Anonymous ID: 94e693 April 19, 2020, 10:44 p.m. No.8859626   🗄️.is 🔗kun   >>9633 >>9800 >>9985 >>0062 >>0088 >>0205 >>0255

This sounds scary:

 

Celularity, the venture-backed developer of novel cell therapies for cancer treatments, has received an initial clearance from the Food and Drug Administration to begin early-stage clinical trials on a potential treatment for COVID-19.

 

The company, which has raised at least $290 million to date (according to Crunchbase), uses “Natural Killer” (NK) cell therapies to boost the immune system’s disease-fighting response.

 

For Celularity, those NK cells are derived from stem cells cultivated from placental tissue, which hospitals typically treat as medical waste.

 

Backed by the venture investment firm Section 32, and strategic investors including Celgene, now a division of Bristol Myers; United Therapeutics, a biomedical technology developer; Human Longevity, the troubled venture-backed startup founded by J. Craig Venter; and Sorrento Therapeutics, a publicly traded biomedical company, Celularity was pursuing a number of applications of the novel cell therapy, but its initial focus was on cancer treatments.

 

The real breakthrough for the company, and one of the reasons it has attracted so much capital, is that its cell therapies don’t need to be cultivated from a patient donor — a lengthy and expensive process. Celularity is able to produce NK cells and store them, so that they can be ready for transfusion when they’re needed.

 

With the the FDA’s clearance, Celularity is going to begin a small, 86-person trial to test the efficacy of its CYNK-001 immunotherapy to treat COVID-19 infected adults, the company said.

 

There are at least two studies underway in China that are also testing whether Natural Killer cells can be used to treat COVID-19.

 

NK cells are a type of white blood cell that are part of the body’s immune system. Unlike t-cells, which target particular pathogens, NK cells typically work to support the immune system by identifying and destroying cells in the body that appear to be stressed, either from an infection or a mutation.

 

The therapy seems to be successful in treating certain types of cancer, and the company’s researchers speculate that it can provide similar results in stopping the ability of the novel coronavirus, which causes COVID-19 to spread throughout the body.

 

However, there are some potential roadblocks and risks to pursuing the NK therapy. Chiefly, COVID-19 is deadly in part because it can push the immune system into overdrive. The “cytokine storm” that results from the infection means that the body starts attacking healthy cells in the lungs, which leads to organ failure and death. If that’s the case, then boosting the immune response to COVID-19 might be dangerous for patients.

 

There’s also the possibility that NK cells might not be able to detect which cells are infected with the coronavirus which causes COVID-19, rendering the therapy ineffective.

 

“Studies have established that there is robust activation of NK cells during viral infection regardless of the virus class,” said Celularity’s chief scientific officer, Xiaokui Zhang, in a statement. “These functions suggest that CYNK-001 could provide a benefit to COVID-19 patients in terms of limiting SARS-CoV-2 replication and disease progression by eliminating the infected cells.”

Anonymous ID: 94e693 April 19, 2020, 10:54 p.m. No.8859684   🗄️.is 🔗kun   >>9800 >>9985 >>0088 >>0205 >>0255

FDA Approves First Generic of a Commonly Used Albuterol Inhaler to Treat and Prevent Bronchospasm

 

For Immediate Release:

April 08, 2020

 

The U.S. Food and Drug Administration today approved the first generic of Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation, for the treatment or prevention of bronchospasm in patients four years of age and older who have reversible obstructive airway disease, as well as the prevention of exercise-induced bronchospasm in this age group.

 

“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Stephen M. Hahn, M.D. “We remain deeply committed to facilitating access to medical products to help address critical needs of the American public.”

 

According to the National Heart, Lung, and Blood Institute, bronchospasms occur when the muscles surrounding the airways swell and tighten, causing them to squeeze the airways and make them smaller. Exercise and other physical activity can bring on symptoms in most people who have asthma and may occur either during or right after being active. Asthma causes recurring periods of wheezing (a whistling sound when breathing), chest tightness, shortness of breath and coughing. The coughing often worsens at night or early in the morning. Asthma affects people of all ages, but it most often starts during childhood. In the United States, more than 26 million people are known to have asthma, about 7 million of these people are children.

 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-commonly-used-albuterol-inhaler-treat-and-prevent-bronchospasm