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 second 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).
This article, which comes one week before
PharmaCyte’s pre-IND meeting with the FDA, is with Dr. Manuel
Hidalgo, the Principal Investigator of PharmaCyte’s clinical trial
in LAPC. Dr. Hidalgo is Chief of the Division of
Hematology/Oncology and the Director of the Rosenberg Clinical
Cancer Center of the Beth Israel Deaconess Medical Center in
Boston, Massachusetts. He is also a Member of the Faculty of
Medicine of the Harvard Medical School and Co-Director of the
international Pancreatic Cancer Research Program.
What are your thoughts on PharmaCyte's therapy
for LAPC and its technology Cell in a Box®?
Dr. Manuel Hidalgo: “Locally
advanced inoperable pancreas adenocarcinoma (pancreatic cancer or
PDAC) is a significant health issue. About 30% of patients with
pancreatic cancer present with disease that is localized but cannot
be resected in full. These patients are now managed with
chemotherapy and radiation therapy with poor results. One of the
reasons why these results are poor is because the concentration of
chemotherapy that reaches the pancreas tumor may be too
low to exert its therapeutic effects. However, Cell in a Box®
is a new innovative technology that may result in higher
concentrations of chemotherapy at the site of the pancreas cancer.
The way this is achieved is by encapsulating living cells
that have the capacity to enzymatically activate a drug called
ifosfamide in the pancreas tumor itself. By doing so, the
concentration of active drug in the tumor bed increases which
likely results in better efficacy while there is less systemic
exposure to the active drug with the corresponding decrease in
toxicity.”
What did you see in the early data from the 2
previous clinical trials that gives you confidence with
PharmaCyte’s therapy heading into the upcoming clinical trial?
Dr. Manuel Hidalgo: “The data
is promising and suggests this approach should be further tested.
In addition to early evidence of efficacy, the study showed minimal
toxicity, consistent with decreased systemic exposure to the active
drug and improvement in quality of life. These are very
important observations. However, the previous studies were small,
and we need additional data.”
As the Principle Investigator for the upcoming
clinical trial, why is it important for you to be involved with
this clinical trial?
Dr. Manuel Hidalgo: “As
investigators involved in PDAC research, we are always looking for
new, safe strategies to improve patient outcome. In this disease,
we really need innovation. We need new approaches
and strategies, and Cell in a Box® is indeed a
new strategy. I am very excited because of the novelty of the
approach. I am also very glad to be working with a
terrific group of people both on the PharmaCyte side and in the
investigators team.”
You have been a part of so many clinical
trials. What have you learned or experienced from those
previous clinical trials that you can bring to this clinical
trial?
Dr. Manuel Hidalgo: “When
conducting a clinical trial, the most important thing is to
preserve the safety of the subjects and integrity of the data. To
that end, it is critical to meticulously select the subjects
and follow the protocol. As overall Principal Investigator, I will
be working closely with other investigators and the sponsor to make
sure the study is conducted according to good clinical practice and
other pertinent regulations. Of course, in the day to day, there
are always special situations. Here is where the expertise of the
investigators team plays an important role. The two key features
are to properly document every observation and to communicate and
ask any question that may emerge.”
As a long-time friend and colleague of Dr. Von
Hoff and relatively new friend and colleague of Dr. Löhr, what are
your thoughts about being teamed up with them for this upcoming
clinical trial?
Dr. Manuel Hidalgo: “I am
naturally very excited with the opportunity to work with such
terrific doctors and investigators. The conduct of the study is a
team effort, and having such high caliber investigators on the team
provides us with the expertise needed for the success of this
clinical trial.”
What experiences can you draw on from the
Abraxane® clinical trial that you were involved in with Dr. Von
Hoff that you can bring to PharmaCyte’s clinical trial?
Dr. Manuel Hidalgo: “Through a
series of clinical and preclinical studies led by Dr. Von
Hoff, myself and many other excellent investigators, we showed
that Abraxane® is effective in pancreatic cancer leading to its
approval. The development of this drug provided us with a firsthand
experience on how to take a new agent from concept to approval. We
will now apply all of this knowledge and expertise to
develop Cell in a Box® for pancreas cancer
treatment. These are obviously very different technologies, but the
principles of conducting a high quality step-wise development plan
are similar.”
For those who aren't familiar with the clinical
trial process and the development of a therapy for pancreatic
cancer, why is it important to have an experienced team surrounding
PharmaCyte's technology heading into its clinical trial?
Dr. Manuel Hidalgo: “I cannot
emphasize enough how important having an experienced team is to
conducting any clinical trial, but even more a trial with a new
technology like Cell in a Box®. Elements of an
experienced team range from proper patient selection to the
delivery of the treatment and monitoring safety and efficacy. Each
one of these elements, just to name a few, requires careful
attention to details, proper documentation and communication. As
this is a new technology and is a non-conventional one, these
details become even more important. This is like a performance. The
sheet music (protocol) is important but the conductor
(investigator) and the orchestra (research team) are also
critical.”
What do you think about going head to head with
gemcitabine as the comparator arm in PharmaCyte’s clinical
trial?
Dr. Manuel Hidalgo: “While
patients with locally advanced pancreatic cancer are managed in
many different ways around the globe, one can argue that the data
from the LAP007 trial shows that gemcitabine alone is as good as
gemcitabine combined with radiation therapy. Based on these data,
from a regulatory perspective, we think gemcitabine alone is the
accepted standard of care and have written the protocol that
way.”
About PharmaCyte
BiotechPharmaCyte 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 may contain forward-looking
statements regarding PharmaCyte 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 studies 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 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