Top Stories for Week of March 23, 2020

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One after another, states are ordering residents to mainly stay indoors; Fauci says efforts to contain spread of coronavirus are “working.”

More US states are enacting strict stay-at-home orders to slow the community spread of COVID-19. And in Europe, as of Saturday, Italy’s daily death toll continued to climb: almost 800 more people died there from the virus, officials said, a new day-to-day high. There are at least 278 deaths and over 20,000 confirmed cases in the US. The worldwide death toll has topped 12,000, with at least 4,825 deaths in Italy, the country that has witnessed the most deaths.

The world was nearing 300,000 total cases as of Saturday, according to the Johns Hopkins University data dashboard. The Federal Aviation Administration has issued a temporary ground stop for all flights leaving from New York City-area airports after an FAA air traffic controller tested positive for COVID-19. In an alert posted online Saturday, the agency advised air traffic controllers to “stop all departures” to Kennedy, LaGuardia, Newark and other airports in the region. The directive also affects Philadelphia International Airport.

New Jersey Governor Phil Murphy announced Saturday that he would be ordering residents to stay at home, effective at 9 p.m. He also canceled gatherings of any number, including parties, weddings and religious ceremonies.

“We need you to just stay at home,” Murphy said. “We have to change our behaviors.”

Illinois plans to require residents to stay home as much as possible, aside from meeting their basic needs, starting Saturday evening. New York plans to ban all nonessential travel beginning Sunday evening, following California’s lead, which began Friday. Connecticut and Oregon were preparing to do the same.

Dr. Anthony Fauci said efforts to contain the spread of the virus are working, but Americans need to continue to follow the 15-day guidelines for containing the disease.

“I think we’re getting to the solution that everybody in the country is looking for,” said Fauci, director of the National Institute of Allergy and Infectious Diseases. “We know we are clearly having an effect,” Fauci said. “We will get through it, I promise you.”

Fauci encouraged Americans who do not have symptoms to not get tested. Doing so, he warned, would make it harder for healthcare workers to prioritize the highest risk Americans. It would also use up highly needed personal protective equipment.

“When you go in and get tested you are consuming personal protective equipment masks and gowns,” Fauci added. “Those are high priority for the healthcare workers who were taking care of people who have coronavirus disease.” Fauci also repeated the call for healthcare providers to, “Please, put off, cancel, elective medical and surgical procedures.”

COVID-19 Addenda: The Food and Drug Administration has been told by President Donald Trump to see if it can expand the use of a decades-old malaria drug as an experimental treatment for coronavirus patients, Bloomberg News reports.

“It’s not going to kill anybody,” Trump said at the White House.

The drug, chloroquine, hasn’t yet been approved for treatment of COVID-19. While it’s been available for decades for malaria, it’s not clear whether it will work against the new illness. A March 10 review of existing research found there’s little solid proof one way or the other. During an at-times-confusing White House press conference, Trump said that chloroquine was approved for use and that he wanted to “remove every barrier” to test more drugs against COVID-19 and “allow many more Americans to access drugs that have shown really good promise.”

Trump added, “Normally the FDA would take a long time to approve something like that, and it’s–it was approved very, very quickly and it’s now approved by prescription.”

An FDA spokesperson said the drug hadn’t been approved for use in COVID-19 patients. However, US doctors are legally able to prescribe a drug for any illness or condition they think is medically appropriate. More than a dozen generic drugmakers, including Teva Pharmaceutical Industries Ltd., Mylan NV and Novartis AG‘s Sandoz unit, manufacture chloroquine, also called hydroxychloroquine. It comes with few major known side effects, is relatively inexpensive and is widely used around the world.

Separately, CanSino Biologics Inc. said it received Chinese regulatory approval to start human trials of a vaccine against the novel coronavirus, another example of a potential weapon against the illness being fast-tracked for testing as the global death toll escalates and nations impose lockdowns on their citizens. The vaccine, co-developed by the Hong Kong-listed company and China’s Academy of Military Medical Sciences, will undergo clinical trials in Wuhan, CanSino Biologics said in a statement to the Hong Kong Stock Exchange last Wednesday. Wuhan is the epicenter for the pandemic for the virus that has infected more than 190,000 people and killed more than 7,800.

Medical Stock Spotlight: As is the custom nowadays, many companies associated with the COVID-19 space continue to see their valuations increase significantly.

  • Micro-cap biotherapeutics company Bellerophon Therapeutics Inc. (Nasdaq:BLPH) led advancing issues, rocketing 227% over the week to $18.00. The Warren, NJ-based company said the FDA has granted emergency expanded access for its proprietary inhaled nitric oxide delivery system, INOpulse, which would allow it to be immediately used for the treatment of COVID-19. Nitric oxide is a naturally produced molecule that is critical to the immune response against pathogens and infections. Lab studies have shown nitric oxide impedes replication of SARS-CoV, a strain of coronavirus that caused the SARS epidemic in 2003, according to Bellerophon. It also improved survival of cells infected by the virus. SARS-CoV patients treated with INOpulse in clinical studies showed improvements in arterial oxygenation, a reduction in the need for ventilation support and an improvement in lung infiltrates observed on chest radiography, Bellerophon said.

 

  • Elsewhere, Biomerica Inc. (Nasdaq:BMRA) soared 180% to $7.15 after announcing that international shipments of initial samples of its COVID-19 IgG/IgM Rapid Test–a disposable, one-use test–have taken off. The finger prick test takes about 10 minutes. It can be performed by trained professionals at any location, the Irvine, CA-based company said. Biomerica said distribution partners working with government agencies in multiple countries have placed orders for the tests. Differentiating its test from the current polymerase chain reaction, or PCR, tests, Biomerica said its serology tests can detect if a person has been exposed to the COVID-19 virus and if they are infected with the virus even if they have never shown or are no longer showing symptoms. The PCR test shows positive if a person is infected and the virus is still present. The PCR tests can be performed only in a lab. Therefore, Biomerica said its test can be used in conjunction to the PCR test to pre-screen larger group of individuals who, if they test positive, could be tested further using PCR. The test will be sold for less than $10, according to Biomerica.

 

  • And Allied Healthcare Products Inc. (Nasdaq:AHPI) surged 66% to $19.40, pushing it to new multi-year highs. The catalyst, of course, was the coronavirus outbreak, which has been spreading rapidly across the world and has resulted in a surging demand for medical supplies and other healthcare equipment. St. Louis, MO-based AHPI, which specializes in the production of home respiratory care products, oxygen cylinders and emergency medical products, has drawn the attention of investors looking for exposure to companies and industries which figure to benefit from the virus’s spread. The healthcare sector has been one of the market’s best performers over the past month with the medical devices group enjoying particular success. The near-term catalyst has been the development and mass production of a reliable coronavirus test kit, something that, thus far, has proven elusive. Recently, Co-Diagnostics (Nasdaq:CODX) has made available its COVID-19 testing kits, boosting the value of other coronavirus names, including AHPI, in the process.

 

  • But DBV Technologies SA (Nasdaq:DBVT) plummeted 37% to $3.72. The downdraft came after another regulatory setback derailed the Montrouge, France-based company’s peanut allergy patch off the track to approval. Last Monday, the company disclosed that the FDA, which is currently reviewing the marketing application for the patch, had questions regarding the patch’s adhesion and efficacy concerns if the patch was not fully adhered to the patient’s skin. Consequently, the FDA advisory committee meeting scheduled for May 15 will not be taking place–although no changes to the FDA’s action date of August 5 were announced. DBV said it already has the data necessary to answer the FDA’s questions, has previously found that patch adhesion did not have a significant impact on clinical efficacy and is confident that no additional studies will be required, it said in a conference call following the press release. Investors weren’t impressed.

IPO Sector: The IPO market showed little activity last week, with no launches or pricings.

  • However, Keros Therapeutics Inc., a Phase 1/2 biotech developing treatments for hematological and musculoskeletal disorders, filed last Monday with the SEC to raise up to $86 million in an initial public offering.  Lead candidate is KER-050, an engineered ligand trap, designed to increase red blood cell and platelet production in myelodysplastic syndrome and myelofibrosis patients with low blood counts. The Lexington, MA-based company was founded in 2015 and booked $10 million in collaboration revenue for the 12 months ended December 31, 2019. It plans to list on the Nasdaq under the symbol “KROS.” Keros filed confidentially on January 21, 2020. Jefferies, SVB Leerink and Piper Sandler are the joint bookrunners on the deal.

 

  • Elsewhere, forget the global stock meltdown, says Endpoints, which reported that Chinese biotech InnoCare Pharma Ltd. did just that, forging ahead with a more than $250-million IPO in Hong Kong. It worked. InnoCare wrote in a filing that retail investors subscribed to 7.98 billion shares–about 300 times the amount the number offered to them, according to the South China Morning Post. With institutional investors agreeing to chip in and buy US$164 million (HK$1.28 billion) of shares, the company will raise $289 million (HK$2.2 billion). Shares priced at the high end of an HK$8.18 to HK$8.95 range.

InnoCare’s success was likely driven by the same forces collapsing stocks around the globe. As the COVID-19 pandemic has slowed economic activity around the world and driven the stock market down, investors have turned to pharmaceutical stocks, particularly for those companies who have joined in on the hunt for a coronavirus treatment or vaccine. InnoCare, focused on cancer and autoimmune disorders, is not one of those companies, but a local venture capitalist suggested they still likely benefited from the frenzy.

The highly contagious novel coronavirus that has exploded into a global pandemic can remain viable and infectious in droplets in the air for hours and on surfaces up to days, according to a new study that should offer guidance to help people avoid contracting the respiratory illness called COVID-19.

Scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, attempted to mimic the virus deposited from an infected person onto everyday surfaces in a household or hospital setting, such as through coughing or touching objects. They used a device to dispense an aerosol that duplicated the microscopic droplets created in a cough or a sneeze. The scientists then investigated how long the virus remained infectious on these surfaces, according to the study that appeared online in the New England Journal of Medicine last week. The tests show that when the virus is carried by the droplets released when someone coughs or sneezes, it remains viable, or able to still infect people, in aerosols for at least three hours.

On plastic and stainless steel, viable virus could be detected after three days. On cardboard, the virus was not viable after 24 hours. On copper, it took 4 hours for the virus to become inactivated. In terms of half-life, the research team found that it takes about 66 minutes for half the virus particles to lose function if they are in an aerosol droplet. That means that after another hour and six minutes, three quarters of the virus particles will be essentially inactivated but 25% will still be viable. The amount of viable virus at the end of the third hour will be down to 12.5%, according to the research led by Neeltje van Doremalen of the NIAID’s Montana facility at Rocky Mountain Laboratories. On stainless steel, it takes 5 hours 38 minutes for half of the virus particles to become inactive. On plastic, the half-life is 6 hours 49 minutes, researchers found.

On cardboard, the half-life was about three and a half hours, but the researchers said there was a lot of variability in those results “so we advise caution” interpreting that number. The shortest survival time was on copper, where half the virus became inactivated within 46 minutes. (Ref: Reuters)

A single dose of tetrahydrocannabinol (THC), roughly the equivalent of one marijuana joint, can induce psychotic and other psychiatric symptoms in healthy adults with no history of a major mental illness, results of a new meta-analysis suggests. The research shows large effect sizes for these symptoms, which were induced even with low doses of THC, which is the psychoactive component in cannabis.

The new findings underscore that a single, “one-off exposure” to THC, even in a fit and healthy person, increases vulnerability to experiencing psychiatric symptoms, including psychotic symptoms, senior investigator Oliver D. Howes, MD, PhD, professor of molecular psychiatry, King’s College London, UK, told Medscape Medical News.

“As clinicians, we need to be aware that the medical use of marijuana comes with a risk of inducing psychiatric symptoms, even in people with no vulnerability, and this needs to be factored into decisions to prescribe and to monitor,” he said. “That’s not to say we shouldn’t use cannabis where there’s good evidence of potential benefit,” Howes added.

Notably, the review failed to show clear evidence that concurrent administration of cannabidiol (CBD), another constituent of cannabis, mitigates THC-related psychiatric symptoms.

“That goes against some of the suggestions that have been out there,” Howes said. “If we increase the amount of CBD in cannabis, that would help counter the effects of THC. I think this tells us we need to do more work before we come to any conclusions about whether CBD is going to help or not.”

The study was published online March 17 in Lancet Psychiatry.

“While there’s a lot of evidence that cannabis is associated with a risk of psychotic symptoms, the big question has been whether this was due to the cannabis constituents or whether people who already had symptoms or vulnerabilities were using cannabis to try to cope with that, and so we didn’t really know the direction of causality,” said Howes.

The meta-analysis included 15 studies that examined acute administration of THC and four studies on CBD plus THC.

“Overall, I think it’s fair to conclude there’s a lack of consistent evidence that CBD is protecting against THC’s effect,” said Howes.

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