NanOlogy Unveils Drug Development Program for Rare Pediatric Brainstem Tumor

Next Generation Intratumoral Technology Targets Diffuse Intrinsic Pontine Glioma

Investigational New Drug Enabling Studies are Underway with Planned Clinical Trial to Begin Late 2026

FORT WORTH, Texas, Dec. 11, 2025 /PRNewswire/ -- NanOlogy, LLC, a private clinical-stage oncology company, is pleased to announce its drug development program aimed at transforming the treatment of diffuse intrinsic pontine glioma (DIPG), an aggressive highly lethal pediatric brainstem tumor. The company is developing Large Surface Area Microparticle (LSAM) Cisplatin for stereotactic intratumoral (IT) administration in this initial indication.

Plans for Pediatric Clinical Trials

NanOlogy is completing Investigational New Drug (IND) enabling studies required by the U.S. Food and Drug Administration (FDA). Upon completion of these studies, the company plans to submit an IND application for LSAM-Cisplatin to treat malignant neoplasms of the brain including DIPG. Subject to FDA allowance to proceed, NanOlogy aims to initiate a clinical trial in late 2026 to evaluate the safety and response of stereotactic IT administration of LSAM-Cisplatin in children diagnosed with DIPG. According to DIPG.org, DIPG afflicts 150 – 300 children annually in the United States, with median survival of less than one year. Current treatments, like radiation therapy, may delay progression but almost always fail to deliver long term survival. NanOlogy is also assessing future opportunities to extend the use of LSAM-Cisplatin to treat other brain and solid tumors.

The Promise of LSAM-Cisplatin in DIPG

In laboratory research studies, cisplatin has been shown to kill DIPG tumors by binding to DNA and disrupting cell replication, leading to cell death. Unfortunately, current systemically administered cisplatin formulations are associated with numerous severe side effects throughout the body. In addition, cisplatin does not cross the blood brain barrier well, limiting its efficacy in brain tumors, making systemically administered cisplatin a suboptimal treatment for DIPG.

"We believe NanOlogy's innovative LSAM-Cisplatin investigational drug designed for intratumoral administration can overcome the limitations of current treatment options with highly targeted delivery of drug into the tumor, continuous drug release, and minimal systemic toxicity," said H. Paul Dorman, founder and chairman of NanOlogy. "Advancements in minimally invasive surgical procedures and imaging now allow local delivery of LSAMs to solid tumors virtually anywhere in the body, including the brain. We are excited to advance IT LSAM-Cisplatin for DIPG and explore the promise it may hold for children and families facing this devastating disease."

About NanOlogy

NanOlogy, LLC (www.nanology.us) is a private clinical-stage oncology company developing treatments for solid tumors using drugs optimized for intratumoral delivery designed to improve response with minimal to no systemic toxicity. Enabled by the CritiTech Particle Engineering Solutions' Purcision™ technology platform, NanOlogy produces Large Surface Area Microparticles (LSAMs) of pure drug for direct local delivery overcoming issues of systemic toxicity and tumor bioavailability. NanOlogy clinical programs have advanced LSAM investigational drugs in multiple solid tumors including pancreas, lung, bladder, peritoneal, ovarian, prostate, and dermal cancers. Feasibility of the Purcision™ platform has been established in taxanes, platins, tyrosine kinase inhibitors, poly (ADP-ribose) polymerase inhibitors, and other agents. The investigational drugs are covered by composition of matter patents issued in the United States and other major jurisdictions worldwide, including Canada, Europe, Japan, China, South Korea, Australia, and India, which form the foundation of an extensive intellectual property portfolio of over 100 issued patents protecting NanOlogy investigational drugs, formulations, methods, and technology.

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SOURCE NanOlogy, LLC