PharmaCyte Biotech Clears Major Milestone on Path to FDA Clinical Trial
May 05 2016 - 7:15AM
Marketwired
SOURCE: PharmaCyte Biotech,
Inc. May
05, 2016 09:15 ET PharmaCyte Biotech Clears Major Milestone on
Path to FDA Clinical Trial NEW
YORK, NY-(Marketwired - May 05, 2016)
- PharmaCyte
Biotech (OTCQB: PMCB) has now reached a point in its life cycle
where it is ready to start working with the U.S. FDA to get the
company's Phase 2b clinical trial in advanced pancreatic cancer
underway. Let that sink in for a moment. PharmaCyte's Chief
Executive Officer, Kenneth L. Waggoner, has taken up the mantle to
move the company's signature technology, Cell-in-a-Box®, to the
clinic. And now, three short years later, he has the small biotech
on the doorstep of what could be an eye-opening clinical trial to
treat pancreatic cancer patients.
According to the American Cancer Society's cancer
statistics for 2016, pancreatic cancer is the third leading cause
of cancer-related deaths in the United States, and it's one of the
few cancers for which survival has not improved substantially over
nearly 40 years. But help could be on the way. After PharmaCyte
announced last week that the live-cell encapsulation facility where
its Cell-in-a-Box® capsules are produced is now current Good
Manufacturing Practices or cGMP-compliant, the company cleared what
was a major milestone on the way to a clinical trial and is now
closer than ever to taking on the challenge of improving the lives
of pancreatic cancer patients.
These are truly exciting times at PharmaCyte, and
with the cell encapsulation facility now cGMP-compliant, the
company can set its sights on first requesting a pre-IND
(Investigational New Drug application) meeting with the FDA to
discuss the design of its upcoming clinical
trial. This
pre-IND meeting will be crucial to developing a relationship with
the FDA and getting the necessary answers and guidance moving
forward that will allow PharmaCyte to submit its formal IND to the
FDA. The pre-IND meeting and the IND submission to the FDA are the
next two major milestones for PharmaCyte and its
investors. With
the encapsulation facility now ready for the production of clinical
trial material, let's look at the trial design that PharmaCyte has
announced for its Phase 2b clinical trial:
- PharmaCyte's pancreatic cancer therapy consists
of placing microcapsules containing genetically engineered live
cells near the blood supply to the pancreas. The cancer prodrug
ifosfamide is then given at one-third the normal dose. When the
blood carries the chemotherapy drug to where the capsules have been
placed, activation of the drug takes place right at the source of
the cancer instead of in the patient's liver, which eliminates any
side effects in these patients.
- The
trial will be a multi-site trial held in both the United States and
Europe. It will also be an open-label trial in which the patients
will be randomized between two study groups. The trial has been
designed to meet a clear unmet medical need that exists for a
particular group of pancreatic cancer
patients.
- The
randomization ratio of patients between the two study groups will
be 1:1 (an equal number of patients will be randomly assigned to
the capecitabine + radiation group and the PharmaCyte pancreatic
cancer therapy group).
- Only
patients who have locally advanced, non-metastatic, inoperable
cancer and whose tumors no longer respond after 4-6 months of
treatment with either the widely used Abraxane® + gemcitabine
combination therapy or FOLFIRINOX, will be eligible for the trial.
These patients are usually treated with the combination of the
chemotherapy drug capecitabine + radiation, but this treatment is
only marginally effective and is quite toxic for the
patients.
- Study sites under consideration in the U.S.
include the Mayo Clinic in Scottsdale, Arizona, the Beth Israel
Deaconess Cancer Center in Boston, the Dana-Farber Cancer Institute
also in Boston, the Baylor Cancer Center in Dallas, Texas,
Cedars-Sinai Medical Center in Los Angeles, as well as sites in
Germany and Spain.
- It
is believed that 84 patients will be required to complete the
study, although fewer may be required based upon the data developed
during the trial.
- Unlike in earlier clinical trials using
PharmaCyte's pancreatic cancer therapy where patients received only
two cycles of therapy with ifosfamide, multiple cycles of
ifosfamide will be given to those being treated with PharmaCyte's
pancreatic cancer therapy. This will continue until the patients'
tumors no longer respond to PharmaCyte's therapy or until
treatment-related toxicity accumulates to unacceptable
levels.
And
the best news of all for investors heading into these exciting
times is that PharmaCyte has been awarded the Orphan Drug
designation by both the U.S. FDA and the European Medicines Agency
(EMA). This designation means that the company's pancreatic cancer
therapy will have complete protection and market exclusivity for
years to come. After PharmaCyte's therapy is approved for marketing
by these two regulatory agencies, they will enjoy 7 years of market
exclusivity in the United States and 10 years of protection in the
European Union. PharmaCyte's CEO also recently stated that the
company's pancreatic cancer therapy qualifies for 12 years of data
exclusivity because it is considered a "biologic" as outlined by
the Biologics Price Competition and Innovation Act
(BPCIA). So,
as the company marches headlong into a Phase 2b clinical trial in
the U.S. and Europe with a built in "hard stop" about half way
through the trial to review the data, there is no better time than
the present to get excited about this small biotechnology company
and what could very well be a significant contribution to the
treatment of pancreatic cancer.
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