FDA clinical trial to treat COVID-19 coronavirus that “flattens the curve” in patients

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Therapeutics startup Celularity announced Thursday morning that it has received FDA clearance to begin a clinical trial of a proposed stem cell therapy for COVID-19. New Jersey-based company approval IND application allows the company to start a clinical trial with patients with the disease.

The company’s therapy, currently called CYNK-001, uses “Natural Killer” (NK) cells, a form of white blood cells that fight war against cancer and viral infections, derived from placental stem cells. The company has been developing similar treatments for cancer and Crohn’s disease for several years, many of which are also being tested.

The idea behind the therapy is that for patients who are starting to show symptoms, or who may be at risk for a more severe form of the disease, may be given an intravenous infusion of NK cells to boost their immune response to the virus, explains founder and CEO Robert Hariri. This is because extra NK cells help slow the ability of viruses to replicate in the body. It is an approach he compares to social distancing – slowing the spread of COVID-19 so hospitals are not overwhelmed yet – within the patients themselves.

“By administering our NK cells to patients, we are working to” flatten the viral titer curve “so that the patient’s adaptive immune system can turn on and do the job of eliminating the virus,” he said.

Celularity was co-founded by the president of the Hariri and X Prize Foundation Peter Diamandis in 2016 as a spin-off of the pharmaceutical company Celgene. About ten years ago, the company found itself in the field of collecting and storing umbilical cord blood from the placentas after birth. Undifferentiated stem cells in the blood offer a universal way to generate NK cells that potentially reduce the risk of rejection or other complications.

It is a strategy that has won the support of the company from investors like Bill Maris in Section 32, Sorrento Therapeutics and former Apple CEO John Sculley. According to Pitchbook, the company has raised more than $ 327 million in support to date.

The main objective of the company’s therapeutic efforts has been to take advantage of these treatments for forms of cancer such as myeloma and leukemia. But because NK cells are often involved in protecting the body from viruses, Hariri says he still turns to society one day after infectious diseases.

According to Hariri, it may take only a few days to see the results of the first clinical trial of COVID-19 patients. This test will involve the use of the treatment in a group of patients up to 86 people. If successful, Hariri hopes that these results will mean acceleration to a larger trial, and then, if all goes well, to the market.

“It is a very easy product to deploy,” said Hariri. “We hope that if we get enough convincing data, the agency and the CDC and NIH will work with us to increase production. “

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