Sensorion Completes Second Cohort Enrollment in OTOF Gene Therapy Clinical Trial
SENS-501 is a gene therapy candidate being developed to treat a form of congenital deafness linked to mutations in the OTOF (otoferlin) gene.
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Sensorion Announces Disappointing Results from SSNHL Drug Trial
The company reports that SENS-401 was “safe and well tolerated, however, it did not meet the primary endpoint of 15 dB, a significant improvement in pure tone audiometry (PTA, dB) in the affected ear from baseline in comparison to placebo at the end of the four-week treatment period.”
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Sensorion Receives Approval for Additional Military Sites in Phase 2 Drug Study
The new centers will recruit volunteer military personnel exposed to impulse noise during their professional activities and suffering from hearing loss.
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).
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Sensorion Awarded $11 Million Research Grant for Congenital Deafness
The aim of this project is to develop a specific gene therapy program aimed at correcting an inherited monogenic form of deafness caused by a mutation in the gene encoding for the Otoferlin protein (DNBF9).
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Sensorion Awarded $11 Million Research Grant for Congenital Deafness
The aim of this project is to develop a specific gene therapy program aimed at correcting an inherited monogenic form of deafness caused by a mutation in the gene encoding for the Otoferlin protein (DNBF9).
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Sensorion Partners with Institut Pasteur on Research Framework Targeting Hearing Loss
Sensorion and Institut Pasteur have leveraged the last six months to reach a partnership framework agreement. This agreement provides for, after completion of a research program, an exclusive option to obtain licenses.
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University of Connecticut Researchers Find Protein Connected with Hearing Loss
UConn otolaryngologist Kourosh Parham and his colleagues report in “Hearing Research” that levels of prestin, a protein found only in cells in the inner ear, rise sharply when those cells are damaged and start to die.
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Sensorion Announces Positive Topline Results from Vertigo Drug Study
The company reports that Seliforant, in contrast to Meclizine, has no negative CNS side effects such as sedation, impairment of memory, and cognitive performance.
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Sensorion Announces Publication of Paper in ‘Hearing Research’
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.
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Sensorion and Pasteur Institute to Collaborate on Gene Therapy Products
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.
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Sensorion Announces Publication of Seliforant Phase 1 Study Data
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.
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Webinar on Pediatric Chemo-Induced Hearing Loss to Be Held September 13
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.
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Sensorion Receives Approval for SENS-401 Phase 2 Clinical Trial
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.
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Sensorion Announces Initiation of Phase 2 Study for Vertigo Drug Seliforant
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.
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Sensorion Presents SENS-401 Data at Ci2018 Conference
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.
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Sensorion Appoints Dr Christine Petit as Chair, Scientific Advisory Board
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.
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Potential Biomarker for Noise-Induced Hearing Loss Identified by Sensorion, UConn Health
The laboratory study identified changes in prestin blood levels, an outer hair cell (OHC) protein, in a preclinical model with noise-induced hearing loss.
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