University of Pittsburgh Medical Center

OCALA, Fla., Oct. 03, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the United States Patent and Trademark Office (USPTO) has granted U.S. patent No. 12,102,649, covering both compositions and methods comprising the Company’s drug Ampligen® in the treatment of endometriosis, a painful chronic condition that affects nearly 10% of women of reproductive age, or approximately 6.5 million women in the United States. Endometriosis is a disease in which tissue similar to the lining of the uterus grows outside the uterus, causing severe pelvic pain and making it difficult or impossible to become pregnant. It can cause inflammation and infertility, and symptoms such as intense menstrual cramps, severe pelvic pain and chronic fatigue, all of which can significantly impact quality of life. Despite its prevalence, treatment options are limited, and many women experience years of misdiagnosis. The patented method involves the administration of a therapeutically effective amount of a pharmaceutical composition containing AIM’s proprietary double-stranded RNA products. The patent’s claims describe a unique class of therapeutic double-stranded RNAs (e.g., tdsRNA, Ampligen®, rugged dsRNA) which are key components in these potentially groundbreaking treatment methods and compositions. The versatile administration options offer flexibility for patient-specific needs and care. The patent also covers treatments targeting recurrent endometriosis and includes options for co-administration with interferons, including well-known types such as alpha and beta interferons. Patients with endometriosis also are at more than four times the risk of developing ovarian cancer than are people without endometriosis, according to a recent article in JAMA. As we have previously announced, Ampligen has also shown positive results as part of a combination therapy in the treatment of advanced recurrent ovarian cancer. Read more: “AIM ImmunoTech Announces Positive Top-Line, Protocol-Planned Interim Report Data from the Study of Ampligen Combined with Pembrolizumab for the Treatment of Recurrent Ovarian Cancer” Robert Edwards, MD, a world-renowned expert in women’s reproductive health and Chair of Ob/Gyn/RS at the University of Pittsburgh Medical Center, Magee-Womens Hospital, stated: “Endometriosis is a chronic disease that threatens the fertility and wellbeing of greater than 10% of the population, but total incidence is not known. Effective treatment now involves some form of estrogen deprivation or surgery, both of which have serious side effects and fertility risks themselves. A medical therapy that relieves symptoms and abates the inflammatory response would be a significant breakthrough in treatment options. At UPMC we have conducted an extensive clinical evaluation of Ampligen in recurrent ovarian cancer with positive results. Ampligen’s safety profile is well developed and Ampligen has been generally well tolerated.” AIM Chief Executive Officer Thomas K. Equels commented, "This patent is a significant milestone for AIM, not only strengthening our intellectual property portfolio, but also expanding our potential to provide life-changing therapies for women suffering from endometriosis. With the global focus on women's health, we are excited about the possibilities this new treatment presents. At AIM, our goal is to make a difference by improving the quality of life for women suffering from endometriosis." About AIM ImmunoTech Inc. AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system. For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook. Cautionary Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Data, pre-clinical success and clinical success seen to date does not guarantee that Ampligen will be approved as a therapy for endometriosis or ovarian cancer. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/b3aac790-f746-4dac-afe7-796d4ce31897 https://www.globenewswire.com/NewsRoom/AttachmentNg/c697332b-3cca-4968-8f85-b1a98a8882bd

Synchron won FDA breakthrough device designation for the endovascular brain implant in 2020. The Command study is the first investigational device exemption (IDE) trial of a permanently implanted BCI, evaluating safety and efficacy in six patients with severe paralysis. Synchron said the feasibility study’s results highlight its system’s “safety profile, stable signal performance, and reliable surgical delivery.” Instead of open-brain surgery like BCI rival Neuralink‘s implantation procedure, Synchron delivers its nitinol Stentrode implant with a catheter via the jugular and through the brain’s transverse sinus to the superior sagittal sinus for placement. The median deployment time in the study was 20 minutes. “This minimally-invasive approach has the potential to unlock BCI technology at scale for the millions of patients with paralysis and other mobility challenges,” Levy said. Levy is a co-principal investigator on the study as well as chair of neurosurgery at State University of New York at Buffalo and past president of the CNS Foundation. CNS is awarding Levy with the Duke Samson Award, which recognizes the best clinical paper addressing a topic of cerebrovascular surgery. In addition to the study’s finding of no impact on the brain or vasculature in the six patients, the study also showed 100% accurate deployment for target motor cortex coverage, demonstrating consistent capture of brain signals related to motor intent and transformation of them into digital motor outputs (DMOs). Synchron has recently shown amyotrophic lateral sclerosis (ALS) patients using the Stentrode implant to control Apple Vision Pro headsets, communicate with the help of OpenAI technology, and operate smart home devices with Amazon Alexa. The Command study was supported by the National Institutes of Health’s Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative. The study was conducted at Mount Sinai Health System in New York City, University at Buffalo Neurosurgery and University of Pittsburgh Medical Center (UPMC) in collaboration with Carnegie Mellon University College of Engineering. With the completion of the feasibility study’s initial follow-up, patients will start enrollment at additional sites next year. Synchron now has five years of data from 10 research participants, Oxley said. Oxley said Synchron has a “slightly modified version” of the Stentrode implant coming off the manufacturing line early next year in the Minneapolis metro, with verification and testing happening now. “It’s basically high-quality manufacturing at scale,” he said. “We now have a manufacturing line that can achieve very high standards, very low yields, high quality, very robust, meeting all the FDA testing requirements that are preparing for a for a pivotal-trial-level, commercial-level device.” from our interview with Oxley at Medical Design & Outsourcing, including the latest discussions with the FDA about a pivotal trial, lessons learned through the Command study and the potential for consumer use of BCI implants.

PITTSBURGH--( BUSINESS WIRE )--Bayer, UPMC Magee-Womens Hospital and Pennsylvania State Senator Kim Ward (R-Westmoreland County) are collaborating to address the health access gaps that disproportionally impact women in rural communities, specifically those associated with breast health care. The collaboration will provide information on health and food insecurities and will bring mammography breast cancer screenings to those in rural and underserved communities. Arriving on the cusp of Breast Cancer Awareness Month, this public health collaboration kicks off today with the first of two free mammography screening events and coincides with the Luke Bryan Farm tour coming to Smithton, Pa on September 28 th . Ten percent of the nation’s physicians practice in rural areas 1 . Additional health barriers negatively impacting rural women include proportionately fewer rural women receiving recommended preventive screening services for breast cancer 2 , as well as delayed care or no medical care due to cost (18.6%), and no health insurance coverage (23.1%) 3 . These types of barriers to care often result in late-stage health diagnosis. This morning, pre-registered patients from nearby rural communities will bus from the Greater Pittsburgh Community Food Bank to UPMC Magee-Women’s Imaging West Mifflin. A second group of patients will bus from the Westmoreland Food Bank to UPMC Magee Imaging, Monroeville on Wednesday, September. 25. All patients will receive a 3D mammography. “Women in rural America are more likely to be diagnosed with late-stage breast cancer 4 – a potential result of lower screening utilization,” Senate President Pro Tempore Kim Ward said. “As a breast cancer survivor, I know first-hand the importance of early detection and how it plays a critical role in women’s health. In fact, had more testing and screening options been covered by insurance when I was diagnosed, my breast cancer may have been caught sooner, or I may have considered a different option. It is also the reason why I championed legislation that eliminates all costs associated with supplemental imaging and BRCA-related genetic testing and counseling for high-risk Pennsylvanians. This first-of-its-kind law has saved lives, and thanks to these efforts led by Bayer and UPMC, it will continue to help many of our neighbors for years to come.” The event on Wednesday aligns with World Dense Breast Day. Nearly half of all women aged 40 or older who get mammograms are found to have dense breast tissue 5 . “Early detection of breast cancer through annual mammography examination is the single most important way to diagnose cancers early,” said Dr. Margarita Zuley, Chief of Breast Imaging at UPMC Magee. “Recognizing that it’s not always easy for patients to access care, we have important community outreach events, just like this, so we can provide breast screenings to everyone no matter where they live. Now, with Senator Ward’s legislation, we can also provide additional breast screening services such as breast MRI for those with dense breast tissue, where mammography may not be able to pick up the early cancers.” With the support of the local food banks, Bayer and UPMC Magee also are spotlighting the distinct intersection between food and health insecurities, with the goals of disseminating this important breast health information and driving access to care to the Pittsburgh region’s most underserved communities. After returning from the scheduled mammogram appointment today, visitors are invited to shop in The Market , the Greater Pittsburgh Community Food Bank's onsite pantry. Additionally, a food distribution will take place at the Westmoreland Food Bank to coincide with Wednesday’s event. Take Care, Now Campaign with Country Superstar Luke Bryan Today’s announcement is part of Bayer’s “Take Care, Now” campaign in partnership with country superstar Luke Bryan and Kroger, as well as Luke’s annual Farm Tour. The tour, sponsored by Bayer, will take place at six family farms across the country this month. This year’s campaign is focused in two main areas educating communities and facilitating access to nutritious food and vitamins and minerals, as well as the breast screening events leading up to the Smithton tour stop. As part of this year’s “Take Care, Now” campaign Bayer, Luke Bryan and Kroger are hosting their multi-year #HerestotheFarmer initiative benefiting Feeding America during Farm Tour. Together they are asking fans to share the hashtag #HeresToTheFarmer on their social media channels. In support, Bayer will help provide 1 million meals* to people experiencing hunger through the Feeding America network of food banks. Since the partnership began in 2015, Bayer and Luke Bryan have donated more than 9 million meals to Feeding America food banks. Looking ahead, Bayer and UPMC Magee will host additional events with a mobile 3D mammography screening van to provide better access to rural communities. For more information on women’s health and the “Take Care, Now” campaign, please visit: www.bayer.us/takecarenow and www.upmc.com . 1: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10356718/ 2: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10356718/ 3: https://pubmed.ncbi.nlm.nih.gov/22353960/ 4: https://densebreast-info.org/for-patients/5-facts-you-should-know/ 5: https://pubmed.ncbi.nlm.nih.gov/24462273 About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. Find more information: https://pharma.bayer.com/ Follow us on Facebook: http://www.facebook.com/bayer Follow us on X: @BayerPharma Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com . The company assumes no liability whatsoever to update these forward-looking statements or to confirm them to future events or developments.