Following meetings with the FDA (the medicines regulator in the US), Capricor Therapeutics yesterday issued an update yesterday on it’s HOPE-2 phase 2 clinical trial of CAP-1002, a potential treatment for Duchenne muscular dystrophy.
Just before Christmas, a participant in the trial suffered a severe allergic reaction after receiving an infusion of CAP-1002. The company voluntarily placed the trial on hold while it investigated what had happened and since then, Capricor has been working to develop a plan to manage potential allergic reactions. To prevent future events, a new pre-medication strategy that is commonly used to prevent and treat allergic reactions will be include in the trial.
This has now been approved by the trials Data and Safety Monitoring Board, and the FDA have approved the resumption of the trial – encouraging news for families. The timing of the trial’s resumption will depend upon various factors, including the availability of additional funding.
CAP-1002 consists of a specific type of cell called cardiosphere-derived cells taken from donors. These cells have been shown in pre-clinical studies to modify the immune system’s activity and to encourage cellular regeneration. The phase 2 trial is investigating whether this therapeutic approach is safe and effective in people living with Duchenne and is being carried out in centres across the US.
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Contact Neil Bennett, Director of Research, to find out more on 020 7250 8240
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