Rintatolimod

AIM ImmunoTech Inc.’s Drug Ampligen Awarded FDA’s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer

Retrieved on: 
星期一, 十二月 21, 2020
Medical specialties, Clinical medicine, Medicine, Cancer, Rintatolimod, Pancreatic cancer, Pancreatic Cancer Action

Pancreatic cancer is the fourth leading cause of cancer deaths in the United States and the only cancer, among those most commonly diagnosed, with a five-year survival rate at just six percent, according to the Pancreatic Cancer Action Network.

Key Points: 
  • Pancreatic cancer is the fourth leading cause of cancer deaths in the United States and the only cancer, among those most commonly diagnosed, with a five-year survival rate at just six percent, according to the Pancreatic Cancer Action Network.
  • AIM recently announced receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program conducted at Erasmus University Medical Centerin the Netherlands.
  • Because these were not concurrent controls, the assignment to treatment with Ampligen was neither randomized nor blinded to the investigators or the patients.
  • There is no assurance that the European Medicines Agency will grant an orphan drug designation.

AIM ImmunoTech Inc.’s Drug Ampligen Awarded FDA’s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer

Retrieved on: 
星期一, 十二月 21, 2020
Medical specialties, Clinical medicine, Medicine, Cancer, Rintatolimod, Pancreatic cancer, Pancreatic Cancer Action

Pancreatic cancer is the fourth leading cause of cancer deaths in the United States and the only cancer, among those most commonly diagnosed, with a five-year survival rate at just six percent, according to the Pancreatic Cancer Action Network.

Key Points: 
  • Pancreatic cancer is the fourth leading cause of cancer deaths in the United States and the only cancer, among those most commonly diagnosed, with a five-year survival rate at just six percent, according to the Pancreatic Cancer Action Network.
  • AIM recently announced receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program conducted at Erasmus University Medical Centerin the Netherlands.
  • Because these were not concurrent controls, the assignment to treatment with Ampligen was neither randomized nor blinded to the investigators or the patients.
  • There is no assurance that the European Medicines Agency will grant an orphan drug designation.

AIM Announces Milestone in COVID-19 Treatment and Prevention Efforts with First Patient Dosed in Study Evaluating Ampligen as Part of Combination Treatment for Patients with Cancer and COVID-19

Retrieved on: 
星期三, 十一月 25, 2020
Antivirals, Medical specialties, Health, Rintatolimod, Roswell Park Comprehensive Cancer Center, Interferon, Roswell, Clinical trial, Coronavirus disease

First, AIM reports that Roswell Park Comprehensive Cancer Centers Phase 1/2a study evaluating the two-drug combination of AIMs Ampligen and interferon alpha-2b as a potential early-onset treatment for patients with cancer and mild-to-moderate COVID-19 is fully underway, with the first patient enrolled and treated on the study.

Key Points: 
  • First, AIM reports that Roswell Park Comprehensive Cancer Centers Phase 1/2a study evaluating the two-drug combination of AIMs Ampligen and interferon alpha-2b as a potential early-onset treatment for patients with cancer and mild-to-moderate COVID-19 is fully underway, with the first patient enrolled and treated on the study.
  • AIM is a collaborator on that clinical trial, which is funded in part through grants from the National Cancer Institute and AIM, as well as institutional support from Roswell Park.
  • AIM is providing Ampligen at no charge for this study.
  • Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights.

AIM ImmunoTech Announces PLOS ONE’s Publication of New Data Analyses Showing Importance of Disease Duration on Ampligen’s Positive Role in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Retrieved on: 
星期一, 十一月 2, 2020
Medical specialties, Clinical medicine, Medicine, AIM ImmunoTech, Rintatolimod, Chronic fatigue syndrome, Fatigue, Daniel Peterson

The data were published in PLOS ONE , a peer-reviewed open access scientific journal published by the Public Library of Science.

Key Points: 
  • The data were published in PLOS ONE , a peer-reviewed open access scientific journal published by the Public Library of Science.
  • AIM researchers found that the TLR3 agonist Ampligen substantially improved physical performance in a subset of ME/CFS patients.
  • The ME/CFS population of 208 subjects was divided into two subsets based on symptom duration.
  • AIM filed a provisional patent application for the use of Ampligen for COVID-19-induced chronic fatigue in June of 2020 (See: AIM ImmunoTech PR June 11, 2020 ).

AIM ImmunoTech Announces IRB Approval to Enroll COVID-19 ‘Long Haulers’ in the AMP-511 ME/CFS Clinical Trial of Ampligen

Retrieved on: 
星期二, 十月 6, 2020
Medical specialties, Rintatolimod, Immunology, Medicine, Chronic fatigue syndrome, Coronavirus disease, Food and Drug Administration, AIM ImmunoTech, Daniel Peterson

Patients in the trial are treated with AIMs flagship pipeline drug Ampligen.

Key Points: 
  • Patients in the trial are treated with AIMs flagship pipeline drug Ampligen.
  • Up to 20 of the 100 active participants can be Long Haulers, according to the new trial protocol amendment.
  • AIM is currently preparing the IRB-approved protocol for submission to the U.S. Food and Drug Administration (FDA).
  • In June, AIM filed a provisional utility patent application for Ampligen as a potential therapy for COVID-19-induced ME/CFS-like illness (See: https://aimimmuno.irpass.com/AIM-ImmunoTech-Files-Provisional-Patent-App... ).

DGAP-News: AIM ImmunoTech Receives Statistically Significant Positive Survival Results in Pancreatic Cancer from Erasmus University Medical Center, Rotterdam, Netherlands

Retrieved on: 
星期二, 九月 22, 2020
RTT, Clinical medicine, Medical specialties, Health, AIM ImmunoTech, Pancreatic cancer, Rintatolimod, Cancer

AIM ImmunoTech Receives Statistically Significant Positive Survival Results in Pancreatic Cancer from Erasmus University Medical Center, Rotterdam, Netherlands

Key Points: 
  • AIM ImmunoTech Receives Statistically Significant Positive Survival Results in Pancreatic Cancer from Erasmus University Medical Center, Rotterdam, Netherlands
    The issuer is solely responsible for the content of this announcement.
  • Median survival approximately two-fold higher in Ampligen arm compared to historical controls; AIM to seek FDA Fast Track designation and orphan drug status in late stage pancreatic cancer
    OCALA, FL / ACCESSWIRE / September 22, 2020 / AIM ImmunoTech Inc. (NYSE American:AIM) today announced receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program (EAP) conducted at Erasmus University Medical Centerin the Netherlands.
  • Prof. Casper van Eijck, MD Ph.D., and his team at Erasmus MC found a statistically significantly positive survival benefit when using Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy.
  • Median survival was approximately two-fold higher, that is 200%, in the Ampligen arm as compared to the historical controls.

Heron Therapeutics Receives Complete Response Letter for HTX-011 for the Management of Postoperative Pain

Retrieved on: 
星期一, 六月 29, 2020
Health, United States Public Health Service, Food and Drug Administration, Articles, Pharmaceutical industry, Life sciences, Rintatolimod

Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues or CMC issues.

Key Points: 
  • Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues or CMC issues.
  • There are four non-clinical issues in the CRL, none of which relate to any observed toxicity.
  • A Complete Response Letter (CRL) was received from the FDA regarding the NDA for HTX-011 on June 26, 2020 relating to nonclinical information.
  • Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer.

AIM ImmunoTech Files Three Provisional Patent Applications Surrounding Ampligen® for Use Against the SARS-like Wuhan 2019 Novel Coronavirus

Retrieved on: 
星期二, 二月 11, 2020
Viruses, Coronaviridae, Zoonoses, Animal virology, Rintatolimod, Severe acute respiratory syndrome-related coronavirus, Coronavirus, Severe acute respiratory syndrome

The SARS virus is very similar in key RNA sequences to the Wuhan coronavirus, and the company expects Ampligen to be similarly effective with the Wuhan coronavirus.

Key Points: 
  • The SARS virus is very similar in key RNA sequences to the Wuhan coronavirus, and the company expects Ampligen to be similarly effective with the Wuhan coronavirus.
  • AIM believes that Ampligen has the potential to be both an early-onset treatment for and prophylaxis against the Wuhan coronavirus, which originated in China before quickly spreading to other countries.
  • The companys three provisional patent applications include: 1) Ampligen as a therapy for the Wuhan coronavirus; 2) Ampligen as part of a proposed intranasal universal coronavirus vaccine that combines Ampligen with inactivated Wuhan coronavirus, conveying immunity and cross-protection and; 3) a high-volume manufacturing process for Ampligen.
  • Under the Patent Cooperation Treaty of 1970, which provides international protections for patents, the three provisional patent applications can convert to international patent applications based on the date of their filings.

Hemispherx Biopharma, Inc. Changes Name to AIM ImmunoTech Inc. Reflecting Ampligen’s® Immuno Modulation Progress in Ongoing Oncology Clinical Trials and ME/CFS

Retrieved on: 
星期五, 八月 23, 2019
Health, Medicine, Medical specialties, Rintatolimod, Hemispherx Biopharma, Melanoma, Renal cell carcinoma, Clinical trial

Amplified Immunological Modulation or AIM is what our company is all about.

Key Points: 
  • Amplified Immunological Modulation or AIM is what our company is all about.
  • Based on results of published, peer-reviewed pre-clinical studies and clinical trials, Hemispherx believes that Ampligen may have broad-spectrum anti-viral and anti-cancer properties.
  • Clinical trials of Ampligen already conducted include studies of the potential treatment of cancer patients with renal cell carcinoma and malignant melanoma.
  • Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful data.

Hemispherx Issues 2019 Second Quarter Report Citing Strong Steady Progress in Cancer Clinical Trials

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星期四, 八月 15, 2019
Cancer treatments, Clinical medicine, Medicine, Antineoplastic drugs, Breakthrough therapy, Merck, Pembrolizumab, Ovarian cancer, Rintatolimod, Cancer treatments, Clinical medicine, Medicine, Antineoplastic drugs, Breakthrough therapy, Merck, Pembrolizumab, Ovarian cancer, Rintatolimod, Cancer treatments, Clinical medicine, Medicine, Antineoplastic drugs, Breakthrough therapy, Merck, Pembrolizumab, Ovarian cancer, Rintatolimod

"Especially significant are the larger clinical trials, such as our Phase 2 recurrent ovarian cancer trial combining Ampligen and pembrolizumab .

Key Points: 
  • "Especially significant are the larger clinical trials, such as our Phase 2 recurrent ovarian cancer trial combining Ampligen and pembrolizumab .
  • Research and development manufacturing-related expenses for the second quarter of 2019 were $1,096,000, compared with $1,341,000 million for the second quarter of 2018.
  • General and administrative expenses for the second quarter of 2019 were $1,942,000, compared with $1,733,000 for the second quarter of 2018.
  • Advanced Recurrent Ovarian Cancer A Phase 1/2 clinical trial of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer.