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Hemispherx rises as five trials for cancer drug Ampligen kick off this year

The biopharma is focusing on the use of Ampligen as a cancer immuno-therapy

cancerous cells
Nine trials in the US involving Ampligen are in 'various stages of advancement'

Hemispherx Biopharma Inc (NYSE American:HEB) updated investors Wednesday on the progress being made with its cancer drug candidate Ampligen which is being evaluated as part of a series of trials at major cancer research institutions.

The Ocala, Florida-based biopharmaceutical company also said that five Ampligen trials are set to kick off this year, subject to funding.

READ: Hemispherx Biopharma gets green light from Dutch health regulators to extend access program for Ampligen to pancreatic cancer patients

The company is now focusing on the use of Ampligen (rintatolimod) as an immuno-therapy as preclinical and early clinical evidence showcases the drug’s potential in the battle against cancer.

So far, nine trials in the US involving Ampligen in combination with checkpoint blockade therapies are in “various stages of advancement” at important cancer research centers, including the Roswell Park Comprehensive Cancer in Buffalo, New York and the University of Pittsburgh Medical Center.

In Europe, Ampligen is also being assessed as a way to treat advanced pancreatic cancer as part of an early access program at the Erasmus Medical Center in Rotterdam, the Netherlands. 

Investors applauded the update, sending Hemispherx shares up 12.1% to $0.18 in morning trade Wednesday.

“We believe steady progress in these combination therapy clinical trials will be an important driver for Hemispherx’s long-term success,” said CEO Thomas Equels in a statement. Scientists involved in the research note that Ampligen has been particularly effective in working with checkpoint blockade therapies such as Merck’s Keytruda (pembrolizumab).

Checkpoint inhibitors function by releasing a natural brake on the immune system so that immune cells called T cells recognize and attack tumors, according to Memorial Sloan Kettering.

“Preclinical studies in mice combining Ampligen with checkpoint inhibitors in various mouse models have yielded very promising results. Transitioning to human tumor explant work has established that Ampligen modifies the human tumor microenvironment by increasing T effector cells without raising T suppressor cell levels, thus creating a better environment for checkpoint therapy,” said Dr David Strayer, chief scientific officer of Hemispherx.

“The objective of our currently ongoing clinical trials is to determine the optimal integration of Ampligen with standard checkpoint inhibitor therapy in the clinic in a variety of solid tumors with the goal of improving survival,” Strayer added.

READ: Hemispherx Biopharma started with a Buy rating at Ascendiant Capital Markets

The four Ampligen immuno-oncology trials that have already started in the US include a Phase ½ study of chemo-immunotherapy in recurrent ovarian cancer at the University of Pittsburgh Medical Center, with an interim report expected soon.

Also on the list is an open label study of metastatic triple-negative breast cancer using therapy that includes Ampligen and Merck’s blockbuster cancer checkpoint therapy Keytruda (pembrolizumab) at the Roswell Park Comprehensive Cancer Center in Buffalo.

Another University of Pittsburgh study underway is a Phase 2 trial being conducted in advanced recurrent ovarian cancer that will evaluate Ampligen in combination with Keytruda.

Five new Ampligen trials set for this year​

In other news, five Ampligen trials are set to kick off this year, subject to funding. A Phase 2 study is planned that will evaluate Ampligen in combination with Keytruda in refractory metastatic colorectal cancer at Roswell Park.

A second Phase 2 study at Roswell taking aim at advanced bladder, melanoma and renal cancer, which are resistant to checkpoint blockade therapies, will assess Ampligen in combination with a checkpoint blockade therapy at Roswell.

A University of Nebraska study looking at Ampligen in combination with Keytruda as a weapon against non-small cell lung cancer at the University of Nebraska Medical Center is also under development. A Phase 2 study in advanced pancreatic cancer using checkpoint blockade therapy plus Ampligen is in the works too at the University of Nebraska.

Hemispherx’s flagship products include Ampligen, which fights both cancer and chronic fatigue syndrome, and the FDA-approved drug Alferon N Injection, a treatment for genital warts.

Contact Ellen Kelleher at [email protected] 


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