NanOlogy, LLC, a Texas-based, private clinical-stage oncology company, announced on Thursday that it has launched a drug development program aimed at transforming the treatment of diffuse intrinsic pontine glioma (DIPG), an aggressive, highly lethal paediatric brainstem tumour.
The company is developing Large Surface Area Microparticle (LSAM) Cisplatin for stereotactic intratumoral (IT) administration in this initial indication.
NanOlogy is completing Investigational New Drug (IND) enabling studies required by the US 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 approval to proceed, NanOlogy says that it 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.
Sobi s Aspaveli marketing authorisation receives positive European regulatory opinion
BioCryst wins FDA approval for oral HAE prophylaxis in young children
NanOlogy launches drug development program for diffuse intrinsic pontine glioma treatment
Amgen's UPLIZNA receives US FDA approval
FDA grants priority review to Bristol Myers Squibb's Opdivo regimen for advanced Hodgkin lymphoma
Zydus Lifesciences enters licence and supply partnership with Formycon
Cereno Scientific's Phase IIb trial of CS1 in PAH approved by US FDA
ALR Technologies announces GluCurve Pet CGM relaunch in Canada
Mirum Pharmaceuticals to acquire Bluejay Therapeutics for HDV treatment
PureTech clears key FDA milestone for Phase 3 development of deupirfenidone
J & D Pharmaceuticals' investigational therapy for HCC receives US FDA Orphan Drug Designation