SILVER SPRING, MD, September 25, 2015 (GLOBE NEWSWIRE) – PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes announced today that it has contracted with Chamow & Associates, located in the San Francisco Bay Area, to assist with the Chemistry, Manufacturing and Control (CMC) regulatory requirements for its Phase 2b clinical trial in advanced pancreatic cancer. CMC information is a crucial part of the Investigational New Drug (IND) application that PharmaCyte Biotech will be submitting to the regulatory authorities. PharmaCyte Biotech will leverage the expertise of Chamow & Associates in this process.
The IND application is the seminal document that must be acceptable to drug regulatory authorities and is the final step before PharmaCyte Biotech’s Phase 2b clinical trial can commence. The trial will assess 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) against current therapies for the unmet medical need for the disease.
Chamow & Associates, which was referred to PharmaCyte Biotech by oncology research organization TD2 in Scottsdale, Arizona, provides a variety of important services for biotechnology companies. These services are related to CMC requirements that PharmaCyte Biotech must take into account in preparing its first IND application.
“We are excited to work with PharmaCyte Biotech to support their work to develop a drug for advanced pancreatic cancer,” said Dr. Steven Chamow, principal at Chamow & Associates. “We look forward to using our expertise in drug development, quality and compliance to help them bring their novel encapsulated live cell product to market.”
The initial services provided by Chamow & Associates will involve sending experts to audit the Austrianova encapsulation facility in Bangkok, Thailand, to ensure that it complies with current Good Manufacturing Practices (cGMP). This encapsulation facility will produce the Cell-in-a-Box® capsules that will be used in PharmaCyte Biotech’s upcoming clinical trial in the treatment of pancreatic cancer.
PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, commented, “We are very pleased to have retained Chamow & Associates to perform critically important CMC-related tasks for us. We are grateful to TD2 for recommending Chamow & Associates. We believe we now have one of the most capable consultants in the CMC arena that will enable us to accurately develop information pertaining to the composition, stability and controls used for the manufacturing of the encapsulated live cells we will use in our treatment for advanced pancreatic cancer.”
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 pancreatic cancer and its symptoms, and diabetes are being developed.
PharmaCyte Biotech’s treatment for cancer involves encapsulating genetically modified live cells capable of converting 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 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 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.
About Chamow & Associates, Inc.
Chamow & Associates, Inc. is a biopharmaceutical services group, based in the San Francisco Bay Area, offering strategic guidance and operational management of CMC activities. Drawing on the expertise of seasoned professionals with broad experience in pharmaceutical development, the group’s services range from early development of therapeutics (pre-IND or IND enabling) through NDA or BLA in support of all aspects of CMC. These include process development, manufacturing, quality, regulatory affairs and project management.
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.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: [email protected]
