OCALA, FL / ACCESSWIRE / September 10, 2019 / AIM ImmunoTech Inc., (NYSE American:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers and immune-deficiency diseases - such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) - announced progress toward the opening of Roswell Park Comprehensive Cancer Center's Phase 1 clinical study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer (TNBC) using Ampligen. Roswell Park informed AIM ImmunoTech that it received FDA authorization to proceed with the study.

The objective is to evaluate the safety and tolerability of a combination incorporating Ampligen, celecoxib with or without Intron A, and chemotherapy. The goal of this approach is to improve clinical responses in patients with early-stage TNBC tumors through combination chemo-immunotherapy prior to tumor resection. Dr. Shipra Gandhi from Roswell Park's medical oncology team is the Principal Investigator.

'This positive progress in commencing a new neoadjuvant triple negative breast cancer clinical trial, providing parallel data to contrast with our ongoing Ampligen plus pembrolizumab Stage 4 triple negative breast cancer clinical trial, is just one more important step in our focused plan for R&D success,' said AIM ImmunoTech CEO Thomas K. Equels. 'We are now using Ampligen to treat cancers in conjunction with checkpoint therapies in clinical trials at major cancer research centers such as Roswell Park Comprehensive Cancer Center and the University of Pittsburgh Medical Center. Our planned success in immuno-oncology R&D is predicated on such steady consistent execution of our milestones."

About AIM ImmunoTech

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat 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^® already conducted include studies of the potential treatment of cancer patients with renal cell carcinoma and malignant melanoma. 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

Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For example, no assurance can be given as to whether the 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, we cannot assure that the clinical studies will be successful or yield any useful data. Among other things, for forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.aimimmuno.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

Contacts:

Crescendo Communications, LLC
Phone: 212-671-1021
Email: [email protected]

Hayden IR
Phone: 646-755-7412
Email: [email protected]

AIM ImmunoTech Inc.
Phone: 800-778-4042
Email: [email protected]

SOURCE: AIM ImmunoTech Inc