FLAG Therapeutics' FLAG-003 Receives Rare Pediatric Disease Designation from FDA for Diffuse Intrinsic Pontine Glioma (DIPG) Treatment

FLAG Therapeutics announces FLAG-003 granted Rare Pediatric Disease designation by FDA. FLAG-003 is an investigational therapy for treating Diffuse Intrinsic Pontine Glioma (DIPG), a rare, aggressive brain tumor in children. The therapy targets and kills cancer cells by blocking tumor vascular formation and disrupting cancer cell replication by inhibiting tubulin.

Publish Date: 31-01-2023 Source: FLAG Therapeutics, Inc.

Diffuse intrinsic pontine glioma (DIPG) is a lethal malignant pediatric tumour that spreads throughout the pons. Pediatric gliomas with a K27M mutation in histone H3 with a diffuse growth pattern in a midline location are referred to as diffuse midline glioma, H3 K27M mutant; this designation is inclusive of DIPG cases bearing the K27M mutation. This devastating disease has a median age of 6-7 years at diagnosis and is rarely detected in adults. Given its eloquent location, current treatment options are limited, and the prognosis is dismal—with less than 10% of patients surviving beyond two years from the time of diagnosis. DIPGs account for 80% of all paediatric brain tumours in the brainstem. These tumours share histological characteristics with anaplastic astrocytomas (grade III) or glioblastomas (GBM) (grade IV. Brainstem gliomas affect approximately 350 to 450 children in the United States annually and are the major cause of death in children with brain tumours. The most common of these is DIPG comprising 80% of the cases.

DIGP incidence is 1 to 2 cases per 100,000 population, with a peak incidence of 6-9 years and slightly higher among males.

However, the current Diffuse Intrinsic Pontine Glioma treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (ONC201, BXQ-350, MTX110, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Diffuse Intrinsic Pontine Glioma (DIPG) treatment. The key companies in the advanced development stage are Bexion Pharmaceuticals, Inc., Chimerix, Midatech Pharma US Inc., etc., targeting DIPG.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Diffuse Intrinsic Pontine Glioma (DIPG) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

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