LAS VEGAS– PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that PharmaCyte has decided to accelerate preparations for the start of its Phase 2b clinical trial in locally advanced, inoperable pancreatic (LAPC) using its CypCapsTM clinical trial product.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of accelerating enrollment of the first patient, “The plan is to begin the work now to prepare for the enrollment of the first patient so that we can begin the trial almost immediately upon getting the clinical hold lifted.
“Because we continue to receive favorable results from each of the studies that we have conducted to satisfy the FDA’s requirements and because of the company’s financial position, we are ideally situated to begin the work necessary to enroll the first patient now to run parallel with the work being done to get the clinical hold lifted. Previously, our plan was to begin the work to commence a clinical trial in LAPC after the FDA lifted the clinical hold.”
The work to enroll the first patient includes finalizing the (i) clinical trial protocol; (ii) pharmacy manual; (iii) investigator’s brochure; (iv) angiography manual; (v) informed consent; and (vi) drug product label.
PharmaCyte will also need to reengage with Medpace, the Contract Research Organization that PharmaCyte has selected to conduct its proposed clinical trial. PharmaCyte will also need to reengage its subcontractors who will assist Medpace. Catalent Pharma Solutions, PharmaCyte’s supply chain vendor, must also be reengaged and the supply chain requirements must be updated.
Clinical trial syringes containing CypCaps™ will need to be manufactured and delivered to Catalent’s locations throughout the U.S. for storage and distribution for the clinical trial. Those syringes have already been ordered from Austrianova and are in the process of being manufactured.
The final list of cancer centers will need to be selected and contracts must be negotiated and finalized with each center.
Also, the lead interventional radiologist must be selected, a training film must be developed, and the lead interventional radiologist will need to train additional interventional radiologists.
