Looking back...
Into January: KW couldn't have predicted 2016 any more accurately as PharmaCyte is now set, "in preparation", to meet with the FDA. Coming into the new year he 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.”
Into February: Plowing forward to develop the CMC information section of the IND, TD2 takes the lead and works in concert with Chamow and Austrianova.
Into March: PharmaCyte designed a Phase 2b clinical trial that will include a hard-stop at 6 months to evaluate the data. Strategic site locations allowed substantially reduced cost and shorter time period relative to typical studies. Also, in the design, a series of measurable secondary endpoints will eliminate the need to launch costly separate trials or studies to track the pain associated with pancreatic cancer in 20-25% of patients.....Additionally, regarding PharmaCytes key therapy processes, KW made it clear that he has a protection strategy in place, that includes filing an application with the U.S. Patent and Trademark Office for interim extensions extending the life of those patents 1 year at a time for up to 5 years, which he believes will be long enough to get PharmaCyte through clinical trials and the regulatory approval process.
Into April: PharmaCyte becomes GMP compliant. PharmaCyte reports that the encapsulation facility for its pancreatic cancer therapy is ready to manufacture PharmaCyte’s biologic product under current Good Manufacturing Practices standards.
Into May: PharmaCyte announces that Kenneth L. Waggoner, the Chief Executive Officer of PharmaCyte, will be a featured presenter at the 5th Annual Marcum MicroCap Conference. The conference is a signature showcase for superior quality, lesser-known public companies with less than $500 million in market capitalization, and dedicated to providing a forum where these companies can network with the investment community. The event attracts fund managers and high net worth investors who focus on small cap equities, a number of whom Mr. Waggoner will be meeting.
Into June: PharmaCyte announced that its entire senior management team will attend the American Society of Clinical Oncology’s (ASCO) 52nd annual meeting. KW said the meeting was invaluable for Phase 2b clinical trial, and that there would be discussions with top oncologist investigators who have expressed interest in PharmaCyte’s technology and participation in the clinical trial. The discussions would include Dr. Gerald W. Crabtree, Dr. Matthias Löhr, Dr. Manuel Hidalgo, Prof. Dr. Walter H. Günzburg, Dr. Brian Salmons and Dr. Sanjay Batra. Presentations will also be made.
Into July: PharmaCyte announced it now has 20 years of patent protection in the United States for the "Melligen" cells. Also, PharmaCyte announced that a published scientific article supports PharmaCyte’s ongoing research efforts that concern medical uses for constituents of Cannabis known as cannabinoids. KW stated..."This research again demonstrates the potential benefit of cannabinoids in treating deadly and debilitating diseases such as cancer and neurodegenerative diseases. Our Cell-in-a-Box® live-cell encapsulation technology provides a unique, versatile and natural platform for the delivery of potentially beneficial cannabinoids. It is PharmaCyte’s goal to use the combination of the Cell-in-a-Box® technology and cannabinoids or cannabinoid-like compounds to develop effective and safe treatments for some of the deadliest forms of cancer for which such treatments do not presently exist, such as cancer of the pancreas, brain and breast, which affect hundreds of thousands of individuals worldwide every year.” .....Additionally, It was reported that PharmaCyte Biotech's signature live-cell encapsulation technology, Cell-in-a-Box®, is being used in treatments for both cancer and diabetes. For diabetes, the company's therapy, which is made up of pinhead-sized, porous capsules filled with insulin producing cells, will create an "artificial pancreas" for type 1 diabetics and insulin-dependent type 2 diabetics that no longer produce their own insulin. Meanwhile, for cancer, the company's therapy is made up of those same pinhead-sized, porous capsules; however, for advanced pancreatic cancer, they're filled with genetically modified cells that act as a type of "artificial liver."
Into August: The DEA announced it still refused to reschedule the drug as a less dangerous one, but said it would end a long-standing monopoly on the production of cannabis for medical research. The DEA also decided to allow researchers and drug companies to use cannabis grown outside the DEA’s facilities in their research and trials, and allow those to register to grow marijuana “not only to supply federally-funded or other academic researchers but also for strictly commercial endeavors funded by the private sector and aimed at drug product development." KW stated, “Now that all…governmental approvals have been obtained and UNCO has [already] received the research cannabis, we are finally able to build upon the firm foundation that had been laid in our quest to develop targeted cannabinoid cancer chemotherapies that utilize the Cell-in-a-Box(R) technology.” As a result of the DEA’s decision, PharmaCyte contracted with the University of Northern Colorado (“UNCO”), led by Dr. Richard M. Hyslop, to conduct the research related to PharmaCyte’s medical cannabis program. The UNCO has obtained all of the necessary approvals and has now received all of the approvals necessary to research cannabis to advance PharmaCyte’s program.
Into September: With numerous moving parts on many fronts of the upcoming clinical trial, KW asks shareholders to remain calm as the process continues forward. He commented, “We understand that shareholders are frustrated with our current share price; however, the share price doesn’t reflect where PharmaCyte is today. In what has been a relatively short time for a biotech company, we have dramatically moved our Cell-in-a-Box® technology forward along the path toward the clinic, we have surrounded our technology with some of the best minds in the industry and we have put together a team that is working diligently every single day to get PharmaCyte in front of the U.S. Food and Drug Administration (FDA) so that we can clear the final hurdles that will allow us to begin our clinical trial in advanced pancreatic cancer." And...“It is important for our shareholders to realize that PharmaCyte’s pancreatic cancer therapy is classified by drug regulatory authorities as a ‘biologic’ rather than a single molecule drug or a New Chemical Entity (NCE). This is because our therapy involves the use of living, genetically altered human cells. The overall development process is much more involved and more complex for a biologic than an NCE.
Into October: PharmaCyte announced that it has advanced into a new and promising phase of research at the University of Northern Colorado (UNCO) in its quest to develop targeted cannabinoid-based chemotherapy utilizing the Cell-in-a-Box® technology. “We are quite pleased with the progress UNCO has made and to have all the necessary components in place to advance our research,” commented cannabinoid medicine expert and member of PharmaCyte’s Medical and Scientific Advisory Board, Dr. Mark L. Rabe. “Having a candidate enzyme (produced by the live cells within the capsules that activate the prodrug in a targeted fashion, initiating cancer cell death) and knowing the gene behind it is huge. It is now a matter of completing a series of steps and making sure everything we have planned works. If so, it is a fairly straight line to the clinic. Our initial goal is to tackle glioblastoma, an almost untreatable form of brain cancer.”
Into November: PharmaCyte announces the Pre-IND meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has been granted by the FDA. PharmaCyte will be submitting a full Pre-IND package of information to the FDA that describes what PharmaCyte intends on submitting in its Investigational New Drug (IND) application for review....Additionally, PharmaCyte arrives at the door of U.S. FDA as it reaches the final test before it can begin its pivotal clinical trial in advanced pancreatic cancer. In PharmaCyte's clinical trial, Dr. Hidalgo will once again be teamed up with renowned pancreatic cancer expert Dr. Daniel Von Hoff. Dr. Von Hoff is the Chief Development Officer at Translational Drug Development (TD2), the nation's premiere oncology CRO and the company responsible for organizing and conducting PharmaCyte's clinical trial. Dr. Von Hoff and Dr. Hidalgo worked together on the clinical trials that brought the industry what is now the gold standard and the FDA approved treatment for advanced pancreatic cancer, Abraxane® plus gemcitabine.
Into December: The quarterly 10-Q reveals NO DILUTION. PharmaCyte announced that it submitted its pre-Investigational New Drug (pre-IND) meeting package to the U.S. FDA .....Additionally, Pre-IND meeting with FDA makes ATM funding possible (hopefully better financing options will come later).
I would like to thank all those who have provided the valuable and informative information to this board. Without the debates and feedback here this board would be totally boring.....NOT!!! lol
I wish us all a very happy and prosperous new year.
Go PMCB!!! Go KW!!!
