PharmaCyte Biotech Discusses Upcoming Clinical Trial in Pancreatic Cancer with First Principal Investigator
December 07 2016 - 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®, released today the first article in a
series of Q&A articles that will be conducted with some of the
key team members of PharmaCyte’s planned clinical trial in locally
advanced, inoperable pancreatic cancer (LAPC). PharmaCyte’s first
Q&A article is with Dr. Matthias Löhr of the famed Karolinska
Institute in Stockholm, Sweden. Dr. Löhr was the Principal
Investigator of the two earlier clinical trials using the
Cell-in-a-Box® technology in patients with advanced, inoperable
pancreatic cancer.
As PharmaCyte prepares to meet with the FDA in a
Pre-IND meeting, what are your general thoughts of the
Cell-in-a-Box® plus low dose ifosfamide therapy for pancreatic
cancer once again getting a chance to prove itself in patients?
Dr. Matthias Löhr: “I feel very confident and
also happy to see the revival of this treatment concept. I consider
Cell-in-a-Box® as a platform technology. The previously raised
concerns relating to the consistent reproducibility of the
micro-capsules have been met by Austrianova in the meantime.
Pancreatic cancer is a medical emergency
(https://www.researchgate.net/publication/265394214_Pancreatic_cancer_should_be_treated_as_a_medical_emergency)
and is rising amongst the cancer related deaths, this year
surpassing breast cancer to become number three, and by 2030 to
become number two.”
As the Principle Investigator of both of the
earlier clinical trials, what are some of the highlights you
recognized that you feel will once again be seen in PharmaCyte’s
upcoming trial?
Dr. Matthias Löhr: “When we treated the first
patients, they did not believe that they were receiving
chemotherapy because there were NO side effects at all in the
initial trial. That should be the case in PharmaCyte’s upcoming
trial. Besides this very subjective impression, albeit repeated by
all patients, we measured the quality of life, which was excellent
- considering the dire disease. We will be measuring the quality of
life in the upcoming trial as well. Further, we saw an effect not
only on the primary tumor in the pancreas (where the capsules were
injected) but also in some patients on the liver metastasis. This
can only be explained by an immunological bystander effect that
will likely be investigated in more depth in the upcoming clinical
trial. Finally, in the first trial, certain patients’ tumors went
from inoperable to operable. That is certainly a possibility in
PharmaCyte’s trial, especially since we will be giving more than
two courses of ifosfamide like we did in the first trial.”
Why do you feel this new trial design can
succeed?
Dr. Matthias Löhr: “The locally advanced
pancreatic cancers are not sufficiently covered by guidelines -
there is no standard of care, hence a highly unmet medical need.
This refers particularly to those patients who received first line
therapy, e.g. a very strong one (FOLFIRINOX) or combination of
gemcitabine with Abraxane®. AFTER this therapy, there is nothing
left, especially an alternative with a low likelihood of side
effects. The selection of these patients (group) is certainly to an
advantage of the Cell-in-a-Box® technology, which is mostly
localized, may have a systemic (immunological) effect and has
virtually no side effects. We consider this an ideal setting to the
advantage of our patients in this upcoming clinical trial.”
What are your thoughts on the benefits of using
more rounds of the chemotherapy prodrug ifosfamide as PharmaCyte’s
trial design calls for in this upcoming clinical trial?
Dr. Matthias Löhr: “This will definitively
improve the outcome of the patients in this upcoming clinical
trial. We couldn’t do this in the original trial(s) as we had no
information on the stability of the capsules and activity of the
cells converting the chemotherapy drug ifosfamide. This has changed
now with the data developed from the first two trials. We
will continue to administer ifosfamide until the patients receive
no further benefit from our therapy. We can do that because we know
the capsules are robust for at least two years and that the cells
within them continue to convert ifosfamide during the life of the
patient.”
What are your thoughts on going head to head
with gemcitabine?
Dr. Matthias Löhr: “No sweat. Gemcitabine is
still the standard, due to the excellent tolerability of the drug
and will be the drug used second line, especially after heavy
protocols such as FOLFIRINOX or gemcitabine/ Abraxane®. In this
pretreated patient group, one has to use something with a very low
profile on side effects. This is certainly the case with our
Cell-in-A-Box®.”
What are your impressions of the team that
surrounds the technology as PharmaCyte heads into its planned
clinical trial?
Dr. Matthias Löhr: “PharmaCyte has the visionary
capacity to see the potential of this platform technology, with
pancreatic cancer being the first indication. They reached out to
the original team, both those developing the technology and
conducting the early phase clinical trials. Taking this knowledge
on board is certainly the most important factor to ensure success.
Further, with both Dr. Manuel Hidalgo and Dr. Daniel Von Hoff, two
eminent oncologists with a lifetime track record in oncology and
especially pancreatic cancer, the starting conditions could not be
better.”
About PharmaCyte Biotech
PharmaCyte Biotech 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 may contain forward-looking
statements regarding PharmaCyte Biotech and its future events and
results that involve inherent risks and uncertainties. The words
"anticipate", "believe", "estimate", "expect", "intend", "plan" and
similar expressions, as they relate to PharmaCyte or its
management, are intended to identify forward-looking statements.
Important factors, many of which are beyond the control of
PharmaCyte, could cause actual results to differ materially from
those set forth in the forward-looking statements. They include
PharmaCyte's ability to continue as a going concern, delays or
unsuccessful results in preclinical and clinical trials, flaws or
defects regarding its product candidates, changes in relevant
legislation or regulatory requirements, uncertainty of protection
of PharmaCyte’s intellectual property and PharmaCyte’s continued
ability to raise capital. PharmaCyte does not assume any obligation
to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be
found at www.PharmaCyte.com. It can also be obtained by contacting
Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com