NEW YORK, NY--(Marketwired - December 12, 2016) - All of the pieces are starting to fall into place for PharmaCyte Biotech (OTCQB: PMCB) and its upcoming human clinical trial in advanced pancreatic cancer. Just one week after the U.S. Food and Drug Administration (FDA) granted the biotech a pre-IND (Investigational New Drug) meeting to discuss the company's clinical trial, PharmaCyte qualified to use its multi-million dollar "at-the-market" funding arrangement with Chardan Capital in order to enroll every single patient into its upcoming clinical trial.
PharmaCyte's CEO, Kenneth L. Waggoner, commenting on why this funding source is so important to his small biotech said, "We are fortunate that our shareholders saw the value proposition in the company to invest at a level that enables us to once again qualify to use this source of capital. Small biotech companies often run out of money before their products even get a chance to succeed, and this funding opportunity goes a long way in minimizing that possibility.
"We are in the process of finalizing PharmaCyte's ability to use this funding source to help us pay for our upcoming clinical trial and our continued operations. Of course we are always exploring other sources of funding as well, but this opportunity is a very cost effective way to fund the clinical trial. The key is to get the trial underway and validate our therapy for pancreatic cancer.
"Dr. Matthias Löhr recently commented on the technology, the trial design and the team that will be involved with the trial. In my opinion, we couldn't be in better shape at this point. All of the pieces are falling into place quite nicely."
This funding is key to PharmaCyte's success and the key to bringing pancreatic cancer patient's hope. The company's therapy is expected to meet an unmet medical need, and it's hard to imagine any company in the entire bio-pharmaceutical industry that has a more impressive team surrounding its technology and its treatment than PharmaCyte does.
Waggoner has been able to land a team of world-renowned oncologists to surround his company's signature live-cell encapsulation technology, Cell-in-a-Box®, that includes leading pancreatic cancer expert Dr. Daniel Von Hoff from Translational Drug Development (TD2), Dr. Manuel Hidalgo from Harvard Medical School, and Dr. Matthias Löhr from the Karolinska Institute in Stockholm, Sweden.
Waggoner said that the one thing he's constantly thinking about is the infinite possibilities for his company's platform technology Cell-in-a-Box® to treat so many forms of solid tumor cancers -- liver, breast, ovarian -- to name a few.
Waggoner added, "Closely behind the infinite possibilities are the amazing oncologists that are involved with our technology and our clinical trial. In my opinion, we couldn't have put together a stronger team to insure our technology has the best chance for success. I often think of the benefit that so many pancreatic cancer patients, who have little to no hope when they receive no further benefit from the first line standard of care, may get if our therapy performs in the way we believe it will perform. Of course, being in front of the FDA means we are with a drug regulatory agency that leads the world in regulating drug development and therapies to treat diseases. That's pretty awesome."
Waggoner's excitement about getting through a whole host of milestones and now having PharmaCyte's therapy before the FDA is contagious. After all it was this latest milestone -- being granted a pre-IND meeting by the FDA -- that sent his company's stock flying over 590% and giving the company the $75-million unaffiliated market capitalization (now over $100 million) that it needed to qualify for the opportunity it now has to fund its pivotal clinical trial.
"We've come a long way since I took over in January 2014. Now that we're at the FDA, it's extremely satisfying and exciting. But being there is just another new beginning. We are fully committed to seeing this technology validated so that we can be but a small part of a very long journey in changing how solid cancerous tumors will be treated in the future.
"It is very gratifying to be part of developing a therapy for solid cancerous tumors that are treated with chemotherapy that results in no meaningful side effects. Just think of the quality of life of a cancer patient with our therapy verses what a patient has to endure with traditional chemotherapy."
PharmaCyte's CEO knows the FDA's pre-IND process is a vital step to submitting an Investigation New Drug application (IND), and he says his team will be ready for that most important pre-IND meeting in front of the FDA.
"We will be submitting a very lengthy pre-IND package that provides detailed information and data on our therapy and proposed clinical trial. We will be flying key members of our team from Europe to the U.S. to prepare for and participate in the meeting with the FDA. There will be substantial preparation before the meeting with our team of new regulatory experts. They have extensive experience with the FDA in pre-IND and other meetings. We are in good hands."
While PharmaCyte is certainly in good hands with its upcoming clinical trial, the company's shareholders must be feeling they too are in good hands with a CEO that has done everything he said he would do since he came on board. Waggoner said he knows that PharmaCyte is in a marathon -- not a sprint. "In my opinion, the potential of our therapy is grossly undervalued, but one day I believe that our share price and our great story will match."
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