Thursday, December 08, 2016 11:15:04 AM
http://ih.advfn.com/p.php?pid=nmona&article=73083699
Date : 12/07/2016 @ 9:00AM
Source : GlobeNewswire Inc.
Stock : Pharmacyte Biotech, Inc. (QB) (PMCB)
Quote : 0.154 0.04 (35.09%) @ 10:38AM
PharmaCyte Biotech Discusses Upcoming Clinical Trial in
Pancreatic Cancer with First Principal Investigator
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 http://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
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