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AIM ImmunoTech well positioned with $57.3M to advance clinical trials of flagship drug Ampligen

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AIM ImmunoTech Inc (NYSE:AIM) posted second-quarter results that demonstrated that it is in a strong financial position with $57.3 million to press ahead with clinical trials and execute on its corporate strategy.

For the period ended June 30, 2021, the Ocala, Florida-based immuno-pharma company had cash, equivalents and marketable securities of $57.3 million, compared to $54.4 million as of December 31, 2020.

“We continued to make positive clinical and operational progress during the second quarter. With our strong balance sheet, we are well positioned to execute on our corporate strategy and advance our clinical trials to meaningful milestones that we believe will drive significant shareholder value.,” said AIM ImmunoTech CEO Thomas Equels in an earnings statement. 

READ: AIM ImmunoTech inks contract to sponsor Phase 2a trial to test Ampligen as a cold and flu therapy

“We anticipate reporting material developments throughout the remainder of this year and through 2022. We remain extremely encouraged by the outlook for Ampligen,” he added.

After years of success in studies and trials, AIM has decided to strategically narrow its focus to trials that have the shortest path to potential US Food and Drug Administration (FDA) and European Medicines Agency (EMA) drug approval. AIM anticipates that these planned trials primarily will be AIM-sponsored and AIM-funded.

Analyses of data collected in the Early Access Program at Erasmus Medical Center in the Netherlands found a positive survival benefit when using Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy.

Based on the encouraging data, AIM is developing a protocol design and schema — in consultation with Amarex Clinical Research, Buffet Cancer Center at the University of Nebraska and Erasmus MC — to seek regulatory approval to initiate a Phase 2/3 clinical trial of Ampligen in the US and European Union.

Multiple additional Ampligen clinical trials are underway including in a follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin and pembrolizumab, plus Ampligen. “Up to 45 patients to be enrolled; enrollment has commenced, and 17 subjects have now commenced treatment,” said the company.

The firm has a Phase 1/2 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab. “Eight patients were enrolled and treated,” said the firm.

In addition, AIM ImmunoTech has Phase IIa study of Ampligen as a component of a chemokine modulatory regimen on colorectal cancer metastatic to liver and a Phase II study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. “Patient enrollment has been initiated in this study designed for up to 45 patients,” said the company.

The company reported a net loss from operations for the 2Q of $5.9 million, or $0.12 per share, compared to $3.4 million, or $0.11 per share, for the 2Q of June 2020. Research expenses for the quarter totaled $1.3 million.

In January, AIM entered into a sponsor agreement with the Centre for Human Drug Research (CHDR), to manage a Phase I randomized, double-blind study to evaluate the safety and activity of repeated intranasal administration of Ampligen. The aim was to establish safety for intranasal Ampligen as a potential broad-spectrum prophylaxis for respiratory viruses, including SARS-CoV-2, which causes coronavirus (COVID-19).

“A successful Phase IIa Human Challenge Trial (HCT) study could also establish Ampligen’s potential as a prophylaxis against future viral variants and future novel respiratory viruses for which there are no current vaccines or therapies, as well as known viruses such as SARS-CoV-2,” said the company.

Contact the author Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive

Story by ProactiveInvestors


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