PharmaCyte Biotech Begins Second Follow-Up Study on Ascites


SILVER SPRING, Md., July 23, 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®, announced today that its follow-up study on ascites began this week. That study is being conducted by Translational Drug Development (TD2) to determine the effectiveness of PharmaCyte Biotech’s pancreatic cancer treatment on the rate of accumulation of malignant ascites fluid in patients with pancreatic cancer and other abdominal tumors.

This study was designed by Dr. Daniel D. Von Hoff of TD2 and key members of PharmaCyte Biotech’s scientific team. This is the third study on ascites being conducted by TD2. In this study, as in the previous two studies, mice with ovarian cancer are being used in a model that grows rapidly and produces significant amounts of malignant ascites fluid. Nine groups of mice will be used in this study, with 10 mice in each group. One group will be used as a vehicle control, and in the other eight groups, four different doses of ifosfamide will be used.

The goal of the study is to “fine tune” PharmaCyte’s treatment to slow down the accumulation of ascites that will serve best in the clinical setting.  The Company’s treatment uses low doses of the prodrug ifosfamide together with Cell-in-a-Box® capsules that are filled with live cells capable of converting ifosfamide into its cancer-killing form.

In the initial “proof of principle” study, four groups of mice were used. The mice in Group 1 served as a control group. Group 2 was made up of mice treated with PharmaCyte Biotech’s pancreatic cancer treatment. Group 3’s mice were treated with cisplatin, a chemotherapy drug often used to treat ovarian cancer, and the mice in Group 4 were treated with a combination of PharmaCyte Biotech’s pancreatic cancer treatment and cisplatin. Because of the positive results from this pilot study, the first follow-up study using 12 groups of mice was done to begin to define parameters that will be needed in defining the most appropriate treatment regimen to be used in a clinical trial.

PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, commented, “After careful consideration and analysis of data from the first two studies on ascites, we believe that this follow-up study is appropriate. In conjunction with the results of the first follow-up study, the parameters that will be necessary for designing a Phase 1 clinical trial should be more clearly defined when this study is completed. All of these studies are extremely important, not only for PharmaCyte Biotech but also for the many patients who endure malignant ascites – a serious symptom without a cure or even a way to slow down its accumulation.”

The accumulation of ascites fluid is problematic for patients with an abdominal cancer, such as pancreatic, liver, ovarian, uterine and colon cancers. This is because it is very painful and can cause breathing and other serious problems. Once it gets to a certain stage, it must be removed on a regular basis. This procedure in itself is very uncomfortable for patients as well as costly. PharmaCyte Biotech expects that the Cell-in-a-Box® plus ifosfamide combination will ultimately prove to be effective in slowing the accumulation of malignant ascites fluid and thus reduce the number of withdrawals of the fluid that patients with abdominal cancers must endure over a given period of time.

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 its symptoms, and diabetes are being developed.

PharmaCyte Biotech’s treatment for pancreatic cancer involves encapsulating modified live cells capable of converting the prodrug ifosfamide into its active or “cancer-killing” form. These encapsulated live cells are placed as close to the tumor as possible to enable the delivery of the highest levels of the cancer-killing drug at the source of the cancer. Ifosfamide is then given intravenously at one third the normal dose to eliminate adverse side effects. When the ifosfamide comes in contact with the encapsulated live cells through the circulatory system, the activation of the drug takes place at or near the tumor. This “targeted chemotherapy” has proven remarkably effective and safe to use in past clinical trials.

PharmaCyte Biotech is also developing treatments for cancer based upon chemical constituents of the Cannabis plant. It is examining ways to exploit the benefits of Cell-in-a-Box® technology in optimizing the anticancer effectiveness of Cannabis, while minimizing or outright eliminating the debilitating side effects usually associated with cancer treatments.

In addition to developing treatments for pancreatic and other cancers, PharmaCyte Biotech is developing a treatment for Type 1 diabetes and Type 2 insulin-dependent diabetes. PharmaCyte Biotech plans to encapsulate a human cell line, which has been genetically engineered to produce, store and secrete insulin on demand at levels in proportion 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 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.PharmaCyte.com. It can also be obtained by contacting Investor Relations.


            

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