CinnoVex (IFN-β-1a biosimilar) / CinnaGen - LARVOL DELTA

Efficacy and safety of peginterferon beta-1a compared to interferon beta-1a in relapsing remitting multiple sclerosis patients: A phase 3, randomized, non-inferiority clinical trial (PEGINTEGRITY). (PubMed, Mult Scler Relat Disord) - P3 | "The results demonstrate the non-inferiority of peginterferon beta-1a to interferon beta-1a with similar efficacy in 96-week ARR in RRMS patients. Both arms were also comparable in other efficacy outcomes and safety profiles with no statistically significant differences. These findings support considering peginterferon beta-1a as a safe and efficient option in patients with RRMS. This study was registered on Iranian Registry of Clinical Trials (IRCT201612306135N8) and clinicaltrials.gov (NCT05242133)."

Head-to-Head • Journal • P3 data • CNS Disorders • Multiple Sclerosis

The effect of interferon in the therapy of severe coronavirus infection. (PubMed, J Educ Health Promot) - "Based on the results of this study, the use of interferon in the treatment of COVID-19 can improve health and reduce the severity of the disease and mortality."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNB1

Effectiveness of different treatment regimens on patients with COVID-19, hospitalized in Sanandaj hospitals: a retrospective cohort study. (PubMed, J Pharm Policy Pract) - "The study results showed the drug regimens 2 and 5 increased the days of hospitalization and hospitalization in ICU, respectively, while the other drug regimens had no significant effect on mortality and use a ventilator in the studied patients and none of the drug regimens had an effect on reducing mortality compared to other ones."

Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease

Efficacy and Safety of Peginterferon Beta-1a (CinnaGen) in Participants With Relapsing Remitting Multiple Sclerosis (clinicaltrials.gov) - P3 | N=168 | Completed | Sponsor: Cinnagen | Active, not recruiting ➔ Completed

Head-to-Head • Trial completion • CNS Disorders • Multiple Sclerosis

Comparative Toxicity of Interferon Beta-1a Impurities of Heavy Metal Ions. (PubMed, Medicina (Kaunas)) - "Materials and ReciGen and Rebif are pharmaceutical interferon beta-1a (IFNβ-1a) contained in preparations that are used for parenteral administration. It was hypothesized that the IFNβ-1a complex binds heavy metals affecting the tertiary protein structure and may lead to some side effects of drug administration. Further testing of IFNβ-1a bioequivalence for parenteral application is necessary."

Journal • IFNB1

Efficacy and Safety of Peginterferon Beta-1a (CinnaGen) in Participants With Relapsing Remitting Multiple Sclerosis (clinicaltrials.gov) - P3 | N=168 | Active, not recruiting | Sponsor: Cinnagen

Head-to-Head • New P3 trial • CNS Disorders • Multiple Sclerosis

Economic burden of multiple sclerosis: a cross-sectional study in Iran. (PubMed, Health Econ Rev) - "Considering the findings of this study and in order to reduce the burden of the disease, the following suggestions are presented: providing necessary facilities for the production of MS drugs in the country; proper and equitable distribution of neurologists; expanding the provision of home care services; and using the technologies related to the Internet, including WhatsApp, to follow up the MS patients' treatment."

HEOR • Journal • Observational data • CNS Disorders • Multiple Sclerosis

An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a in severe COVID-19: The COVIFERON II randomized controlled trial. (PubMed, Int Immunopharmacol) - P2 | "The use of high-dose IFN-β 1a did not improve TTCI in hospitalized patients with moderate to severe COVID-19. Also, it did not have any significant effect on mortality reduction compared with treating with low-dose IFN-β 1a."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNB1

A randomized pharmacokinetic-pharmacodynamic evaluation of the potential biosimilar interferon beta-1a product, CinnoVex®. (PubMed, Expert Opin Biol Ther) - "Background: The objective of the trial was to evaluate the bioequivalence of the interferon beta-1a (IFN beta-1a) biosimilar product candidate CinnoVex® with the reference product Avonex® by comparing the pharmacokinetics/pharmacodynamics (PK/PD), safety and immunogenicity of the two products in healthy subjects. A total of 41 healthy subjects were randomized in a two-stage design to receive single doses of CinnoVex® and Avonex®. Clinical trials registration: EudraCT Number 2016-000139-41."

Clinical • Journal • PK/PD data

The efficacy and safety of Ivermectin in patients with mild and moderate COVID-19: A structured summary of a study protocol for a randomized controlled trial. (PubMed, Trials) - "Use of anticoagulants (e.g., warfarin) and ACE inhibitors (e.g., captopril)...Control groups: The outpatient group will receive hydroxychloroquine sulfate (Amin Pharmaceutical Company, Iran) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for seven subsequent days. The inpatient group will receive 200/50 mg Lopinavir/Ritonavir (Heterd Company, India) twice a day for the seven days, plus five doses of 44 mcg Interferon beta-1a (CinnaGen, Iran) every other day...The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol."

Clinical • Journal • Allergy • Asthma • Human Immunodeficiency Virus • Immunology • Infectious Disease • Nephrology • Novel Coronavirus Disease • Pneumonia • Renal Disease • Respiratory Diseases

Evaluation of the efficacy and safety of favipiravir and interferon compared to lopinavir/ritonavir and interferon in moderately ill patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial. (PubMed, Trials) - "The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol."

Clinical • Journal • Allergy • Chronic Kidney Disease • Fibrosis • Gastroenterology • Hepatitis C Virus • Hepatology • Immunology • Infectious Disease • Novel Coronavirus Disease • Peptic Ulcer • Pneumonia • Renal Disease • Respiratory Diseases

An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a (the base therapeutic regimen) in moderate to severe COVID-19: A structured summary of a study protocol for a randomized controlled l trial. (PubMed, Trials) - P2 | "The intervention group (Arms1) will be treated with lopinavir / ritonavir (Kaletra) + high dose Interferon-β 1a (Recigen) and the control group will be treated with lopinavir / ritonavir (Kaletra) + low dose Interferon-β 1a (Recigen) (the base therapeutic regimen)...The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol."

Clinical • Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Fatigue • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Psychiatry • Substance Abuse

[VIRTUAL] Types of pharmaceutical intervention in patients with Multiple sclerosis (MS): A fine line between immunosuppressive and risk of COVID-19 infection (MSDC 2020) - "The patients were taking these drugs: Synovex (195, 52.5%), Rebif (56, 15.2%), Fingolimod (41, 11%), Avonex (24, 6.4%), ReciGen (27, 7.5%), IFN-β (18, 4.9%), Ocrelizumab (3, 0.8%), and unexposed patients (7, 2%).Results When diagnosing associations with individual infections, exposure to any of DMTs was associated with a lower risk of pneumonia compared with no DMT exposure. Besides, exposure to fingolimod and Ocrelizumab were associated with an increased risk of an upper respiratory infection when compared to no exposure or other drug exposure.Conclusions By analyzing MS DMTs, we thought that IFN-β is associated with a lower risk of pneumonia due to its antiviral effect. Thus, Interferon Beta Drugs can provide a less experienced risk in confronting with COVID-19."

Clinical • Late-breaking abstract • CNS Disorders • Infectious Disease • Multiple Sclerosis • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19: structured summary of a study protocol for a randomized controlled trial. (PubMed, Trials) - P2 | "The first group (Arm 1) will receive Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1a (Recigen), the second group (Arm 2) will be administered Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1b (Ziferon), and the control group (Arm 3) will be treated by Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra). The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol."

Clinical • Journal • Addiction (Opioid and Alcohol) • Atrial Fibrillation • Cardiovascular • CNS Disorders • Fatigue • Infectious Disease • Novel Coronavirus Disease • Pain • Substance Abuse

Understanding tumor biology complexity in the advanced cancer setting: PreciGENE platform predictions correlate with exceptional responses to cancer treatment (AACR 2018) - "The algorithm used by the PreciGENE decision-support platform correctly ranked the treatment response in 70 published cancer patients having received 202 different regimens and presented an exceptional response to at least one therapeutic regimen. In this retrospective study, we show that such systems may empower oncologists in their choice of treatment. Prospective studies of the use of decision-support platforms in advanced cancer are warranted."

Oncology

Pharmacokinetics and Pharmacodynamics of CinnoVex (Interferon Beta-1a) Compared to Avonex (Interferon Beta-1a) (clinicaltrials.gov) - P1; N=40; Completed; Sponsor: Cinnagen; Recruiting ➔ Completed

Clinical • Trial completion • IL10 • IL4