Case Study

Advancing A Cell Therapy Drug To The Clinic: Safety Tox Package

Source: Syngene International Ltd.

Cytopeutics was searching for a partner to prove the safety of its cell therapy products (e.g., hMSCs) prior to submission to regulatory authorities in the Asia Pacific region and National Pharmaceutical Regulatory Agency, Malaysia. The company was interested in conducting clinical trials for disease indications like autoimmune and other diseases.

Cytopeutics partnerned with Syngene to conduct safety and tumorigenicity studies in appropriate animal models (including immunocompromised) for its hMSC product as per regulatory guidelines. The data was used to design human clinical trials prior to NDA filing. Based on these studies, Cytopeutics went on to receive Malaysia’s precedent CTX license under Cell and Gene Therapy for the manufacturing of its hMSCs for clinical and investigational use.

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