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

Rhea-AI Summary

Nanopharmaceutics and Northwestern University have announced the launch of a Phase I clinical study combining Triapine® with Temozolomide (TMZ) for treating recurrent glioblastoma. The study aims to determine the recommended phase 2 dose and evaluate safety, progression-free survival, overall survival, response rate, and quality of life. Forty to forty-five patients will participate, with an exploratory arm for those undergoing re-resection of recurrent glioblastoma. Funded by BrainUp, the study follows promising preliminary research indicating Triapine® may enhance TMZ efficacy by overcoming chemoresistance.

Positive

• Initiation of Phase I clinical study for recurrent glioblastoma treatment.
• Study funded by nonprofit BrainUp, showing strong financial backing.
• Clinical focus on determining recommended phase 2 dose (RP2D).
• Evaluation of multiple important outcomes: safety, progression-free survival, overall survival, response rate, and quality of life.
• Involvement of reputable institution: Robert H. Lurie Comprehensive Cancer Center of Northwestern University.
• Exploratory arm to further investigate drug delivery and target engagement.
• Preliminary research suggests Triapine® could improve Temozolomide (TMZ) efficacy by overcoming chemoresistance.

Negative

• No immediate financial gains reported for investors.
• Potential risks associated with clinical trials, including adverse safety outcomes.
• Study results and benefits are speculative and long-term.
• Recruitment of 40-45 patients may be for broad applicability.

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

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SOURCE Nanopharmaceutics, Inc.

FAQ

What is the focus of the Phase I clinical study announced by Nanopharmaceutics and Northwestern University?

The study aims to determine the recommended phase 2 dose of Triapine® in combination with Temozolomide (TMZ) for patients with recurrent glioblastoma.

When was the Phase I clinical study for Triapine® and Temozolomide (TMZ) announced?

The study was announced on May 14, 2024.

Which institution is collaborating with Nanopharmaceutics on the Glioblastoma study?

The Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

What are the secondary objectives of the Phase I clinical study involving Triapine® and TMZ?

The secondary objectives include evaluating the safety profile, progression-free survival, overall survival, response rate, and quality of life.

How many patients will be recruited for the Phase I clinical study?

The study will recruit 40-45 patients with recurrent glioblastoma.

What is the role of BrainUp in the Phase I clinical study?

BrainUp is providing financial support for the study.

What is the potential benefit of Triapine® in combination with Temozolomide (TMZ) for glioblastoma patients?

Preliminary research suggests Triapine® may overcome chemoresistance and improve the clinical efficacy of TMZ therapy.