Longeveron Inc (NASDAQ: LGVN) is a clinical biotech firm that develops cellular therapies to treat life-threatening and aging-related conditions. It announced that it had received approval from the FDA for the RPD (Rare Pediatric Disease) designation for its Lomecel-B to treat Hypoplastic Left Heart Syndrome.
HLHS is a life-threatening and rare congenital heart complication in infants. Longeveron’s Lomecel-B clinical product is a bone marrow-derived, investigational allogeneic MSC (medicinal signaling cell) product that the company is currently evaluating in Phase II clinical trial.
What does top brass say?
Longeveron’s Chief Science Officer and Co-Founder, Joshua Hare, M.D. said:
We are pleased by FDA’s acknowledgment of the urgent need for a safe and effective treatment for children born with this rare and devastating congenital heart defect.
The CSO continued to say:
We are encouraged by our Phase 1 clinical data, and the progress being made in the ongoing Phase 2 trial. Lomecel-B represents a unique cell therapy approach that could potentially be administered at the same time as surgery in these critically impacted infants.
Important facts about HLHS
Roughly 1000 babies in the United States are born with Hypoplastic Left Heart Syndrome every year. Infants that are suffering from HLHS have a heart that’s got an underdeveloped left ventricle. This makes it harder for the infant’s heart to pump blood to the rest of the body.
HLHS will often kill an infant if surgery isn’t performed to give the duty of pumping blood to the right ventricle. The whole process involves 3 surgical procedures that should be done over around 5 years. Longeveron is analyzing how safe a Lomecel-B injection to the right ventricle will be during the second surgery.
Phase I clinical trials
The company recently reported its results for its Phase I safety-focused clinical trials for Lomecel-B.
When surgeons injected it into the hearts of the babies undergoing surgery, their bodies tolerated it well with no infections and no major detrimental cardiac events that could be linked back to Longeveron’s investigational medical treatment.
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