Study Results Suggests Ampligen Could Materially Enhance the Effectiveness of Checkpoint Blockade Technology
Hemispherx
Biopharma, Inc. (NYSE American:HEB) announced today that its TLR3
agonist Ampligen outperformed two other TLR3 agonists, poly IC and
natural double stranded RNA, in creating an enhanced tumor
microenvironment for checkpoint blockage therapy. Hemispherx is an
advanced specialty pharmaceutical company engaged in the treatment of
serious and debilitating disorders.
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
the other two TLR3 agonists, it did so without causing regulatory T cell
(Treg) attraction. These findings are considered 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
regulator T cells. The study, conducted at the University of Pittsburgh
and Roswell Park Comprehensive Cancer Center, as a part of the
NIH-funded P01 CA132714 and Ovarian Cancer Specialized Program of
Research Excellence (SPORE), was published online in the journal Cancer
Research (http://cancerres.aacrjournals.org/content/early/2018/05/31/0008-5472.CAN-17-3985).
“This
has the potential to be clinically significant because a robust killer T
cell population in the tumor microenvironment without attraction of
Treg cells is important to help optimize checkpoint blockade-induced
tumor shrinkage.” said Robert P. Edwards MD, executive vice chair of
gynecologic services at Magee-Womens Hospital of UPMC and Professor of
Obstetrics, Gynecology & Reproductive Services, University of
Pittsburgh School of Medicine.
Lead investigator
Pawel Kalinski, MD, PhD, Vice Chair for Translational Research and
Professor of Oncology, Department of Medicine at Roswell Park, commented
that the study “provides a strong foundation for moving forward with
solid tumor studies to clinically demonstrate the extent to which
Ampligen reprograms the tumor microenvironment in various clinical
settings, with the goal of developing more effective immune therapies
with checkpoint blockers.”
“We believe this is a
valuable survival-enhancing medical strategy, building on the known
capability of immuno-oncology agents such as Keytruda and Opdivo and
potentially giving them a significant boost in tumor killing activity”
said Thomas K. Equels, Chief Executive Officer of Hemispherx.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for the treatment of serious and debilitating disorders. Hemispherx's flagship products include the FDA-approved drug Alferon N Injection® and the Argentina-approved drug rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx's platform technology includes components for the potential treatment of various severely debilitating and life-threatening diseases. Because rintatolimod has not been designated safe and effective by the FDA for general use, it is legally available in the United States only through clinical trials; however, Ampligen® has been approved in Argentina for severe ME/CFS. The company is working toward legal access in other countries where early access programs exist for serious diseases, such as ME/CFS, with unmet medical needs. Ampligen® is the only therapy approved anywhere in the world for ME/CFS. An Ampligen® EAP approval has also been obtained for therapeutic use in the Netherlands for pancreatic cancer.
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for the treatment of serious and debilitating disorders. Hemispherx's flagship products include the FDA-approved drug Alferon N Injection® and the Argentina-approved drug rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx's platform technology includes components for the potential treatment of various severely debilitating and life-threatening diseases. Because rintatolimod has not been designated safe and effective by the FDA for general use, it is legally available in the United States only through clinical trials; however, Ampligen® has been approved in Argentina for severe ME/CFS. The company is working toward legal access in other countries where early access programs exist for serious diseases, such as ME/CFS, with unmet medical needs. Ampligen® is the only therapy approved anywhere in the world for ME/CFS. An Ampligen® EAP approval has also been obtained for therapeutic use in the Netherlands for pancreatic cancer.
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