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Cynata Therapeutics Ltd crosses major milestone in the U.S.

The company recently announced a strategic agreement with Fujifilm.

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Regulatory approval path cleared for stem cell therapies

Cynata Therapeutics Ltd (ASX:CYP) has crossed a major milestone by successfully completed the pre-IND (investigational new drug) meeting with the U.S. FDA (Food and Drug Administration).

The company has received written advice from the FDA regarding the regulatory approval path for its proprietary Cymerus™ mesenchymal stem cell (MSC) products in the U.S.

Cynata is developing cellular therapies to treat respiratory disease, cardiovascular disease and a number of other serious conditions.

The FDA confirmed that the scope and substance of Cynata’s “Chemistry, Manufacturing and Controls” dossier is commensurate with its expectations.

This indicates that Cymerus™ MSC products are expected to be of suitable quality for clinical trial use in the U.S.

Cynata also received clarification on the design of preclinical studies required to support a U.S. IND.

The company anticipates conducting those studies in parallel with the ongoing clinical trial of CYP-001 for the treatment of graft-versus-host disease (GvHD) being conducted in the UK and Australia.

The FDA also provided advice regarding the protocol for a planned GvHD clinical trial in the U.S.

Earlier this year, Cynata announced a strategic agreement with Fujifilm which included the Japanese company investing A$4 million in Cynata to become its largest shareholder.

The global regenerative medicine market was worth US$18.9 billion in 2016 and is expected to exceed US$53.7 billion by 2021.

Quick facts: Cynata Therapeutics Ltd

Price: 0.83 AUD

ASX:CYP
Market: ASX
Market Cap: $97.21 m
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Cynata Therapeutics Ltd (ASX:CYP) (OTCMKTS:CYYNF) CEO Ross Macdonald tells Proactive's Christine Corrado the cell therapy company has met the clinical endpoints of a Phase 1 trial of its Cymerus mesenchymal stem cell (MSC) product candidate in people with steroid-resistant acute...

on 09/10/2018

2 min read