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, released today the second in a series of articles that
will serve to educate the public on its technology and how it is
used in the treatment of advanced pancreatic cancer. This latest
article, written by Dr. Matthias Löhr of the famed Karolinska
Institute in Stockholm, Sweden, and the Chairman of PharmaCyte
Biotech’s Scientific Advisory Board, discusses the unmet clinical
need of a large group of patients suffering from locally advanced
pancreatic cancer.
PharmaCyte Biotech’s Chief Executive Officer,
Kenneth L. Waggoner, commented on Dr. Löhr’s article, “Dr. Löhr
understands the severity of the unmet medical need he addresses in
his article as much as anyone. Dr. Löhr explains his rationale for
believing there is an urgent need to develop a therapy for patients
with pancreatic cancer that is not currently being addressed by the
medical community. Our other prominent oncologists also believe
that new therapeutic options are needed for those with locally
advanced pancreatic cancer. We agree with Dr. Löhr that PharmaCyte
Biotech’s pancreatic cancer treatment has the potential to address
squarely this unmet medical need.”
The Unmet Clinical Need in Locally
Advanced Pancreatic Cancer
Pancreatic cancer is a medical emergency(1).
There is a highly unmet medical need for all patients as survival
rates from pancreatic cancer are the lowest of all solid tumors. If
nothing happens to change that situation, pancreatic cancer will
become the number two cause of cancer-related deaths by 2030(2).
There is evidence for the use of chemotherapy to prevent possible
relapse in patients whose pancreatic cancer tumors have been
removed surgically, but this situation occurs in only 20% of all
patients at best.
The large remaining group of patients whose
tumors are inoperable may receive palliative chemotherapy
(treatment designed to prolong survival and ease symptoms), but
these patients only exhibit survival rates oscillating around 6
months. Recent progress in the chemotherapy of pancreatic cancer
has pushed this survival to 10-11 months through the use of either
the combination of gemcitabine and nab-paclitaxel (Abraxane®)(3) or
a rather harsh combination of conventional cancer chemotherapy
drugs, known as FOLFIRINOX, that not all patients can
tolerate(4).
These therapeutic strategies are part of recent
guidelines for the treatment of pancreatic cancer. In addition,
evidence for “second-line” therapy for patients whose tumors
continue to grow exists(5). There is, however, a group of patients
for whom we have nothing to offer today: patients with locally
advanced disease (LAD) whose tumors are inoperable due to
overgrowth of the arterial blood vessels, namely the superior
mesenteric artery (SMA) or the celiac trunk. Current practice is to
treat these patients with what is termed “neoadjuvant” chemotherapy
using gemcitabine plus nab-paclitaxel (Abraxane®) or FOLFIRINOX to
reduce the size of their tumors to the point where they become
operable. This strategy works in only about 20% of patients with
LAD.
In about 30% of patients, while they are
receiving neoadjuvant chemotherapy, their tumors advance and
metastasize (spread to other organs). This makes their primary
pancreatic cancer tumors no longer eligible for curative surgery,
and therapy is usually continued as a palliative measure. However,
for the group (about 50%) of patients whose tumors neither progress
nor show signs of tumor reduction, i.e. patients who exhibit stable
disease, there is no effective treatment alternative. For this
cadre of patients, a localized tumor therapy, such as that being
developed by PharmaCyte Biotech, could present a welcomed
therapeutic option.
PharmaCyte Biotech’s combination of
encapsulated, live genetically-engineered cells capable of
converting the cancer drug ifosfamide into its cancer-killing form
implanted at the site of the tumor, followed by low doses of
intravenously administered ifosfamide(6), may fill the unmet
medical need that has escaped the medical community for far too
many years. Results derived from the pending Phase 2b clinical
trial could provide critical data to confirm this.
References:
1. Löhr JM. Personal view: Pancreatic cancer
should be treated as a medical emergency. British Medical
Journal, 2014; Vol.
349:g52612.
2. Rahib L, Smith BD, Aizenberg R, et al.
Projecting cancer incidence and deaths to 2030: the unexpected
burden of thyroid, liver, and pancreas cancers in the United
States. Cancer Research, 2014; Vol. 74:2913-2921.
3. Von Hoff DD, Ervin T, Arena FP, et al.
Increased survival in pancreatic cancer with nab-paclitaxel plus
gemcitabine. New England Journal of Medicine, 2013; Vol.
369:1691-1703.
4. Conroy T, Desseigne F, Ychou M, et al.
FOLFIRINOX versus gemcitabine for metastatic pancreatic
cancer. New England Journal of Medicine, 2011; Vol.
364:1817-1825.
5. Pelzer U, Schwaner I, Stieler J, et al. Best
supportive care (BSC) versus oxaliplatin, folinic acid and
5-fluorouracil (OFF) plus BSC in patients for second-line advanced
pancreatic cancer: a phase III-study from the German CONKO-study
group. European Journal of Cancer, 2011; Vol. 47:1676-1681.
6. Löhr M, Hoffmeyer A, Kroger J, et al.
Microencapsulated cell-mediated treatment of inoperable pancreatic
carcinoma. Lancet, 2001; Vol. 357:1591-1592.
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage
biotechnology company focused on developing and preparing to
commercialize treatments for cancer and diabetes based upon a
proprietary cellulose-based live cell encapsulation technology
known as “Cell-in-a-Box®”. This unique and patented technology will
be used as a platform upon which treatments for several types of
cancer and diabetes are being developed.
PharmaCyte Biotech’s treatment for cancer
involves encapsulating genetically modified live cells capable of
converting an inactive chemotherapy drug (ifosfamide) into its
active or “cancer-killing” form. These encapsulated live cells are
placed as close to a cancerous tumor as possible. Once implanted in
a patient, ifosfamide is then given intravenously at one-third the
normal dose. The ifosfamide is carried by the circulatory system to
where the encapsulated cells have been placed. When ifosfamide,
which is normally activated in the liver, comes in contact with the
encapsulated live cells, activation of the drug takes place at the
source of the cancer without any side effects from the
chemotherapy. This “targeted chemotherapy” has proven remarkably
effective and safe to use in past clinical trials.
In addition to developing a novel treatment for
cancer, PharmaCyte Biotech is developing a treatment for Type 1
diabetes and Type 2 insulin-dependent diabetes. PharmaCyte Biotech
plans to encapsulate a human cell line which has been genetically
engineered to produce, store and secrete insulin at levels in
proportion to the levels of blood sugar in the human body. The
encapsulation will be done using the Cell-in-a-Box® technology.
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 Biotech or its
management, are intended to identify forward-looking statements.
Important factors, many of which are beyond the control of
PharmaCyte Biotech, 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 Biotech’s intellectual property and PharmaCyte
Biotech’s continued ability to raise capital. PharmaCyte Biotech
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