PharmaCyte Biotech Outlines 2016 Milestones as Its Pancreatic Cancer Treatment Moves Into a Clinical Trial
January 04 2016 - 8:45AM
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 the Company’s 2016
milestones as it advances its new treatment for pancreatic cancer
into the clinic in the United States with study sites in Europe and
Australia.
PharmaCyte’s Chief Executive Officer, Kenneth L.
Waggoner, stated, “We are excited to see 2016 arrive as this is the
year that we will get into the clinic with our pancreatic cancer
treatment. Our shareholders should understand that nothing
whatsoever will deter our efforts to get into the clinic and to
showcase our novel treatment for pancreatic cancer.”
Waggoner highlighted the 2016 milestones that
PharmaCyte’s shareholders and investment community can look forward
to this year:
- PharmaCyte’s CEO will attend the 2016 JP Morgan Healthcare
conference in San Francisco to meet with pharmaceutical companies
and potential institutional investors.
- The manufacturing facility in Bangkok, Thailand, where the live
cells that convert the cancer prodrug ifosfamide into its
cancer-killing form will be encapsulated, will receive a factory
license from the Thai government enabling production of the
encapsulated cells for PharmaCyte to use in its clinical
trials.
- The Austrianova manufacturing facility will become fully
compliant with current Good Manufacturing Practices (cGMP)
standards.
- An Investigational New Drug Application (IND) will be filed
with the FDA following a pre-IND meeting with the FDA.
- Appropriate arrangements will be made with cancer centers in
the United States to begin PharmaCyte’s pancreatic cancer trial
that will address the critical unmet medical need that exists when
a patient’s non-metastatic, pancreatic cancer no longer benefits
from receiving the “gold standard” treatment – the combination of
gemcitabine and Abraxane®.
- PharmaCyte’s clinical trial in pancreatic cancer will get
underway with Translational Drug Development (TD2) coordinating the
trial globally and conducting it in the United States. Clinical
Network Services (CNS) will conduct the trial in Europe and
Australia in alliance with TD2.
- After the pancreatic cancer clinical trial has been in process
for approximately six months, there will be an evaluation of
PharmaCyte’s pancreatic cancer treatment on the patients enrolled
in the trial with the interim results being reported to the
public.
- Additional preclinical studies to determine if PharmaCyte’s
pancreatic cancer treatment can slow down the production and
accumulation of malignant ascites fluid will take place in 2016. If
successful, plans to conduct a clinical trial in ascites will be
undertaken by PharmaCyte with the goal of having TD2 begin the
clinical trial by year end or early 2017.
- Numerous preclinical studies will be conducted concurrently and
in parallel by members of PharmaCyte’s international Diabetes
Consortium to condense the time it will take for PharmaCyte to
enter into a clinical trial that will test the ability of the
Melligen insulin-producing cells encapsulated using the
Cell-in-a-Box® technology to treat Type 1 diabetes and
insulin-dependent Type 2 diabetes, with the goal of reaching the
clinic in 2017.
- PharmaCyte will fill its open Board of Directors positions as
appropriate.
- PharmaCyte will conduct periodic shareholder calls, rather than
communicating through shareholder updates, with the CEO responding
to questions during the calls.
- PharmaCyte will hold an annual shareholder meeting.
PharmaCyte’s
Chief Operating Officer, Dr. Gerald W. Crabtree stated, “2016
promises to be both busy and productive for the Company and those
associated with it. Of course the major highlight will be the start
of our clinical trial in pancreatic
cancer. 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