Hemispherx Biopharma Announces IRB Approval of Clinical Study in Metastatic Triple Negative Breast Cancer in Collaboration wi...
January 08 2019 - 12:50PM
Hemispherx Biopharma, Inc. (NYSE American: HEB), an immuno-pharma
R&D and emerging commercial growth company focused on unmet
medical needs in immunology, announced today Roswell Park
Comprehensive Cancer Center Institutional Review Board (“IRB”)
approval and shipment of Ampligen to start an oncology clinical
study combining its dsRNA TLR3 agonist Ampligen with Merck’s
Keytruda (pembrolizumab) in Metastatic Triple Negative Breast
Cancer. The study will enroll at least six participants and be
conducted by Drs. Mateusz Opyrchal and Pawel Kalinski at Roswell
Park, a National Cancer Institute-designated comprehensive cancer
center in Buffalo, New York.
This trial will study how well Ampligen-based chemokine
modulation therapy works when given prior to Keytruda in treating
participants with triple-negative breast cancer that has spread to
other places in the body. Drugs used in this chemokine modulation
therapy — celecoxib, recombinant interferon alfa-2b, and
Ampligen — work by unleashing or enhancing the cancer immune
responses that already exist by either blocking inhibitory
molecules or by activating stimulatory molecules. Monoclonal
antibodies such as Merck’s Keytruda interfere with the ability of
tumor cells to grow and spread when present in a “hot” tumor
microenvironment (i.e. - Teff cells outnumber Treg cells). The
clinical trial tests whether chemokine modulation therapy before
Keytruda will work better than Keytruda alone in treating
participants with metastatic triple-negative breast cancer by
altering the tumor microenvironment to favoring immune rejection.
Studies from the University of Pittsburgh and Roswell Park
Comprehensive Cancer Center, in preclinical models and human
tumor explants have demonstrated that Ampligen is a TLR3 restricted
and targeted modulator of “hot” tumor microenvironments (Nature
Protoc. 2018 Feb;13(2):335-357 and Cancer Res. 2018 Aug
1;78(15):4292-4302).
The study will enroll 6 participants with unresectable or
metastatic triple negative breast cancer who will undergo a
pre-treatment biopsy. Participants then receive two cycles of
chemokine modulation therapy consisting of celecoxib, recombinant
interferon alfa-2b, and Ampligen/rintatolimod (three days of
treatment per cycle). Participants will then undergo an additional
biopsy. Following the biopsy and chemokine modulation therapy,
participants receive Keytruda every three weeks for two cycles.
A second clinical trial combining Ampligen with Keytruda in
ovarian cancer and a cohort of forty subjects is scheduled to
launch later this month at the University of Pittsburgh. This
clinical trial in which Hemispherx supplies the Ampligen, and Merck
the Keytruda plus funding assistance is sponsored by the University
of Pittsburgh. It will be an important and more extensive test of
Ampligen as an immune system primer that can change cold tumors
into hot tumors, thereby making the formerly cold tumors more
responsive to Keytruda.
“At Team Hemispherx we are determined to pursue an aggressive
R&D program focused on improved immune therapies for lethal
malignancies, and we are grateful for the support and attention we
are getting from big pharma and these major research institutions,”
said Hemispherx CEO Thomas K. Equels. “The work beginning at
Roswell Park Comprehensive Cancer Center is an important step in
Hemispherx’ overall clinical plan in immuno-oncology. Relevant
preclinical experiments in several types of solid tumors and
conducted at different major U.S. cancer research centers support
the proposition that Ampligen can change the micro-environment of
tumors so as to create a robust and significant positive synergy
with check point blockade therapies. We have seen a clear
synergistic effect in our laboratory studies, and human tumor
explants indicate this phenomenon is extended to humans. To the
extent this follows through in vivo with humans in these clinical
trials, that synergy with the checkpoint inhibitors will put
Ampligen at the forefront of a major medical breakthrough in
immuno-oncology.”
Cautionary StatementSome of the statements
included in this press release may be forward-looking statements
that involve a number of risks and uncertainties. Among other
things, for those statements, we claim the protection of the safe
harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995. Any forward-looking
statements set forth in this press release speak only as of the
date of this press release. We do not undertake to update any of
these forward-looking statements to reflect events or circumstances
that occur after the date hereof. This press release and prior
releases are available at www.hemispherx.net. The information found
on our website is not incorporated by reference into this press
release and is included for reference purposes only.
Contacts:Hemispherx Biopharma, Inc.Phone:
800-778-4042Email: IR@hemispherx.net
Or
LHA Investor RelationsMiriam Weber MillerSenior Vice
PresidentPhone: +1-212-838-3777Email: mmiller@lhai.com
Hemispherx Biopharma (AMEX:HEB)
Historical Stock Chart
From Mar 2024 to Apr 2024
Hemispherx Biopharma (AMEX:HEB)
Historical Stock Chart
From Apr 2023 to Apr 2024