$PMCB PharmaCyte Biotech, Inc (OTCMKTS:PMCB) Continues to Work Toward IND Filing PMCB
The last time we touched upon PharmaCyte Biotech, Inc (OTCMKTS:PMCB) here at Street Register was back in March, when the company had no clear cut timeline for the filing process on its IND (Investigational New Drug) application for its upcoming clinical trial in locally advanced pancreatic cancer (LAPC).
While it’s still a fluid process with several boxes to tick in terms of preparing for the application and study, we did receive updates in the form of a company Q & A this week that could shed some light on the story. We always try to keep our readers abreast of any new press coming from the stocks we profile, so we want to pass along some snippets from the Q & A released by the company.
Sarah DeMare, the Product Development Champion with Facet Life Sciences and U.S. Agent for PharmaCyte Biotech, Inc (OTCMKTS:PMCB) was asked about several topics pertaining to the IND. Perhaps most importantly, she was asked to list off some of the items that are standing between PMCB and filing of the application.
“The single most important item PharmaCyte needed to learn from the FDA at the pre-IND meeting was the acceptability of PharmaCyte’s proposed cell line. Without that understanding, PharmaCyte was unable to move forward with the manufacture of its product candidate for the LAPC clinical trial.”
“An IND encompasses many things, dealing with the manufacture and characterization of the product candidate, the clinical study design and nonclinical studies. PharmaCyte’s therapy for pancreas cancer has undergone or been part of several studies, so incorporation of that information into the IND is not ‘rate limiting’ or ‘slowing down the progress towards submitting an IND.’ The clinical study design that PharmaCyte agreed to undertake after meeting with the FDA is currently being drafted. This is also not rate limiting. To conduct the clinical trial, PharmaCyte will need to manufacture, test and release a Master Cell Bank, a Working Cell Bank and the encapsulated live cells. This information is also required to be described and documented in detail in the IND. The manufacture of these items is the rate limiting factor involved in submitting the IND.”
“Before the IND is filed, the following items must be available for inclusion:
(a) Documentation of preclinical work done on the cells.
(b) Toxicology studies.
(c) Documentation of preclinical work done on the capsules themselves.
(d) A wide array of CMC (Chemistry, Manufacturing and Controls) documentation that verifies that the final biologic product (the encapsulated cells) has been produced under current Good Manufacturing Practices (cGMP)-compliant conditions.
(e) Labeling for the final investigational biologic product.
(f) Previous evidence of human experience with the pancreas cancer therapy (low-dose ifosfamide plus Cell-in-a-Box® encapsulated genetically modified human cells).
(h) The Investigator’s Brochure.
(i) The Informed Consent Form
(j) The Case Report Form”
(Source: Globe Newswire)