Thursday, February 15, 2018 10:38:17 AM
SILVER SPRING, MD, March 27, 2015 (GLOBE NEWSWIRE) – PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that the genetically modified cells that are required for its three planned clinical trials have been fully tested and are in the process of being propagated to produce all of the cells necessary for the clinical trials.
The cells being produced came from a fully characterized single-cell clone of the cells that were used in the previous clinical trials in pancreatic cancer. These cells are being grown under conditions that comply with current Good Manufacturing Practices (cGMP) standards.
One of PharmaCyte Biotech’s clinical trials consists of a Phase 2b trial where PharmaCyte Biotech’s pancreatic cancer treatment will be compared “head-to-head” with the best available chemotherapy (Abraxane® plus gemcitabine) for advanced pancreatic cancer. The Phase 2b clinical trial will be conducted in Australia by Clinical Network Services (CNS). PharmaCyte Biotech’s pancreatic cancer treatment consists of encapsulating the genetically modified cells, using the Cell-in-a-Box® live cell encapsulation technology, and placing the capsules with the live cells inside them near the site of the cancerous tumor. The patient is then given an inactive cancer drug, ifosfamide, intravenously at one-third the normal dose. When the blood carrying the ifosfamide comes in contact with the encapsulated cells the ifosfamide is converted into its cancer-killing form.
Two additional clinical trials will be conducted in the U.S. by Translational Drug Development (TD2). These trials will determine the effectiveness of PharmaCyte Biotech’s treatment in (i) reducing the severe pain that occurs in patients with advanced pancreatic cancer; and (ii) slowing the accumulation of malignant fluid (ascites) that accompanies the development of pancreatic and other solid cancerous tumors in the abdomen.
Kenneth L. Waggoner, the Chief Executive Officer of PharmaCyte Biotech, stated, “We are very pleased that work being done to grow the cells required for our clinical trials has proceeded according to our plans. Together with our partner, Austrianova, we are complying with all current regulatory guidelines to ensure that these cells will be made available to us as quickly as possible so we can commence our clinical trials in a timely fashion.”
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