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Hemispherx Biopharma kicks off Phase 1 trial to treat advanced breast cancer with key drug Ampligen

The first participant in the study at Roswell Park Comprehensive Cancer Center received initial dosing this week
cancerous cells
Ampligen has the potential to make cancerous tumors easier targets for checkpoint blockade therapies

Hemispherx (NYSEAMERICAN:HEB) on Tuesday said a Phase 1 clinical trial to test its flagship cancer drug Ampligen in combination with Merck’s blockbuster cancer drug Keytruda for the treatment of advanced breast cancer has kicked off at Roswell Park Comprehensive Cancer Center in Buffalo, New York.

The study’s first participant received initial dosing this week and the trial is looking to enroll at least six patients.

Hemispherx shares traded 1.8% higher before the opening bell on Tuesday to hit $0.17.

READ: Hemispherx Biopharma makes headway in advancing flagship cancer drug Ampligen in 2018

"We are very excited to see the first patient treated as part of this important clinical trial evaluating Ampligen in combination with Keytruda (pembrolizumab) in patients with metastatic triple-negative breast cancer. We could not ask for better partners than the world-class team at Roswell Park Comprehensive Cancer Center, as we seek to evaluate the impact of the combined therapy on this high risk and very sick patient population,” said Hemispherx CEO Thomas Equels in a statement.

The study’s lead investigators Drs. Mateusz Opyrchal and Pawel Kalinski of Roswell Park will evaluate the impact of Ampligen-based chemokine modulation therapy when given prior to the checkpoint blockade therapy Keytruda (pembrolizumab) in the treatment of patients with metastatic triple-negative breast cancer.

The Roswell team is undertaking the study to determine whether this approach can modify the tumor microenvironment to convert previously ‘cold’ tumors not susceptible to checkpoint blockade therapy into ‘hot’ tumors which are primed for checkpoint-blockade therapies.

"Our extensive work with Ampligen has led many top oncologists to conclude, including in peer-reviewed medical journal articles, that Ampligen has the potential to change the tumor microenvironment,” said Equels. “Making tumors easier targets for checkpoint blockade therapies creates an exciting new approach with the potential to significantly improve clinical outcomes for patients in multiple solid tumor cancer types."

Contact Ellen Kelleher at [email protected]

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