Phase I Study of Oral Triapine® and Temozolomide for Recurrent Glioblastoma Begins

ALACHUA, Fla. and CHICAGO, May 14, 2024 – Nanopharmaceutics, Inc. has announced the commencement of a Phase I clinical trial in collaboration with the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. The study, 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 identify the recommended phase 2 dose (RP2D) for the combination of Triapine® and temozolomide (TMZ).

The primary goal of this Phase I trial is to establish the optimal dosage for a subsequent Phase II trial. Secondary goals include assessing the safety profile of this drug combination, progression-free survival (PFS), overall survival (OS), response rate per RANO criteria, and quality of life as per FACT-Br. The study plans to enroll between 40 to 45 patients diagnosed with recurrent glioblastoma. Additionally, an exploratory arm will focus on drug delivery into brain tumor tissue and target engagement in patients who are surgical candidates for re-resection.

The study is funded by the nonprofit organization BrainUp, which was founded by Dan and Meg Kresach after their daughter Olivia was diagnosed with glioblastoma. BrainUp has been instrumental in funding brain cancer research, contributing over $1.2 million to support clinical trials and research at Chicago healthcare institutions.

Previous clinical studies have demonstrated that Oral Triapine® is safe, tolerable, and easy to administer. Triapine® aims to target the Ribonucleotide Reductase (RNR) Regulatory Subunit 2 (RRM2), which may help overcome resistance to chemotherapy and enhance the effectiveness of TMZ therapy. Preliminary studies by Dr. Atique Ahmed’s lab at Northwestern University have identified key factors contributing to glioblastoma's resistance to chemotherapy, highlighting the potential of Triapine® in improving treatment outcomes.

The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, designated as a Comprehensive Cancer Center by the National Cancer Institute, is a renowned institution located within the Northwestern Memorial Hospital's downtown medical campus in the Streeterville neighborhood of Chicago, Illinois.

BrainUp, the study's financial backer, was established by the Kresachs after their daughter Olivia was diagnosed with glioblastoma at the young age of 22. Despite her passing in 2014, BrainUp continues to fundraise through annual events and has significantly contributed to brain cancer research. The organization supports researchers like Karan Dixit, M.D. and Atique Ahmed, Ph.D., both affiliated with Northwestern University.

Nanopharmaceutics, Inc. is a clinical-stage pharmaceutical company specializing in the development of oral, topical, and injectable products targeting cancer, central nervous system disorders, and infectious diseases. Utilizing its expertise in nanoparticle and fine-particle formulations, Nanopharmaceutics aims to enhance drug absorption and stability, particularly for challenging BCS category II and IV drugs.

This new phase of research represents a promising collaboration aimed at developing more effective treatments for glioblastoma, an aggressive and often resistant form of brain cancer. 

The initiation of this study underscores the commitment of Nanopharmaceutics and its partners to advancing cancer treatment through innovative pharmaceutical development and targeted research efforts.

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