Positive preclinical results supporting investigational new drug application for anti-inflammatory cell therapy for heart failure

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BioCardia has announced data from a recent animal study performed that, according to a press release, demonstrate meaningful improvements in heart function for patients treated with its allogenic neurokinin 1 receptor positive mesenchymal stem cell (NK1R+ MSC) programme for heart failure (CardiALLO). Additionally, BioCardia is planning further exploration and discussion with the US Food and Drug Administration (FDA) on the use of its allogenic cells for COVID-19 related acute respiratory distress syndrome.  

The press release reports that in the 26 animals treated with both low dose and high dose NK1R+ MSC, echocardiographic measures of cardiac ejection fraction, fractional shortening and cardiac outflow were meaningfully improved, with all three measures being statistically significant for both dosage levels over control animals. It adds that the CardiALLO cell therapy is being developed initially to treat heart failure patients whose cells do not qualify for its lead autologous cell therapy, CardiAMP (BCDA-01).

BioCardia chief scientific officer Ian McNiece, PhD, says: “In light of these positive data on our allogenic NK1R+ MSC therapy, we expect to meet our internal timeline to complete our submission to the FDA for our first indication for CardiALLO, and potentially receive IND acceptance by the end of the second quarter. The MSCs that were studied are subtypes of MSC that we have delivered previously in our co-sponsored trials, which we believe have enhanced potency over MSC generated from unselected bone marrow cells. We look forward to seeing additional data from this animal study that are currently being analysed, including histology and pathology of the heart and lungs.”

The company also intends to submit an IND for the use of its NK1R+ MSC delivered via intravenous (IV) infusion for acute respiratory distress syndrome caused by COVID-19. The anti-inflammatory effects of MSC have been well-documented and MSC have been shown to reduce inflammation and injury in models of lung disease. The specific MSCs used in BioCardia’s allogenic cell therapy are expanded from cells selected for the presence of the NK1 receptor, which is known to bind to substance P, an important neuropeptide associated with inflammation throughout the body and a primary mediator of inflammation in the airways.

BioCardia CEO Peter Altman, comments: “Our NK1R+ allogenic MSC may have more potential than other MSC approaches being advanced today due to their interaction with Substance P. This COVID-19 related work will be the company’s first clinical investigation outside of the cardiac space and our first exploring therapy for the lung. A recent patent publication shows that BioCardia has long intended for these remarkable reparative cells to be targeted for respiratory disorders, in addition to cardiovascular disease. Addressing inflammation in the lungs is an important contribution we may be able to make using our NK1R+ allogenic MSC therapy.”


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