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.”
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as Cell-in-a-Box®. This unique and patented technology will be used as a platform upon which treatments for several types of cancer, including advanced, inoperable pancreatic cancer, and diabetes are being built. PharmaCyte Biotech’s treatment for pancreatic cancer involves low doses of the well-known anticancer prodrug ifosfamide, together with encapsulated live cells, which convert ifosfamide into its active or “cancer-killing” form. These capsules are placed as close to the cancerous tumor as possible to enable the delivery of the highest levels of the cancer-killing drug at the source of the cancer. This “targeted chemotherapy” has proven remarkably effective in past clinical trials. PharmaCyte Biotech is also working towards improving the quality of life for patients with advanced pancreatic cancer and on
treatments for other types of solid cancerous tumors. In addition, PharmaCyte Biotech is developing treatments for cancer based upon chemical constituents of the Cannabis plant, known as cannabinoids. In doing so, PharmaCyte Biotech is examining ways to exploit the benefits of Cell-in-a-Box® technology in optimizing the anticancer effectiveness of cannabinoids, while minimizing or outright eliminating the debilitating side effects usually associated with cancer treatments. This provides PharmaCyte Biotech the rare opportunity to develop “green” approaches to fighting deadly diseases, such as cancer of the pancreas, brain and breast, which affect hundreds of thousands of individuals worldwide every year.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan” and similar expressions, as they relate to PharmaCyte Biotech or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte Biotech, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte’s ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte Biotech’s intellectual property and PharmaCyte Biotech’s continued ability to raise capital. PharmaCyte Biotech does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyteBiotech.com. It can also be obtained by contacting Investor Relations.
Investor Relations Contacts:
Jamien Jones
Blueprint Life Science Group
Telephone: 917.595.2856 Ext. 103
[email protected]
