Hemispherx Biopharma Inc (NYSEAMERICAN:HEB) stock flew in premarket trade Thursday after it issued a final report on its phase 1 trial supporting the safety of using its flagship drug Ampligen as a combination therapy with Intron A and Celecoxib for treating recurrent ovarian cancer.
In a statement, the company said the research team, led by Dr Robert Edwards, Anda Vlad and Brian Orr, found that Ampligen was “well tolerated” as a combination therapy.
Investors cheered the news, sending Hemispherx Biopharma stock up 30.4% to $2.70 before the opening bell.
In the report, Dr Orr concluded that the “drugs can be given in this combination with no major toxicities.”
“The Phase 1 study, in addition to generating excellent safety data, has also produced positive survival data with regard to the stage 4 ovarian cancer patients participating in the recently completed recurrent ovarian cancer Phase 1 Study,” said Dr Edwards added.
Based on the Phase 1 study results, the company said that a new Phase 2 recurrent ovarian cancer clinical study has already begun at the University of Pittsburgh Medical Center treating stage 4 patients with Ampligen, cisplatin and pembrolizumab.
The 45-patient, Phase 2 trial in combination with pembrolizumab is designed to test the combinational synergy with checkpoint blockade therapy when Ampligen is administered by injection in the peritoneal cavity where the tumor is located.
Hemispherx Biopharma CEO Thomas K Equels said the positive results linked to safety and survival using Ampligen, as seen in the first stage 4 patients treated in the Phase 1/2 study, are “extremely encouraging.”
“The results are consistent with foundational research Hemispherx obtained in animals, as well as in clinical trials in humans with melanoma and renal cell carcinoma where Hemispherx chief medical officer Dr David Strayer was the principal investigator,” Equels added.
He noted that Dr Strayer’s investigations supported Ampligen’s ability to alter what’s 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, and an open label study for metastatic triple negative breast cancer.
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