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FDA approved that Alzheimer’s drug that doesn’t work according to the science… time for another run at ampligen approval.
$AIM is headed up in the premarket hours after a peer-reviewed publication shows Ampligen has potential as a COVID-19 treatment in cancer patients. https://cnafinance.com/aim-immunotech-aim-stock-climbs-on-ampligen-publication/
AIM ImmunoTech Announces Positive Safety Data from the Third Cohort of Its Phase 1 Intranasal Clinical Trial
May 26 2021 - 09:15AM
GlobeNewswire Inc.
AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has completed dosing of Cohort 3 in a Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as an intranasal therapy, reporting no serious adverse events.
This is consistent with results in the first two cohorts of the study and at escalating doses.The study protocol called for a total of 40 healthy subjects to receive repeated administration of either Ampligen or a placebo. Subjects in Cohort 1 received 75 µg of Ampligen, subjects in Cohort 2 received 200 µg of Ampligen and subjects in Cohort 3 received 500 µg. The study is already proceeding with Cohort 4, with subjects receiving 1250 µg.
The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the Phase 1 clinical study AMP-COV-100 (CHDR2049), titled “A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects.” AIM is sponsoring and funding the clinical study.
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 disease caused by the SARS-CoV-2 virus.
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” 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, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company cannot assure that the CHDR study will be successful or continue to yield favorable data and 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. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
Contacts:
Crescendo Communications, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com
AIM ImmunoTech Inc
Phone: 800-778-4042
Email: IR@aimimmuno.com
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AIM ImmunoTech Inc (AIM)
2.08 ? 0.04 (1.96%)
Volume: 684,258 @05/26/21 11:46:34 AM EDT
Bid Ask Day's Range
- - 2.04 - 2.17
AIM Detailed Quote
AIM ImmunoTech Inc (AIM)
2.03 ? -0.07 (-3.33%)
Volume: 490,672 @04/19/21 7:58:23 PM EDT
Bid Ask Day's Range
- - 2.02 - 2.11
AIM Detailed Quote
$AIM this is good AIM ImmunoTech Added to Russell Microcap(R) Index
ACCESSWIRE ACCESSWIRE•June 29, 2020
https://finance.yahoo.com/news/aim-immunotech-added-russell-microcap-105500883.html
OCALA, FL / ACCESSWIRE / June 29, 2020 / AIM ImmunoTech (NYSE American:AIM), today announced that it has been added to the Russell Microcap® Index, following the annual Russell indexes reconstitution, effective after the market open on June 29, according to a final list of additions posted on June 26.
[ https://aimimmuno.com/all-articles/ ]
Annual Russell indexes reconstitution captures the 4,000 largest US stocks, ranking them by total market capitalization.
Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes.
FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
Tom Equels, CEO of AIM ImmunoTech, commented "This addition to the Russell Microcap® Index reflects our progress as we continue to advance both our COVID-19 and oncology programs.
Inclusion in the Russell Microcap® Index should also help increase our exposure within the global investment community as we continue to execute on important milestones."
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies.
Approximately $9 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider. For more information on Russell Microcap® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.
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.
The Company is also advancing Ampligen® as a potential treatment
for COVID-19, the disease caused by the SARS-CoV-2 coronavirus,
and believes Ampligen® has significant therapeutic potential as both
an early-onset treatment and prophylaxis against this new and deadly virus.
The U.S. Food and Drug Administration has authorized the first human trial assessing the safety and effectiveness of
Ampligen® in combination with interferon alfa-2b,
in cancer patients with COVID-19.
About FTSE Russell
FTSE Russell is a leading global index provider creating and managing a wide range of indexes, data and analytic solutions to meet client needs across asset classes, style and strategies. Covering 98% of the investable market, FTSE Russell indexes offer a true picture of global markets, combined with the specialist knowledge gained from developing local benchmarks around the world.
FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $16 trillion is currently benchmarked to FTSE Russell indexes.
For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create investment funds, ETFs, structured products and index-based derivatives.
FTSE Russell indexes also provide clients with tools for asset allocation, investment strategy analysis and risk management.
A core set of universal principles guides FTSE Russell index design
and management: a transparent rules-based methodology is informed by independent committees of leading market participants.
FTSE Russell is focused on index innovation and customer partnership applying the highest industry standards and embracing the IOSCO Principles. FTSE Russell is wholly owned by London Stock Exchange Group.
For more information, visit http://www.ftserussell.com.
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. 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.
Contact:
Crescendo Communications, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com
SOURCE: AIM ImmunoTech Inc.
View source version on accesswire.com:
https://www.accesswire.com/595266/AIM-ImmunoTech-Added-to-Russell-MicrocapR-Index
$AIM this is good AIM ImmunoTech Added to Russell Microcap(R) Index
ACCESSWIRE ACCESSWIRE•June 29, 2020
https://finance.yahoo.com/news/aim-immunotech-added-russell-microcap-105500883.html
OCALA, FL / ACCESSWIRE / June 29, 2020 / AIM ImmunoTech (NYSE American:AIM), today announced that it has been added to the Russell Microcap® Index, following the annual Russell indexes reconstitution, effective after the market open on June 29, according to a final list of additions posted on June 26.
[ https://aimimmuno.com/all-articles/ ]
Annual Russell indexes reconstitution captures the 4,000 largest US stocks, ranking them by total market capitalization.
Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes.
FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
Tom Equels, CEO of AIM ImmunoTech, commented "This addition to the Russell Microcap® Index reflects our progress as we continue to advance both our COVID-19 and oncology programs.
Inclusion in the Russell Microcap® Index should also help increase our exposure within the global investment community as we continue to execute on important milestones."
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies.
Approximately $9 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider. For more information on Russell Microcap® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.
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.
The Company is also advancing Ampligen® as a potential treatment
for COVID-19, the disease caused by the SARS-CoV-2 coronavirus,
and believes Ampligen® has significant therapeutic potential as both
an early-onset treatment and prophylaxis against this new and deadly virus.
The U.S. Food and Drug Administration has authorized the first human trial assessing the safety and effectiveness of
Ampligen® in combination with interferon alfa-2b,
in cancer patients with COVID-19.
About FTSE Russell
FTSE Russell is a leading global index provider creating and managing a wide range of indexes, data and analytic solutions to meet client needs across asset classes, style and strategies. Covering 98% of the investable market, FTSE Russell indexes offer a true picture of global markets, combined with the specialist knowledge gained from developing local benchmarks around the world.
FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $16 trillion is currently benchmarked to FTSE Russell indexes.
For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create investment funds, ETFs, structured products and index-based derivatives.
FTSE Russell indexes also provide clients with tools for asset allocation, investment strategy analysis and risk management.
A core set of universal principles guides FTSE Russell index design
and management: a transparent rules-based methodology is informed by independent committees of leading market participants.
FTSE Russell is focused on index innovation and customer partnership applying the highest industry standards and embracing the IOSCO Principles. FTSE Russell is wholly owned by London Stock Exchange Group.
For more information, visit http://www.ftserussell.com.
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. 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.
Contact:
Crescendo Communications, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com
SOURCE: AIM ImmunoTech Inc.
View source version on accesswire.com:
https://www.accesswire.com/595266/AIM-ImmunoTech-Added-to-Russell-MicrocapR-Index
AIM ImmunoTech Inc (AIM)
2.08 ? -0.03 (-1.42%)
Volume: 526,244 @04/16/21 8:00:00 PM EDT
Bid Ask Day's Range
- - 2.07 - 2.12
AIM Detailed Quote
AIM ImmunoTech Inc (AIM)
2.08 ? -0.03 (-1.42%)
Volume: 526,244 @04/16/21 8:00:00 PM EDT
Bid Ask Day's Range
- - 2.07 - 2.12
AIM Detailed Quote
There are 2 new 8K out, aim is upgrading the production of ampligen, something coming ?
AIM ImmunoTech Announces Addition of Single-Agent Ampligen Arm to Cancer Center’s Ongoing Study in Cancer Patients with COV...
March 22 2021 - 08:45AM
GlobeNewswire Inc.
AIM ImmunoTech Inc. (NYSE American: AIM) today announced that the Institutional Review Board (IRB) of Roswell Park Comprehensive Cancer Center (Roswell Park) has approved a protocol amendment to Roswell Park’s ongoing Phase 1/2a study evaluating the two-drug combination of AIM’s Ampligen and interferon alpha-2b as a potential early-onset treatment for patients with cancer and mild-to-moderate COVID-19.
The IRB-approved amendment calls for randomization of an additional twenty patients. Ten of these patients will receive a single dose of Ampligen, but no interferon treatment, and the other ten will receive best available care only. Ampligen alone has a generally well-tolerated safety profile with lower risk of adverse events than is generally expected with interferon therapy.
"We are excited to see Ampligen tested not only as part of an antiviral treatment combination for COVID-19 among cancer patients, but also as a possible standalone therapy for this terrible virus,” said AIM CEO Thomas K. Equels. “An early-onset treatment is especially critical for cancer patients, who face significantly increased risk of severe symptoms or death."
AIM previously announced in November 2020 that the first patient had been enrolled and received treatment in Roswell Park’s study. Funding for the clinical trial is provided, in part, through grants from the National Cancer Institute and AIM, as well as institutional support from Roswell Park.
Full details about this trial under way at Roswell Park, led by co-Principal Investigators Drs. Brahm Segal and Pawel Kalinski, are available at ClinicalTrials.gov.
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 disease caused by the SARS-CoV-2 virus.
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, 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. In this regard, the Roswell Park Clinical Trial Agreement is one of the first steps and no assurance can be given as to whether the Roswell Park trial and/or subsequent trials will prove successful. Some of the world’s largest pharmaceutical companies 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, even if Ampligen proves effective, another treatment that eventually proves effective will not make our efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that are different from those reported in studies the Company is relying on. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its potential foreign operations will not be adversely affected by these risks. With regard to the Company’s activities with Ampligen generally, 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. 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 the Company’s website is not incorporated by reference herein and is included for reference purposes only.
Contacts:
Crescendo Communications, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com
AIM ImmunoTech Inc
Phone: 800-778-4042
Email: IR@aimimmuno.com
$aim $2.44 ^ 0.02 (0.83%)
Volume: 917,599 @03/19/21 6:57:04 PM EDT
AIM ImmunoTech to Present at the H.C. Wainwright Global Life Sciences Conference on March 9th
March 04 2021 - 06:50AM
GlobeNewswire Inc.
AIM ImmunoTech Inc. (NYSE American: AIM) today announced that Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech, will be presenting at the H.C. Wainwright Life Sciences Conference to be held virtually between March 9-10, 2021.
AIM’s presentation will be available on-demand to registered attendees via the conference platform beginning Tuesday, March 9, 2021, at 7:00 AM Eastern Time. The webcast will be accessible here, and the presentation will be available on the investor relations section of AIM's website at https://aimimmuno.com/events-presentations/. Management will also be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.
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 disease caused by the SARS-CoV-2 virus.
Contacts:
Crescendo Communications, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com
AIM ImmunoTech Inc
Phone: 800-778-4042
Email: IR@aimimmuno.com
Great post thanks
EC Form 4: Stewart Appelrouth bought $24,999 worth of Common Stock (10,638 units at $2.35), increasing ownership by 13% to 92,538 units
https://ih.advfn.com/stock-market/AMEX/aim-immunotech-AIM/stock-news/84436416/statement-of-changes-in-beneficial-ownership-4
$aim $2.47 v -0.02 (-0.80%)
Volume: 1,152,164 @02/19/21 8:00:00 PM EST
AIM ImmunoTech Inc (AIM)
2.47 ? -0.02 (-0.80%)
Volume: 1,152,164 @02/19/21 8:00:00 PM EST
Bid Ask Day's Range
- - 2.46 - 2.55
AIM Detailed Quote
AIM ImmunoTech Announces Ethics Committee Approval to Commence Phase 1 Clinical Study of Ampligen as an Intranasal Therapy
February 16 2021 - 09:15AM
GlobeNewswire Inc.
AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has received approval from the required Ethics Committee in the Netherlands to commence its Phase 1 clinical study on the safety of AIM’s drug Ampligen as an intranasal therapy, a critical step in the company’s ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.
Earlier this year, the company announced that it had entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR) for the proposed AMP-COV-100 (CHDR2049) trial. Last week, approval was received from the Dutch local Ethics Committee, clearing the road for execution of the trial.
The current study plans call for the enrollment of eight healthy subjects in each of four Ampligen treatment groups and eight placebo subjects, for a total of 40 healthy subjects. This will assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. The subjects will receive intranasal dosing every other day for 13 days, for a total of seven doses each. AIM is funding the clinical study.
“We are delighted and honored to receive Ethics Committee approval, an important step toward initiation of the trial,” said AIM CEO Thomas K. Equels. “We are on track for site initiation later this month and expect to begin enrolling participants in the study during the first quarter of 2021. Importantly, our prior in vitro modeling at The Institute for Antiviral Research at Utah State University demonstrated that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage concentrations. As a result, we are highly encouraged by the potential of an intranasal prophylactic approach using Ampligen to prevent infection and spread of COVID-19 and are excited to commence safety tests of potential dosing regimens.”
Dr. Matthijs Moerland, principal investigator at CHDR: “We’re very happy helping AIM with this important step. Together with AIM’s study team, we feel we have not only designed a trial evaluating Ampligen’s intranasal safety profile, but also yielding important mechanistic data on the compound’s immunomodulatory activities.”
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 disease caused by the SARS-CoV-2 virus.
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” 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, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company cannot assure that the CHDR study will be successful or yield favorable data and 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. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. 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. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
Contacts:
Crescendo Communications, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com
AIM ImmunoTech Inc
Phone: 800-778-4042
Email: IR@aimimmuno.com
AIM ImmunoTech Announces the Expansion of its Pancreatic Cancer Program to Include New Patients in the Netherlands
February 10 2021 - 09:15AM
GlobeNewswire Inc.
AIM ImmunoTech Inc. (NYSE American: AIM) today announced that the Dutch Health and Youth Care Inspectorate (IGJ) has approved treatment for six pancreatic cancer patients as part of a new, follow-up Early Access Program (EAP) at Erasmus Medical Center in the Netherlands. Subject to further authorization we plan to treat up to 16 pancreatic cancer patients with rintatolimod (Ampligen) under the EAP, which follows the success of a previous multi-year Ampligen EAP for pancreatic cancer patients at Erasmus MC. The new approval was designed to include several patients treated under the previous EAP, who are still alive despite their diagnoses several years ago of locally advanced or metastatic pancreatic cancer.
AIM announced on September 22, 2020 that the initial EAP had demonstrated statistically significant positive pancreatic cancer survival benefits in its Ampligen arm, as compared to a historical control cohort. The use of Ampligen, following the current standard of care for pancreatic cancer (FOLFIRINOX), yielded an overall survival of 19 months, or 7.9 months greater than FOLFIRINOX treatment alone. This new group will help focus on immunological markers which will aid in identifying high-level Ampligen responders.
“We are extremely pleased to continue our study in pancreatic cancer patients with Ampligen, given the hopeful previous results,” said Prof. Casper van Eijck, MD, PhD, the lead investigator for the EAP at Erasmus MC. “By more selectively including patients for this treatment, we hope to better define the ultimate application area. We are grateful to AIM ImmunoTech Inc. for their constructive contribution to enabling this treatment in this aggressive cancer.”
This announcement is an important step in AIM’s ongoing efforts to expand its pancreatic cancer treatment program, as data gathered in the new study may assist in the company’s plans to transition into a clinical trial with clinical sites in the European Union (EU) and the United States. Both Erasmus MC and the Buffett Cancer Center at the University of Nebraska Medical Center (K. Klute, MD, M.A. Hollingsworth, PhD) have tentatively agreed to serve as clinical trial sites. Additionally, AIM announced in December 2020 that the U.S. Food and Drug Administration had granted Orphan Drug Designation to Ampligen as a treatment for pancreatic cancer; the European Medicines Agency (EMA) recently recommended to the European Commission (EC) that AIM’s wholly owned subsidiary – Hemispherx Biopharma Europe – receive a similar designation in the EU for Ampligen in pancreatic cancer, and the company awaits a final EC decision.
AIM’s planned next steps in its pancreatic cancer program include filing an Investigational New Drug (IND) application in the United States and a Clinical Trial Application (CTA) in the EU to move forward in the study of Ampligen for treating this disease. The company is also exploring the possibility of applying for Fast Track status to assist in the swift advance of Ampligen as a potential treatment for this unmet medical need. Fast Track designation would give AIM the opportunity to meet more often with the FDA to quickly advance Ampligen through the different phases of the IND, potentially accelerating approval.
The benefits of having an orphan-designated medication with commercial approval in the EU include up to ten years of protection from market competition from similar medicines with similar active components, and indication for use that are not shown to be clinically superior.
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 disease caused by the SARS-CoV-2 virus.
Cautionary Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) 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. Orphan Medicinal Production Designation, while beneficial, does not assure commercial approval. The statistical analysis of the Erasmus study was based on comparison of the patient group treated with Ampligen to a historical control group of patients with similar characteristics who were previously treated for pancreatic cancer but who did not receive Ampligen. Because these were not concurrent controls, the assignment to treatment with Ampligen was neither randomized nor blinded to the investigators or the patients. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of pancreatic cancer in humans, and no assurance can be given that it will be the case. No assurance can be given as to whether future pancreatic 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. While the company believes that it is adequately funded for current trials over the next two years, no assurance can be given that additional funding will not be required for future studies or the full anticipated IND and CTA processes. Additionally, we recognize that all cancer centers, like all medical facilities, must make the ongoing COVID-19 pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing and future 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.
Contacts:
Crescendo Communications, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com
AIM ImmunoTech Inc
Phone: 800-778-4042
Email: IR@aimimmuno.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b061229e-efb9-4a4d-8387-f105edcc08a2
AIM ImmunoTech Completes and Closes ATM Facility; Current Capital Expected to Meet Needs for Current Clinical Trials
February 05 2021 - 06:50AM
GlobeNewswire Inc.
AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has completed its At-The-Market (ATM) facility and closed the ATM’s Equity Distribution Agreement (EDA). Management believes, based on the company’s current financial condition, that it has adequate funds to meet its anticipated operational cash needs and fund current clinical trials over approximately the next twenty-four months.
“Our robust financial state should allow us to move forward on many important shots on goal, as we advance towards many of our previously stated important inflection points, without the need for a renewed EDA-based ATM facility. While we have an outstanding track record of initiating investigator-sponsored clinical trials based on governmental, non-governmental organization (NGO) or industry grants, we now hope to accelerate AIM-sponsored developmental programs in oncology, COVID, ME/CFS and Long COVID, by independently financing activities where situations demand swift action,” states AIM CEO Thomas K. Equels. “I believe our clear progress to date in oncology, ME/CFS, COVID and Long COVID signals the shape of things to come in 2021. Our team at AIM will work hard to achieve material forward progress to accomplish our clearly stated objectives.”
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 disease caused by the SARS-CoV-2 virus.
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" 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, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company’s anticipated financial and operational needs are based upon assumptions including, but not limited to, positive results from current studies and that such results will not require additional unanticipated changes to such studies or additional studies. Should some or many of these unanticipated events occur, the Company could very well need additional funding. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
Contacts:
Crescendo Communications, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com
AIM ImmunoTech Inc
Phone: 800-778-4042
Email: IR@aimimmuno.com
* * $AIM Video Chart 02-04-2021 * *
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Yes, Ampligen was not chosen. THey went another direction, regrettably.
Did any news ever come out of Japan on that COVID trial?
$aim $2.01 ^ 0.02 (1.01%)
Volume: 1,491,391 @01/29/21 8:00:00 PM EST
AIM ImmunoTech Enters into Agreement for Proposed Intranasal Safety Study of Ampligen
January 29 2021 - 06:55AM
GlobeNewswire Inc.
AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR) for the proposed AMP-COV-100 (CHDR2049) clinical study on the safety of AIM’s drug Ampligen as an intranasal therapy, a critical step in the company’s ongoing efforts to develop Ampligen as a COVID-19 treatment.
CHDR, an independent institute located in Leiden in the Netherlands, will conduct and manage the proposed clinical study, titled “A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects.”
Current study plans call for the enrollment of eight healthy subjects in each of four Ampligen treatment groups and one placebo group, for a total of 40 healthy subjects. They will receive intranasal dosing every other day for 13 days, for a total of seven doses each.
AIM is funding the clinical study. The company is working to finalize the study protocol and will announce new information as it becomes available.
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 disease caused by the SARS-CoV-2 virus.
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" 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, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company cannot assure that the CHDR study will be successful or yield favorable data and 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. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
Contacts:
Crescendo Communications, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com
AIM ImmunoTech Inc
Phone: 800-778-4042
Email: IR@aimimmuno.com
$aim $1.93 ? 0.0 (0.00%)
Volume: 1,842,486 @01/06/21 7:57:44 PM EST
AIM ImmunoTech Announces First COVID-19-Induced Chronic Fatigue “Long Hauler” Patient Dosed with Ampligen
January 06 2021 - 06:45AM
GlobeNewswire Inc.
AIM ImmunoTech Inc. (NYSE American: AIM) today announced that the active AMP-511 Expanded Access Program (EAP) has dosed its first COVID-19 “Long Hauler” patient with the drug Ampligen (rintatolimod), marking a significant milestone in AIM’s efforts to develop an effective therapeutic for people suffering from post-COVID-19 infection chronic fatigue-like symptoms. Additional patients are in the process of being enrolled. The Company also reported it will host an investor conference call on January 12, 2020 at 11AM ET to discuss the AMP-511 trial, believed to be the first clinical trial to treat a patient with COVID-19-induced chronic fatigue-like symptoms, as well as to provide an overall status update on the Company.
The Ampligen EAP protocol is authorized at any one time to enroll up to 100 active Chronic Fatigue Syndrome trial participants, 20 of whom may be Long Haulers. All study subjects will receive the same Ampligen treatments. The EAP is being conducted by investigators Charles Lapp, MD, at Hunter-Hopkins Center in Charlotte, N.C., and Daniel Peterson, MD, at Sierra Internal Medicine in Incline Village, Nevada.
“AIM is committed to helping the untold number of people who are already dealing with the long-term effects of COVID-19 infection,” said AIM CEO Thomas K. Equels. “The development of an effective therapy for COVID-19-induced chronic fatigue is a critical unmet public health need. SARS-CoV-2 infection-induced chronic fatigue may affect millions in the aftermath of the pandemic. Although AMP-511 is not a controlled trial, patients in this AIM-sponsored study are monitored closely and it may be possible to report important observations as early as May.”
“Hunter-Hopkins Center is excited to have started Ampligen therapy for the first time on a Long Hauler with CFS-like symptoms,” said Dr. Lapp. “This is a historic moment. We believe that Long Haulers experience a post-viral fatigue syndrome similar to many persons with Chronic Fatigue Syndrome, and starting treatment early and aggressively should enhance the potential to improve their symptoms and outcomes.”
AIM announced late last year that the Ampligen-involved myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) EAP would be expanded to include patients previously diagnosed with SARS-CoV-2 – which causes the disease COVID-19 – and whose persistence of symptoms has led to the group being dubbed “Long Haulers.” Studies show that patients who recover from COVID-19 can report the persistence of symptoms (See: JAMA Network). In addition, many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report classic chronic fatigue-like symptoms after recovering from the acute illness. In fact, approximately 27% of survivors in a JAMA Internal Medicine study met the U.S. Centers for Disease Control and Prevention’s criteria for chronic fatigue syndrome. Early treatment may be a key to successful therapy (See: PLOS ONE).
View a recent U.S. National Institutes of Health workshop on Post-Acute Sequelae of COVID-19.
“Ampligen is approved in Argentina as the world’s first therapy for severe Chronic Fatigue Syndrome and is the only late-stage drug in the U.S. development pipeline for ME/CFS,” said Equels. “We are highly encouraged by the prospects for Ampligen as a potential therapeutic for this devastating illness, and believe that the AMP-511 clinical trial will help validate Ampligen’s potential role in combatting COVID-19-induced chronic fatigue.”
For more information, see discussion of AIM in The Wall Street Journal, “Long-Haul COVID Patients Put Hope in Experimental Drugs.”
Conference Call
AIM CEO Thomas K. Equels will host a conference call at 11:00 AM Eastern Time Tuesday, January 12, 2020. The conference call will be available on the Company’s website at https://aimimmuno.com/events-presentations/, or via telephone by dialing toll free 877-407-8031 for U.S. callers, or +1 201-689-8031 for international callers.
For those unable to participate at that time, a replay of the call will be archived on the Company’s website or can be accessed by dialing 877-481-4010 for U.S. callers, or +1 919-882-2331 for international callers and entering the pass code 39447. The replay will be available for 90 days.
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 disease caused by the SARS-CoV-2 virus.
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” 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, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. For example, no assurance can be given that the Ampligen (rintatolimod) EAP protocol described above will yield positive results and additional testing and trials will be required. 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. There is the potential for delays in clinical trial enrollment and reporting 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. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
Contacts:
Crescendo Communications, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com
AIM ImmunoTech Inc
Phone: 800-778-4042
Email: IR@aimimmuno.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e293adfc-822c-47d9-a917-9b6b233789d4
* * $AIM Video Chart 12-21-2020 * *
Link to Video - click here to watch the technical chart video
Screaming for the top eh?
$AIM is screaming for the top in the market this morning after announcing that it has received Orphan Drug Designation. https://cnafinance.com/aim-stock-aim-immunotech-climbs-on-orphan-drug-designation/
$aim $1.78 v -0.02 (-1.11%)
Volume: 541,298 @12/11/20 8:00:00 PM EST
AIM ImmunoTech Inc (AIM)
1.895 ? -0.085 (-4.29%)
Volume: 1,044,988 @12/07/20 1:56:43 PM EST
Bid Ask Day's Range
- - 1.86 - 2.01
AIM Detailed Quote
Good news must be coming soon!
Big money is loading this stock and holding. Next big support is 2.28 if broken we see $4 and higher... news has to be good from the results of combo therapy and covid-19 trial!
$aim $1.96 v -0.05 (-2.49%)
Volume: 604,847 @11/17/20 8:00:00 PM EST
Bid Ask Day's Range
- - 1.92 - 2.0
This is a very old company and the FDA has had a vendetta against Ampligen under the tenure of Dr. Carter. He was forced out maybe 5 years ago, but the FDA came back and wanted another trial, which would be great if we could pay for it. Since then there has been huge interest in using Ampligen to enhance immunotherapy cancer treatments, we’re even partnered with a company that’s paying for the trial. There was a lot of hype around a treatment for corona that allowed us to raise some money. But in a nutshell, this is still risky and under the radar of many institutions, plus chronic fatigue syndrome itself is still somewhat of a controversial diagnosis and a small population. But I’ve been here for 6 years and I know someone who has worked on the trials since the early 90’s (yes Ampligen has been trying to get approval for that long) and I believe in the drug.
$aim $1.92 v -0.12 (-5.88%)
Volume: 1,473,985 @11/09/20 5:59:12 PM EST
I am in very early stages of taking a look here, does anyone have the short answer as to why the institutional investment is so low here? When I came across this I imagined a huge institutional base. What am I missing?
$aim $2.14 ^ 0.06 (2.88%)
Volume: 684,198 @10/23/20 8:00:00 PM EDT
AIM ImmunoTech Inc (AIM)
2.14 ? 0.06 (2.88%)
Volume: 684,198 @10/23/20 8:00:00 PM EDT
Bid Ask Day's Range
- - 2.05 - 2.13
AIM Detailed Quote
$aim $2.21 ^ 0.1 (4.74%)
Volume: 924,452 @10/02/20 8:00:00 PM EDT
$aim $2.14 v -0.06 (-2.73%)
Volume: 846,773 @09/29/20 7:57:43 PM ED
AIM ImmunoTech Inc (AIM)
2.18 ? 0.15 (7.39%)
Volume: 1,507,415 @09/25/20 7:37:14 PM EDT
Bid Ask Day's Range
- - 1.9909 - 2.2
AIM Detailed Quote
LOCK YOUR SHARES TO $8.81 - 9.00 BOOMAGE!!! $$$$
* * $AIM Video Chart 09-22-2020 * *
Link to Video - click here to watch the technical chart video
I have to agree. No position.
Lock your Shares now to 6.50 PT $$$$
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AIM ImmunoTech Inc. is an immuno-pharma company headquartered in Ocala, Florida and focused on the research and development of therapeutics to treat multiple types of cancers,
as well as immune-deficiency disorders. We have established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids
and natural interferon to enhance the natural antiviral defense system of the human body and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.
AIM ImmunoTech’s flagship products include Ampligen® (Rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon N Injection® (Interferon Alfa-N3).
Ampligen® represents an RNA being developed for globally important cancers, viral diseases and disorders of the immune system.
Ampligen® is also being evaluated for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
Alferon N Injection® is approved for a category of STD infection and patients that are intolerant to recombinant interferon in Argentina.
Alferon is the only natural-source, multi-species alpha interferon currently approved for sale in the U.S. for the intralesional treatment of refractory (resistant to other treatment)
or recurring external Condylomata Acuminata/genital warts (GW) in patients 18 years of age or older.
We operate a 30,000 sq. ft. facility in New Brunswick, NJ with the objective of producing Ampligen® and Alferon®.
We are committed to a focused business plan oriented toward finding senior co-development partners with the capital and
expertise needed to commercialize the many potential therapeutic aspects of Ampligen® and our FDA-approved drug Alferon® N.
April 4th, 2019
CEO Roadshow Interviews Hemispherx Thomas K. Equels Hemispherx CEO Thomas K. Equels recently sat down with Mike Elliot of CEO Roadshow to provide an update on everything the company is working at [...]
March 25th, 2019
Introducing You to the First Ampligen Quarterly Update Today we announced significant progress in our Ampligen pancreatic cancer program and our multiple Ampligen plus checkpoint blockade immuno-oncology programs. We also announced the [...]
March 9th, 2020
AIM ImmunoTech Reaches Deal with Japan's National Institute of Infectious Diseases to Test Ampligen as a Potential Treatment for Coronavirus
On March 9 th we announced that Japan’s National Institute of Infectious [...]
https://aimimmuno.com/all-articles/
AIM ImmunoTech Describes Their Approach and Progress with Ampligen to Combat COVID-19 SNNLive caught up with Thomas Equels, CEO AIM ImmunoTech Inc. Watch the full video here. [...]
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 We recently announced [...]
AIM ImmunoTech Announces Further Efforts to Establish Clinical Trials Assessing Ampligen as a Potential Protective and Early-Onset Treatment for the Current COVID-19 Pandemic We recently announced the AIM ImmunoTech team is working [...]
AIM ImmunoTech Reaches Deal with Japan's National Institute of Infectious Diseases to Test Ampligen as a Potential Treatment for Coronavirus On March 9 th we announced that Japan’s National Institute of Infectious [...]
Ampligen® represents an RNA being developed for globally important cancers, viral diseases and disorders of the immune system.
Ampligen® has in the clinic demonstrated the potential for standalone efficacy in a number of solid tumors.
We have also seen success in increasing survival rates and efficacy in the treatment of animal tumors when
Ampligen® is used in combination with checkpoint blockade therapies.
This success in the field of immuno-oncology has guided our focus toward the potential use of Ampligen®
as a combinational therapy for the treatment of a variety of solid tumor types.
There are currently multiple Ampligen® clinical trials — both underway and planned — at major cancer research centers around the country.
Ampligen ® is also being used as a monotherapy to treat pancreatic cancer patients in an Early Access Program (EAP)
approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.
Ampligen® is also being evaluated for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). AIM ImmunoTech
is currently sponsoring an expanded access program (EAP) for ME/CFS patients in the U.S.
In August 2016, we received approval of our NDA from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT)
for commercial sale of Ampligen® in the Argentine Republic for the treatment of severe CFS. With regulatory approval in Argentina,
Ampligen® is the world’s only approved therapeutic for ME/CFS.
We continue to pursue our Ampligen New Drug Application, or NDA, for the treatment of CFS with the Food and Drug Administration, or FDA.
Alferon N Injection® is approved for a category of STD infection and patients that are intolerant to recombinant interferon in Argentina.
Alferon is the only natural-source, multi-species alpha interferon currently approved for sale in the U.S. for the intralesional treatment of refractory
(resistant to other treatment) or recurring external Condylomata Acuminata/genital warts (GW) in patients 18 years of age or older.
Certain types of human papilloma viruses cause GW. AIM ImmunoTech also has approval from ANMAT for the treatment of
refractory patients that failed or were intolerant to treatment with recombinant interferon in Argentina.
We have developed and, with proper funding, will be seeking FDA Pre-Approval Inspection of a high-volume, high-efficiency,
upgraded manufacturing process to allow for the commercial viability of Alferon®.
Pipeline
https://aimimmuno.com/pipeline/
Please direct your inquiries regarding business development and licensing opportunities to: info@AIMImmunoTech.com
2117 SW Highway 484
Ocala, FL 34473
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