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Tue Apr 28, 2020, 02:50 PM

Atrium Health launches first clinical trial for Covid-19 patients (Xpovio/Selinexor)

Charlotte Business Journal
By Caroline Hudson
29 minutes ago

Charlotte's Atrium Health is participating in an international clinical trial to treat coronavirus (Covid-19) patients.

The trial is with Selinexor, an oral drug used to treat multiple myeloma, a type of cancer in bone marrow. The anti-viral and anti-inflammatory drug has also been shown to kill the Covid-19 virus. This trial, known as the XPORT trial, spans about 15 countries, including more than 10 sites in the United States, said Dr. Zainab Shahid, medical director of bone marrow transplant infectious diseases at Levine Cancer Institute. Shahid is the trial's principal investigator.

Patients at Carolinas Medical Center, Atrium Health-Cabarrus, Atrium Health-Pineville and Atrium Health-University may be eligible to participate. They take the pill every other day and can do so at home. The trial lasts two weeks.

Shahid hopes to enroll one to two patients per week. Atrium screened its first patient on Tuesday morning, she said. Part of her role is to work with doctors to find eligible patients and then connect those patients with the clinical trial team. The trial is for patients with more serious Covid-19 symptoms — they could be hospitalized with upper-respiratory issues, for example. Supportive care is more appropriate for mild cases, Shahid said.

More here: https://www.bizjournals.com/charlotte/news/2020/04/28/atrium-health-launches-first-clinical-trial-for.html

About Selinexor/Xpovio

Selinexor (INN, trade name Xpovio; development code KPT-330) is a selective inhibitor of nuclear export used as an anti-cancer drug. It works by binding to exportin 1 and thus blocking the transport of several proteins involved in cancer-cell growth from the cell nucleus to the cytoplasm, which ultimately arrests the cell cycle and leads to apoptosis.[1] It is the first drug with this mechanism of action.[2][3]

Selinexor was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in July 2019, for use in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.[4] In clinical trials, it was associated with a high incidence of severe side effects, including low platelet counts and low blood sodium levels.[3][5][6]


Please don't ask me what "a selective inhibitor of nuclear export" is.

This is another very expensive drug:

Xpovio's price tag also raised eyebrows. Steensma called it “ridiculous to charge $22,000 per month for such a marginal drug.” Rajkumar went further. “It's laughable to think selinexor is worth $22,000

FDA approved a myeloma drug. Some doctors say it was the wrong decision

In a series of tweets, a myeloma expert called the FDA accelerated approval of Karyopharm's Xpovio "baffling" and "incorrect" and the drug's $22,000 monthly price tag "outrageous." A member of ODAC also agreed that the drug should not have been approved so early. The company defended the drug and its pricing.


One fear I'm beginning to have is that COVID-19 clinical trials are becoming a dumping ground for expensive drugs of dubious efficacy. But hopefully I'm wrong.

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Reply Atrium Health launches first clinical trial for Covid-19 patients (Xpovio/Selinexor) (Original post)
Mike 03 Apr 2020 OP
tableturner Apr 2020 #1

Response to Mike 03 (Original post)

Tue Apr 28, 2020, 02:59 PM

1. About your fear, it makes sense to try anything plausible...test results will rule in the end.

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