Delving into the Latest Updates on Interferon alfa-2b biosimilar(Center For Genetic Engineering And Biotechnology) with Synapse

Overview

Basic Info

Drug Type

Interferons, Biosimilar

Synonyms

Heberon Alfa R, Inrec

Target

IFNAR

Action

agonists, stimulants, inducers

Mechanism

IFNAR agonists(Interferon alpha/beta receptor agonists), Immunostimulants, Innate antiviral immune response inducers

Therapeutic Areas

Infectious Diseases

Active Indication

Virus Diseases

Inactive Indication-

Originator Organization

Centro de Ingenieria Genetica y Biotecnologia

Active Organization

Heber Biotec SA

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Cuba (01 Dec 2000),

Virus Diseases

Regulation-

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Structure/Sequence

Sequence Code 26333714

The sequence is quoted from: *****

This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains white blood cells (dendritic cells or DCs) that stimulates the immune system. Interferon alpha-2 can improve the body's natural response to infections and other diseases. It can also interfere with the division of cancer cells and slow tumor growth. Rintalolimid may stimulate the immune system. Celecoxib is a drug that reduces pain. This study is being done to find out if the combination of the study cell-based treatment (aDC1 dendritic cells) and interferon alpha-2, rintatolimod, and celecoxib can prevent the growth and/or progression of melanoma.

Start Date13 Nov 2024

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

[+1]

RPCEC00000412

/ SuspendedPhase 2/3

Evaluation of intranasal recombinant human interferon alfa-2b in the treatment of acute respiratory viral infections with mild clinical classification. Dose study. NASIRA studio. Phase II-III trial - IFNARI

Start Date01 Feb 2023

Sponsor / Collaborator

Centro de Ingenieria Genetica y Biotecnologia

RPCEC00000407

/ SuspendedPhase 2/3

Evaluation of intranasal recombinant human interferon alfa-2b in the treatment of acute respiratory viral infections with mild clinical classification. Dose and frequency study. INDIRA study. Phase II-III trial - NASALFERON-ARI

Start Date01 Sep 2022

Sponsor / Collaborator

Centro de Ingenieria Genetica y Biotecnologia

100 Clinical Results associated with Interferon alfa-2b biosimilar(Center For Genetic Engineering And Biotechnology)

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100 Translational Medicine associated with Interferon alfa-2b biosimilar(Center For Genetic Engineering And Biotechnology)

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100 Patents (Medical) associated with Interferon alfa-2b biosimilar(Center For Genetic Engineering And Biotechnology)

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2

Literatures (Medical) associated with Interferon alfa-2b biosimilar(Center For Genetic Engineering And Biotechnology)

01 Jan 2004·Drugs in R & DQ4 · MEDICINE

Bioequivalence of Two Recombinant Interferon ??-2b Liquid Formulations in Healthy Male Volunteers

Q4 · MEDICINE

ArticleOA

Author: Armando Correa-Fernandez ; Jorge Ducongé ; Idrian Garcia-Garcia ; Lourdes Olivera-Ruano ; Francisco Hernandez-Bernal ; Carmen Valenzuela-Silva ; Majel Cervantes-Llano ; Joel Ferrero-Bibilonia ; Carlos Alberto Gonzalez-Delgado ; Pedro Lopez-Saura ; Ramon Soto-Hernandez

OBJECTIVEInterferon (IFN) alpha-2b is a protein with antiviral, antiproliferative and immunoregulatory properties that is approved for several clinical indications. A new liquid, albumin-free, IFNalpha-2b formulation has recently been developed. This study aimed to evaluate the equivalence of the pharmacokinetic, pharmacodynamic and safety properties of the new formulation with a reference one in healthy male volunteers.METHODSA randomised, crossover, double-blind study with a 3-week washout period was performed in which Heberon Alfa R (formulation A) and Viraferon (formulation B) were compared. A single 20 x 10(6) IU IFNalpha-2b dose was administered subcutaneously to 14 apparently healthy male subjects. Serum IFN level was measured over 48 hours by enzyme immunoassay (EIA) and by antiviral activity titration. Clinical and laboratory variables were determined, as were pharmacodynamic and safety criteria.RESULTSGroups were homogeneous with regard to all demographic and baseline variables. Pharmacokinetic comparison by EIA did not show differences between the formulations: area under the curve (AUC) 2572 versus 2561 ng x h/L, maximum plasma concentration (Cmax) 318 versus 354 ng/L, time to Cmax (tmax) 8.2 versus 8.5 h, elimination half-life (t(1/2)) 5.87 versus 6.08 h, terminal elimination rate (lambda) 0.122 versus 0.118 h(-1), and mean residence time (MRT) 10.9 versus 12.0 h for formulations A and B, respectively. The differences never reached 20%, which is the clinically significant threshold. The 90% confidence interval of the ratio between them was in all cases within the 0.8, 1.25 range. The two formulations were clinically equivalent with regard to serum IFN antiviral activity titration (0.8, 1.25 criterion) regarding their pharmacokinetic parameters. There were no significant differences with respect to the pharmacodynamic variables: serum beta2-microglobulin and temperature increase. Heart rate and blood pressure changes did not differ either. Both products provoked similar haematological count decreases and had similar safety profiles. The most frequent adverse reactions were fever, tachycardia, headache and arthralgias.CONCLUSIONThe overall analysis strongly suggests the bioequivalence of these two products.

G.E.N

[Long term study of the treatment with recombinant alfa 2b interferon in chronic active hepatitis due to B virus in children and adolescents].

Article

Author: Borbolla Bousquets, E ; García Bacallao, E ; Escobar Capote, M D ; Castañeda Guillot, C

To assess the efficacy of recombinant alfa 2b-interferon treatment "Heberon alfa R" in children with chronic active hepatitis (CAH) B virus, we conducted a long-term study (three years) in 22 children infected with hepatitis B virus (17 males and 5 females), age range 3 to 15 years. Diagnostic criteria included the clinical picture, laboratory tests, virus markers (HBeAg, HBsAg), laparoscopy and liver biopsy. Children under 12 years received 3 million IU of interferon per day whereas those older than 12 years received 6 million IU of interferon per day by intramuscular injection, three times per week for four months. Alanine aminotransferase (ALT) levels had been elevated for six months in all patients and hepatitis B viral infection was replicative. A variance analysis was made to evaluate ALT response to interferon administration and the Mc Nemar test was used to analyze HBeAg/anti-HBe behavior. Seventeen (77%) out of 22 patients responded to treatment (clearance of HBeAg and ALT levels returned to normal. HBeAg seroconversion (anti-HBe) occurred in 36% of patients during the first year (p < 0.01) and it increased to 50% by the third year follow-up. ALAT levels also decreased and the difference was statistically significant (p < 0.01). This occurred during and after treatment with a steady and increasing tendency to return to normal levels within the first and third year. Side effects were scarce, transient and tolerable and they only appeared during the initial phase of treatment; symptoms were mainly influenza-like and they disappeared very soon. There were no late side effects such as medullar depression, renal toxicity and glycemia alterations.(ABSTRACT TRUNCATED AT 250 WORDS)

100 Deals associated with Interferon alfa-2b biosimilar(Center For Genetic Engineering And Biotechnology)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L03AB05	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Virus Diseases	Cuba	-	01 Dec 2000

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03403634 (CTgov)	Phase 2	Liver metastases \| Colorectal cancer recurrent \| Colorectal Cancer	19	Laboratory Biomarker Analysis+Intron A+Heberon Alfa+Urifron+Rintatolimod+Celecoxib	vnavrafsap(arixlxwdyj) = yfkvrprpmt ilauvhjmri (fwglkaxmpz, wyckeyxemr - mxwezylpeh) View more	-	02 Mar 2022
NCT01460875 (CTgov)	Not Applicable	Melanoma, Cutaneous Malignant	34	laboratory biomarker analysis+Intron A+Heberon Alfa	sxbqxdgivb(ggdiziwjjf) = hwpabozyox pznbwmbtmi (blhpbseeli, hstimurnnb - rpxtokakcr) View more	-	02 Nov 2018
NCT00126594 (CTgov)	Phase 2	Metastatic Renal Cell Carcinoma	80	Laboratory Biomarker Analysis+Sorafenib Tosylate (Sorafenib Tosylate)	xxuuadcatq(kyranztuwa) = nzqzqrhpph bowsnymlhq (kqcjmijfnu, miyfftznkj - kiftuxldds) View more	-	16 Sep 2016
NCT00126594 (CTgov)	Phase 2	Metastatic Renal Cell Carcinoma	80	Laboratory Biomarker Analysis+Sch 30500+Heberon Alfa+Urifron+Sorafenib Tosylate (Sorafenib Tosylate, Recombinant Interferon Alfa-2b)	xxuuadcatq(kyranztuwa) = hogdoarqgs bowsnymlhq (kqcjmijfnu, nawkwzxeuu - feibrexrhx) View more	-	16 Sep 2016

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Interferon alfa-2b biosimilar(Center For Genetic Engineering And Biotechnology)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation