Hemispherx Biopharma, Inc. (NYSE American: HEB)
announces that Thomas K. Equels, President and Chief Executive
Officer, has issued a Letter to Stockholders providing a business
update. The full text of the Letter, which has also been posted to
the Company's website, is as follows.
To Our Stockholders,
The primary focus of today’s Letter is to update you on the
great strides we have made in our oncology programs with Ampligen.
In recent months Hemispherx has made significant advancements with
our Ampligen oncology program and Ampligen’s potential use as an
immuno-oncology agent for the treatment of multiple types of
cancer. This has been a priority for our Company, and me
personally, since I became CEO in 2016. We have remained focused on
fulfilling our promises to advance these important clinical goals.
I am pleased to announce that we are supporting six separate
clinical studies in eight solid tumors at major research
institutions.
In parallel, we continue to pursue Ampligen for the treatment of
severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
Ampligen is approved for this indication in Argentina (the first
and only meaningful therapy approved anywhere in the world for
ME/CFS) and is available through an U.S. Food and Drug
Administration (FDA) authorized expanded access program (EAP),
AMP-511, a program where the FDA has approved the reimbursement
rate of $200 per vial for the direct costs and where we are
expanding participation at clinics in Nevada and North
Carolina.
Ampligen and Oncology
In collaboration with major cancer research centers in the U.S.
and around the world, we have been making tremendous progress and
strongly believe in the future of our cancer-fighting efforts. We
believe the true value of Ampligen is not yet well-understood by
the pharma industry, many clinicians or investors. Therefore, I
believe it is important that you, our stockholders, understand not
only what we are doing in this field, but also why
we are doing it. It is also important that you have the opportunity
to see what these top experts in immuno-oncology have to say about
their recent successes with Ampligen and its importance as a
promising agent for advances in oncology. Progress in oncology
provides a clear opportunity for commercial success for
Hemispherx.
We are working closely with and have initiated the steps to
proceed with important clinical studies at the University of
Pittsburgh Medical Center (UPMC), the University of Nebraska
Medical Center (UNMC) and Roswell Park Comprehensive Cancer Center
(Roswell Park). We expect that the Institutions will conduct and
complete these clinical trials on an expedited basis. The goal of
these various studies will be to conclusively test the hypothesis
that the combination of Ampligen with checkpoint blockade therapies
will improve clinical tumor responses, time to progression and
survival in humans. Checkpoint inhibitors have provided dramatic
responses for a number of advanced end stage cancers by enabling
the patient’s immune system to attack the cancer. Although a
minority of patients respond dramatically to the checkpoint
inhibitors, we believe that use of combinational immune therapy to
enhance immune killing of tumor cells provides a rational mechanism
for expanding the clinical response rate for checkpoint inhibitor
therapy.
In early October, Hemispherx signed a Clinical Trial Agreement
with Roswell Park in Buffalo, N.Y. to conduct clinical studies of
Ampligen in combination with checkpoint inhibitors in three solid
tumors, namely urothelial carcinoma (bladder and associated
structures), renal cell carcinoma and melanoma. Additional clinical
studies of Ampligen plus checkpoint blockade therapies in five
other solid tumors — triple-negative breast, colorectal, ovarian,
non-small cell lung and pancreatic carcinomas — are at various
stages of development, from early protocol drafts to having secured
FDA authorization to proceed with human subjects. These five other
clinical trials will be conducted at Roswell Park, UPMC or UNMC
beginning in the near future.
In summary, Hemispherx is currently collaborating on the start
of clinical trials with three U.S.-based world-class cancer
research centers to study Ampligen in combination with checkpoint
inhibitors that are already approved by the FDA. Checkpoint
inhibitors are powerful immuno-therapy drugs that block proteins
that restrain the body’s immune system from fighting cancer, and
they are used in a number of advanced solid tumor malignancies. The
object of these combination clinical trials is to measure
improvements in therapeutic outcomes. The need stems from the fact
that checkpoint blockade therapies work poorly with so-called
“cold” tumors. Clinical proof-of-concept findings using an Ampligen
cocktail in colorectal carcinoma demonstrated a more favorable
ratio of killer T-cells to regulatory T-cells in the tumor
microenvironment. Killer T-cells attack cancer cells, and their
presence in the tumor microenvironment can be inhibited by
regulatory (suppressor) T-cells in the tumor microenvironment. The
suppressor cells thereby reduce a patient’s immune response to
cancer. Increases in killer T-cells, without a corresponding
increase in suppressor T-cells, therefore, is an indicator of the
body’s increased ability to mount a potentially effective immune
response, supporting strong pre-clinical evidence of Ampligen’s
activity in converting “cold” tumors into “hot” tumors.
In a head-to-head study in explant culture models, Ampligen
activated the TLR3 pathway and promoted an accumulation of killer
T-cells, but unlike two other TLR3 agonists, it did so without
causing regulatory T-cell (Treg) attraction. These findings,
published in the journal Cancer Research
(http://cancerres.aacrjournals.org/content/early/2018/05/31/0008-5472.CAN-17-3985),
are important because they show that Ampligen selectively
reprograms the tumor microenvironment by inducing the beneficial
aspects of tumor inflammation (attracting killer T-cells), without
amplifying immune-suppressive elements such as regulatory,
‘suppressor’, T-cells. The anti-tumor activity of Ampligen has been
recognized by oncology investigators in a multiplicity of peer
reviewed scientific publications. The ability to reprogram the
tumor microenvironment favoring enhanced anti-cancer activity of
the checkpoint inhibitors has provided the rationale for initiating
clinical proof of concept studies in a variety of advanced (lethal)
cancers.
"Ampligen has the potential to be clinically significant because
a robust killer T-cell population in the tumor microenvironment
without attracting Treg cells is important to help optimize
checkpoint blockade induced tumor shrinkage," said Robert P.
Edwards, MD, chair of gynecologic services at Magee-Women’s
Hospital of the University of Pittsburgh School of Medicine (UPMC),
Professor of Obstetrics, Gynecology & Reproductive Services at
UPMC, a world-class expert in ovarian cancer and a pioneer in
Ampligen research.
His views are vigorously reiterated by another world renowned
expert and Ampligen pioneer, Pawel Kalinski, MD, PhD, Rustum Family
Professor for Molecular Therapeutics and Translational Research,
Vice Chair for Translational Research and Director of Cancer
Vaccine and Dendritic Cell Therapies at Roswell Park Comprehensive
Cancer Center, who states, “There is significant and pressing need
for new therapy options that can extend the benefits of checkpoint
inhibition to the patients who currently do not respond to these
treatments. We’re excited about initiating our planned basket trial
incorporating Ampligen to see whether these combination approaches
can successfully convert ‘cold’ tumors into ‘hot’ ones that will
respond to these therapies. Our preclinical findings indicate that
this is a worthwhile strategy to pursue.”
One of the solid tumors that we are targeting at UNMC in our
combination therapy clinical studies with Ampligen is pancreatic
cancer, which is a prime example of the unmet medical needs we are
striving to meet. We also have an ongoing Dutch-approved standalone
Ampligen EAP in pancreatic cancer at Erasmus M.C. that is more than
a year old. Statistically, only 6-7% of patients diagnosed with
pancreatic cancer are alive five years after diagnosis, and more
than 100,000 people will die this year in the U.S. and Europe from
this dreaded malignancy. Today, a diagnosis of pancreatic cancer is
a virtual death sentence. Hemispherx, working with Erasmus and
UNMC, intends to change that. We have every hope that the upcoming
clinical trial at UNMC will pave the way for progress in pancreatic
cancer. We at Hemispherx strongly believe that this work is
important, will make a difference and ultimately will save lives.
As one of the world’s top pancreatic cancer researchers, Michael A.
(Tony) Hollingsworth, PhD, head of pancreatic cancer research at
UNMC’s Buffett Cancer Center states, “We are working hard to
discover better treatments for pancreatic cancer. We believe
Ampligen is an agent that holds tremendous promise — not only for
pancreatic cancer, but also for a variety of other cancers.”
I hope that if, as stockholders, you understand this program,
you may better appreciate why we are moving so aggressively on this
clinical path. I believe success in oncology will lead to lasting
commercial success for our company. Over the past two years we have
aggressively and successfully pursued meaningful relationships with
top cancer research centers in the U.S. We then, at these same
institutions, aggressively and successfully pursued pre-clinical
animal studies to show our hypothesis has great merit. Initial
proof of concept clinical work was similarly successful. Now we are
commencing at these same top institutions, led by top experts in
their fields, clinical studies in a variety of solid tumors which
we have every expectation will establish Ampligen as an important
agent in immuno-oncology.
Fighting Cancer and Beyond
We have two pipeline drugs that show tremendous progress in
fighting debilitating conditions for countless people with unmet
medical needs, Ampligen, and our FDA approved product, Alferon® N
Injection. We have our own manufacturing site and a proven ability
to produce our pipeline products. We have an active EAP in the
Netherlands in pancreatic cancer, and are in midst of expanding our
EAP for ME/CFS in the U.S. We have the first ever commercial
approval in severe ME/CFS from Argentina. What’s more, over the
past two years, we have successfully collaborated with Erasmus
M.C., the Hillman Cancer Center at UPMC, the Fred & Pamela
Buffett Cancer Center at UNMC and Roswell Park. These are all
highly respected research centers in the field of cancer treatment.
We strongly believe that successes in our six independent
immuno-oncology clinical studies targeting eight types of solid
tumors will create significant long-term value for our
stockholders.
In addition to the above detailed clinical work:
We can manufacture our product
- Two commercial sized lots totaling over 16,000 vials have been
filled, finished and released for use. We announced in August that
the new Ampligen batch manufactured earlier this year was released
for patient use in the pancreatic cancer EAP in the Netherlands.
This was the initial shipment (500 vials) of a previously announced
2,100 vial standing stock order issued by myTomorrows, our EAP
provider in Europe.
We are making a difference in the U.S. and
Globally
- We are working to expand the U.S.-based EAP, known as AMP-511,
an FDA-authorized open-label program for severe ME/CFS.
- We announced in September that our regulatory inspection and
clearance for distribution of our second commercial scale lot of
Ampligen, slated for multiple uses including product launch in
Argentina for the treatment of ME/CFS, our ME/CFS EAP in the U.S.
and Europe and the pancreatic cancer EAP in the Netherlands.
Hemispherx is a small company, but holds great promise. Our
pledge to stockholders is that we will continue to pursue all
available opportunities to advance our pipeline, with the goals of
offering therapeutics that will truly make a difference in the
lives of patients and, at the same time, build stockholder
value.
We will continue to keep you apprised of our progress in these
efforts as we go forward. Thank you for your continued support of
Hemispherx Biopharma.
Sincerely,Thomas K. EquelsPresident and Chief Executive
OfficerOctober 22, 2018
Contact Hemispherx Biopharma, Inc. Phone:
800-778-4042 Email: IR@hemispherx.net
Or
LHA Investor Relations Miriam Weber Miller Phone: 212-838-3777
Email: mmiller@lhai.com
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