Asieris Pharmaceuticals, a China-based biotech company, has received approval for its Phase I clinical trial of APL-1501 from the Australian regulatory authorities, it was reported on Wednesday.
The aim of this Phase I study is to assess APL-1501's safety, tolerability, and pharmacokinetic characteristics for the treatment of non-muscle invasive bladder cancer (NMIBC).
The product has been independently developed by the company's Prodrug Accurate Drug Delivery platform and is an oral sustained-release product based on APL-1202 and will be the second-generation product of APL-1202 to support new clinical development globally. It inherits the oral administration of APL-1202 and the druggability of APL-1501 and has been improved by the design of prodrug molecules.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA