PharmaCyte Biotech Moves Closer to Enrolling
Patients in Pancreatic Cancer Clinical
Trial
Company Aiming to Produce 6-Month Breakthrough
Data
NEW
YORK, NY-(Marketwired - December 01, 2016) -
PharmaCyte Biotech
(OTCQB: PMCB)is
now one step closer to enrolling patients in a pivotal clinic trial
in advanced, inoperable pancreatic cancer after the FDA granted its
request for a pre-IND (Investigational New Drug) meeting. A host of
oncologists, clinicians and scientists that represent PharmaCyte
will now sit down with the U.S. regulatory agency to gain valuable
insight that will assist them in filing an Investigational New Drug
application - the final step before patients can be enrolled in a
clinical trial.
With
PharmaCyte and a team of world-renowned oncologists 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, set to begin a clinical trial in
the U.S. and Europe, the FDA's IND process is vital to getting
there.
After the IND process runs its course,
shareholders should be prepared for what a planned 6-month "hard
stop" in the clinical trial could bring in the way of data to the
industry. If past performance in earlier clinical trials is any
indication, PharmaCyte may be a short time away from what could be
a very powerful story for patients with advanced, inoperable
pancreatic cancer.
PharmaCyte Could Apply for Breakthrough Therapy
Designation
The
review of data at the 6-month hard stop could very well lead to
PharmaCyte's therapy being given the Breakthrough Therapy
Designation by the FDA.
A
breakthrough therapy is a drug/therapy:
- Intended alone or in combination with one or more
other drugs to treat a serious or life threatening disease or
condition, and
- Preliminary clinical evidence indicates that the
drug may demonstrate substantial improvement over existing
therapies on one or more clinically significant endpoints, such as
substantial treatment effects observed early in clinical
development.
According to the FDA, if a drug/therapy is
designated as breakthrough therapy, the FDA will speed up the
development and review of the
drug/therapy.
PharmaCyte's pancreatic cancer therapy has
already received the Orphan Drug Designation from both the FDA and
the European Medicines Agency (EMA), so if the company can repeat
the data from earlier clinical trials, there is a very good chance
that PharmaCyte could earn the breakthrough therapy designation
from the FDA as well.
There are two areas specifically that could lead
to this designation: (1) quality of life and (2) how well
PharmaCyte's therapy can shrink inoperable tumors so that they may
become operable. In earlier trials, the company's treatment did
improve the quality of life and it did show the ability to shrink a
pancreatic tumor.
PharmaCyte Addressing an Unmet Medical
Need
PharmaCyte has recognized that there is currently
an unmet medical need for patients with locally advanced pancreatic
cancer (LAPC) that no longer receive any benefit from using the
standard of care for the disease (the combination of Abraxane® plus
gemcitabine) after 4-6 months of treatment. PharmaCyte expects that
its therapy can meet that unmet medical need. The company will
enroll those patients whose cancer no longer responds after 4-6
months of treatment using the current gold
standard.
In
PharmaCyte's clinical trial, about 84 patients with LAPC will be
randomly placed into two equal groups.
- Group 1 will receive just the chemotherapy drug
gemcitabine
- Group 2 will receive PharmaCyte's pancreatic
cancer therapy
Those who are familiar with PharmaCyte are also
familiar with the impressive data from earlier clinical trials
where PharmaCyte's pancreatic cancer therapy dramatically
outperformed historical data from gemcitabine. In this upcoming
clinical trial the company's therapy will go head-to-head with
gemcitabine.
PharmaCyte's pancreatic cancer therapy uses the
company's signature live-cell encapsulation technology,
Cell-in-a-Box® plus low doses of the FDA-approved chemotherapy drug
ifosfamide.
The
pinhead-sized, porous capsules (Cell-in-a-Box®), which are placed
as close to the pancreatic tumor as possible, are filled with
thousands of genetically modified cells that act as a type of
"artificial liver" in the sense that these genetically modified
cells (about 10,000 cells per capsule) are capable of converting
ifosfamide from its normally inactive form into its active
cancer-killing form - just as the enzyme system in a patient's
liver would normally do.
By
moving the conversion site of the chemotherapy drug (from the liver
to the Cell-in-a-Box®capsules) closer to the pancreatic tumor,
PharmaCyte's therapy can use a lower dose (1/3 the normal dose) of
the chemotherapy drug. The benefit to using a lower dose is that it
eliminates the side effects normally seen in patients undergoing
chemotherapy, and it is the elimination of these side effects that
improved the patient's quality of life in earlier clinical
trials.
Improved Imaging Should Allow PharmaCyte to
Provide the FDA Better Data
Just
as 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, so too did Dr. Ron
Korn.
Dr.
Korn is the Founder, Chairman and Chief Medical Officer of Imaging
Endpoints, and just as he was a part of bringing the industry
Abraxane® plus gemcitabine, he has signed on to be a part of
PharmaCyte's clinical trial as well. This is significant because in
earlier clinical trials, PharmaCyte's therapy showed that it could
shrink a patients' pancreatic tumor. And, in images posted on the
company's website, we see a patients' tumor shrinking dramatically
in just 20 weeks (5 months or 1 month sooner than PharmaCyte's
planned 6-month hard stop), but that was years ago when imaging
wasn't nearly as good as it is today.
Imaging Endpoints will provide PharmaCyte
advanced imaging that will help researchers identify biological
activity during the clinical trial where traditional imaging fails.
So, is there the likelihood that data will show the patients'
tumors shrinking even earlier than 5 months and even more
dramatically?
Experts from Imaging Endpoints will be involved
in training radiologists at all of the clinical trial study sites
to ensure the Cell-in-a-Box® capsules are correctly implanted into
patients.
Also, Imaging Endpoints will be responsible for
coordinating the data obtained from CT (computerized tomography)
and PET (positron emission tomography) scans of the patients'
tumors as they progress through the clinical trial. Imaging
Endpoints will also analyze all of the imaging data obtained during
the trial using its state-of-the-art
methodology.
The
table is certainly set for PharmaCyte's therapy to succeed in the
clinic. PharmaCyte's Chief Executive Officer, Kenneth L. Waggoner,
has surrounded the technology with the brightest minds in the
industry, he's obtained the orphan drug designation for the
therapy, the FDA has now granted PharmaCyte a pre-IND meeting and
the path to the clinic has narrowed to just getting through the
final steps of the IND process. 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 in advanced pancreatic cancer.
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