PharmaCyte Biotech CEO Addresses IND Submission Questions
March 17 2017 - 9:00AM
PharmaCyte Biotech, Inc. (OTCQB: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®, today released a statement by Chief
Executive Officer Kenneth L. Waggoner that addresses the company’s
position on releasing a date for filing its Investigational New
Drug application (IND). Mr. Waggoner’s statement can be read below:
PharmaCyte does not plan to publish a date for the filing of its
IND. At the current time, it’s extremely difficult for the company
to supply a development timeline that will accurately predict when
the IND will be filed. It would be irresponsible of the company to
release what, at this point, would be a “hopeful” date for filing
the IND. This date could change from day-to-day and week-to-week
based upon several unforeseen variables – many of which are beyond
PharmaCyte’s control. This means that we cannot give an accurate
timeline for filing the IND because we too are awaiting a list of
items to be completed by others.
What can be said with certainty is that PharmaCyte is on the
right track for filing its IND at the earliest opportunity. With
the help of Facet Life Sciences and TD2, the company is committed
to doing everything the right way by following the guidance given
to the company by the FDA during the pre-IND meeting. In doing
that, PharmaCyte will maximize the possibility of preparing a
successful IND rather than having the company’s IND put on clinical
hold or even outright denied because it didn’t follow the FDA’s
guidance. Getting to a point where the IND can be filed is not an
overnight or even a one-month process. During the company’s
conference call, I tried to convey this point to shareholders. Any
shareholder who thought that the pre-IND meeting would be held one
day and then the IND would be filed the next had completely
unrealistic expectations. This never occurs.
PharmaCyte’s pre-IND meeting with the FDA was the best possible
way for the company to introduce its pancreatic cancer therapy,
past clinical trial results and trial design to the FDA, and, in
turn, received invaluable feedback from the FDA and suggestions and
ideas to best advance our therapy in the clinical trial. The
pre-IND meeting served as the starting point of getting PharmaCyte
and the FDA on the same page for the company to properly prepare
for a clinical trial in inoperable locally advanced pancreatic
cancer (LAPC).
The pre-IND meeting represented a critical point in the
regulatory process for PharmaCyte and allowed the company to
establish a strong relationship with the FDA. It also provided
PharmaCyte and the FDA the opportunity to agree on a development
strategy that should lead to a successful IND and, hence, the start
of the clinical trial. The discussions held during the pre-IND
meeting have the potential to save PharmaCyte both time and money
in the long run, and have definitively shaped the overall strategy
for the development of PharmaCyte’s therapy for LAPC.
If you’re wondering how the pre-IND meeting could have
meaningfully benefited PharmaCyte and possibly reduce time to
market, the FDA has addressed this question on its website,
indicating the following benefits pertaining to
PharmaCyte:
- Identifying and avoiding unnecessary studies;
- Ensuring that necessary studies are designed to provide useful
information to the FDA;
- Gaining FDA support for PharmaCyte’s proposed
strategy;
- Minimizing the chance for a clinical hold being issued by the
FDA after filing the IND which would, of course, delay the start of
the clinical trial;
- Providing an opportunity for PharmaCyte and the FDA to
creatively embark upon an exchange of ideas about all aspects of
the clinical trial;
- Obtaining regulatory insight from the FDA into the proposed
clinical trial, particularly about PharmaCyte’s cell therapy for
LAPC;
- Minimizing costs so PharmaCyte doesn’t unnecessarily spend
money on its development program;
- Defining acceptable endpoints and goals that the FDA finds
acceptable; and
- Allowing early interactions and ongoing negotiations with the
FDA related to the clinical trial.
The company now has the guidance it needs to
complete what is expected to be a successful IND process.
PharmaCyte was charged with completing numerous tasks identified by
the FDA during the pre-IND meeting. Many of these tasks came about
because PharmaCyte’s treatment for LAPC is novel in that it is a
live cell-based therapy that also involves a unique form of cell
encapsulation technology. When these tasks are completed by
PharmaCyte, Austrianova, TD2 and others, PharmaCyte will file its
IND. It will be then that the public is notified the IND has
been filed.
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage
biotechnology company developing therapies for cancer and diabetes
based upon a proprietary cellulose-based live cell encapsulation
technology known as “Cell-in-a-Box®.” This technology will be used
as a platform upon which therapies for several types of cancer and
diabetes are being developed. PharmaCyte’s therapy for cancer
involves encapsulating genetically engineered human cells that
convert an inactive chemotherapy drug into its active or
“cancer-killing” form. These encapsulated cells are implanted as
close to the patient’s cancerous tumor as possible. Once implanted,
a chemotherapy drug that is normally activated in the liver
(ifosfamide) is given intravenously at one-third the normal dose.
The ifosfamide is carried by the circulatory system to where the
encapsulated cells have been implanted. When the ifosfamide comes
in contact with the encapsulated cells they act as an artificial
liver and activate the chemotherapy drug at the source of the
cancer. This “targeted chemotherapy” has proven effective and safe
to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for
cancer, PharmaCyte is developing a treatment for Type 1 diabetes
and insulin-dependent Type 2 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. Once the encapsulated cells are
implanted in a diabetic patient they will function as a
“bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release contains forward-looking
statements, which are generally statements that are not historical
facts. Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," "outlook" and similar expressions. Forward-looking
statements are based on management's current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. We undertake no obligation to update any forward-looking
statement in light of new information or future events, except as
otherwise required by law. Forward-looking statements involve
inherent risks and uncertainties, most of which are difficult to
predict and are generally beyond our control. Actual results or
outcomes may differ materially from those implied by the
forward-looking statements because of the impact of a number of
risk factors, many of which are discussed in more detail in our
Annual Report on Form 10-K and our other reports filed with the
Securities and Exchange Commission.
More information about PharmaCyte Biotech can be
found at www.PharmaCyte.com. It can also be obtained by contacting
Investor Relations.
Contact:
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com