PharmaCyte Biotech End of Year Shareholder Update on Pancreatic Cancer and Diabetes Programs
December 30 2015 - 09:00AM
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®, announced today a shareholder update on
PharmaCyte’s pancreatic cancer and diabetes programs.
PharmaCyte’s Chief Executive Officer, Kenneth L.
Waggoner, highlighted the following developments since the
Company’s last shareholder update:
- PharmaCyte announced a complete redesign of its clinical trial
in advanced pancreatic cancer. After consulting with
world-renowned experts in the filed of pancreatic cancer;
including, Dr. Mathias Löhr, Dr. Manuel Hidalgo, and experts at
Translational Drug Development (TD2), PharmaCyte’s Phase 2b
clinical trial was completely redesigned in an attempt to satisfy a
critical unmet medical need that exists for patients with
inoperable, but not metastatic, pancreatic cancer whose tumors no
longer respond after 4 to 6 months of treatment with the current
“gold standard” for the disease, the combination of Abraxane® plus
gemcitabine. In most cases, therapy consisting of another
chemotherapy agent plus radiation is given to such patients.
However, the beneficial effects of these treatments are marginal at
best.
- The clinical trial will now be conducted in the United States
by TD2 with study sites in both Europe and Australia.
- Eligible patients will be randomly placed into two groups.
Group 1 will receive PharmaCyte’s pancreatic cancer treatment of
Cell-in-a-Box® plus low doses of ifosfamide. Group 2 will receive
treatment with the combination of capecitabine + radiation.
- The primary endpoints for the trial will be: (i)
progression-free survival (PSF); and (ii) the side effects that
occur in the patients. PSF is the time that elapses from the first
day of treatment until the disease gets worse. The trial design
also includes several secondary endpoints; the most important of
which are: (i) the onset of pain and the patient’s need for pain
medications; (ii) whether the inoperable tumors become operable as
a result of the treatment; (iii) the change in tumor size; and (iv)
the patients’ overall quality of life during the
treatment.
- PharmaCyte will now include in this trial the evaluation of its
pancreatic cancer treatment on the treatment of pain, a severe
consequence of pancreatic cancer. A separate clinical trial on
pancreatic cancer pain is no longer necessary.
- Regarding PharmaCyte’s work on ascites fluid production and
accumulation, a series of additional preclinical studies has been
initiated and are being continued by TD2. The initial studies using
an ovarian tumor model in mice indicated that PharmaCyte’s
pancreatic cancer treatment might have value in treating the
malignant ascites fluid condition. These preclinical studies are
now being continued with other abdominal tumor models, beginning
with colon cancer, in an effort to better define the conditions
under which PharmaCyte’s pancreatic cancer treatment can modulate
the production or accumulation of malignant ascites
fluid.
- In late 2015, PharmaCyte obtained the Orphan Drug designation
(ODD) for its pancreatic cancer treatment from the European
Medicines Agency (EMA). With this designation, PharmaCyte now has
ODD in Europe and the United States, which was obtained in late
2014 when the FDA granted the ODD to PharmaCyte. Obtaining the ODD
allows for 10 years of marketing exclusivity in the European Union
and 7 years of marketing exclusivity in the United States upon
approval by the EMA and the FDA of PharmaCyte’s pancreatic cancer
treatment.
- PharmaCyte appointed Dr. Manuel Hidalgo as a member of its
Scientific Advisory Board and as a consultant. For several years,
Dr. Hidalgo worked closely with pancreatic cancer expert Dr. Daniel
D. Von Hoff, Chief Development Officer of TD2. Recently, Dr.
Hidalgo was appointed Head of Hematology and Oncology at the Beth
Israel Deaconess Hospital in Boston, an institution that is
affiliated with the renowned Dana-Farber Cancer Institute in
Boston.
- PharmaCyte contracted with Imaging Endpoints, one of America’s
leading Contract Research Organizations for radiologic imaging, to
perform the radiologic imaging that will be the cornerstone of many
of the measurements conducted during the pancreatic cancer clinical
trial.
- Prior to the initiation of a clinical trial, an Investigational
New Drug Application (IND) must be filed and reviewed by the FDA. A
major part of the IND is a section termed “Chemistry, Manufacturing
and Controls” or “CMC.” Within the CMC section, a pivotal portion
describes the characteristics of the drug or treatment production
facility and supplies supporting documentation to ensure that the
facility meets cGMP standards. PharmaCyte retained CMC experts
Chamow and Associates (Chamow) to assist in evaluating the facility
in Bangkok, Thailand, that will produce and supply the
Cell-in-a-Box® technology for PharmaCyte’s clinical trial, and in
preparing the relevant portions of the CMC section of the IND for
submission to the FDA and other regulatory agencies. PharmaCyte and
TD2 are awaiting receipt of Chamow’s audit report to finalize the
timeline for commencement of the clinical trial.
- In November 2015, the second annual meeting of the
international Diabetes Consortium was held in Vienna, Austria.
Members of the Consortium presented results of studies done to date
and finalized research plans for future studies. A video that
discusses PharmaCyte’s diabetes program was filmed at the meeting
and can be viewed at www.PharmaCyte.com/diabetes.
- A guest at the meeting of the Diabetes Consortium was Prof. Dr.
Hans-Peter Hammes, one of Europe’s leading authorities on diabetes
and its complications. Dr. Hammes currently serves as Section Head
of Endocrinology at the 5th Medical Department, University Medical
Center Mannheim at the University of Heidelberg in Germany. Dr.
Hammes received the prestigious Camillo Golgi Prize awarded at the
2015 meeting of the European Association for the Study of Diabetes.
After attending the Diabetes Consortium meeting and becoming
acquainted with the Consortium members, Dr. Hammes agreed to join
PharmaCyte’s Scientific Advisory Board and become a member of the
Consortium. Dr. Hammes also agreed to serve as a consultant to
PharmaCyte.
About PharmaCyte
BiotechPharmaCyte 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’s
treatment for cancer involves encapsulating genetically modified
live cells that convert 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 is developing a treatment for Type 1 diabetes
and Type 2 insulin-dependent 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.
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 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