Astrocyte Pharmaceuticals Reports IND Clearance of AST-004 by the US FDA for Treating Acute Ischemic Stroke
Shots:
- Astrocyte’s IND of AST-004 has been cleared by the US FDA for the treatment of acute ischemic stroke to commence its P-II clinical evaluation. The clearance will allow its evaluation in stroke, TBI as well as concussion
- The P-II study for acute ischemic stroke patients is built on the previous stroke studies by medical device companies; however, this new trial will be conducted to treat those stroke patients with large vessel occlusions to reduce brain damage
- The preclinical study of AST-004, with a high dose, depicted a 64% reduced brain lesion growth & a 45% decrease in the overall lesion size. The company also concluded 2 P-I safety studies across the EU in 80 individuals revealing no new AEs or safety outcomes
Ref: Astrocyte Pharmaceuticals | Image: Astrocyte Pharmaceuticals
Related News:- DiaMedica Reports the US FDA’s Clinical Hold on the P-II/III (ReMEDy2) Trial of DM199 for the Treatment of Acute Ischemic Stroke
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
