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Sensorion Announced Orphan Drug Designation for OTOF-GT

Sensorion (FR0012596468 – ALSEN) a clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat, and prevent within the field of hearing loss disorders, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to OTOF-GT, Sensorion’s lead gene therapy program, intended for the treatment of otoferlin gene-mediated hearing loss. Sensorion is on track to file a Clinical Trial Application for OTOF-GT in the first half of 2023.

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Sensorion Announces Updated Timelines for Phase 2 Study of Hearing Loss Drug

Sensorion (FR0012596468 – ALSEN) a clinical-stage biotech company which specializes in the...

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Sensorion Receives European Medicines Agency Approval for PIP on Hearing Loss Treatment

SENS-401 is under development in the treatment of Sudden Sensorineural Hearing Loss (or SSNHL).

Sensorion Announces Publication of Paper in ‘Hearing Research’

by Stefani Kim | Dec 11, 2018 | Research | 0

The paper, published in the peer-reviewed monthly journal “Hearing Research,” found that the outer-hair-cell-specific protein prestin, in circulation, may act as a biomarker for sensory hair cell damage and death.

Sensorion and Pasteur Institute to Collaborate on Gene Therapy Products

by Karl | Nov 28, 2018 | Vestibular Training, Vestibular Treatment | 0

Sensorion announced a letter of intent with Pasteur Institute in Paris to exclusively negotiate a framework agreement to obtain the exclusive licenses to develop and commercialize gene therapy product candidates for restoration, treatment, and prevention of hearing loss disorders. They will collaborate on several lead programs to correct monogenic forms of hereditary hearing loss including, among others, the Usher syndrome type 1 and otoferlin deficiency, according to the announcement.

Sensorion Announces Publication of Seliforant Phase 1 Study Data

by Karl | Sep 27, 2018 | Vestibular Training, Vestibular Treatment | 0

Seliforant (formerly SENS-111) is currently being studied in an ongoing Phase 2 trial for the treatment of acute unilateral vestibulopathy, a debilitating disease of the inner ear. Its maker, Sensorion, has announced the publication of data in the ‘British Journal of Clinical Pharmacology’ from a Phase 1 study evaluating the safety, tolerability, pharmacokinetics of the drug in healthy subjects. More data are expected at the end of 2018.

Webinar on Pediatric Chemo-Induced Hearing Loss to Be Held September 13

by Stefani Kim | Sep 7, 2018 | Health & Wellness | 0

This half-day event follows the Food and Drug Administration’s (FDA) model for externally-led Patient Focused Drug Development meetings and serves to inform the agency’s regulatory decision-making in pediatric oncology.

Sensorion Receives Approval for SENS-401 Phase 2 Clinical Trial

by Stefani Kim | Aug 21, 2018 | Vestibular Training, Vestibular Treatment | 0

The randomized, double-blind, placebo-controlled Phase 2 study will be conducted across 50 sites in Europe, the US, Canada, Israel, and Turkey, and enroll approximately 260 patients.

Sensorion Announces Initiation of Phase 2 Study for Vertigo Drug Seliforant

by Stefani Kim | Jul 26, 2018 | Vestibular Care, Vestibular Training, Vestibular Treatment | 0

By comparing the effects of seliforant to meclizine, a drug with known anticholinergic side effects, and placebo, the SENS-111-202 study aims to confirm the absence of anticholinergic effects such as sedation and memory loss in patients receiving seliforant.

Sensorion Presents SENS-401 Data at Ci2018 Conference

by Stefani Kim | Jul 5, 2018 | Cochlear Implants, Events, Research | 0

Data from the presented studies showed that SENS-401 protected inner ear function and enhanced sensory hair cell survival in preclinical models of acoustic trauma and, separately, cisplatin infusion.

Sensorion Appoints Dr Christine Petit as Chair, Scientific Advisory Board

by Stefani Kim | May 23, 2018 | People, Research | 1

Petit presently serves concurrently as professor at College de France, chair of genetics and cellular physiology, professor at Institut Pasteur (Paris), and head of the Laboratory of Genetics and Physiology of Hearing of the Pasteur Institute.

Potential Biomarker for Noise-Induced Hearing Loss Identified by Sensorion, UConn Health

by Stefani Kim | Apr 24, 2018 | Common Risk Factors | 0

The laboratory study identified changes in prestin blood levels, an outer hair cell (OHC) protein, in a preclinical model with noise-induced hearing loss.

Sensorion to Present Data at ANS Annual Meeting, April 20-22

by Stefani Kim | Apr 13, 2018 | Research | 0

The data being presented by Sensorion include results from a study of SENS-401 in preclinical models, designed to determine how long after hearing loss onset SENS-401 could be administered, and results from a study conducted in collaboration with the University of Connecticut (UConn Health) of a circulating blood biomarker for hearing loss.

Sensorion Presents SENS-401 Data at ARO 2018 MidWinter Meeting

by Stefani Kim | Feb 16, 2018 | Evaluation, Research | 0

SENS-401, R-azasetron besylate, is a drug candidate that aims to protect and preserve inner ear tissue when lesions are present that can cause progressive or sequelar hearing impediments.

Sensorion Announces USD $1.9 Million Placement with Cochlear

by Stefani Kim | Dec 21, 2017 | Bone-Conduction Solutions, Implants & Bone Conduction | 0

Sensorion will principally use the funds to finance the preclinical combination studies that will evaluate SENS-401’s therapeutic effect on hearing outcomes achieved with Cochlear’s implantable devices.

Sensorion and Cochlear Announce Strategic Collaboration for Patients with Cochlear Implants

by Stefani Kim | Dec 18, 2017 | Bone-Conduction Solutions, Implants & Bone Conduction | 0

The collaboration will evaluate therapeutic approaches using SENS-401—R-azasetron besylate, a drug candidate that aims to protect and preserve inner ear tissue when lesions are present that can cause progressive or sequelar hearing impediments—in combination with cochlear implants.

Sensorion Receives Orphan Drug Designation for Chemotherapy-Induced, Hearing Loss Treatment

by Stefani Kim | Aug 23, 2017 | Research | 0

The drug is a therapy in development for the treatment of hearing disorders, for the prevention of Platinum-Induced Ototoxicity in pediatric patients.

Tag: sensorion

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Sensorion Announced Orphan Drug Designation for OTOF-GT

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Sensorion, Cochlear Ltd Start Pilot Study for SENS-401

Sensorion Announces Gene Therapy Collaboration

Sonova to Acquire 3.7% Ownership Stake in Sensorion

Sensorion Appoints Edwin Moses as Chairman of its Board of Directors

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Sensorion Announces Updated Timelines for Phase 2 Study of Hearing Loss Drug

Sensorion Receives Approval for Additional Military Sites in Phase 2 Drug Study

Sensorion Appoints Géraldine Honnet as Chief Medical Officer; Juergen Heitmann as Chief Business Officer

Sensorion Scuttles SENS-111 Vestibulopathy Drug to Focus on Sudden Hearing Loss

Sensorion Appoints John Furey As Independent Board Member

Sensorion Receives IND Clearance from FDA on Hearing Loss Drug

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Sensorion Receives European Medicines Agency Approval for PIP on Hearing Loss Treatment

Sensorion Receives European Medicines Agency Approval for PIP on Hearing Loss Treatment

Sensorion Awarded $11 Million Research Grant for Congenital Deafness

Sensorion Awarded $11 Million Research Grant for Congenital Deafness

Sensorion Partners with Institut Pasteur on Research Framework Targeting Hearing Loss

University of Connecticut Researchers Find Protein Connected with Hearing Loss

Sensorion Announces Positive Topline Results from Vertigo Drug Study

Sensorion Announces Publication of Paper in ‘Hearing Research’

Sensorion and Pasteur Institute to Collaborate on Gene Therapy Products

Sensorion Announces Publication of Seliforant Phase 1 Study Data

Webinar on Pediatric Chemo-Induced Hearing Loss to Be Held September 13

Sensorion Receives Approval for SENS-401 Phase 2 Clinical Trial

Sensorion Announces Initiation of Phase 2 Study for Vertigo Drug Seliforant

Sensorion Presents SENS-401 Data at Ci2018 Conference

Sensorion Appoints Dr Christine Petit as Chair, Scientific Advisory Board

Potential Biomarker for Noise-Induced Hearing Loss Identified by Sensorion, UConn Health

Sensorion to Present Data at ANS Annual Meeting, April 20-22

Sensorion Presents SENS-401 Data at ARO 2018 MidWinter Meeting

Sensorion Announces USD $1.9 Million Placement with Cochlear

Sensorion and Cochlear Announce Strategic Collaboration for Patients with Cochlear Implants

Sensorion Receives Orphan Drug Designation for Chemotherapy-Induced, Hearing Loss Treatment