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

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-

Drug Highest PhaseApproved

First Approval Date

CU (01 Dec 2000),

Virus Diseases

Regulation-

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Gene 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 Date20 Nov 2024

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

[+1]

NCT04379518 / SuspendedPhase 1/2IIT

Phase 1/2A Study of Rintatolimod and IFN Alpha Regimen in Cancer Patients With COVID-19

This phase I/IIa trial studies the best dose and side effects of rintatolimod and interferon (IFN) alpha-2b in treating cancer patients with COVID-19 infection. Interferon alpha is a protein important for defense against viruses. It activates immune responses that help to clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to mimic viral infection by stimulating immune pathways that are normally activated during viral infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to limit the replication and spread of the virus.

Start Date17 Nov 2020

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

[+1]

NCT04081389 / CompletedPhase 1IIT

Phase I Clinical Trial Assessing the Combination of Chemokine Modulation With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

This phase I trial studies how well chemokine modulation therapy and standard chemotherapy given before surgery work in treating patients with early stage triple negative breast cancer. Chemokine modulation therapy, including celecoxib, recombinant interferon alfa-2b, and rintatolimod, may stimulate the immune system and stop tumor cells from growing. Drugs used in standard chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemokine modulation therapy together with standard chemotherapy may work better than giving either therapy alone in treating patients with triple negative breast cancer.

Start Date06 Dec 2019

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

[+1]

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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4

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

01 Dec 2020·Journal of Interferon & Cytokine Research

Therapeutic Effectiveness of Interferon Alpha 2b Treatment for COVID-19 Patient Recovery

Article

Author: González, Daniel ; Pereda, Ricardo ; Betancourt, Julio Roberto ; Rivero, Hubert Blas ; Domínguez, Rodolfo Emilio ; Nodarse, Hugo ; Mezquia, Natacha ; Lopez, Lissette Del Rosario ; Venegas, Rafael ; Rivero, Juan Carlos ; Pérez, Albadio

A previous report on 814 patients who were coronavirus disease 2019 (COVID-19) positive provided preliminary therapeutic efficacy evidence with interferon-α2b (IFN-α2b) in Cuba, from March 11 to April 14, 2020. This study re-evaluates the effectiveness of IFN-α2b during the period from March 11 to June 17, 2020. Patients received a combination of oral antivirals (lopinavir/ritonavir and chloroquine) with intramuscular or subcutaneous administration of IFN-α2b. The primary endpoint was the proportion of patients discharged from the hospital; the secondary endpoint was the case fatality rate, and several outcomes related to time variables were also evaluated. From March 11 to June 17, 2,295 patients had been confirmed to be severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive in Cuba, 2,165 were treated with Heberon^® Alpha R, and 130 received the approved protocol without IFN. The proportion of fully recovered patients was higher in the IFN-treated compared with the non-IFN-treated group. Prior IFN treatment decreases the likelihood of intensive care and increases the survival after severe or critical diseases. Benefits of IFN were significantly supported by time variables analyzed. This second report confirmed our preliminary evidence about the therapeutic effectiveness of IFN-α2b in SARS-CoV-2 infection and postulated Heberon Alpha R as the main component within antiviral drugs used in the Cuban protocol COVID-19.

01 Sep 2020·Journal of Interferon & Cytokine ResearchQ4 · MEDICINE

Therapeutic Effectiveness of Interferon-α2b Against COVID-19: The Cuban Experience

Q4 · MEDICINE

Article

Author: González, Daniel ; López, Lissette Del Rosario ; Pereda, Ricardo ; Betancourt, Julio Roberto ; Rivero, Hubert Blas ; Domínguez, Rodolfo Emilio ; Mezquia, Natacha ; Venegas, Rafael ; Rivero, Juan Carlos ; Pérez, Albadio

A prospective observational study was conducted for assessing the therapeutic efficacy of interferon (IFN)-α2b in patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the first month after the coronavirus disease 2019 (COVID-19) outbreak began in Cuba. From March 11th to April 14th, 814 patients were confirmed SARS-CoV-2 positive in Cuba. Seven hundred sixty-one (93.4%) were treated with a combination of oral antivirals (lopinavir/ritonavir and chloroquine) with intramuscular administration of IFN-α2b (Heberon^® Alpha R, Center for Genetic Engineering and Biotechnology, Havana, Cuba), 3 times per week, for 2 weeks. Fifty-three patients received the approved COVID protocol without IFN treatment. The proportion of patients discharged from hospital (without clinical and radiological symptoms and nondetectable virus by real-time polymerase chain reaction) was higher in the IFN-treated compared with the non-IFN treated group (95.4% vs. 26.1%, P < 0.01). The case fatality rate (CFR) for all patients was 2.95%, and for those patients who received IFN-α2b the CFR was reduced to 0.92. Intensive care was required for 82 patients (10.1%), 42 (5.5%) had been treated with IFN. This report provides preliminary evidence for the therapeutic effectiveness of IFN-α2b for COVID-19 and suggests that the use of Heberon Alpha R may contribute to complete recovery of patients.

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.

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
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Virus Diseases	CU	-	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	bvlnxbhosw(ifkhayavkm) = gmfzapdopz gosangvnsh (ljlqiuywlz, clkzkffssx - fhtauphweq) View more	-	02 Mar 2022
NCT01460875 (CTgov)	Not Applicable	Melanoma, Cutaneous Malignant \| stage IIB melanoma	34	laboratory biomarker analysis+Intron A+Heberon Alfa	bxxiqajwts(goeuyqrkbo) = opejjioxte zjncsqxcyb (kbpzuhanxe, tgwhhebixx - qdaubofqzf) View more	-	02 Nov 2018
NCT00126594 (CTgov)	Phase 2	Metastatic Renal Cell Carcinoma	80	Laboratory Biomarker Analysis+Sorafenib Tosylate (Sorafenib Tosylate)	vijztpvvtc(juolhpdatd) = hpxcvncsvo dleldryzyz (bjqgvxhgnl, pbubntlxzk - oyvwpdgplr) 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)	vijztpvvtc(juolhpdatd) = xhqmbudexc dleldryzyz (bjqgvxhgnl, tkslvgeglh - ftkghvfjjt) View more	-	16 Sep 2016