Author: Carlton Hoyt

Collaboration to Enhance Preclinical and Clinical Research Capabilities

CHARLOTTE, N.C.; Oct. 22, 2024 (Business Wire) – Catawba Research, a leading global full-service Clinical Research Organization (CRO), is proud to announce a strategic partnership with PharmaLegacy Laboratories, a recognized leader in preclinical contract research services. This collaboration is set to leverage both companies’ strengths, driving innovation and excellence in drug development and provides Catawba Research with new access to China, further expanding their APAC capabilities.

PharmaLegacy Laboratories specializes in advanced preclinical models and pharmacology research, with an emphasis on supporting biotechnology and pharmaceutical companies in their drug discovery and development efforts. The collaboration enhances Catawba Research’s outstanding agile solution offerings and scientific focus. 

“We are thrilled to partner with PharmaLegacy,” said Andy Silverman, CEO of Catawba Research. “Their depth of expertise in preclinical research aligns perfectly with Catawba’s commitment to delivering high-quality, efficient clinical trial management. This collaboration allows us to offer end-to-end solutions for our clients, accelerating the drug development process while maintaining the highest standards of scientific integrity.”

Jeff Duan, CEO of PharmaLegacy, added, “Catawba Research has a stellar reputation in the clinical research space, and we believe that by combining our capabilities, we can offer our clients a truly comprehensive research experience. Together, we can help to bring new therapies to market to benefit patients more effectively and efficiently.”

The partnership will streamline drug development for our customers by offering a single source for both preclinical and clinical trial services. The combined expertise will ensure that drug candidates are tested and validated using the most rigorous methods, enabling faster and more reliable delivery of new treatments to patients in need.

About Catawba Research

Catawba Research is a global full-service Clinical Research Organization that provides oversight, management, and implementation for Phase II and Phase III clinical trials. Headquartered in Charlotte, NC, Catawba works with drug-development sponsors to bring innovative treatments to the global market.

About PharmaLegacy Laboratories

PharmaLegacy Laboratories, headquartered in Shanghai, a global leading preclinical Contract Research Organization, is dedicated to accelerating the adoption of new therapies, resulting from the integration of new drug R&D and translational research, by providing the most clinically relevant, science-based specialty pharmacology and toxicology services to global pharmaceutical and biotech companies enabling the development of new drugs and therapies.

Recently, The Lancet published the world’s first clinical trial study on gene therapy for hereditary deafness. This study has proved the safety and demonstrated the great potential of gene therapy for the treatment of hereditary deafness, which has attracted extensive attention from medical community.

The deafness gene therapy drug RRG-003 (AAV1-hOTOF), used in this study was jointly developed by Eye & ENT Hospital of Fudan University, Harvard Medical School and Shanghai Refreshgene Therapeutics Co., Ltd. This study reported the safety and efficacy of gene therapy with an adeno-associated virus (AAV) serotype 1 carrying a human OTOF transgene (AAV1-hOTOF) as a treatment for children with autosomal recessive deafness 9.

Preclinical studies of this gene therapy were published in November 2023 in Molecular Therapy-Methods & Clinical Development. PharmaLegacy participated in the preclinical safety evaluation of the gene therapy, helping it to smoothly start the IIT study.

PharmaLegacy’s advanced and comprehensive hearing research platform can provide services ranging from early product development to preclinical research, including pharmacokinetic, efficacy, and safety evaluation. The team has extensive experience helping clients all over the globe in their preclinical stage R&D.

Hearing Loss Model

A variety of hearing impairment models can be provided by PharmaLegacy, including noise exposure, chemotherapy drug induction (e.g. cisplatin), aminoglycoside antibiotic induction, transgenic mice, aged mice, and others.

Local Delivery

PharmaLegacy’s hearing team has rich experience in local delivery, and accurately completed the injection without affecting hearing.
Middle ear delivery (1. Transtympanic injection; 2. Bulla ostomy)
Inner ear delivery (3. Round window membrane delivery; 4. Posterior semicircular canal injection; 5. Cochlea ostomy)

Pharmacokinetic (PK) Studies

PharmaLegacy provides drug PK laboratory services, including local PK (Perilymph collection).

Auditory Function Evaluation

PharmaLegacy has multiple sets of hearing test system that provide high-throughput auditory brainstem response, ABR) and distortion product otoacoustic emissions (DPOAES).

Cochlear Explants & SGNs Culture

PharmaLegacy provides isolation, culture, and drug evaluation in newborn animals of cochlear explants and spiral ganglion neurons (SGNs).

Lab Animals for Hearing Studies

PharmaLegacy conducts hearing studies in mice, rats, guinea pigs, and non-human primates.

Ex vivo Assays

A variety of ex vivo assay services are available, including cochlear implants, frozen/paraffin sections, immunofluorescence and immunohistochemistry.

PharmaLegacy’s confocal imaging platform (Nikon AX laser confocal microscope) can fully meet various requirements for high-quality imaging.

References:

• Lv J, Wang H, Cheng X, et al. AAV1-hOTOF gene therapy for autosomal recessive deafness 9: a single-arm trial. Lancet. Published online January 24, 2024.
• Zhang L, Wang H, Xun M, et al. Preclinical evaluation of the efficacy and safety of AAV1-hOTOF in mice and nonhuman primates. Mol Ther Methods Clin Dev. 2023; 31:101154.
• Fang QJ, Wu F, Chai R, Sha SH. Cochlear Surface Preparation in the Adult Mouse. J Vis Exp. 2019; (153):10.3791/60299.
• https://mp.weixin.qq.com/s/foSOaFxOhIvYRxXT09DCLA