Hemispherx Biopharma Inc (NYSEAmerican:HEB) shares rose on Friday after the firm said it is set to debut with a new name, AIM ImmunoTech Inc and trading symbol “AIM” on September 30.
In morning trading, Hemispherx shares were 4% higher at US$2.00.
The Ocala, Florida-based company’s stock will continue to trade on the NYSE American, which is also referred to as the NYSE MKT.
In a statement, the company said it is changing its name to reflect what it does as an immuno-tech company focused on the development of immunological agents to treat multiple cancers and immune deficiency diseases.
“Amplified Immunological Modulation — or ‘AIM’ — is what our company is all about. We are delighted to announce this name change, which we believe better reflects the core mission of the company — developing synergistic immunological agents in the fields of lethal cancers and severe ME/CFS,” CEO Thomas K Equels said in the statement.
Myalgic encephalomyelitis/chronic fatigue syndrome, or ME/CFS is a disease marked by profound fatigue, sleep abnormalities, pain and other symptoms that are made worse by exertion.
“We are a small company, fighting hard to bring meaningful cures to sick people currently without hope. Our AIM is to help others by advancing immunology and unlocking the human body’s ability to heal itself, in both ME/CFS and in highly lethal malignancies,” Equels added.
The company is making steady progress with its flagship drug Ampligen that is in clinical trials to treat multiple cancers.
Equels expects results from ongoing clinical trials for Ampligen over the next 18 months to act as strong value drivers for the stock
The company said five Ampligen clinical trials are “open for enrollment” to evaluate the safety and ability of Ampligen to increase the effectiveness of cancer immunotherapy. The trials are focused on Ampligen’s ability to alter what’s known as the microenvironment of a tumor, essentially making it more susceptible to other cancer treatments.
Six additional cancer trials are in various pre-enrollment stages using Ampligen plus checkpoint blockades.
While the Food and Drug Administration has already granted Ampligen orphan drug status and authorized a compassionate care program using Ampligen for ME/CFS, the drug’s new drug application for ME/CFS is still pending approval in the US.
The FDA has asked the company to do a number of things, but primarily a confirmatory Phase 3 clinical trial on top of the existing Phase 3 trial.
Ovarian and prostate cancer too
Ampligen, which is approved in Argentina to treat Chronic Fatigue Syndrome, is also involved in a pair of Phase 2 trials for recurrent ovarian cancer and prostate cancer.
In a 45-patient ovarian cancer trial, treatment of the first patient began on June 11, while the 60-patient prostate cancer trial has received US Food and Drug Administration approval.
"Especially significant are the larger clinical trials, such as our Phase 2 recurrent ovarian cancer trial combining Ampligen and pembrolizumab. All our trials are paid for by third parties without Hemispherx conceding any rights for development,” said Equels.
“I believe that third parties' fronting of trial costs shows that it's not just Hemispherx that believes in Ampligen, but that major cancer research centers, governmental grantors and the pharmaceutical industry grantors also see the potential of Ampligen as a combination therapy."
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.
“We remain highly encouraged by the clinical data to date, which supports the biological activity and strong safety profile of Ampligen,” Equels continued.
“We look forward to announcing key upcoming catalysts, which we believe will drive significant shareholder value. As our new name suggests, we are taking AIM at serious and lethal unmet medical needs,” he concluded.
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Contact Uttara Choudhury at [email protected]
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