Pharmacyte Biotech Inc (OTCMKTS:PMCB) is excited to announce that its clinical trial product has passed all the release tests required by the US FDA and ready for submission to the FDA for an investigational drug application. The company seeks the UD FDA approval to proceed with the Phase 2b clinical trial of its trial product, which is developed to treat locally advanced, pancreatic cancer in patients across the US.
Two batches of clinical trial products
More than two batches of the clinical trial products of Pharmacyte have undergone series 10 release tests and passed all the tests and qualify for phase 2b clinical trial. The cell-in-a-box, the signature live-cell encapsulation technology, has performed well and proven to be safe for administering to humans during the clinical trial. Over 20,000 genetically modified live cells that fit a cell-in-box capsule have functioned as expected during the tests. They are produced, kept in the syringes and frozen, and tested for cell viability, enzymatic activity, and biologic activity.
Receives certificates of analysis
Pharmacyte will receive two certificates of analysis from Austrianova because the clinical trial products have passed all the release tests. The company will also get all the completed batch records for the production runs and subsequent release testing. It needs to enter data generated from these tests for submission to the US FDA for the IND application.
To achieve success after submission of IND to the US FDA, Pharmacyte has taken two steps. In the first step, the company has manufactured and tested two batches of the clinical trial products as required by cGMP validation. The company takes responsibility for releasing the product into the US for a clinical trial.
Kenneth L. Waggoner, Chief Executive Officer of Pharmacyte, said its GMP consultant has informed that two manufacturing runs are not necessary to request a phase 2b clinical trial from the FDA. However, the two manufacturing runs demonstrate to FDA that its production process is robust and maintains the qualities.
Pancreatic cancer is the third leading cause of death in the US. Pharmacyte has put in significant efforts to ensure perfection in the process and engage with the FDA to get an opportunity to begin a clinical trial.
Business intelligence from Akerna Corp (NASDAQ:KERN) Says Liquor Sales are Up 10% Year-over-Year
Post Views: 388 Liquor sales are up 10% year-over-year according to business intelligence from Akerna Corp (NASDAQ:KERN). Red wine took...
Pyxis Tankers Inc. (NASDAQ:PXS) Announce Q1 2020 Financial Results Amid COVID-19 Uncertainties
Post Views: 227 Pyxis tankers Inc. (NASDAQ:PXS) has announced its unaudited financial results for the quarter that ended March 31,...
Innovative Industrial Properties Inc (NYSE:IIPR) Enters Into a Lease Amendment Agreement with Green Leaf
Post Views: 249 With pot being legalized in many countries, the market is likely to get even bigger. As a...
Liberty Leaf Holdings Ltd (OTCMKTS:LIBFD) Takes Over Nova Mentis Biotech Corp And Add Synergies To Its Cannabis Assets In The Wellness And Health Sector
Post Views: 253 Liberty Leaf Holdings Ltd (OTCMKTS:LIBFD) gained access to the psilocybin by acquiring Nova Mentis Biotech Corp. The...
Aleafia Health Inc (OTCMKTS:ALEAF) Begins Cultivation At Its Entire Niagara Facility And Provides Consistent Supplies for Health: Settles Disputes With Aphria
Post Views: 357 Aleafia Health Inc (OTCMKTS:ALEAF) will commence cultivation operations at its whole Niagara facility. It obtained a license...
Pure Capital Calls For Shareholders Meeting of Therapix Biosciences Ltd (NASDAQ:TRPX): Demands For Dismissal Of Board Members
Post Views: 296 Pure Capital called for an emergency meeting of investors of Therapix Biosciences Ltd (NASDAQ:TRPX) to discuss actions...