Hemispherx Announces First Participant Received Initial Dosing in Breast Cancer Clinical Trial

Hemispherx (NYSE American:HEB) has announced the active initiation of a clinical trial sponsored by Roswell Park Comprehensive Cancer Center, evaluating the company’s experimental drug Ampligen in combination with Merck’s (NYSE:MRK) Keytruda in treating metastatic triple-negative breast cancer.

As quoted in the press release:

The study’s first participant received initial dosing this week. The phase I trial seeks to enroll at least six patients

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 pembrolizumab in the treatment of patients with metastatic triple-negative breast cancer. Drugs used in this chemokine modulation therapy — celecoxib, recombinant interferon alfa-2b, and Ampligen — potentially work by unleashing or enhancing the cancer immune responses that already exist by either blocking inhibitory molecules or by activating stimulatory molecules. Based on past experimental and clinical data, the research team is undertaking the study to determine whether this approach can positively modify the tumor microenvironment to convert previously ‘cold’ tumors not susceptible to checkpoint blockade therapy into ‘hot’ tumors which are optimally primed for checkpoint-blockade therapies.

“We are very excited to see the first patient treated as part of this important clinical trial evaluating Ampligen in combination with 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 K. Equels. “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. 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.”

Click here to read the full press release.