#United States #Fort Worth #DIPG #NanOlogy #CISPLATIN

NanOlogy Launches Drug Development Initiative for Rare Pediatric Brainstem Tumors

On December 11, 2025, NanOlogy, LLC, a clinical-stage oncology firm, made a significant announcement regarding its new drug development venture aimed specifically at addressing diffuse intrinsic pontine glioma (DIPG), a highly aggressive brainstem tumor affecting children. This innovative program revolves around a novel treatment, Large Surface Area Microparticle (LSAM) Cisplatin, designed for targeted intratumoral administration.

Understanding DIPG

DIPG poses a considerable challenge in pediatric oncology, with approximately 150 to 300 children diagnosed each year in the United States. The prognosis for these patients is grim, with a median survival rate of less than one year. Current standard treatments, such as radiation therapy, might offer temporary relief but typically fail to provide long-term survival benefits. Recognizing the urgent need for effective new therapies, NanOlogy is dedicated to advancing the field with its innovative approach.

Plans for Pediatric Clinical Trials

NanOlogy is in the process of completing Investigational New Drug (IND) enabling studies mandated by the U.S. Food and Drug Administration (FDA). Once these studies are finalized, the company intends to file an IND application for LSAM-Cisplatin as a treatment for malignant brain tumors, including DIPG. Pending FDA approval, a clinical trial is anticipated to launch in late 2026, focusing on assessing the safety and efficacy of this targeted therapeutic strategy in children diagnosed with DIPG.

Why LSAM-Cisplatin? The Promise of Targeted Delivery

Traditional chemotherapy treatments like cisplatin have shown efficacy in killing DIPG tumors on a molecular level by binding to DNA, inhibiting cell replication, and ultimately leading to cancer cell death. However, systemic administration of cisplatin often results in severe side effects, and its ability to penetrate the blood-brain barrier is limited, reducing its effectiveness in treating brain tumors. With LSAM-Cisplatin, NanOlogy aims to circumvent these limitations.

H. Paul Dorman, the company's founder and chairman, stated, "We believe NanOlogy's LSAM-Cisplatin can overcome the shortcomings of existing treatment options, allowing for targeted drug delivery directly into the tumor, achieving continuous drug release with minimal systemic toxicity." This precision approach is made possible by advancements in minimally invasive surgical techniques and imaging technologies, enabling local drug delivery in various locations throughout the body, including the brain.

Further Applications of LSAM-Cisplatin

Beyond DIPG, NanOlogy is exploring the potential of LSAM-Cisplatin for treating other solid tumors. The innovative nature of their drug-delivery technology promises to broaden the scope of pediatric oncology treatments in the future.

About NanOlogy

NanOlogy, LLC, is at the forefront of developing therapeutic options for solid tumors, leveraging its advanced approach tailored for intratumoral delivery. Utilizing the Purcision™ technology from CritiTech Particle Engineering Solutions, they produce LSAMs of pure drug to directly address challenges related to systemic toxicity and optimal drug distribution. Their clinical portfolio spans various malignancies, including pancreatic, lung, bladder, and ovarian cancers, and their investigational drugs are protected by a robust intellectual property foundation, featuring over 100 issued patents worldwide.

NanOlogy is steadfast in its commitment to transforming oncology treatments, particularly for traditionally hard-to-treat conditions like DIPG. As they prepare for upcoming clinical trials, the hope is to offer new avenues of healing for children and families directly impacted by this devastating illness.