Otolaryngology Head & Neck Surgery

Mount Sinai, NY, United States

Otolaryngology Head & Neck Surgery

Mount Sinai, NY, United States
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Strekin AG, a privately held clinical-stage biopharmaceutical company, announced today the presentation of new preclinical data and an update on Strekin's Phase 2 clinical development program for STR001 in the treatment of hearing loss at the Association for Research in Otolaryngology Conference (ARO), Baltimore, USA. STR001-201 is a Phase 2 clinical trial of STR001 intratympanic injection for the treatment of Sudden Sensorineural Hearing Loss (SSHL) caused by Cochlear Implantation (CI) surgery. An undesired outcome of CI is the loss of residual low-frequency hearing due to electrode insertion. STR001-201 is an international, multicenter, randomized, placebo-controlled trial evaluating the efficacy, safety and tolerability of STR001-IT in 110 patients undergoing CI.  As of 10 Feb 2017, the STR001-201 trial has enrolled 50 patients in four countries.  STR001-IT treatment has been very well tolerated with no adverse events of concern identified. Top-line clinical trial results are expected in the 4th quarter of 2017. In a poster presentation (#PS792) entitled "Peroxisome proliferator activated receptor -gamma and -alpha agonists protect auditory hair cells from gentamicin-induced oxidative stress and apoptosis", researchers observed that the PPAR agonist pioglitazone, the active ingredient in STR001, was highly effective in preventing damage to sensory hair cells of the inner ear. The research was led by Daniel Bodmer, MD, PhD, and Chairman of the Department of Otolaryngology Head & Neck Surgery at the University Hospital of Basel, Switzerland. Dr. Bodmer's analysis was performed in a model in hearing research in which the organ of Corti, the structure containing auditory hair and sensory cells, was studied in tissue culture. Treatment of cultures with gentamicin, an antibiotic that leads to hearing loss in humans, caused loss of hair cells which was almost completely prevented by STR001.  Further analysis showed that gentamicin induced oxygen free radicals, promoted lipid oxidation, and activated the cell death pathway (apoptosis) in hair cells, all of which were prevented by STR001. In a second presentation (PS159) entitled "Intra-tympanic Administration of Pioglitazone, a Peroxisome Proliferator-Activated Receptor Gamma Agonist, Protects from Noise-Induced Hearing Loss"  Dr. Anna-Rita Fetoni and her colleagues from the Catholic University of Rome, showed that a single intratympanic injection of STR001-IT was highly effective in a rodent model of noise-induced hearing loss. STR001 promted complete recovery of hearing when given shortly afer noise. Recovery was accompanied by a strong reduction in markers of oxidative stress in auditory hair cells. Delayed STR001 treatment to 48h after noise promoted partial recovery, which has not, to our knowledge, been shown for other drugs. These data, together with the data from Dr. Bodmer's group, suggest that STR001 has the potential to be a new and differentiated therapy for many types of hearing loss through favorable effects on multiple pathways. Strekin is a privately held clinical-stage biopharmaceutical company in Basel, Switzerland. Strekin is led by an experienced team in research and clinical development. Strekin has secured funding to complete the Phase 2 study of STR001 and to pursue further development with the support of investors and partners. According to the World Health Organization, 642 million people around the world including 181 million children suffer from disabling hearing loss. Daily activities that most people take for granted, like having a conversation, enjoying music, and advancing in the workplace, are difficult or impossible for individuals suffering from hearing loss. With no approved pharmaceutical therapies available today, there is urgency to develop effective treatments.

Molfenter S.M.,New York University | Amin M.R.,New York University | Branski R.C.,New York University | Brumm J.D.,New York University | And 3 more authors.
Dysphagia | Year: 2015

Age-related loss of muscle bulk and strength (sarcopenia) is often cited as a potential mechanism underlying age-related changes in swallowing. Our goal was to explore this phenomenon in the pharynx, specifically, by measuring pharyngeal wall thickness and pharyngeal lumen area in a sample of young versus older women. MRI scans of the neck were retrospectively reviewed from 60 women equally stratified into three age groups (20s, 60s, 70+). Four de-identified slices were extracted per scan for randomized, blinded analysis: one mid-sagittal and three axial slices were selected at the anterior inferior border of C2 and C3, and at the pit of the vallecula. Pixel-based measures of pharyngeal wall thickness and pharyngeal lumen area were completed using ImageJ and then converted to metric units. Measures of pharyngeal wall thickness and pharyngeal lumen area were compared between age groups with one-way ANOVAs using Sidak adjustments for post-hoc pairwise comparisons. A significant main effect for age was observed across all variables whereby pharyngeal wall thickness decreased and pharyngeal lumen area increased with advancing age. Pairwise comparisons revealed significant differences between 20s versus 70+ for all variables and 20s versus 60s for all variables except those measured at C2. Effect sizes ranged from 0.54 to 1.34. Consistent with existing sacropenia literature, the pharyngeal muscles appear to atrophy with age and consequently, the size of the pharyngeal lumen increases. © 2015, Springer Science+Business Media New York.

PubMed | New York Eye and Ear Infirmary of Mount Sinai, The Voice and Swallowing Institute and Otolaryngology Head & Neck Surgery
Type: Journal Article | Journal: The Annals of otology, rhinology, and laryngology | Year: 2016

Evaluate the histologic effects of grafting porcine-derived small intestinal submucosa (SIS) into the vocal fold superficial lamina propria (SLP) layer for the potential treatment of vocal fold scar, sulcus and superficial lamina propria atrophy.Small intestinal submucosa was implanted into the right vocal fold SLP of 6 mongrel dogs. The left vocal fold served as a sham surgical control. At 2, 4, and 6 weeks postoperative, bilateral vocal fold specimens were evaluated histologically.At 2 and 4 weeks, respectively, SIS-implanted vocal folds demonstrated moderate and mild inflammation and acute and chronic inflammation. At 6 weeks, inflammation was minimal and chronic. The 6-week specimens showed copious amounts of newly generated hyaluronic acid (HA) within the graft. There was no reactive fibrosis at 6 weeks.In the canine model, SIS appears safe for SLP grafting. Inflammation is similar to that of sham surgery. Small intestinal submucosa results in newly generated HA without concomitant fibrosis. Small intestinal submucosa has potential to be used in treatment of disorders with SLP, including vocal fold scar, sulcus, and atrophy. Studies evaluating the effect of SIS implantation on vocal fold function, as well as the ultimate fate of the graft, are required.

PubMed | Otolaryngology Head & Neck Surgery;
Type: Journal Article | Journal: The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale | Year: 2012

To retrospectively review trends in clindamycin resistance among Staphylococcus aureus head and neck abscesses between January 2000 and June 2008.Between January 2000 and June 2008, inpatient and out-patient S aureus isolates were reviewed for antibiotic susceptibility. In particular, cultures from 153 abscesses in the head and neck region were assessed for clindamycin and methicillin resistance patterns.Annual clindamycin resistance rates for all S aureus isolates, and specifically for S aureus head and neck abscesses, revealed concerning levels of clindamycin and methicillin resistance. After 2002, the mean clindamycin resistance rate in head and neck abscesses was approximately 27%. The number of new cases of methicillin-resistant S aureus per year increased from four cases in 2000 to 44 cases in 2007.Antibiotic resistance should be considered following failed empirical therapy of head and neck abscesses with clindamycin.

News Article | February 15, 2017
Site: www.prnewswire.co.uk

Strekin AG, una compañía biofarmacéutica de propiedad privada y en fase clínica, anunció hoy la presentación de los nuevos datos preclínicos y la actualización del programa de desarrollo clínico en fase 2 de Strekin para STR001 en el tratamiento de la pérdida auditiva durante la celebración de la Association for Research in Otolaryngology Conference (ARO) en Baltimore, Estados Unidos. STR001-201 es un ensayo clínico en fase 2 de la inyección intra-timpánica STR001 para el tratamiento de la pérdida auditiva repentina sensorineural (SSHL) causada por la cirugía de implantación coclear (CI). Un resultado no deseado de CI es la pérdida de audición residual de baja frecuencia debido a la inserción de electrodos. STR001-201 es un ensayo internacional, multicentro, aleatorio y controlado por placebo que evaluó la eficacia, seguridad y tolerabilidad de STR001-IT en 110 pacientes con CI. A fecha de 10 de febrero de 2017, el ensayo STR001-201 había reclutado a 50 pacientes en cuatro países. El tratamiento con STR001-IT se había tolerado correctamente y sin efectos secundarios preocupantes identificados. Los resultados de los ensayos clínicos de primera línea se esperan para el cuarto trimestre de 2017. En una presentación poster (#PS792) titulada "Peroxisome proliferator activated receptor -gamma and -alpha agonists protect auditory hair cells from gentamicin-induced oxidative stress and apoptosis", los investigadores han observado que la pioglitazona agonista PPAR, ingrediente activo de STR001, fue altamente eficaz en la prevención de los daños de las células sensoriales del pelo del interior de la oreja. La investigación la dirigió Daniel Bodmer, doctor, PhD y presidente del Department of Otolaryngology Head & Neck Surgery del Hospital Universitario de Basilea, Suiza. El análisis del doctor Bodmer lo llevó a cabo en un modelo de investigación de audición en el que el órgano de Corti, la estructura que contiene el pelo auditorio y células sensoriales, se estudió dentro del cultivo del tejido. El tratamiento de los cultivos con gentamicina, un antibiótico que lleva a la pérdida de audición en los humanos, causó una pérdida de células de pelo que era casi completamente prevenible con STR001. Un análisis posterior demostró que los radicales sin oxígeno inducidos por gentamicina promueven la oxidación de los lípidos y activan la ruta de muerte celular (apoptosis) en las células de los pelos, todo ello prevenible con STR001. En una segunda presentación (PS159) titulada "Intra-tympanic Administration of Pioglitazone, a Peroxisome Proliferator-Activated Receptor Gamma Agonist, Protects from Noise-Induced Hearing Loss", la doctora Anna-Rita Fetoni y sus colegas de la Universidad Católica de Roma, demostraron que una única inyección intra-timpánica de STR001-IT fue altamente eficaz en un modelo de roedor con pérdida de audición inducida por ruido. STR001 promovió la recuperación completa de audición cuando se le suministró justo después del ruido. La recuperación estuvo acompañada de una reducción destacada en los marcadores de estrés de oxidación en las células de pelos de audición. El tratamiento retrasado con STR001 hasta 48 horas después del ruido promocionó una recuperación parcial, que por lo que sabemos, no se ha demostrado en otros fármacos. Estos datos, junto a los datos del grupo del doctor Bodmer, sugieren que STR001 cuenta con potencial para ser una terapia nueva y diferente de muchos tipos de pérdida auditiva a través de los efectos favorables en múltiples rutas. Strekin es una compañía de ciencias de la vida en fase clínica de propiedad privada localizada en Basilea, Suiza. Strekin está dirigida por un equipo experimentado con un fuerte historial en investigación y desarrollo clínico. Strekin está financiada suficientemente para completar el estudio de fase 2 de STR001 y preparar otros desarrollos clínicos con el apoyo de inversores o socios. Según la Organización Mundial de la Salud, 642 millones de personas de todo el mundo, incluyendo 181 millones de niños, sufren hoy de pérdida auditiva discapacitadora. Las actividades diarias que la mayoría de las personas dan por hecho, como tener una conversación, escuchar música y avanzar en el espacio de trabajo, son difíciles o imposibles para las personas que padecen pérdida auditiva. Sin terapias farmacéuticas aprobadas disponibles hoy, hay una renovada urgencia por desarrollar tratamientos efectivos para la pérdida auditiva.

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