Hemispherx Biopharma Inc (NYSEAMERICAN:HEB) updated shareholders Monday on the progress of five ongoing immuno-oncology clinical trials for its drug Ampligen.
Ampligen, approved in Argentina to treat Chronic Fatigue Syndrome, is involved in a pair of Phase 2 trials for recurrent ovarian cancer and prostate cancer.
In the 45-patient ovarian cancer trial, treamtent of the first patient began on June 11, while the 60-patient prostate cancer trial has received US Food and Drug Administration approval and is expected to proceed in late June.
The trials are evaluating Ampligens ability to alter whats known as the microenvironment of a tumor, essentially making it more susceptible to other cancer treatments.
Additionally, Ampligen is being used in a Phase 2a trial for colorectal cancer that has metastasized to the liver, a Phase 1/2 study for recurrent ovarian cancer and an open label study for metastatic triple negative breast cancer.
Seven members of the 12-patient colerectal study have begun treatment, and data are expected in 2020. Ten of the 12 patients in the ovarian cancer study have completed treatment, while just two patients out of six patients in the breast cancer study have started treatment.
The drug is also part of an Early Access Program at Erasmus Medical Center in the Netherlands for the treatment of pancreatic cancer for the past two years. A paper analyzing data from the treatment is expected to be published in 2020.
Looking ahead, a trio of Phase 2 studies are expected to begin later in 2019. Two studies at the Roswell Park Comprehensive Cancer Center in Buffalo, New York will evaluate Ampligen in colon and bladder/kidney cancers.
Meanwhile, a first-line therapy for non-small cell lung cancer is expected to be delayed as other projects move ahead.
Thus far, we have had steady and consistent clinical progress in immuno-oncology. I believe this is critical to creating long-term stockholder value, as success in any one of our trials has the potential to be a strong driver of the market, CEO Thomas Equels said. Especially significant are the larger clinical trials, such as our Phase 2 recurrent ovarian cancer trial. I believe that third parties fronting of trial costs shows that its not just Hemispherx that believes in Ampligen, but that major cancer research centers, public grantors and private grantors also see the potential of Ampligen as a combination therapy.
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