If Only Steve Jobs Had Known PharmaCyte Biotech &
Cell-in-a-Box
SAN DIEGO, CA -- September 17, 2015 -- InvestorsHub NewsWire
-- If only Steve Jobs had access to this therapy before
Pancreatic Cancer took his life. Had he known of PharmaCyte
Biotech's (OTCQB:
PMCB) signature live-cell encapsulation
technology, Cell-in-a-Box®, then,
he may still be with us today. A diagnosis of Pancreatic Cancer is
considered tantamount to a death sentence. Pancreatic Cancer has no
early warning signs, and is therefore rarely detected until it is
in the very late stages. Hence, its one of the most difficult
cancers to treat.
Something amazing happened in the late 1990's and the early part
of the 21st Century. There were two studies done using a new
technology for treating Pancreatic Cancer. At a clinic in Germany,
14 patients with Stage III and Stage IV Pancreatic Cancer were
treated. The standard chemotherapy was used but it was activated in
a new and revolutionary manner. Instead of just using the usual
Chemotherapy in the blood stream, a technology allowed scientists
to specially target the tumor with the usually toxic medicine with
laser like accuracy right at the site of the tumor, and in turn,
dramatically improved the outcome and lowered toxicity.
Capsules the size of the head of a pin were placed near the
tumors through a catheter. These unique capsules contained
genetically modified cells that are capable of activating the
anticancer drug ifosfamide at the site of the tumor instead of in
the liver where its normally activated, which allows the
chemotherapy drug to be activated right at the site of the tumor.
Much like a laser guided missile; the capsule paints the target for
the chemotherapy drug.
Referred to as Cell-in-a-Box, this platform technology was
so effective it allowed the doctors to reduce the dosage of the
chemotherapy drug to one-third the normal dose, thereby minimizing
or virtually eliminating the side effects of the toxic
medication.
The patients median survival rate doubled compared to historical
norms when using the common Chemo drug - Gemzar®
(gemcitabine). The one year survival rate tripled and remember the
treatment uses only 1/3 the standard chemo dosage in conjunction
with PharmaCyte's (PMCB)
unique targeted chemotherapy therapy.
Thus began a 15 year journey to bring this remarkable treatment
to clinical trials, and eventually possibly to patients.
This technology was acquired by U.S.-based microcap public
company PharmaCyte Biotech (PMCB). After investing many millions of
dollars and years of studies, it has been determined this platform
has a far greater reach than cancer.
Early studies have shown that the Cell-in-a-Box technology can
be used to encapsulate a human cell line genetically engineered to
produce, store, and secrete insulin, thereby representing a
potential cure for Diabetes through a true
bio-artificial pancreas.
Its a remarkable technology, and its closer to getting into an
FDA clinical trial than ever.
Path To Clinical Trials
PharmaCyte (PMCB)
has been working feverishly over the past year to position itself
to move into FDA trials and work towards its first FDA Approval as
a therapy for Pancreatic Cancer.
Orphan Drug status has already been awarded to PharmaCytes
Pancreatic Cancer treatment, which gives the company 7 years of
marketing exclusivity in the United States and could simplify and
shorten the process. The company is moving towards completing the
following steps to get into the pivotal human clinical trials:
- Finalize Trial Design: With pivotal input from PharmaCyte
Biotechs renowned team of oncologists, the design of its clinical
trial will be finalized with the goal of creating the highest
probability of developing positive data during the trial that could
lead to marketing approval of its treatment for pancreatic
cancer.
- Cell-in-a-Box Manufacturing: PMCB has an arrangement with
Austrianova to manufacture the Cell-in-a-Box capsules in Singapore.
Regulatory agencies will have to review and approve the
facility.
- IND Team: A myriad of professionals have been retained to work
on the Investigational New Drug study. The Project manager, Medical
Officer, Statistician, Controls Experts, and Regulatory Affairs
people are nearly all in place, which will allow the process to
begin.
- Clinical Protocol: This is the recipe or design of the clinical
trial that needs to be reviewed and approved by the FDA before
clinical trials can begin. The protocol is being designed now.
- Pre-IND Meeting with FDA- The company must meet with the FDA is
to go over the plan for the final submission of the IND
(Investigational New Drug Application) in order to set the stage
for submission of the IND.
- Submission of IND: PharmaCyte (PMCB) will submit its New Drug
Application to the FDA. Once reviewed and approved by the FDA,
PharmaCyte (PMCB) will be in position to begin its first clinical
trials.
Rather than the standard Phase 1 clinical trial, PharmaCyte
(PMCB) plans to move directly to a Phase 2b trial as the data from
the original treatment on humans is expected to suffice in place of
Phase 1-2.
The Opportunity
The market tends to adjust the valuations for Biotech companies
as they publish the results of studies and trials and move towards
and into clinical trials.
PharmaCyte (PMCB) represents a unique opportunity to make a
little capital go a long way over time. This stock is not widely
followed by the Biotech community at present, but as the company
hits its milestones in the coming weeks and months, more and more
investors in the sector will take notice of their progress.
The stock only trades in the $.09 to $.10 range, but has the
unfathomable upside potential of representing possible therapies
for many kinds of cancer and diabetes.
Owning a position in PharmaCyte (PMCB) is a bit like owning an
option that never expires. The upside of the investment is
magnified by the shear scope of the potential therapies - rarely do
you find a low priced stock in the biotech sector that has a
legitimate shot at becoming a treatment for cancer and a cure for
diabetes.
The trading range of the stock is low, so investors can control
a lot of shares for a small amount of capital. Like an option,
investors have magnified leverage. However, unlike an option, your
ownership never expires.
A quick review of the release string of press releases should
lead you to the conclusion this company is on the verge of major
breakthroughs, which is likely to lead to higher prices.
Read more about PharmaCyte Biotech and its Cancer and Diabetes
treatments at: www.PharmaCyte.com.
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