Pharmacyte Biotech Inc (OTCMKTS:PMCB) has released several Q&A articles that provide insight into the submission process of IND (investigational new drug application), and the FDA required tests. Dr. Gerald W. Crabtree, Chief Operating Officer of Pharmacyte, provides the details into the IND submission process and the necessary tests. He brings in more than fifty years of experience in pharmaceutical and biotech companies and in academia. Gerald played a major role in developing drugs and cancer treatments. He also coordinated and monitored several drug candidates’ development and prepared several clinical protocols, monographs, and investigator brochures.
Pharmacyte awaits test results of the pyrogenicity test
What is the pyrogenicity test, and why is it needed?
According to Gerald, FDA intends to know whether the Cell-in-a-Box capsules, which are used in the LAPC treatment, have any fever inducing properties. Pyrogenicity is conducted to collect this data and submit to the US FDA. The treatment for this tumor uses the combination of a biologic, which comprises genetically engineered and live human cells that are encapsulated with the help of unique cellulose-based technology, and cancer prodrug.
Hundreds of empty Cell-in-a-Box Capsules
Pharmacyte needs hundreds of empty Cell-in-a-Box Capsules to conduct the pyrogenicity test. Its partner – Austrianova will produce these Cell-in-a-Box Capsules in large quantity at its production facility in Thailand. Austrianova has filled the syringes with empty Cell-in-a-Box Capsules and congealed those syringes with the same freeze medium which is used for the clinical study. The company shipped the resultant materials to the US for conducting the pyrogenicity test.
The crushed Cell-in-a-Box Capsules and saline are injected into three rabbits. It takes a month to complete the test, get the audited results report, and submit to the US FDA. This is part of the IND package of Pharmacyte.
What goes into submission of IND?
The size and complexity of an IND depend on the development stage of a product. If Pharmacyte files an application requesting permission to conduct phase 1 clinical study, then the product in question is an innovative drug. The IND comprises details about how the drug is manufactured, and the animal and preclinical data provide details about what type of tumor it attacks. It also gives dosage information to cure the tumor and provides details of side effects effectively.