PharmaCyte Biotech advances manufacturing process for pancreatic cancer product used in clinical trial.
M2 PHARMA-May 8, 2019-PharmaCyte Biotech advances manufacturing process for pancreatic cancer product used in clinical trial
(C)2019 M2 COMMUNICATIONS
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.
((Comments on this story may be sent to firstname.lastname@example.org))
|Printer friendly Cite/link Email Feedback|
|Date:||May 8, 2019|
|Previous Article:||Ascelia Pharma announces receipt of constructive feedback from EMA on the phase 3 programme for Mangoral.|
|Next Article:||Ligand Pharmaceuticals acquires economic rights to Novan's SB206.|