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PharmaCyte Biotech Provides Update on Malignant Ascites and New Colon Cancer Studies

PharmaCyte Biotech, Inc. (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 issued an update on the preclinical studies that are designed to determine the effectiveness of the Cell-in-a-Box® plus ifosfamide therapy in delaying the accumulation of malignant ascites fluid in the abdomen of mice with abdominal tumors. Each of the preclinical studies in ascites are being conducted by Translational Drug Development (TD2) – the premier CRO in the United States specializing in oncology.  TD2 is also the CRO conducting PharmaCyte’s upcoming clinical trial in advanced pancreatic cancer.

PharmaCyte’s initial series of preclinical studies were done with mice that had been inoculated with a human ovarian cancer. This tumor type grows aggressively and is prolific in producing malignant ascites fluid. The data obtained from these studies provided information that is being used as a foundation for future studies on other tumor types. In the earlier preclinical studies, the effects of varying the number of Cell-in-a-Box® capsules and the amount of ifosfamide on mouse survival and on the production of malignant ascites fluid were studied. The results from this initial series of studies are now being used in connection with new colon cancer studies that may prove to be effective in developing a treatment that delays the production of malignant ascites fluid in cancer patients.

In part because colon cancer is the most commonly diagnosed cancer of the digestive tract, a new preclinical study has just begun in mice that have been inoculated with the regularly used Colon 26 mouse model. This new study is based upon the results of previous work using this same model system that was performed by Dr. Matthias Löhr, the Chairman of PharmaCyte’s Scientific Advisory Board, and his colleagues at the University of Heidelberg, Germany. The results of the previous study were reported in the scientific publication Cancer Gene Therapy in 2006. This publication can be viewed athttps://www.nature.com/cgt/journal/v13/n1/full/7700849a.html.

The results of the study performed by Dr. Löhr demonstrated that the intraperitoneal administration of a combination of the Cell-in-a-Box® capsules (then known as CapCell®) and ifosfamide was effective in treating the spread of colon cancer that was caused by malignant ascites fluid. It is believed that the new “Colon 26” study being conducted at TD2 will serve to verify the results of the previous work and provide additional information on how best to use the intraperitoneal administration of the combination of Cell-in-a-Box® capsules and ifosfamide to control the spread of colon cancer from malignant ascites fluid as well as the production of malignant ascites fluid.

The Chief Executive Officer of PharmaCyte, Kenneth L. Waggoner, commented, “Through the use of different animal model systems such as the ES-2 for ovarian cancer and the Colon 26 model for colon cancer, we believe that we will be able to better define the parameters by which the combination of the Cell-in-a-Box® capsules and ifosfamide is most effective in controlling the production of malignant ascites fluid brought on by abdominal cancers. If we are successful in our endeavors, PharmaCyte will have developed a treatment that will help combat the spread of abdominal tumors and reduce the suffering of cancer patients from the accumulation of ascites fluid within the abdominal cavity.”

Malignant ascites fluid is produced by abdominal cancers, such as colon, ovarian, stomach, intestine, pancreas and uterus. It is this fluid that is responsible, in large part, for the spread of cancer cells from the original tumor to other sites in the peritoneal cavity. The accumulation of ascites fluid is extremely problematic. In the case of pancreatic cancer, large volumes of malignant ascites fluid are usually produced. As a consequence, severe swelling of the abdomen occurs. Not only is this exceedingly painful for the patient, but unless the ascites fluid is removed on a periodic basis (painful for the patient and expensive to perform), the accumulation of ascites fluid can be life-threatening. There is no treatment on the market that will slow the production of malignant ascites fluid.

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 (ifosfamide) 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, 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 ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells, activation of the 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 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 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 can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.

Contact:
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856

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