Waggoner highlighted the 2016 milestones that PharmaCyte’s shareholders and investment community can look forward to this year:
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.
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