Palm Beach, FL – April 23, 2020 – America’s biopharmaceutical companies have recently reiterated that they are committed to developing solutions to help diagnose and treat those with COVID-19, a disease caused by a novel strain of coronavirus. In addition to applying their scientific expertise to find ways to diagnose, treat and prevent infections from the virus, the biopharmaceutical industry is providing financial support and in-kind donations to organizations and collaborating with U.S. and global health authorities to combat this global public health emergency. More than half of PhRMA members have R&D for potential treatments and vaccines under way or are providing donations of medicines and critical medical supplies as well as providing financial donations to support patients and first responders in addressing this evolving crisis. Active healthcare stocks in news today include: BioSig Technologies, Inc. (NASDAQ: BSGM), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Gilead Sciences, Inc. (NASDAQ: GILD), CytoDyn Inc. (OTCQB: CYDY), Novavax, Inc. (NASDAQ: NVAX).
An article in The Atlantic said: “Antivirals are likely to work best early in an infection, when the virus has not infected many cells nor made too many copies of itself yet… Much of the early research into drugs against COVID-19 has focused on repurposing existing drugs because they are the fastest way to get something to a patient in a hospital bed. Doctors already know their side effects, and companies already know how to manufacture them. Unless researchers get very lucky, though, these repurposed drugs are unlikely to be a cure-all for COVID-19. Still, they might just work well enough to keep a mildly ill person from becoming severely ill, which is enough to free up a ventilator. “We can do better probably as time goes by,” says García-Sastre a microbiologist at the Icahn School of Medicine at Mount Sinai, “but right now we need something to start.”
BioSig Technologies, Inc. (NASDAQ:BSGM) BREAKING NEWS – ViralClear Publishes Comparative In Vitro Data on Merimepodib and Remdesivir Activity Against the COVID-19 Novel Coronavirus in F1000 Research – BioSig Technologies, today announced that an article titled, “The IMPDH inhibitor merimepodib has similar antiviral activity against SARS-CoV-2 replication in vitro to the adenosine analogue remdesivir” was accepted by F1000 Research, an online peer-reviewed life sciences journal publishing program in biology and medicine.
This manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear Pharmaceuticals, Inc. (“ViralClear”) as a corresponding author.
The article highlights emerging pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch. The work was started with Trek Therapeutics and after merimepodib was acquired by ViralClear has been continued by ViralClear.
“The concentrations of merimepodib used in the cell culture studies described in this article are achievable in humans by our oral solution formulation,” said Dr. Zeldis, Executive Chair and Founder of ViralClear Pharmaceuticals, Inc. “We are now exploring whether remdesivir and merimepodib are synergistic in this in vitro model. We look forward to starting our first clinical trial in COVID-19 patients upon receiving FDA clearance to commence with the proposed phase 2 trial.”
Vero cells in tissue culture were pre-treated with two concentrations (2.5 and 5 µM) of either merimepodib or remdesivir for 4 hours before the SARS-CoV-2 coronavirus was added. The amount of virus released to the media was measured at baseline and 16 hours and 24 hours after infection. At 16 hours, a significant reduction in viral production was observed for both concentrations of merimepodib (1.9 log decrease in titer, p = 0.003 and 2.1 log decrease in titer, p = 0.001) but only at the higher concentration of remdesivir (1 log decrease in titer, p = 0.103 and 2.1-log decrease in titer, p = 0.001). At 24 hours both concentrations of both drugs significantly reduced viral production; however, 2.5 µM remdesivir reduced viral titer by 1.5 logs (p = 0.002) as compared to a decrease of 3.9 logs for 5 µM remdesivir (p < 0.001), whereas 2.5 and 2.7 log reductions (p = 0.001 and p < 0.001, respectively) were observed for the 2.5 and 5 µM concentrations of merimepodib.
Merimepodib, a broad-spectrum anti-viral candidate, demonstrated strong activity against COVID-19 in cell cultures in laboratory testing and additional antiviral studies are underway. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with a 12 clinical trials conducted (including 315 chronic hepatitis C patients, 24 psoriasis patients, and 98 healthy volunteers) and an extensive preclinical safety package completed . ViralClear intends to pursue development of this agent for the treatment of COVID-19 through FDA-approved clinical trials in Q2 2020. Read this entire press release and more news for BSGM at: https://financialnewsmedia.com/news-bsgm
In other healthcare news of note:
Gilead Sciences, Inc. (NASDAQ: GILD) announced this month the creation of the global Gilead CARES (COVID-19 Acute Relief and Emergency Support) Grantee Fund to provide financial support to current grantees facing an imminent closure or termination of vital services due to losses attributable to the COVID-19 pandemic. The fund will provide up to $20 million in donations to these nonprofit groups.
Gilead will also make two significant community donations: $1 million to the San Mateo County Strong Fund, which is providing financial support to individuals, small businesses and nonprofit organizations in San Mateo County where Gilead is based, and $1 million to the Mayor’s Fund for Los Angeles, which is providing support for families and small businesses, relief for healthcare workers and other services in response to the COVID-19 crisis. Kite, Gilead’s operating company that is focused on cell therapy, is headquartered in the Los Angeles area.
Additionally, Gilead will match employee donations to three global relief organizations through the company’s Giving Together corporate match program as part of a special campaign. Proceeds will be split equally between Direct Relief, the UN Foundation’s COVID-19 Solidarity Response Fund and International Medical Corps.
CytoDyn Inc. (OTCQB: CYDY) recently announced the treatment of the first patient with leronlimab in its Phase 2b/3 trial for severe and critical COVID-19 indications. About 30 patients have been administered leronlimab under Emergency Investigational New Drug (EIND) authorizations granted by the U.S. Food and Drug Administration (FDA) and about 15 patients have been enrolled in our current Phase 2b mild-to-moderate COVID-19 patients.
The Company recently received clearance from the FDA to commence enrollment in this Phase 2b/3 clinical trial for severe and critically ill COVID-19 patients. The Phase 2b/3 trial is for 390 patients, double blinded with 2:1 ratio (active drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients.
Inovio Pharmaceuticals, Inc. (NASDAQ: INO) News: INO announced earlier this month the International Vaccine Institute (IVI) announced today that the Coalition for Epidemic Preparedness Innovations (CEPI) has granted $6.9 million funding to INOVIO to work with IVI and the Korea National Institute of Health (KNIH) for a Phase 1/2 clinical trial of INOVIO’s COVID-19 vaccine candidate (INO-4800) in South Korea. IVI will conduct the trial in parallel to INOVIO’s Phase 1 INO-4800 study currently underway in the US since April 6, 2020 with 40 healthy adults receiving the vaccine candidate and eventually expanding to older adults.
Dr. Jerome H. Kim, Director General of IVI, said, “Vaccines are the long-term solution to controlling the COVID-19 pandemic. The rapid global response to developing vaccine candidates has been a profound demonstration of governments, industry, and the scientific community coming together to confront a common crisis, and we’re looking forward to accelerating one of those candidates through clinical testing. IVI has achieved promising trial results with INOVIO’s DNA vaccine platform in the past, and we’re pleased to partner again to test the safety and immunogenicity of an urgently needed COVID-19 vaccine.”
Novavax, Inc. (NASDAQ: NVAX) recently announced it has identified a coronavirus vaccine candidate, NVX-CoV2373, a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology, and will initiate a first-in-human trial in mid-May. Novavax’ proprietary Matrix-M™ adjuvant will be incorporated with NVX-CoV2373 in order to enhance immune responses and stimulate high levels of neutralizing antibodies.
NVX-CoV2373 was shown to be highly immunogenic in animal models measuring spike protein-specific antibodies, antibodies that block the binding of the spike protein to the receptor and wild-type virus neutralizing antibodies. High levels of spike protein-specific antibodies with ACE-2 human receptor binding domain blocking activity and SARS-CoV-2 wild-type virus neutralizing antibodies were observed after a single immunization. In addition, the already high microneutralization titers seen after one dose increased eight fold with a second dose. High titer microneutralizing antibodies are generally accepted evidence that a vaccine is likely to be protective in humans.
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