Delving into the Latest Updates on Filgrastim(Axaron Bioscience) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

Target

CSF-3R

Mechanism

CSF-3R agonists(Colony stimulating factor 3 receptor agonists)

Therapeutic Areas

Nervous System DiseasesCardiovascular Diseases

Active Indication-

Inactive Indication

Acute Ischemic Stroke

Originator Organization

Axaron Bioscience AG

Active Organization-

Inactive Organization

Sygnis Bioscience GmbH & Co KGAxaron Bioscience AG

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 4190

The sequence is quoted from: *****

The AXIS study is a randomized, double-blind, placebo-controlled, dose-escalating phase IIa trial to investigate treatment with AX200 (granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke. The primary objective of the present phase IIa study is to assess the safety and tolerability of AX200 compared to placebo in subjects suffering from acute stroke. The secondary objective is to assess the effect of AX200 on subject outcome in comparison to placebo.

Start Date01 Dec 2004

Sponsor / Collaborator

Axaron Bioscience AG

100 Clinical Results associated with Filgrastim(Axaron Bioscience)

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100 Translational Medicine associated with Filgrastim(Axaron Bioscience)

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100 Patents (Medical) associated with Filgrastim(Axaron Bioscience)

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8

Literatures (Medical) associated with Filgrastim(Axaron Bioscience)

01 Mar 2021·StrokeQ1 · MEDICINE

Imaging Markers of Brain Frailty and Outcome in Patients With Acute Ischemic Stroke

Q1 · MEDICINE

Article

Author: Grond, Martin ; Norrving, Bo ; Thijs, Vincent ; Wilms, Guido ; Ringelstein, E. Bernd ; Lemmens, Robin ; Fiebach, Jochen B. ; Laage, Rico ; Chamorro, Angel ; Bu, Ning ; Khlif, Mohamed Salah ; Wouters, Anke ; Brodtmann, Amy

Background and Purpose:Functional outcome after stroke may be related to preexisting brain health. Several imaging markers of brain frailty have been described including brain atrophy and markers of small vessel disease. We investigated the association of these imaging markers with functional outcome after acute ischemic stroke.Methods:We retrospectively studied patients with acute ischemic stroke enrolled in the AXIS-2 trial (AX200 in Ischemic Stroke Trial), a randomized controlled clinical trial of granulocyte colony-stimulating factor versus placebo. We assessed the ratio of brain parenchymal volume to total intracerebral volumes (ie, the brain parenchymal fraction) and total brain volumes from routine baseline magnetic resonance imaging data obtained within 9 hours of symptom onset using the unified segmentation algorithm in SPM12. Enlarged perivascular spaces, white matter hyperintensities, lacunes, as well as a small vessel disease burden, were rated visually. Functional outcomes (modified Rankin Scale score) at day 90 were determined. Logistic regression was used to test associations between brain imaging features and functional outcomes.Results:We enrolled 259 patients with a mean age of 69±12 years and 46 % were female. Increased brain parenchymal fraction was associated with higher odds of excellent outcome (odds ratio per percent increase, 1.078 [95% CI, 1.008–1.153]). Total brain volumes and small vessel disease burden were not associated with functional outcome. An interaction between brain parenchymal fraction and large vessel occlusion on excellent outcome was not observed.Conclusions:Global brain health, as assessed by brain parenchymal fraction on magnetic resonance imaging, is associated with excellent functional outcome after ischemic stroke.Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00927836.

14 Mar 2016·The Medical letter on drugs and therapeuticsQ4 · MEDICINE

Zarxio--a filgrastim biosimilar.

Q4 · MEDICINE

Review

01 Oct 2015·Journal of Cerebral Blood Flow & MetabolismQ2 · MEDICINE

Association between the Perfusion/Diffusion and Diffusion/FLAIR Mismatch: Data from the AXIS2 Trial

Q2 · MEDICINE

Article

Author: Laage, Rico ; Dupont, Patrick ; Chamorro, Angel ; Wouters, Anke ; Schneider, Armin ; Thomalla, Götz ; Ringelstein, Erich B ; Lemmens, Robin ; Thijs, Vincent N ; Wilms, Guido ; Grond, Martin ; Norrving, Bo

The perfusion-/diffusion-weighted imaging (PWI/DWI) mismatch and the diffusion/fluid attenuated inversion recovery (DWI/FLAIR) mismatch are magnetic resonance imaging (MRI) markers of evolving brain ischemia. We examined whether the DWI/FLAIR mismatch was independently associated with the PWI/DWI mismatch. Furthermore, we determined whether the presence of the DWI/FLAIR mismatch in patients with the PWI/DWI mismatch would provide additional information regarding last seen normal time (LTM). We used data from the ‘AX200 for ischemic stroke’ trial (AXIS 2 study NCT00927836). We studied the association between the presence of the DWI/FLAIR and PWI/DWI mismatch, baseline National Institute of Health Stroke Scale (NIHSS), age, ischemic-core volume, gender, intravenous (IV) tissue plasminogen activator (tPA), and perfusion-mismatch volume in univariate analysis. Significant variables ( P < 0.05) were added into the final multivariate model. We analyzed 197 patients. Seventy-two (37%) had both the PWI/DWI and the DWI/FLAIR mismatch. Patients with the double mismatch pattern had a shorter LTM than patients with the PWI/DWI mismatch alone (Median difference 90 minutes, P < 0.01). Multivariate analysis confirmed the independent association between the two mismatch patterns (odds ratio (OR) 2.6, 95% confidence interval (CI) 1.2 to 5.4). Our study implies that the DWI/FLAIR mismatch and PWI/DWI mismatch are strongly associated, independent from LTM. Furthermore, in the presence of the PWI/DWI mismatch, the DWI/FLAIR pattern indicates a shorter LTM. This could have implications in selecting patients for reperfusion therapy.

100 Deals associated with Filgrastim(Axaron Bioscience)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Ischemic Stroke	Phase 2	DE	Axaron Bioscience AG	01 Dec 2004

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_ASIA2022	Not Applicable	Chemotherapy-Induced Febrile Neutropenia	112	Filgrastim	(oijqcpkkdd) = eqyzaynttx nqdlmbfqit (zkuulzqbmz ) View more	-	03 Dec 2022
				Pegfilgrastim	(oijqcpkkdd) = nttlpwsxoq nqdlmbfqit (zkuulzqbmz ) View more
ASCO2020	Not Applicable	Multiple Myeloma	57	Pegfilgrastim	(igxaghncmw) = main side effects were mild fever and bone pain (21.2%) mzimcygqrl (dnlurutvrg )	Positive	25 May 2020
				Filgrastim
ESMO2019	Not Applicable	Sarcoma	79	Filgrastim	jnjimraeua(poableykbu) = The use of peg-F was associated with a significantly higher rate of neutropenic infections requiring hospitalization compared with F in adult sarcoma pts receiving HMC zsdgejkymm (sdtkeifllw )	-	28 Sep 2019
				Pegfilgrastim
ASCO2019	Not Applicable	Prostatic Cancer	65	As-needed filgrastim (ANF)	qsdlsphbnb(sautmmngfg) = opsaetwhna jzprhrolfx (qarqdrdyyx ) View more	Positive	26 May 2019
				Prophylactic pegfilgrastim (PPF)	qsdlsphbnb(sautmmngfg) = pzlmfhtzjf jzprhrolfx (qarqdrdyyx ) View more
EHA2019	Not Applicable	Stem cell mobilisation	40	Once-daily filgrastim (1*10 mcg/kg)	hpudnypcic(racqgolqqo) = jellfjhgoi anhtvhlgxs (luhifeyyyr )	-	16 May 2019
				Twice-daily filgrastim (2*5 mcg/kg)	hpudnypcic(racqgolqqo) = wmzjbgoyss anhtvhlgxs (luhifeyyyr )
EHA2017	Not Applicable	Hairy Cell Leukemia	202	Pegfilgrastim	rimzmicfdm(jtllythqvj) = hhoxooipub mhrkvlbirt (jwlpdvvcvh )	-	18 May 2017
				Filgrastim	rimzmicfdm(jtllythqvj) = dbrsyhhnve mhrkvlbirt (jwlpdvvcvh )
TULIP (ASCO2016)	Not Applicable	Neoplasms	1,119	Filgrastim	dmbjhiaznq(msoozfiryy) = ejctvtbuec tjiecorhve (chzseazwmc ) View more	Positive	20 May 2016
EHA2015	Not Applicable	B-Cell Lymphoma	177	Filgrastim	mndehpckvh(aisrydqllg) = xyitrlelnc yawqkwsljz (fosndbvizc ) View more	-	21 May 2015
ASCO2012	Phase 1	-	24	BCD-017 1 mg	aszqqfrlix(qkwxwbhwcj) = qpfayglonl kcwfadmvny (hrcubqldhh, 10.62 - 21.02) View more	-	20 May 2012
				BCD-017 3 mg	aszqqfrlix(qkwxwbhwcj) = djkvbeelst kcwfadmvny (hrcubqldhh, 15.43 - 28.07) View more
ASCO2010	Not Applicable	Core binding factor acute myeloid leukemia	153	Fludarabine, cytarabine, filgrastim,Fludarabine, cytarabine, filgrastim,Fludarabine, cytarabine, filgrastim, and gemtuzumab ozogamicin (FLAG-GO)	(cbmpmczslq): hazard ratio = 3.2 (95% CI, 2.04 - 4.36), P-Value = 0.01	-	20 May 2010
				Idarubicin, cytarabineIdarubicin, cytarabine ± filgrastim (IA/IAG)