Phase 1/2a trial of Ampligen in combination with interferon alfa-2b in cancer patients with COVID-19 is on track for enrollment
OCALA, FL / August 17, 2020 / AIM ImmunoTech (NYSE American:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today provided a business and pre-clinical/clinical update for the second quarter ended June 30, 2020.
Second Quarter 2020 Financial Highlights:
- As of June 30, 2020, AIM had cash, cash equivalents and marketable securities of $40.3 million, as compared to $8.8 million as of December 31, 2019.
- Research and development expenses for the second quarter ended June 30, 2020 were $1.46 million, compared to $1.10 million for the second quarter ended June 30, 2019.
- General and administrative expenses for the second quarter ended June 30, 2020 were $1.72 million, compared to $1.94 million for the second quarter ended June 30, 2019.
The Company's complete financial results are available in the Company's June 30, 2020 Form 10-Q filed with the Securities and Exchange Commission on August 14, 2020, which is available at www.sec.gov and on the Company's website.
"AIM is engaged in extremely important and potentially groundbreaking pre-clinical and clinical research in critical unmet medical needs such as COVID-19 and cancer-providing us ‘multiple shots on goal' within large addressable markets. Given these multiple indications, AIM's strategy to support these trials has been to maximize third-party, non-dilutive funding directly awarded to the clinical sites, which we have accomplished in many of our trials. In addition, we had more than $40 million in cash, cash equivalents, and marketable securities on our balance sheet as of June 30, 2020. As a result, we believe we are extremely well positioned to execute on our strategy going forward, which, in turn, we expect will drive significant value for stockholders," said AIM CEO Thomas K. Equels.
COVID-19 General Updates:
- Following the FDA's authorization of an IND on May 11, 2020, AIM entered into a clinical trial agreement on July 6, 2020, with Roswell Park Comprehensive Cancer Center to support Roswell Park's Phase 1/2a trial of Ampligen in combination with interferon alfa-2b in cancer patients with COVID-19, the disease caused by SARS-CoV-2. The trial is on track to commence patient enrollment soon.
- AIM signed a trilateral material transfer and research agreement with Japan's National Institute of Infectious Diseases and Shionogi & Co., Ltd., a leading global pharmaceutical company headquartered in Japan, in order to test Ampligen as a potential vaccine adjuvant for COVID-19. Ampligen has been shipped to Japan, to be followed up with an additional shipment.
- AIM is currently collaborating with Shenzhen Smoore, the world's largest vaping device manufacturer, to research the use of their innovative inhalation technology for enhaced delivery of Ampligen deep into the lungs at the first signs of COVID-19. The Company believes this approach may initiate a robust, therapeutic TLR3 response against the SARS-CoV-2 virus throughout the upper and lower respiratory system. Ampligen is scheduled to be shipped to Smoore for testing, pending resolution of various China import regulatory requirements.
- Ampligen has been shipped to Utah State University to support the University's Institute for Viral Research in its pre-clinical testing againast SARS-CoV-2 and testing is underway.
COVID-19-induced Chronic Fatigue-like Illness Update:
- Ampligen has proven to be a powerful drug conferring protective survival in SARS-CoV-1 animal experiments. Ampligen has also shown heightened levels of activity in Phase 2 and 3 trials with Chronic Fatigue Syndrome (CFS) patients. Ampligen, while experimental in the United States for CFS, is approved in Argentina and is the only late-stage experimental drug for CFS in the U.S. pipeline. Ampligen is also the first drug approved for severe CFS in the world. AIM is preparing to test Ampligen as a potential therapy for a SARS-CoV-2-induced chronic fatigue-like illness. AIM believes Ampligen may play an important role in addressing this multifaceted disease, including the potential post-infection debilitating aspects.
"There is a significant risk that SARS-CoV-2, the virus that causes COVID-19, will trigger a large number of chronic fatigue-like cases, similar to what occured in the prior SARS-CoV-1 epidemic," said Equels. "Ampligen's strong history of preclinical outcomes with the SARS-CoV-1 virus gives AIM hope for the drug's potential as a prophalaxis, as a vaccine adjuvant and as an early-onset treatment for the SARS-CoV-2 virus and for COVID-19-induced chronic fatigue-like illness. This potential therapy may be especially important for cancer patients, who face significantly increased risk of severe symptoms or death from COVID-19."
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Update:
- AIM received clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen to Argentina. The next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the product and release tests before granting final approval to begin commercial sales. AIM has shipped Ampligen to its partner in Argentina, GP Pharm, which is required for testing and ANMAT release. Once final approval by ANMAT is obtained, the commercial launch of Ampligen in Argentina is planned. Further, AIM continues to pursue its Ampligen New Drug Application, or NDA, for the treatment of traditional CFS with the FDA.
Immuno-oncology Update: Equels further noted, "Given the advances in our third-party funded, investigator-sponsored cancer clinical trials, we believe there is real potential for AIM to become a powerhouse in oncology, as clinical data is reported in these trials. The fact that tens of millions of dollars in grants have been provided to world-class investigator/oncologists at top national cancer centers, from such esteemed organizations as Merck, the U.S. Department of Defense and the National Cancer Institute, clearly supports my faith in Ampligen."
- Roswell Park Comprehensive Cancer Center and Moffitt Cancer Center have both received "Breakthrough Awards" from the U.S. Department of Defense in Brain Metastatic Breast Cancer. Together, these separate-but-parallel proposed clinical trials are receiving approximately $15 million in federal funding in part with a significant focus upon Ampligen as a potential synergistic agent in combination with several other immunotherapies, including pembrolizumab (Keytruda) and Intron A.
- The National Cancer Institute issued an award of $14.5 million to Roswell Park Comprehensive Cancer Center to fund five clinical trials in melanoma, colorectal and ovarian cancers. These trials will test chemokine modulation incorporating Ampligen as an immuno-modulator, as part of a strategy to turn "cold" tumors into "hot" tumors.
- Advanced Recurrent Ovarian Cancer - This Phase 1/2 study of Ampligen as an intraperitoneal therapy in advanced recurrent ovarian cancer has completed 12 subjects in Phase 1; the Phase 1 portion established intraperitoneal safety sufficient to proceed with a larger Phase 2 study (See below). (https://aimimmuno.irpass.com/Hemispherx-Reports-Positive-Safety-and-Survival-Data-in-Phase-1-Stage-4-Ovarian-Cancer-Clinical-Stud) We are awaiting publication of results. https://clinicaltrials.gov/ct2/show/NCT02432378
- Advanced Recurrent Ovarian Cancer - Based upon the above, a 45-subject follow-up Phase 2 study of advanced recurrent ovarian cancer is underway principally funded via a Merck grant and using cisplatin, pembrolizumab and Ampligen. Enrollment commenced in January 2019 and numerous patients are now well into treatment. https://clinicaltrials.gov/ct2/show/NCT03734692 (https://aimimmuno.irpass.com/Hemispherx-Biopharma-Announces-Commencement-of-a-New-45-Subject-Clinical-Trial-Combining-Ampligen-an)
- Stage 4 Metastatic Triple Negative Breast Cancer - Phase 2 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab. All patients have been treated or are near completion of treatment. https://www.clinicaltrials.gov/ct2/show/NCT03599453
- Stage 4 Colorectal Cancer Metastatic to the Liver - Phase 2a study of Ampligen as
component of chemokine modulatory regimen on colorectal cancer metastatic to liver; the majority of the 12 planned patients enrolled and treated. https://clinicaltrials.gov/ct2/show/NCT03403634
- Early-Stage Prostate Cancer - Phase 2 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. https://clinicaltrials.gov/ct2/show/NCT03899987
- Early-Stage Triple Negative Breast Cancer - Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer has received FDA authorization; the objective of this study is to evaluate the safety and tolerability of a combination of Ampligen, celecoxib with or without Intron A, when given along with chemotherapy; the goal of this approach is to increase survival. This study is recruiting and is designed for up to 24 patients. https://clinicaltrials.gov/ct2/show/NCT04081389
- A study of Ampligen as a drug for late-stage pancreatic cancer is complete and the research team at Erasmus M.C. is currently compiling the final data from this early access approval-based study. We are enthusiastically awaiting the publication of these results.
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 subsequent reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency. However, AIM intends to move forward without delay and we believe the teams at all of the clinical sites are eager to keep forward momentum.
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.
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. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. No assurance can be given as to whether current or planned immuno-oncology clinical 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. Some of the world's largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive. We recognize 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. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks.
Crescendo Communications, LLC
AIM ImmunoTech Inc
SOURCE: AIM ImmunoTech Inc.