CILcare
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Montferrier on Lez, FR
A preclinical provider in otology, we are uniquely qualified in the functions of the ear, a complex sensory organ which remains under-explored. Established in Boston, Paris, and Montpellier, we have state-of-the art laboratories, research experts in otology and neurosciences, as well as a global network of partners. This enables us to offer fully customizable and comprehensive R&D programs including pharmacokinetics, preclinical efficacy, and GLP ototoxicology studies.
Our talented team is deeply committed to its mission: “To accelerate the development of novel therapies to prevent and treat hearing loss, tinnitus, and otitis, in order to provide solutions to millions of patients suffering from ear diseases, waiting for effective treatment.”
Drawing on our extensive industrial background, we also provide consultancy services to speed up your product’s R&D cycle time. CILcare works with academic research centers, private companies operating in pharmaceuticals, medical devices, nutraceuticals, and animal health, as well as patient associations and venture capital funds. A trusted CRO partner with the ambition to catalyze research & development in hearing disorders on a global scale, join us as we fight for this cause:
The care of this extraordinary sense: hearing.
CILcare provides a broad range of in vivo validated pharmacological models to assess hearing loss, tinnitus, and ear inflammation. With our state-of-the-art facilities and the most advanced instrumentation and technology, we offer you customized studies to best address your requirements. We operate with 3 different preclinical platforms:
Hearing loss platform
- Age-related hearing loss
- Noise-induced hearing loss (permanent and temporary)
- Drug-induced ototoxicity (cisplatin and gentamicin)
Tinnitus platform
- Salicylate-induced tinnitus
- Noise-induced tinnitus
Otitis platform
- Otitis Media with effusion
- Acute Otits Media
Whatever the route of administration, the drug candidate in hearing loss or tinnitus has to reach its target, the inner ear, at the desired concentration. CILcare’s PK studies allow to assess the bioavailability of the candidate in the inner ear, to determine its kinetic profile, and to estimate the best time-point and concentration for dosing in a following efficacy study.
- Route of administration: local (transtympanic, intrabullar, intracochlear, round window niche) and systemic (PO, IP, IV, SC)
- Samplings: perilymph, tympanic bulla, CSF, different brain structures, plasma
- Bioanalysis
Services provided in partnership with CBSET
Clinical data confirms that many therapeutic compounds, including those targeting indications unrelated to hearing and otic disorders, should be tested for auditory safety. Ototoxicity and associated auditory pathology may affect millions of patients taking medications, potentially contributing to diminished quality of life.
Additionally, several promising drugs and devices are currently in development for improving the lives of 466 million people suffering from hearing loss, the majority of which are suffering from conditions for which regulatory agencies recognize no efficacious therapy. To meet these challenges, the auditory specialists at CILcare and the Boston-based GLP-compliant CRO CBSET, Inc. have created a strategic alliance to offer drug and device developers cutting-edge preclinical services for the evaluation of auditory functions in a regulated GLP environment.
How to evaluate auditory safety?
FDA guidance documents specify auditory safety evaluation utilizing two methodologies* :
1/ In vivo assessment : measure of Auditory Brainstem Responses (ABR)
Auditory Brainstem Responses (ABR)are electric potentials recorded from scalp electrodes. This non-invasive method allows to determine auditory response threshold. It is translational between rodents and human, and is commonly used for screening newborns.
2/ Ex vivo assessment : cytocochleogram
The cytocochleogram allows histopathological assessment of ototoxic damage on inner hair cells and outer hair cells of the cochlea, with anatomical localization corresponding to predicable patterns of functional deficits.
Fortify your IND application
CILcare and CBSET combine scientific excellence in otology with experienced, GLP-compliant, preclinical experience to reduce risk in your regulatory filings. From general toxicology studies to surgical services, our team has the capability to customize a full preclinical program in line with your IND approach and project milestones. The collaboration between CILcare and CBSET creates a highly experienced team offering complex transtympanic and intracochlear drug delivery methods which limit systemic exposure and provide robust, reproducible data in support of your ototoxicity or auditory function program.
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