SILVER SPRING, Md., Jan. 06, 2016 — 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 the Company’s 2016 milestones as it advances its new treatment for pancreatic cancer into the clinic in the United States with study sites in Europe and Australia.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, “We are excited to see 2016 arrive as this is the year that we will get into the clinic with our pancreatic cancer treatment. Our shareholders should understand that nothing whatsoever will deter our efforts to get into the clinic and to showcase our novel treatment for pancreatic cancer.”
Waggoner highlighted the 2016 milestones that PharmaCyte’s shareholders and investment community can look forward to this year:
- PharmaCyte’s CEO will attend the 2016 JP Morgan Healthcare conference in San Francisco to meet with pharmaceutical companies and potential institutional investors.
- The manufacturing facility in Bangkok, Thailand, where the live cells that convert the cancer prodrug ifosfamide into its cancer-killing form will be encapsulated, will receive a factory license from the Thai government enabling production of the encapsulated cells for PharmaCyte to use in its clinical trials.
- The Austrianova manufacturing facility will become fully compliant with current Good Manufacturing Practices (cGMP) standards.
- An Investigational New Drug Application (IND) will be filed with the FDA following a pre-IND meeting with the FDA.
- Appropriate arrangements will be made with cancer centers in the United States to begin PharmaCyte’s pancreatic cancer trial that will address the critical unmet medical need that exists when a patient’s non-metastatic, pancreatic cancer no longer benefits from receiving the “gold standard” treatment – the combination of gemcitabine and Abraxane®.
- PharmaCyte’s clinical trial in pancreatic cancer will get underway with Translational Drug Development (TD2) coordinating the trial globally and conducting it in the United States. Clinical Network Services (CNS) will conduct the trial in Europe and Australia in alliance with TD2.
- After the pancreatic cancer clinical trial has been in process for approximately six months, there will be an evaluation of PharmaCyte’s pancreatic cancer treatment on the patients enrolled in the trial with the interim results being reported to the public.
- Additional preclinical studies to determine if PharmaCyte’s pancreatic cancer treatment can slow down the production and accumulation of malignant ascites fluid will take place in 2016. If successful, plans to conduct a clinical trial in ascites will be undertaken by PharmaCyte with the goal of having TD2 begin the clinical trial by year end or early 2017.
- Numerous preclinical studies will be conducted concurrently and in parallel by members of PharmaCyte’s international Diabetes Consortium to condense the time it will take for PharmaCyte to enter into a clinical trial that will test the ability of the Melligen insulin-producing cells encapsulated using the Cell-in-a-Box® technology to treat Type 1 diabetes and insulin-dependent Type 2 diabetes, with the goal of reaching the clinic in 2017.
- PharmaCyte will fill its open Board of Directors positions as appropriate.
- PharmaCyte will conduct periodic shareholder calls, rather than communicating through shareholder updates, with the CEO responding to questions during the calls.
- PharmaCyte will hold an annual shareholder meeting.
PharmaCyte’s Chief Operating Officer, Dr. Gerald W. Crabtree stated, “2016 promises to be both busy and productive for the Company and those associated with it. Of course the major highlight will be the start of our clinical trial in 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 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.