Delving into the Latest Updates on Cepeginterferon alfa-2b with Synapse

Overview

Basic Info

Drug Type

Interferons

Synonyms

Algeron, CEPEG-IFN, Cepeginterferon Alfa 2 B

+ [2]

Target

IFNAR

Mechanism

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

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis C

Inactive Indication

Hepatitis C, ChronicHIV Infections

Originator Organization

Biocad Medical, Inc.

Active Organization

Biocad Medical, Inc.

Inactive Organization

Biocad CJSC

Drug Highest PhaseApproved

First Approval Date

RU (01 Dec 2013),

Hepatitis C

Regulation-

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Gene Sequence

Sequence Code 26333714

Source: *****

Multicenter Open-label Randomized, Comparative Clinical Study to Evaluate Efficacy and Safety of Algeron (Cepeginterferon Alfa-2b, CJSC "BIOCAD", Russia) With Ribavirin Compared to PegIntron (Peginterferon Alfa-2b, Schering-Plough Labo N.V., Belgium) With Ribavirin in Treatment of Chronic Hepatitis C in Human Immunodeficiency Virus-1 Infected Patients

The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to PegIntron in combination with ribavirin in treatment of chronic hepatitis C in Human Immunodeficiency Virus-1 infected patients

Start Date06 Jun 2013

Sponsor / Collaborator

Biocad CJSC

NCT01740089 / CompletedPhase 2/3

Multicenter Open-label Randomized Prospective Clinical Study of Efficacy and Safety of Algeron (Cepeginterferon Alfa-2b) in Comparison With PegIntron (Peginterferon Alfa-2b) in the Combined Treatment of Chronic Hepatitis C

The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0 μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron.

Start Date01 Nov 2011

Sponsor / Collaborator

Biocad CJSC

100 Clinical Results associated with Cepeginterferon alfa-2b

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100 Translational Medicine associated with Cepeginterferon alfa-2b

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100 Patents (Medical) associated with Cepeginterferon alfa-2b

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35

Literatures (Medical) associated with Cepeginterferon alfa-2b

01 Jan 2022·Urologic Oncology: Seminars and Original InvestigationsQ3 · MEDICINE

Intravesical sequential gemcitabine and docetaxel versus bacillus calmette-guerin (BCG) plus interferon in patients with recurrent non-muscle invasive bladder cancer following a single induction course of BCG

Q3 · MEDICINE

Article

Author: Brooks, Nathan ; Thomas, Lewis J ; Packiam, Vignesh T ; Kates, Max ; Kamat, Ashish M ; Nepple, Kenneth G ; O'Donnell, Michael A ; Vitale, Andrew ; Bivalacqua, Trinity J ; Wang, Jonathan ; DeWolf, William C ; Crump, Trafford ; Hyndman, M Eric ; Mott, Sarah L ; Steinberg, Ryan L ; Lamm, Donald L

INTRODUCTIONRepeat BCG induction remains an option for select non-muscle invasive bladder cancer (NMIBC) patients who fail initial therapy. Alternative salvage intravesical regimens such as Gemcitabine and Docetaxel (Gem/Doce) have been investigated. We aimed to compare the efficacy BCG plus interferon a-2b (BCG/IFN) and Gem/Doce in patients with recurrent NMIBC after a single prior BCG course.METHODSThe National Phase II BCG/IFN trial database and multi-institutional Gem/Doce database were queried for patients with recurrent NMIBC after one prior BCG induction course, excluding those with BCG unresponsive disease. Stabilized inverse probability treatment weighted survival curves were estimated using the Kaplan-Meier method and compared. Propensity scores were derived from a logistic regression model. The primary outcome was recurrence free survival (RFS); secondary outcomes were high-grade (HG) RFS and risk factors for treatment failure.RESULTSWe identified 197 BCG/IFN and 93 Gem/Doce patients who met study criteria. Patients receiving Gem/Doce were older and more likely to have HG disease, CIS, and persistent disease following induction BCG (all P < 0.01). After propensity score-based weighting, the adjusted 1- and 2-year RFS was 61% and 53% after BCG/IFN versus 68% and 46% after Gem/Doce (P = 0.95). Adjusted 1- and 2-year HG-RFS was 60% and 51% after BCG/IFN versus 63% and 42% after Gem/Doce (P = 0.68). Multivariable Cox regression revealed that Gem/Doce treatment was not associated with an increased risk of failure (HR = 0.97, P = 0.89) as compared to BCG/IFN.CONCLUSIONPatients with recurrent NMIBC after a single induction BCG failure and not deemed BCG unresponsive had similar oncologic outcomes with Gem/Doce and BCG/IFN in a post-hoc analysis. Additional prospective studies are needed.

01 Jan 2019·Gastroenterology and hepatology from bed to bench

Primary biliary cholangitis with contemporary presence of anti-mithocondrial and anti-rods and rings autoantibodies: literature first case.

Author: Roberto Assandri

Primary biliary cholangitis, previously known as primary biliary cirrhosis (PBC), is the most common autoimmune diseases of the liver (ALD). Patients with PBC may present with typical biliary pattern symptoms. Also the presence of anti-mitochondrial autoantibodies (AMAs) is the laboratory hallmark of PBC, which molecular target antigens are members of 2-oxoacid dehydrogenase complex of enzymes. In recent years, autoantibodies (Aab) targeting subcellular structures described as the rods and rings (R&R) pattern in HEp-2 ANA have been presented as a unique and particular case of Aab generation. These R&R structures are composed of inosine monophosphate dehydrogenase type 2 (IMPDH2), and their formation can be induced in vitro by several small-molecule inhibitors. Aab targeting these relatively unknown structures have been almost exclusively observed in hepatitis C virus (HCV) patients who have undergone treatment with pegylated interferon-a/ribavirin (IFN/RBV) therapy. Literature showed that anti-RR Aab have not been found in no treatment-naïve HCV patients or in patients from any other disease. Now we present and characterized a case patient with contemporary presence of AMAs and R&R Aab in PBC, without any laboratory evidence of HCV and/or other hepatic virus infection. For our knowledge, this is the first case described in the Literature. R&R Aab in patients without any clinical/laboratory signs or symptoms of Hepatitis virus and without pharmacological therapy open the window to the alternative scenario: the association of these Aab to ALD. Our work demonstrated that R&R Aab can be present in PBC case. The interesting idea suggested that R&R Aab may be present also in AMA-negative PBC and they can considered a new possible diagnostic tool in this specific clinical condition. Other study and cases are needed but the presence of R&R Aab linked with AMAs and PBC may be explained by alterations in immune regulation caused by autoimmunity in a particular genetic background.

01 Sep 2017·Urology Case Reports

Hemangioendothelioma of the Bladder: The Youngest Case Report in A Child

Author: Sibarani, Jupiter ; Vijay, Sawkar ; Armella, Laurina ; Tjahjodjati ; Siregar, Safendra ; Atik, Nur ; Rachmadi, Dedi

Hemangioendothelioma is a vascular tumor that commonly found in soft tissue, lungs, heart, liver, and bones, but it is very rare in bladder. We report a case of pediatric hemangioendothelioma of the bladder in a 2 years 7 months-old boy that treated with total excision of the bladder and bilateral ureterocutaneoustomy. This case is the second case in pediatric patients, and the youngest case that reported in a child. Our patient is doing well post operatively. But unfortunately interferon a-2b is not available in our hospital. At 3 months follow up, there was progressive progression of the tumor. Recurrent Abdominal mass was confirmed by Abdominal CT-Scan. The patient was died one week later. Interferon a-2b is might be an effective regimen on this tumor but further study is needed to confirm this statement.

100 Deals associated with Cepeginterferon alfa-2b

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L03AB14	DB12814

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis C	RU	Biocad Medical, Inc.	01 Dec 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis C, Chronic	Preclinical	RU	Biocad CJSC	06 Jun 2013
HIV Infections	Preclinical	RU	Biocad CJSC	06 Jun 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01740089 (CTgov)	Phase 2/3	Hepatitis C, Chronic	150	Algeron+Ribavirin (Algeron 1.5 μg/kg)	bsywdvwydp(qzaxyisbkh) = uhanecyxns cueermfuaj (gbsaddrwix, sscapyxzyi - jcjumutjgu) View more	-	18 Aug 2015
				Algeron+Ribavirin (Algeron 2.0 μg/kg)	bsywdvwydp(qzaxyisbkh) = czwlmrsofw cueermfuaj (gbsaddrwix, znxzqmobha - bcotkifoyg) View more
NCT02103439 (CTgov)	Phase 3	HIV Infections \| Hepatitis C, Chronic	140	Algeron (Algeron)	keeoyzgnal(vdvdikavrw) = uprouxhpcb iqpqptsbgl (rlugyxtdyp, dbjediuhwa - friejtkozr) View more	-	21 Jul 2015
				PegIntron (PegIntron)	keeoyzgnal(vdvdikavrw) = tpmevhidvk iqpqptsbgl (rlugyxtdyp, gwvyrjpksh - ijjfjtaffz) View more