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AIM ImmunoTech Announces the National Cancer Institute’s Award of $14.54M to Study Ampligen as Part of Five Roswell Park-led Chemokine Modulation Clinical Trials in Melanoma, Colorectal and Ovarian Cancers

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OCALA, FL / ACCESSWIRE / April 6, 2020 / The National Cancer Institute issued an award of $14.54 million to Roswell Park Comprehensive Cancer Center to test chemokine modulation incorporating AIM ImmunoTech's Ampligen as an immuno-modulator as part of a strategy to turn ‘cold' tumors into ‘hot' tumors. Chemokine modulation is designed to enhance the effectiveness of common immunotherapies and lead to new, life-saving combination therapies for people battling cancer.


  • Prestigious grant will fund 5 clinical trials in patients with 3 cancer types

  • Focus is targeting chemokine system to make ‘cold' tumors ‘hot'

  • Strategy to be studied in patients with colorectal, ovarian or melanoma tumors

The multi-center team will be led by Pawel Kalinski, MD, PhD of Roswell Park, in collaboration with partners at University of Pittsburgh Medical Center (UPMC) and The Tisch Cancer Institute at Mount Sinai. The planned clinical trials include two studies in patients with metastatic colorectal cancer, two in advanced ovarian cancer and one in patients with checkpoint-resistant advanced melanoma. Three of the five studies will be conducted at Roswell Park, with the two ovarian cancer studies to be led at UPMC's Hillman Cancer Center, with participation from Roswell Park.

Kalinski plans five Phase II or Phase IIA clinical trials to assess the efficacy of combining the chemokine-modulating effects of Ampligen with common checkpoint blockade inhibitors that are used to treat different cancer types. According to Kalinski, traditionally, only about 20% of cancer patients are good candidates for such checkpoint inhibitors.

Pawel Kalinski, MD, PhD, of Roswell Park Comprehensive Cancer Center, is leading the team conducting the planned five clinical trials studying Ampligen. Photo credit Roswell Park Comprehensive Cancer Center.

"Ampligen is a unique and highly selective immune system modulator that can be an important component of chemokine modulation therapy, one of the available strategies for converting cancers that are traditionally checkpoint-resistant into treatable, ‘hot' tumors so that more patients will be able to benefit from some of the most commonly prescribed immunotherapies," said Dr. Kalinski, who is Vice Chair for Translational Research, the Rustum Family Professor for Molecular Therapeutics and Translational Research and Director of Cancer Vaccine and Dendritic Cell Therapies at Roswell Park.

"The work of Professor Kalinski and his team at Roswell Park is charting a path forward for the future of immuno-oncology. Roswell Park, one of our country's first and foremost cancer research centers, lives up to its tradition of excellence," said David Strayer, MD, AIM's medical director and noted oncologist.

All five studies are expected to open by year-end 2021.

Six Ampligen clinical trials are currently underway at academic cancer centers - including several at Roswell Park, under the guidance of Dr. Kalinski - testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors. AIM will promptly update stockholders and the market as more information on these studies becomes available. However, with the nation's health care system increasingly focused on the COVID-19 pandemic - and with cancer patients especially at risk for the disease - AIM recognizes that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency.

Read Roswell Park's full announcement here: https://www.roswellpark.org/newsroom/202003-roswell-parks-dr-pawel-kalinski-lead-145m-nci-funded-immunotherapy-effort.

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple-negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

Cautionary Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. In addition, there is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.


Crescendo Communications, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com

AIM ImmunoTech Inc
Phone: 800-778-4042
Email: IR@aimimmuno.com

SOURCE: AIM ImmunoTech Inc

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