SILVER SPRING, Md., March 03, 2016 (GLOBE NEWSWIRE) — PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted therapies for cancer and diabetes using its live-cell encapsulation technology, Cell-in-a-Box®, reported today on Chamow & Associates’ (Chamow) audit of Austrianova’s live-cell encapsulation facility in Bangkok, Thailand, and the progress being made to establish that the facility will be cGMP compliant. Chamow is a biopharmaceutical consulting firm with industry experts that specialize in the inspection of facilities for current Good Manufacturing Practices (cGMP) compliance and in the preparation of the Chemistry, Manufacturing and Controls (CMC) section of an Investigational New Drug application (IND). The Austrianova facility will employ the Cell-in-a-Box® technology to produce the microcapsules that, together with low doses of the anticancer prodrug ifosfamide, make up PharmaCyte’s therapy for pancreatic cancer.
In December 2015, Chamow representatives visited Austrianova’s encapsulation facility in the Thai Science Park in Bangkok, Thailand, to perform a full cGMP audit of the facility. Chamow subsequently presented a detailed audit report of its findings to Austrianova and PharmaCyte. The audit report included a complete examination of the components of the facility and identified remaining cGMP goals to be finalized before the required CMC section of the IND can be completed.
In commenting on the auditing process and his impressions of the cell encapsulation facility, Dr. Steven Chamow, President of Chamow & Associates, stated, “The Austrianova production facility is a very well-designed facility with state of the art equipment. Chamow & Associates will work with Austrianova and PharmaCyte to ensure and verify that, when complete, the facility and quality system modifications are compliant with cGMP and therefore ready for the manufacture of clinical trial material.” Dr. Chamow has nearly 30 years of experience in biopharmaceutical product development, including contributions to Genentech’s Avastin®, Johnson & Johnson’s Natrecor® and Amgen’s Vectibix®.
Chamow’s audit is proving to be a solid foundation on which the process is based to make certain that the encapsulation facility is cGMP-compliant. Following completion of the audit, Chamow continues to guide Austrianova in responding to audit observations and to consult with PharmaCyte throughout the process, including biweekly, in-depth teleconferences which include personnel from Chamow, Austrianova, Translational Drug Development (TD2) and PharmaCyte.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “When we received the audit report prepared by Chamow & Associates we were pleased to read that the Austrianova production facility is a well-designed, unique facility, with state-of-the-art equipment, and that Austrianova has initiated a robust quality assurance program and secured personnel to competently execute cGMP manufacturing. We believe that, through the use of the biweekly teleconferences between Chamow, Austrianova, TD2 and ourselves, the full documentation necessary to deem the facility cGMP-compliant and ready for the production of clinical trial material can be completed in a timely manner that will not adversely affect the initiation of our clinical trial.”
In the United States, an IND must be submitted to, and cleared by, the FDA before a clinical trial can begin. One major section of an IND is the CMC section and, in turn, the bulk of the CMC section itself, documents manufacture and control of the investigational agent (drug or biologic product) in accordance with cGMP standards and IND regulations. Whether a manufacturing facility meets cGMP standards is not only dependent upon the status and quality of the equipment within the facility, but also depends upon exacting and in-depth documentation of such items as the actual operation of the facility, the qualification and certification of those working within the facility, standards for production of the designated drug product and controls to confirm quality. To ensure that Austrianova’s encapsulation facility meets those standards, PharmaCyte retained Chamow who is acting as a resource to PharmaCyte and Austrianova.
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company focused on developing and preparing to commercialize therapies 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.
About Chamow & Associates
Chamow & Associates is a consulting group made up of industry experts based in the San Francisco Bay Area providing product development and manufacturing services to companies developing biopharmaceuticals. Its services include advice, expertise and management of bulk process development, drug manufacturing, formulation and delivery, quality, regulatory and project management. To learn more, visit www.chamowassociates.com.
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 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]
