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AIM ImmunoTech gets nod from FDA for Ampligen combo drug trial in coronavirus patients with cancer

The Florida-based company extended its cash runway at the end of the first quarter ended March 31, 2020 to $31.1 million to fund the trial

AIM ImmunoTech Inc -- gets nod from FDA for Ampligen combo drug trial in coronavirus patients with cancer
AIM believes Ampligen has potential as a prophylactic/early-onset therapeutic against the coronavirus

AIM ImmunoTech Inc (NYSEAMERICAN:AIM) revealed Thursday that the Food and Drug Administration (FDA) has approved the first human trial of the company's lead drug Ampligen (rintatolimod) with interferon alfa-2b in treating cancer patients battling COVID-19, the disease caused by the SARS-CoV-2 coronavirus.

For its first quarter ended March 31, 2020, the Ocala, Florida-based company reported that it had cash and equivalents of $31.1 million to sponsor the key trial.

In a statement, AIM said the new clinical trial will be conducted at Roswell Park Comprehensive Cancer Center under Dr Pawel Kalinski. Meanwhile, Dr Brahm Segal will test the two-drug regimen’s ability to “promote clearance of the SARS-CoV-2 virus from the upper airway” in cancer patients.

READ: AIM ImmunoTech inks deal to research vaping device as a vehicle for Ampligen to treat coronavirus

The company said Phase 1/2b of the study will enroll around 40 patients in two stages. Phase 1 will see 12-to-24 patients receiving both Ampligen and interferon alfa-2b at escalating doses. Once the initial phase is complete, study participants will be randomized to two arms: one receiving the two-drug combo, and a control group which will not receive Ampligen or interferon alfa, but best available care.

“In the years that followed the first SARS epidemic, studies of SARS-CoV-1 in mouse models showed that Ampligen demonstrated a protective effect,” said the company in a statement. In fact, Ampligen exhibited 100% preclinical efficacy and survival outcomes for mice against the SARS-CoV-1 viral infection.

“A comparison of important pathogenic features of SARS-CoV-1 and SARS-CoV-2 (the virus that causes COVID-19) indicated that both viruses utilized the same ACE2 receptor to bind to and infect human cells. In addition, important genetic sequences of both viruses were almost identical,” said the company.

Dr David Strayer, who is the chief scientific officer at AIM ImmunoTech, said that Ampligen displayed “synergistic antitumor and antiviral activity” when combined with human interferons in studies published in the 1980s.

“A clinical study was conducted using Ampligen in combination with interferon in patients with solid tumors. The study showed that the combination was generally well-tolerated. AIM announced on February 11, 2020, the filing of three provisional patent applications surrounding Ampligen for use against COVID-19,” he added.

“These applications cover the use of Ampligen, both alone and in combination with interferon as an early onset therapy for COVID-19. Further, we filed for Ampligen as a proposed intranasal coronavirus vaccine enhancer that would combine Ampligen with inactive SARS-CoV-2."

Meanwhile, Dr Kalinski who is the vice chair for translational research at Roswell Park, said: "We hope that these two drugs, given together, will limit viral replication in the infected cells, prevent viral transmission to other cells and spur early innate immune response in cancer patients with COVID-19, before the virus spreads and they become seriously ill.”

He added: “While for decades, immuno-oncology drew heavily from virology, this development suggests that recent progress in the immuno-oncology field may allow us to return the favor and to accelerate the development of new treatments of infectious diseases."

AIM believes Ampligen has potential as a prophylactic or early-onset therapeutic against the coronavirus.

AIM ImmunoTech CEO Thomas Equels said Roswell Park “deserves great credit” for exploring the “potentially life-saving role” of Ampligen in cancer patients with COVID-19.

"Following the results of this trial, we hope to expand tests of Ampligen to other high risk and immunocompromised COVID-19 groups as the death rate in these groups is often five to seven times higher than the general population,” he added.  

“Ampligen has a well-developed safety profile based on more than 100,000 IV doses administered to humans, and has shown minimal side effects in multiple clinical trials which makes it an acceptable drug candidate for study in vulnerable patient populations."

First quarter financial highlights:

  • As of March 31, 2020, AIM had cash, equivalents and marketable securities of $31.1 million, compared to $8.8 million as of December 31, 2019.
  • Research and development expenses for the first quarter totaled $898,000, compared to $928,000 for the first quarter in 2019.
  • Net loss for the first quarter was $3.8 million, or $0.22 per share, compared to a net loss of $3.5 million, or $2.91 per share, for the same period a year earlier

AIM CFO Ellen Lintal said: "The strength of our balance sheet allows us to continue to advance both our COVID-19 and oncology programs."

Contact the author Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive

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Price: 2.41 USD

Market: NYSE
Market Cap: $78.62 m


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