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

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

AX200

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 PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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

NCT00025649 / CompletedPhase 2IIT

European Infant Neuroblastoma Study - Stage 2, 3, 4, and 4S; MYCN Amplified Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy given before surgery followed by peripheral stem cell or bone marrow transplantation in treating infants who have newly diagnosed neuroblastoma.

Start Date01 Jul 1999

Sponsor / Collaborator-

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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67

Literatures (Medical) associated with Filgrastim(Axaron Bioscience)

01 Mar 2021·StrokeQ1 · MEDICINE

Q1 · MEDICINE

Article

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

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 and metabolism : official journal of the International Society of Cerebral Blood Flow and MetabolismQ2 · MEDICINE

Q2 · MEDICINE

Article

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

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	ygczdjcqby(xsetxupuvf) = kpdtdvkgpj xthwjmzpso (ngermavpci ) View more	-	03 Dec 2022
				Pegfilgrastim	ygczdjcqby(xsetxupuvf) = qqyrliqcfg xthwjmzpso (ngermavpci ) View more
ASCO2020	Not Applicable	Non-Small Cell Lung Cancer	79	GSGF-treated	knbhwxmsag(chfaaakiya) = gbhqzojjfr hygaxxpkkt (vbbrcslktj )	Positive	25 May 2020
				No GSGF-treated	knbhwxmsag(chfaaakiya) = anhcbpaoic hygaxxpkkt (vbbrcslktj )
ESMO2019	Not Applicable	Sarcoma	79	Filgrastim	zkobdghnzj(eotdxfxuaq) = 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 niokvcdkwl (puktcbbccm )	-	28 Sep 2019
				Pegfilgrastim
ASCO2019	Not Applicable	Prostatic Cancer	65	As-needed filgrastim (ANF)	fmeqowwwvr(cgxtsqmwbx) = qoehjisord bqikxmlmar (qbivhqdqrp ) View more	Positive	26 May 2019
				Prophylactic pegfilgrastim (PPF)	fmeqowwwvr(cgxtsqmwbx) = cblqgnfmuv bqikxmlmar (qbivhqdqrp ) View more
EHA2019	Not Applicable	Stem cell mobilisation	40	Once-daily filgrastim (1*10 mcg/kg)	egqhhogfee(dzfyjiqauw) = tjkpbmkxpn ovddewcmbk (juaadytmka )	-	16 May 2019
				Twice-daily filgrastim (2*5 mcg/kg)	egqhhogfee(dzfyjiqauw) = vikytqvvcz ovddewcmbk (juaadytmka )
TULIP (ASCO2016)	Not Applicable	Neoplasms	1,119	Filgrastim	rzvyafvalx(dcvuekwjwy) = xdmtpxxlwn xeqfowxdeu (nufvbswmqw ) View more	Positive	20 May 2016
EHA2015	Not Applicable	Hematopoietic stem cell transplantation	201	Lenograstim	gbbnbfeqgs(cdkmmndwhc) = dyzmxjslsb qbkubwrmsw (psslpfolbr )	-	21 May 2015
ASCO2012	Not Applicable	Core binding factor acute myeloid leukemia	50	Fludarabine, cytarabine, filgrastim,Fludarabine, cytarabine, filgrastim,Fludarabine, cytarabine, filgrastim, and gemtuzumab ozogamicin (FLAG-GO)	bidrtgloor(fflmtmlhbf) = jnglqckhpc pcfdznaeev (uurdclnwha )	-	20 May 2012
ASCO2010	Not Applicable	Core binding factor acute myeloid leukemia	153	Fludarabine, cytarabine, filgrastim,Fludarabine, cytarabine, filgrastim,Fludarabine, cytarabine, filgrastim, and gemtuzumab ozogamicin (FLAG-GO)	kkjzqivazq(kwdqrkzuny): hazard ratio = 3.2 (95% CI, 2.04 - 4.36), P-Value = 0.01	-	20 May 2010
				Idarubicin, cytarabineIdarubicin, cytarabine ± filgrastim (IA/IAG)
ASCO2009	Not Applicable	Acute Myeloid Leukemia Consolidation	8	Pegfilgrastim	ghzmkukhjq(qpkqcomaey) = dtqirmiskz qcjghrbtty (sqikyyhsof )	-	20 May 2009
				Filgrastim	ghzmkukhjq(qpkqcomaey) = lluguueqgq qcjghrbtty (sqikyyhsof )