PharmaCyte Biotech, a biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, has advanced the manufacturing process for the clinical trial product that will be used in its planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC), it was reported yesterday.
The data received to date from the encapsulation parameters of the manufacturing indicate that the encapsulation portion of the process is fault free and reproducible, which is a fundamental requirement of the US Food and Drug Administration (FDA).
The firm plans to conduct two additional and staggered manufacturing runs in order to maximise the chances for a successful IND submission, given the novelty and complexity of the entire process, on the advice of PharmaCyte's cGMP expert.
Diamyd Medical granted US FDA Fast Track designation for Diamyd diabetes treatment
Aprecia names new chief commercial officer
Insulet's Omnipod 5 integration with Abbott FreeStyle Libre 2 Plus Sensor secures CE Mark approval
Kyowa Kirin enrols first subject in phase two tivozanib eye drops (KHK4951) clinical trial
Novo Nordisk to boost manufacturing capacity with acquisition of three fill-finish sites
Breye Therapeutics commences phase 1b/2a danegaptide clinical trial
DexCom Inc breaks ground on new manufacturing facility in Ireland
VibroSense Dynamics AB secures provisional patent for chemotherapy-induced nerve damage prediction
Innovent Biologics signs collaboration agreement with Sanegene Bio USA
Japan approves GSK's filing for Arexvy vaccination for at-risk adults
Arecor Therapeutics plc extends collaboration with Eli Lilly
OptiBiotix Health partners with Ravenswood for SlimBiome distribution in Australia and New Zealand
Boehringer Ingelheim granted European approval of oral liquid medication for feline diabetes