PharmaCyte Biotech Secures Funding Opportunity for Pancreatic Cancer Clinical Trial
13 December 2016 - 1:00AM
Marketwired
PharmaCyte Biotech Secures Funding Opportunity
for Pancreatic Cancer Clinical Trial
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
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