastoma.

Secondary objectives of the trial include assessing the safety profile of Triapine® combined with temozolomide (TMZ), as well as evaluating progression-free survival (PFS), overall survival (OS), overall response rate (ORR) according to RANO criteria, and quality of life based on FACT-Br. The study plans to enroll 40-45 patients diagnosed with recurrent glioblastoma, with an additional exploratory arm dedicated to investigating drug delivery into brain tumor tissue and target engagement in patients eligible for re-resection of recurrent glioblastoma. Funding for this endeavor is generously provided by BrainUp.

Triapine® in oral form has demonstrated safety, tolerability, and convenience across various clinical studies. The targeting of Ribonucleotide Reductase (RNR) Regulatory Subunit 2 (RRM2) with Triapine® presents a potential strategy to overcome chemoresistance and enhance the effectiveness of TMZ therapy. Dr. Atique Ahmed's research team at Northwestern University has uncovered crucial insights into the mechanisms by which glioblastoma, a highly aggressive brain cancer, resists chemotherapy treatment.

The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, situated on the downtown medical campus of Northwestern Memorial Hospital in Chicago's Streeterville neighborhood, holds the distinction of being a National Cancer Institute-designated Comprehensive Cancer Center.

BrainUp, a nonprofit organization founded by Dan & Meg Kresach of Frankfort, Illinois, emerged from their personal journey with their daughter Olivia's battle against glioblastoma, which began a decade ago when she was diagnosed at 22 years old and tragically passed away on April 19, 2014. BrainUp was established to advance brain cancer research, with the Kresachs spearheading fundraising efforts through an annual run/walk event. Their contributions, totaling over 1.2 million dollars, have supported brain cancer research and trials at healthcare institutions in Chicago. BrainUp serves as the financial sponsor for the work of Karan Dixit, M.D. (Principal Investigator) and Atique Ahmed, Ph.D. at Northwestern University. For further information about BrainUp, visit brainup.ngo.

 

Source: prnewswire.com

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