SILVER SPRING, Md., April 08, 2016 (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 reported that the encapsulation facility located in Bangkok, Thailand, that will be used to encapsulate the live cells used for PharmaCyte’s pancreatic cancer therapy has recently been inspected by the Food and Drug Administration of Thailand (Thai FDA). In its report on that inspection, the Thai FDA stated that, “The facility is built according to the pre-approved floor plan and is now deemed suitable for the manufacture of pharmaceutical products.”
PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, commented, “We are very pleased that our partner, Austrianova, has received a positive opinion from the Thai FDA for Austrianova’s live-cell encapsulation facility. This is an important milestone in the development of PharmaCyte’s treatment for pancreatic cancer and a pre-requisite for our upcoming pancreatic cancer clinical trial.”
The main role of the Thai FDA is to protect consumer’s health, especially, to ensure safety, quality and efficacy of health products within its purview. These products include: foods, drugs, psychotropic substances, narcotics, medical devices, volatile substances, cosmetics and hazardous substances. It is an absolute requirement that the construction and operation of Austrianova’s live-cell encapsulation facility be in accordance with both Thai national legislation as well as international agreements.
PharmaCyte’s product for pancreatic cancer will be manufactured in Austrianova’s facility in Bangkok. It consists of live human cells that have been genetically engineered to convert the anticancer prodrug ifosfamide into its “cancer-killing” form and then encapsulated using the Cell-in-a-Box® encapsulation technology. In PharmaCyte’s upcoming clinical trial, these encapsulated live cells will be used with low doses of ifosfamide (one third the normal dose) as a “consolidation therapy” with the current standard of care for advanced pancreatic cancer when a patient no longer benefits from first line therapy. PharmaCyte’s therapy will be compared with the combination of the anticancer drug capecitabine plus radiation in patients with locally advanced, non-metastatic, inoperable pancreatic cancer whose tumors are stable or progressing after 4-6 cycles of treatment with either the combination of Abraxane® plus gemcitabine or the four-drug combination known as FOLFIRINOX.
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 and diabetes are being developed. PharmaCyte’s treatment for cancer involves encapsulating genetically modified live cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated live cells are placed as close to a cancerous tumor as possible. Once implanted in a patient, a chemotherapy drug which needs to be activated in the body (ifosfamide) is then given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been placed. When the ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells, activation of the chemotherapy drug takes place at the source of the cancer without any side effects from the chemotherapy. This “targeted chemotherapy” has proven remarkably effective and safe to use in past clinical trials.
In addition to developing a novel treatment for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and Type 2 insulin-dependent diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte 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 or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, 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’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations: PharmaCyte Biotech, Inc. Investor Relations Department Telephone: 917.595.2856 Email: [email protected]
