Arch is continuing to prepare MetaMx™ for a single dose, diagnostic imaging trial in humans. MetaMx is composed of novel, synthetic peptides that target and attach to brain tumour initiating cells (BTICs) and invasive glioma cells, for the purpose of imaging, diagnosis and developing targeted therapies to improve patient outcomes and survival rates among glioblastoma patients.
Arch previously disclosed that it is has designed a clinical development plan to characterize the safety and pharmacokinetics of MetaMx, and to demonstrate the efficacy of MetaMx to detect BTICs and invasive glioma cells in human patients.
Arch has since arranged for the formulation and dual manufacturing of MetaMx under Good Manufacturing Practice ("GMP") and Good Laboratory Practice ("GLP") standards by a U.S. chemistry manufacturer. The current prototype formulation of MetaMx was produced by the manufacturer and is currently undergoing quality control and pre-clinical validation prior to Arch proceeding with the large scale and more costly GMP/GLP manufacturing order.
MetaMx produced under GLP will be used for a planned three-month toxicology program. MetaMx produced under GMP will be used for the single dose, diagnostic imaging trial in humans.
Following results of the toxicology studies, Arch intends to request a pre-Investigational New Drug application meeting with the Food and Drug Administration.
To read more: http://www.marketwired.com/press-release/arch-biopartners-2015-agm-results-and-technology-status-update-tsx-venture-ach-2005900.htm