PharmaCyte Biotech Now Awaits U.S. FDA to
Advance Pancreatic Cancer Therapy into Pivotal Clinical
Trial
NEW YORK, NY-(Marketwired - November 16, 2016)
- PharmaCyte Biotech (OTCQB: PMCB)has arrived at the door of U.S. FDA and awaits a
pre-IND meeting with the agency. After years of surrounding its
signature live-cell encapsulation technology, Cell-in-a-Box®, with
some of the brightest minds in pancreatic cancer and fine-tuning
its therapy and clinical trial design, the small biotech has
reached the final test before it can begin its pivotal clinical
trial in advanced pancreatic cancer.
PharmaCyte made two recent announcements that
would be big for any company, but for a small biotech, the
announcements are big news for shareholders who have been patiently
waiting. First, it announced that oncologist, Dr. Manuel Hidalgo,
who is the Chief of the Division of Hematology-Oncology at Harvard
Medical School's Beth Israel Deaconess Medical Center, has accepted
the role of Principal Investigator for PharmaCyte's planned
clinical trial. And the company followed up that news with the
announcement that it has requested a pre-IND meeting with the FDA
for its upcoming pancreatic cancer clinical
trial.
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.
PharmaCyte has already named a handful of
clinical trial sites that are being considered which include the
Mayo Clinic in Scottsdale, Arizona, the Beth Israel Deaconess
Cancer Center in Boston, the Dana-Farber Cancer Institute in
Boston, the Baylor Cancer Center in Dallas, the City of Hope Cancer
Center in Los Angeles and sites in Germany and
Spain.
Creating an "Artificial Liver" to Target
Pancreatic Cancer
PharmaCyte's pancreatic cancer therapy is made up
of pinhead-sized, porous capsules that are filled with thousands of
genetically modified cells that act as a type of "artificial
liver."
PharmaCyte's Cell-in-a-Box® is not a drug
delivery system. There are no drugs encapsulated inside the porous
capsules for any of its treatments. Instead, the capsules are
filled with about 10,000 live cells that are capable of converting
an inactive chemotherapy drug (ifosfamide) into its active
cancer-killing form - just as the enzyme system in a patient's
liver would normally do.
Because the chemotherapy drug ifosfamide is a
prodrug or an inactive drug, it can travel all over the body and
have no effect whatsoever until it is activated in the liver.
PharmaCyte's therapy essentially moves the "normal" conversion site
of that inactive drug (the patient's liver) closer to the cancerous
tumor by using Cell-in-a-Box® capsules and the live cells inside
them to do the job of the patient's liver or to act as an
"artificial liver."
How Does PharmaCyte Biotech Do
It
The encapsulated live cells (Cell-in-a-Box®
capsules) are placed as close to the patient's cancerous tumor as
possible. Once implanted, ifosfamide, the aforementioned
chemotherapy drug that needs to be activated in the body, is given
to the patient intravenously at one-third the normal dose. The
ifosfamide is then carried by the circulatory system to where the
encapsulated cells have been placed.
When the ifosfamide, which is normally activated
in the liver, comes in contact with the encapsulated live cells in
the Cell-in-a-Box® capsules, the chemotherapy drug is activated
into its cancer-killing form right at the site of the cancer. This
is "targeted chemotherapy" in the truest sense, and the company's
therapy has proven effective and safe to use in past clinical
trials.
Chemotherapy with No Side
Effects
The obvious question is why move the conversion
site of the chemotherapy drug at all. Well, there are actually a
number of reasons to move the activation site closer to the tumor.
We'll start with the chemotherapy drug itself.
Ifosfamide, when activated, has a very short
half-life (time before it decays and no longer offers any effect),
so by using the cells inside the Cell-in-a-Box® capsules to
activate the drug at the site of the tumor, ifosfamide can
immediately be the most effective when it's the most potent before
dying off minutes later.
Without a treatment like PharmaCyte's, ifosfamide
would be given to the patient intravenously and then activated
"normally" in the liver, the activated drug would then affect
tissues and organs other than the pancreas, and by the time it
reached the pancreas, it undoubtedly would have lost much of its
effectiveness. So, to be effective against a pancreatic tumor when
the Cell-in-a-Box® capsules are not used, a large dose of the drug
has to be administered.
Using ifosfamide in such large doses has proven
to be damaging for tissues and organs including the patient's
liver, and because the activated drug would come in contact with
such other organs and good cells throughout the body on its way to
the pancreas, the side effects would be intolerable; in fact, this
is known to be the case.
By moving the conversion site as close to the
tumor as possible, PharmaCyte is able to give a much smaller dose
of the chemotherapy drug (one-third the normal dose), which
patient's are able to tolerate, and because of the smaller dose,
the treatment can be administered without any side effects from the
chemotherapy.
Next Stop FDA Clinical Trial
With a list of oncologists and clinicians that
reads like a who's who now in place to lead PharmaCyte's clinical
trial, the company is now awaiting a pre-IND meeting with the FDA.
After submitting questions to the FDA as part of a pre-IND meeting
request where aspects of the content of the Investigational New
Drug (IND) application itself (CMC section, clinical trial
description, etc.) will be discussed, PharmaCyte is ready to fully
engage with the FDA on its way to receiving the final approval it
needs to begin its planned clinical trial in pancreatic
cancer.
Once PharmaCyte navigates the pre-IND process and
files its IND application, then the FDA will have 30 days to make
comments, and if no comments are made, then PharmaCyte is
effectively "approved" to begin its pivotal clinical
trial.
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