SILVER SPRING, Md., Sept. 09, 2015 (GLOBE NEWSWIRE) — 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®, announced today that it has contracted with Imaging Endpoints in Scottsdale, Arizona, to perform radiologic imaging that will be required for PharmaCyte Biotech’s Phase 2b clinical trial in pancreatic cancer. This is the first in a series of announcements that PharmaCyte will release related to the company’s upcoming Phase 2b clinical trial, including a full layout of the dramatically improved clinical trial design. The trial will test the effectiveness of PharmaCyte Biotech’s pancreatic cancer treatment (the combination of microcapsules produced using the Cell-in-a-Box® technology and low doses of the anticancer drug ifosfamide) in patients with this disease.
The involvement of Imaging Endpoints in the Phase 2b trial will be extensive and marks the first of many crucial events related to the start of PharmaCyte’s first clinical trial. Experts from Imaging Endpoints will be involved in training radiologists at the various study sites to ensure the Cell-in-a-Box® capsules are correctly implanted into patients. Imaging Endpoints will also be responsible for coordinating the data obtained from CT (computerized tomography) and PET (positron emission tomography) scans of the patients’ tumors as they progress through the clinical trial. Imaging Endpoints will also analyze all of the imaging data obtained during the trial using state-of-the-art methodology.
In addition to outstanding radiologists, Imaging Endpoints’ Scientific Advisory Board members include world renowned experts in pancreatic cancer. Dr. Daniel D. Von Hoff, Chief Development Officer of Translational Drug Development (TD2), the Contract Research Organization currently performing preclinical studies in the U.S. for PharmaCyte Biotech, is Chairman of the Scientific Advisory Board and Dr. Manuel Hidalgo, a member of that same Board, is also a member of PharmaCyte Biotech’s Scientific Advisory Board and a consultant to PharmaCyte Biotech. Imaging Endpoints currently has 40 “in-house’ radiologists who are working on about 100 clinical trials in various therapeutic areas.
PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, commented, “We are extremely pleased that Imaging Endpoints has agreed to perform some of the most critical activities related to our upcoming trial in pancreatic cancer. The success of this trial will be, in large part, crucial to the overall success of our company. The outstanding individuals associated with Imaging Endpoints and the expertise of that company in analyzing the radiologic imaging results from the trial will, we believe, ensure that the interpretation of those results is both comprehensive and accurate. With Imaging Endpoints, we could not be in better hands.”
“We are honored to be working with PharmaCyte Biotech on this exciting project,” stated Imaging Endpoints’ Founder and Chief Medical Officer, Ron Korn, M.D., Ph.D. “PharmaCyte Biotech has assembled an impressive team of experts to conduct this study and, if successful, their technology promises to provide a new approach for the treatment of pancreatic cancer.”
About Imaging Endpoints Imaging Endpoints is a full-service imaging contract research organization providing services to the pharmaceutical, biotech and medical device industries to accelerate their national and international clinical trials. Extensive expertise in imaging allows Imaging Endpoints to perform real-time qualitative and quantitative assessments of both anatomic and physiologic/metabolic imaging modalities in order to better probe the effectiveness of new therapeutics. In addition to its expertise in oncology, Imaging Endpoints has expertise in neurological, musculoskeletal and cardiovascular radiologic sciences, and experience in all phases of clinical trials from preclinical through Phase 3 and post-market studies.
More information about Imaging Endpoints can be found at: www.imagingendpoints.com.
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 related symptoms and diabetes, are being developed.
PharmaCyte Biotech’s treatment for pancreatic cancer involves encapsulating genetically modified human cells that convert 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 the side effects normally associated with chemotherapy. When the ifosfamide comes in contact with the encapsulated live cells through the circulatory system, the activation of ifosfamide 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 the encapsulation of chemical constituents of the Cannabis plant. It is examining ways to exploit the benefits of the Cell-in-a-Box® technology in optimizing the anticancer effectiveness of Cannabis, while at the same time minimizing or outright eliminating the debilitating side effects often associated with cancer treatments.
In addition to developing treatments for pancreatic and other cancers, PharmaCyte Biotech is developing a treatment for 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 of the insulin producing live cells 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.
Contact:
Investor Relations:
PharmaCyte Biotech, Inc. Investor Relations Department
Telephone: 917.595.2856
Email: [email protected]
