Observational data have suggested no increased risk of adverse pregnancy outcomes associated with exposure to interferon-beta (IFNB) before or during pregnancy. After the emergence of these data, the European Medicines Agency approved a label change for IFNB in September 2019, stating that use of IFNB during pregnancy may be considered, if clinically needed. However, limited data on pregnancies exposed in the 2nd and 3rd trimesters were observed.
INFORM is a secondary use of data drug utilisation study (DUS) to determine late pregnancy exposure (i.e. during the 2nd and 3rd trimester) to IFNB in Finland and Sweden, which will inform whether the number of exposed pregnancies is adequate to conduct a cohort study on adverse pregnancy outcomes, with a focus on late pregnancy exposure.
The number of pregnancies will be initially reported three years after the revised label implementation (September 2019) and will include data on pregnancies from 1996 in Finland and from 2005 in Sweden up through 31 December 2022. If the number of pregnancies is deemed adequate for conducting the cohort study on adverse pregnancy outcomes, this DUS will be finalised with the drug utilisation data accrued up through 31 December 2022. If the number of pregnancies until 31 December 2022 is deemed inadequate, this study may be continued and the primary and secondary objectives may be examined five years after the revised label implementation, including pregnancies until 31 December 2024.

Start Date20 Mar 2024

Sponsor / Collaborator

Bayer AG

[+3]

NCT04079088 / WithdrawnPhase 2

A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis

The primary objectives of the study are to evaluate the safety of BIIB061 versus placebo in participants with Relapsing Multiple Sclerosis (RMS), and to evaluate the efficacy of BIIB061 to improve disability outcome versus placebo in participants with RMS.
The secondary objectives of the study are to evaluate the effects of BIIB061 versus placebo on brain magnetic resonance imaging (MRI) markers of remyelination and axon preservation in chronic Multiple Sclerosis lesions and to evaluate the effects of BIIB061 versus placebo on additional measures of improved disability outcome.

Start Date30 Jun 2021

Sponsor / Collaborator

Biogen, Inc.

EUCTR2020-000620-18-FR / Not yet recruitingPhase 2IIT

Human recombinant interferon gamma-1b for the prevention of hospital-acquired pneumonia in critically ill patients: a double-blind, international phase 2, randomized, placebo-controlled trial - the PREV-HAP study - PREV-HAP

Start Date19 Feb 2021

Sponsor / Collaborator

Nantes University Hospital

100 Clinical Results associated with Interferon Beta-1b

100 Translational Medicine associated with Interferon Beta-1b

100 Patents (Medical) associated with Interferon Beta-1b

1,179

Literatures (Medical) associated with Interferon Beta-1b

01 Jul 2024·Neurotherapeutics

Long-term effectiveness of natalizumab in secondary progressive multiple sclerosis: A propensity-matched study

Article

Author: Marfia, Girolama ; Patti, Francesco ; Maniscalco, Giorgia Teresa ; Morra, Vincenzo Brescia ; Pesci, Ilaria ; Paolicelli, Damiano ; Moiola, Lucia ; Maimone, Davide ; Di Sapio, Alessia ; Bertolotto, Antonio ; Bonavita, Simona ; Gasperini, Claudio ; Solaro, Claudio ; Cocco, Eleonora ; Aguglia, Umberto ; Trojano, Maria ; Cottone, Salvatore ; Rovaris, Marco ; Conte, Antonella ; Granella, Franco ; Lus, Giacomo ; Zaffaroni, Mauro ; Filippi, Massimo ; De Luca, Giovanna ; Cavalla, Paola ; Amato, Maria Pia ; Salemi, Giuseppe ; Lepore, Vito ; Bergamaschi, Roberto ; Gallo, Antonio ; Ragonese, Paolo ; Totaro, Rocco ; Chisari, Clara G ; Vianello, Marika

Treatment options for secondary progressive MS (SPMS) are limited, especially considering that the new drugs recently approved are licensed for actively relapsing patients. We aimed to compare the disability progression in a real-world cohort of SPMS patients treated with natalizumab (NTZ) or interferon beta-1b (IFNb-1b). This multicenter retrospective enrolled patients with a diagnosis of SPMS according to 2014 Lublin criteria, who received NTZ or IFNb-1b for at least 48 months between the 1st June 2012 and the 15th May 2018 at 33 Italian MS centers contributing to the Italian MS Registry NTZ or IFNb-1b. Confirmed Expanded Disability Status Scale worsening (CEW) and progression independent of relapse (PIRA) were evaluated. In order to correct for non-randomization, a propensity score matching of the groups was performed. Out of 5206 MS patients identified at the time of data extraction, 421 SPMS patients treated with NTZ (224 [53.2%] females, mean age 45.3 ± 25.4 years) and 353 with IFNb-1b (133 [37.8%] females, mean age 48.5 ± 19.8 years) were enrolled. After applying the matching procedure, 102 patients were retained in the NTZ group and 98 in the IFNb-2b group. The proportion of patients who reached the 48-month 1-point CEW was significantly higher in IFNb-1b compared to NTZ group (58.2% versus 30.4%, p = 0.01). The proportion of patients who developed PIRA at 48 months were significantly higher in IFNb-1b compared to NTZ (72.4% versus 40.2%, p = 0.01). EDSS before treatment initiation and SPMS duration were risk factors for disability progression in terms of PIRA (HR 2.54, 25%CI 1.67-5.7; p = 0.006 and HR 2.04, 25%CI 1.22-3.35; p = 0.01, respectively). Patients treated with IFNb-1b were 1.64 times more to likely to develop PIRA (HR 1.64, 25%CI 1.04-4.87; p = 0.001). Treatment with NTZ in SPMS patients showed more favorable disability outcomes compared to IFNb-1b with beneficial effects over 48 months.

01 Jul 2024·JOURNAL OF NEUROLOGY

Long-term clinical outcomes in patients with CIS treated with interferon beta-1b: results from the 15-year follow up of the BENEFIT trial

Article

Author: Wicklein, Eva-Maria ; Hartung, Hans-Peter ; Edan, Gilles ; Montalbán, Xavier ; Freedman, Mark S ; Barkhof, Frederik ; Koelbach, Ralf ; MacManus, David G ; Kappos, Ludwig

Abstract:

Multiple sclerosis (MS) treatment intervention with immunomodulating therapy at early disease stage improves short term clinical outcomes. The objective of this study is to describe the long-term outcomes and healthcare utilization of patients with clinically isolated syndrome (CIS) included in the Betaferon®/Betaseron® in Newly Emerging MS for Initial Treatment (BENEFIT) randomized, parallel group trial. In BENEFIT patients were assigned to “early” IFNB-1b treatment or placebo (“delayed” treatment). After 2 years or conversion to clinically definite multiple sclerosis (CDMS), all patients were offered IFNB-1b and were reassessed 15 years later. Of 468 patients, 261 (55.8%) were enrolled into BENEFIT 15 (161 [55.1%] from the early, 100 [56.8%] from the delayed treatment arm). In the full BENEFIT analysis set, risk of conversion to CDMS remained lower in the early treatment group ( – 30.5%; hazard ratio 0.695 [95% CI, 0.547–0.883]; p = 0.0029) with a 15.7% lower risk of relapse than in the delayed treatment group (p = 0.1008). Overall, 25 patients (9.6%; 9.9% early, 9.0% delayed) converted to secondary progressive multiple sclerosis. Disability remained low and stable with no significant difference between groups in Expanded Disability Status Scale score or MRI metrics. Paced Auditory Serial Addition Task-3 scores were better in the early treatment group (p = 0.0036 for treatment effect over 15 years). 66.3% of patients were still employed at Year 15 versus 74.7% at baseline. In conclusion, results 15 years from initial randomization support long-term benefits of early treatment with IFNB-1b.

01 Jun 2024·CNS & neurological disorders drug targets

The Peripheral Profile of the Chitinase 3-like-1 in Benign Multiple Sclerosis – A Single Centre’s Experience

Article

Author: Andone, Sebastian ; Barcutean, Laura ; Hutanu, Adina ; Balasa, Rodica ; Maier, Smaranda

Background::

A limited subgroup of multiple sclerosis (MS) patients present with a longterm disease evolution characterized by a limited disease progression, known as benign MS (BMS). Chitinase 3-like-1 (CHI3L1) levels are sensitive to inflammatory processes and may play a role in the pathogenesis of MS. In this observational, cross-sectional study, we aimed to evaluate the implications of serum CHI3L1 and inflammatory cytokines in BMS patients treated with interferon β-1b for over a decade.

Methods::

We collected serum samples from 17 BMS patients and 17 healthy controls (HC) to measure serum CHI3L1 levels and a Th17 panel of inflammatory cytokines. Serum levels of CHI3L1 were analysed using the sandwich ELISA method and the Th17 panel was assessed using the multiplex XMap technology on a Flexmap 3D Analyzer.

Results::

Serum CHI3L1 levels did not differ significantly from HC. We identified a positive correlation between CHI3L1 levels and relapses during treatment.

Conclusions::

Our findings suggest that there are no differences in serum CHI3L1 levels between BMS patients and HC. However, serum CHI3L1 levels are sensitive to clinical inflammatory activity and may be associated with relapses in BMS patients.

News (Medical) associated with Interferon Beta-1b

18 Sep 2023

·www.biospace.com

Atriva Therapeutics Announces Exclusive Letter Agreement for Reverse Takeover Transaction with Biocure Technology

Atriva Therapeutics and Canadian Biocure Technologies, Inc. entered into an exclusive letter agreement for a reverse takeover transaction. Upon successful completion of the transaction, the resulting entity will continue the business of Atriva Therapeutics. Shareholders of Atriva will receive not less than 75% of the securities of the resulting issuer, with the current shareholders of Biocure Technology holding the remainder. The transaction is subject to various terms and conditions, including satisfactory due diligence, successful implementation of a private placement and shareholder approvals. TÜBINGEN, Germany and MUNICH, Germany, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Atriva Therapeutics GmbH (“Atriva”) is pleased to disclose the signing of an exclusive letter agreement, dated September 14, 2023, with Biocure Technology Inc. (“CURE”) (CSE: CURE), based in Vancouver, Canada. This agreement marks a significant step forward in Atriva’s commitment to combating severe RNA virus infections through innovative host-cell-targeting therapies. “We are delighted to have entered into this exclusive letter agreement with Biocure. Our discussions with the Biocure management and board of directors have been exceptionally productive and constructive. We are eager to embark on this journey and combine the strengths of both companies. Together, we aim to address the urgent medical need for safe and effective therapies for patients suffering from severe RNA virus infections. This agreement marks a significant milestone in our commitment to advancing innovative solutions for the benefit of global healthcare,” said Christian Pangratz, Chief Executive Officer of Atriva. “This letter agreement underscores our commitment to leverage this transaction with CURE as an attractive growth option for Atriva and its stakeholders. We are enthusiastic about the prospect of our companies joining forces and continuing to contribute to improving pandemic preparedness on an extended international scale,” stated Ulrich Dauer, PhD, Chairman of the Advisory Board of Atriva. Highlights of the Transaction: Upon transaction completion, Atriva shareholders and concurrent financing subscribers will collectively hold not less than 75% of the securities of the resulting issuer. Current CURE shareholders will retain a maximum of 25% on a fully diluted basis. The letter agreement stipulates no advances from CURE to Atriva. Atriva will provide CURE with an exclusivity fee of CA$15,000 per month for a minimum of three months. Additionally, a finder's fee of US$2,000,000 is payable through the issuance of CURE shares, with pricing to be determined, aligning with concurrent private placement terms. Transaction Conditions: The completion of the Transaction is contingent upon various terms and conditions, including the successful completion of due diligence, the execution of a definitive agreement by November 30, 2023, (inclusive of typical transaction elements), and the successful completion of a private placement by Atriva or CURE to raise gross proceeds of at least US$15,000,000. Additionally, approval from both companies' shareholders and the endorsement of the CSE and other relevant regulatory authorities are essential prerequisites for finalization. For additional information on this transaction, please visit . About Atriva Therapeutics Atriva Therapeutics’ mission is to develop an antiviral therapy platform against severe respiratory and systemic diseases with a high unmet medical need induced by RNA viruses, e.g., influenza and COVID-19. The clinical-stage biopharmaceutical company is pioneering the development of host-targeting antiviral therapies, making development of viral resistance unlikely, and thereby significantly contributing to pandemic preparedness. The Atriva lead product zapnometinib (ATR-002) is a first-in-class, host-targeting agent that aims to inhibit viral replication and to favorably modulate the body’s immune response to RNA viruses. Atriva Therapeutics was founded in 2015 in Tübingen by a team of leading scientists in viral research and seasoned industry experts and is based with its administrative/operations office in Martinsried (near Munich), Germany. For further information, please visit and follow us on LinkedIn and X (formerly Twitter). About Biocure Biocure owns approximately 45% stakes of BiocurePharm in Korea who is a leading biotech company developing its CAR-T cell therapy for leukemia, lung, breast and pancreatic cancer. BiocurePharm is in the process of pre-clinical trials of three major biosimilar products in South Korea, including Interferon Beta 1b, PEG- Filgrastim as well as Ranibizumab. Interferon Beta 1b is used for treating relapsing forms of multiple sclerosis (“MS”). Filgrastim is used to treat neutropenia, a lack of certain white blood cells caused by bone marrow transplants, chemotherapy, and other conditions. Ranibizumab is used for treating macular degeneration. It is also used to treat a type of eye problem known as macular edema, as well as certain eye problems caused by diabetes. Contact: Atriva Therapeutics GmbH Christian Pangratz, CEO Phone: +49 69 9999 162 10 pangratz@atriva-therapeutics.com

ImmunotherapyCell Therapy

03 Feb 2023

·biocuretech.com

Clarification News Release

VANCOUVER, British Columbia, February 3, 2023 -- Biocure Technology Inc. (“Biocure” or the “Company”) (CSE:CURE) would like to provide the following clarifications to the market and its stakeholders. BiocurePharm Corporation (“BPK”), a subsidiary of Biocure Technology, has neither direct discussion nor relationship with Cigalah Healthcare in the Kingdom of Saudi Arabia. BPK has formed an alliance with a Korean-based RIHU Healthcare and both parties are in the discussion about potential Biopharmaceutical business opportunities. About Biocure Biocure is a leading biotech company developing its CAR-T cell therapy for leukemia, lung, breast and pancreatic cancer. Biocure, headquartered in Korea, has joint venture partners in Asia and Europe with planned clinical trials commencing in 2021. Biocure is in the process of pre-clinical trials of five major biosimilar products in South Korea, including Interferon Beta 1b, PEG- Filgrastim as well as Ranibizumab. Interferon Beta 1b is used for treating relapsing forms of multiple sclerosis (“MS”) Filgrastim is used to treat neutropenia, a lack of certain white blood cells caused by bone marrow transplants, chemotherapy, and other conditions. Ranibizumab is used for treating mascular degeneration. It is also used to treat a type of eye problem known as macular edema, as well as certain eye problems caused by diabetes. ON BEHALF OF THE BOARD OF DIRECTORS /S/ “SANG MOK LEE” CEO and Director For further information, please contact: Biocure Technology Inc. Telephone: 604-609-7146, or info@biocuretech.com PRESS RELEASE ON PDF Certain statements in this news release, which are not historical in nature, constitute “forward looking statements” within the meaning of that phrase under applicable Canadian securities law. These statements include, but are not limited to, statements or information concerning the Company’s proposed activities under the Agreement and the expectations of the Company regarding funding payments due pursuant to the Agreement. These statements reflect management’s current assumptions and expectations and by their nature are subject to certain underlying assumptions, known and unknown risks and uncertainties and other factors which may cause actual results, performance or events to be materially different from those expressed or implied by such forward looking statements. Except as required pursuant to applicable securities laws, the Company will not update these forward-looking statements to reflect events or circumstances after the date hereof. More detailed information about potential factors that could affect financial results is included in the documents filed from time to time with the Canadian securities regulatory authorities by the Company. Readers are cautioned not to place undue reliance on forward looking statements. Neither the Canadian Securities Exchange (the “CSE”) nor the Investment Industry Regulatory Organization of Canada) accepts responsibility for the adequacy or accuracy of this release.

Cell TherapyImmunotherapy

31 Jan 2023

·biocuretech.com

BiocurePharm, Korea (“BPK”) Announces Private Placement

VANCOUVER, British Columbia, January 31, 2023 -- Biocure Technology Inc. (“CURE” or the “Company”) (CSE:CURE) BiocurePharm, Korea (“BPK”), a subsidiary of Biocure Technology Inc. (“CURE”) is pleased to announce that it has closed its non-brokered private placement through its Korean Subsidiary BiocurePharm, Korea (“BPK”), BPK has issued 55,000 shares at $4.32 CAD per share for gross proceeds of 220,000,000 KRW equivalent to $237,600 CAD. All dollar values are based on the published Exchange Rate of CAD 0.001080 / KRW1 on January 27, 2023, Bank of Canada. After the issuance of new BPK shares, CURE holds now 92.10 % interest in BPK. The net proceeds from the non-brokered private placement are intended to be used for general working capital. About Biocure Biocure is a South Korean based Bio Pharmaceutical company specializing in the development and potential commercialization of biosimilar pharmaceutical products. Biocure is in the process of pre- clinical trials of five major biosimilar products in South Korea, including Interferon Beta 1b, PEG- Filgrastim and Ranibizumab as well as CAR-T Cell Therapy. Interferon Beta 1b is used for treating relapsing forms of multiple sclerosis (“MS”) Filgrastim is used to treat neutropenia, a lack of certain white blood cells caused by bone marrow transplants, chemotherapy, and other conditions. Ranibizumab is used for treating macular degeneration. It is also used to treat a type of eye problem known as macular edema, as well as certain eye problems caused by diabetes. ON BEHALF OF THE BOARD OF DIRECTORS /S/ “SANG MOK LEE” CEO and Director For further information, please contact: Biocure Technology Inc. Telephone: 604-609-7146, or info@biocuretech.com PRESS RELEASE ON PDF Certain statements in this news release, which are not historical in nature, constitute “forward looking statements” within the meaning of that phrase under applicable Canadian securities law. These statements include, but are not limited to, statements or information concerning the Company’s proposed activities under the Agreement and the expectations of the Company regarding funding payments due pursuant to the Agreement. These statements reflect management’s current assumptions and expectations and by their nature are subject to certain underlying assumptions, known and unknown risks and uncertainties and other factors which may cause actual results, performance or events to be materially different from those expressed or implied by such forward looking statements.

Cell TherapyImmunotherapy

100 Deals associated with Interferon Beta-1b

External Link

KEGG	Wiki	ATC	Drug Bank
D00746	Interferon Beta-1b	L03AB08	DB00068

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Multiple Sclerosis, Relapsing-Remitting	EU	Bayer AG	30 Nov 1995
Multiple Sclerosis, Relapsing-Remitting	IS	Bayer AG	30 Nov 1995
Multiple Sclerosis, Relapsing-Remitting	LI	Bayer AG	30 Nov 1995
Multiple Sclerosis, Relapsing-Remitting	NO	Bayer AG	30 Nov 1995
Multiple Sclerosis, Secondary Progressive	EU	Bayer AG	30 Nov 1995
Multiple Sclerosis, Secondary Progressive	IS	Bayer AG	30 Nov 1995
Multiple Sclerosis, Secondary Progressive	LI	Bayer AG	30 Nov 1995
Multiple Sclerosis, Secondary Progressive	NO	Bayer AG	30 Nov 1995
Multiple Sclerosis	US	Bayer HealthCare Pharmaceuticals, Inc.	23 Jul 1993

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Multiple sclerosis relapse	Phase 3	US	Bayer AG	01 May 2007
Multiple sclerosis relapse	Phase 3	AR	Bayer AG	01 May 2007
Multiple sclerosis relapse	Phase 3	AU	Bayer AG	01 May 2007
Multiple sclerosis relapse	Phase 3	AT	Bayer AG	01 May 2007
Multiple sclerosis relapse	Phase 3	BE	Bayer AG	01 May 2007
Multiple sclerosis relapse	Phase 3	BR	Bayer AG	01 May 2007
Multiple sclerosis relapse	Phase 3	CA	Bayer AG	01 May 2007
Multiple sclerosis relapse	Phase 3	DK	Bayer AG	01 May 2007
Multiple sclerosis relapse	Phase 3	FI	Bayer AG	01 May 2007
Multiple sclerosis relapse	Phase 3	FR	Bayer AG	01 May 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ECTRIMS2022	Not Applicable	Multiple Sclerosis, Relapsing-Remitting	140	Actoferon®	bttoknkbrf(wbainemaaa) = jzpqwyhsjr mazfqpbvgq (fqnwfjewgn ) View more	Positive	12 Oct 2022
ECTRIMS2022	Not Applicable	Multiple Sclerosis, Relapsing-Remitting	140	Betaferon®	bttoknkbrf(wbainemaaa) = urnkechrxe mazfqpbvgq (fqnwfjewgn ) View more	Positive	12 Oct 2022
NCT00176592 (BECOME, CTgov)	Phase 4	Multiple Sclerosis	75	Betaseron (Betaseron)	tjjfcybsfn(ttzhzuhrvy) = srsodxuubg wtefzbxkgw (arzjnnfvle, bwnsyogtkw - fprrhcsdua) View more	-	16 Nov 2021
NCT00176592 (BECOME, CTgov)	Phase 4	Multiple Sclerosis	75	Copaxone (Copaxone)	tjjfcybsfn(ttzhzuhrvy) = swzjukkpuw wtefzbxkgw (arzjnnfvle, mbmmsujvhi - gltaygldod) View more	-	16 Nov 2021
ECTRIMS2020	Not Applicable	COVID-19 SARS-CoV-2	109	IFN β-1b	wyaaakrtbb(rtaxpynnxs) = ewywcsslyj cjcezmznug (swevsezfat ) View more	-	07 Dec 2020
NCT03134573 (Pubmed \| J Med Internet Res)	Not Applicable	Multiple Sclerosis	96	Interferon Beta-1b (Patients using myBETAapp)	hhgoryryvs(yjjknagpzt) = zszrbxunqd tgogijrptk (cvvtliiild ) View more	-	29 Jul 2019
BENEFIT (EAN2019)	Not Applicable	MRI lesions	261	Interferon beta-1b (early treatment)	wchknisytr(ulvgcqvuxw) = hscnrrpdtu efmofmkqye (xpxoavihdi ) View more	Positive	27 Jun 2019
BENEFIT 15 (ACTRIMS2019)	Not Applicable	MRI lesions	468	Interferon beta-1b (early treatment)	zknnjuvuzc(bnlhzubdbb) = mean 2.5 (1.76); median 2.0 (1.5, 3.5) (EDSS 0-2.5: 162 patients [62.1%], 3.0-5.5: 80 [30.7%], 6.0-6.5: 12 [4.6%], >=7: 7 [2.7%]) kpgkxqniat (lqyirirotn ) View more	Positive	07 May 2019
BENEFIT 15 (ACTRIMS2019)	Not Applicable	MRI lesions	468	Placebo+Interferon beta-1b (delayed treatment)		Positive	07 May 2019
BENEFIT 15 (AAN2019)	Phase 3	Carcinoma in situ of uterine cervix	468	Interferon beta-1b (early treatment)	atbqhbfgbp(ivzkvpqjne) = 0.2083 overall over 15 years dbfdjljufu (ofacicgytc ) View more	Positive	09 Apr 2019
AAN2019	Not Applicable	Pregnancy	2,571	Interferon beta-1b	undulujkyq(udktklksuc) = oodpmufhdr njuofimutt (veseewnnvu ) View more	-	09 Apr 2019
ECTRIMS2018	Not Applicable	Pregnancy	2,571	Pregnancies exposed to interferon beta-1b	wqdhxbbiyw(phmoqbegxn) = cxocuxpzuf kfqdjbsbcn (uizhklswge ) View more	-	09 Oct 2018
BENEFIT 15 (ECTRIMS2018)	Not Applicable	Carcinoma in situ of uterine cervix	468	Interferon beta-1b (early treatment)	oashsmdyzk(vmukiooqku) = rdzucwtggc gxjvoaugrf (qgdolgyhzw )	-	09 Oct 2018

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