Nanopharmaceutics and Northwestern University Announce Initiation of Phase I Adaptive Dose Escalation Clinical Study with Dose Expansion of Oral Triapine® in Combination with Temozolomide (TMZ) for Patients with Recurrent Glioblastoma

ALACHUA, Fla. and CHICAGO, May 14, 2024 /PRNewswire/ -- Nanopharmaceutics, Inc. (OTC:TGRP), a clinical-stage pharmaceutical development company, announced the initiation of a Phase I clinical study with the Robert H. Lurie Comprehensive Cancer Center of Northwestern University "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). The primary objective of this phase 1 study will be to determine the recommended phase 2 dose (RP2D) for Triapine® in combination with temozolomide (TMZ). Secondary objectives include evaluation of the safety profile of Triapine® in combination with temozolomide (TMZ), progression-free survival (PFS), overall survival (OS), overall response rate (ORR) per RANO criteria, and quality of life per FACT-Br. The study will recruit 40-45 patients with an established diagnosis of recurrent glioblastoma, and there will be an exploratory arm to investigate drug delivery into brain tumor tissue and target engagement in a cohort who are surgical candidates for re-resection of recurrent glioblastoma. Funding for the study is provided by BrainUp.

Oral Triapine^® has been shown to be safe, tolerable, and convenient in multiple clinical studies. Ribonucleotide Reductase (RNR) Regulatory Subunit 2 (RRM2) targeting with Triapine^® may overcome chemoresistance and improve the clinical efficacy of TMZ therapy. Preliminary research from Dr. Atique Ahmed's lab at Northwestern University has uncovered a critical factor that helps glioblastoma, an aggressive brain cancer, resist chemotherapy treatment.

About the Robert H. Lurie Comprehensive Cancer Center of Northwestern University

The Robert H. Lurie Comprehensive Cancer Center of Northwestern University is a National Cancer Institute-designated Comprehensive Cancer Center located on Northwestern Memorial Hospital's downtown medical campus in the Streeterville neighborhood of Chicago, Illinois, United States.

About BrainUp

BrainUp is a nonprofit founded by Dan & Meg Kresach of Frankfort, Illinois. They founded BrainUp after their only child Olivia, was diagnosed 10 years ago with a Glioblastoma at the age of 22 years old.   She died on April 19, 2014. The Kresachs formed BrainUp to fund brain cancer research. They have an annual run/walk to raise money for brain cancer research. They have funded over 1.2 million dollars supporting brain cancer research and trials at Chicago healthcare institutions. BrainUp is the financial supporter of Karan Dixit, M.D. (PI) and Atique Ahmed, Ph.D of Northwestern University Chicago, Illinois. To learn more about BrainUp, visit brainup.ngo

About Nanopharmaceutics, Inc.

Nanopharmaceutics, Inc. is a clinical-stage specialty pharmaceutical company developing oral, topical, and injectable products for cancer, central nervous system (CNS) disorders, and infectious diseases. Leveraging its expertise in nanoparticle and fine-particle formulations, which can specifically be used to improve hard-to-deliver BCS category II and IV drugs, Nanopharmaceutics is focused on formulation development aimed at improving drug absorption and stability.

Contact:

Nanopharmaceutics, Inc. (OTC: TGRP)
James D. Talton, Ph.D.
President and Chief Executive Officer
386-401-6304
www.nanopharmaceutics.com

SOURCE Nanopharmaceutics, Inc.