AIM ImmunoTech Granted U.S. Patent for Ampligen® for the Treatment of Endometriosis

Rhea-AI Summary

AIM ImmunoTech Inc. (NYSE American: AIM) has been granted U.S. patent No. 12,102,649 for using Ampligen® to treat endometriosis, a condition affecting nearly 10% of reproductive-age women. The patent covers compositions and methods using AIM's double-stranded RNA products for treating endometriosis, including recurrent cases. It also includes options for co-administration with interferons.

Endometriosis, affecting approximately 6.5 million women in the U.S., causes severe pelvic pain and fertility issues. The patented treatment offers flexible administration options for patient-specific care. Dr. Robert Edwards, Chair of Ob/Gyn/RS at UPMC, noted that a medical therapy relieving symptoms and reducing inflammation would be a significant breakthrough. AIM's CEO, Thomas K. Equels, stated that this patent strengthens their intellectual property portfolio and expands their potential to provide life-changing therapies for women with endometriosis.

Positive

• Granted U.S. patent No. 12,102,649 for Ampligen® in treating endometriosis
• Patent covers compositions and methods using double-stranded RNA products
• Flexible administration options for patient-specific care
• Potential breakthrough in treatment options for endometriosis
• Strengthens AIM's intellectual property portfolio

Negative

• None.

Insights

Medical Research Analyst

The granting of U.S. patent No. 12,102,649 for Ampligen® in treating endometriosis is a significant development for AIM ImmunoTech. This patent strengthens the company's intellectual property portfolio and opens up a potentially large market opportunity. Endometriosis affects approximately 6.5 million women in the U.S. alone, with effective treatment options currently available.

The patent covers both compositions and methods using Ampligen®, a double-stranded RNA product, for endometriosis treatment. Key advantages include:

• Flexibility in administration methods
• Potential for treating recurrent endometriosis
• Option for co-administration with interferons

Additionally, the potential link between endometriosis and increased ovarian cancer risk could make Ampligen® even more valuable, given its positive results in advanced recurrent ovarian cancer treatment. However, it's important to note that while this patent is promising, clinical trials will be necessary to demonstrate efficacy and safety in endometriosis patients before any potential commercialization.

Financial Analyst

This patent grant represents a significant potential value driver for AIM ImmunoTech, expanding Ampligen®'s possible applications into a large, underserved market. The global endometriosis treatment market was valued at $2.32 billion in 2020 and is projected to reach $3.32 billion by 2027, presenting a substantial revenue opportunity.

For a company with a market cap of just $14.28 million, successfully developing and commercializing a treatment for endometriosis could be transformative. However, investors should consider several factors:

• The long and costly process of clinical trials and FDA approval
• Potential competition from other treatments in development
• The company's current financial position and ability to fund further research

While the patent is a positive development, it's important to remember that many patented drugs never reach the market. The true value of this intellectual property will depend on AIM's ability to advance Ampligen® through clinical development for endometriosis and eventually commercialize it successfully.

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

FAQ

What is the new patent granted to AIM ImmunoTech for Ampligen®?

AIM ImmunoTech has been granted U.S. patent No. 12,102,649 for using Ampligen® to treat endometriosis, covering compositions and methods using their double-stranded RNA products.

How many women in the United States are affected by endometriosis?

Endometriosis affects approximately 6.5 million women in the United States, which is nearly 10% of women of reproductive age.

What are the potential benefits of Ampligen® for endometriosis treatment?

Ampligen® offers flexible administration options for patient-specific care and could potentially provide a breakthrough in treatment by relieving symptoms and reducing inflammation without the serious side effects of current treatments.

How does this patent impact AIM ImmunoTech's business (AIM)?

The patent strengthens AIM ImmunoTech's intellectual property portfolio and expands their potential to provide life-changing therapies for women suffering from endometriosis, potentially opening new market opportunities.