NEW YORK, Oct. 7, 2020 /PRNewswire/ -- Infectious diseases are caused by pathogenic microorganisms such as bacteria, viruses, fungi and parasites, and can be transmitted by direct or indirect contact. Globally, infectious diseases such as malaria, HIV, tuberculosis, influenza, hepatitis A, hepatitis C and of course the virus which has caused the current pandemic, put major strains on public health. In response to the outbreak, governments around the world have focused their resources on curing the viral infection. However, in the meantime, the FDA reported yesterday that it will want to see two months of follow-up data after volunteers get their second dose of a vaccine as part of clinical trials testing potential coronavirus vaccines. "Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine's benefit-risk profile, including: adverse events; cases of severe COVID-19 disease among study subjects; and cases of COVID-19 occurring during the timeframe when adaptive (rather than innate) and memory immune responses to the vaccine would be responsible for a protective effect," the FDA said in the guidance. Sunshine Biopharma Inc. (OTC: SBFM), RELIEF THERAPEUTICS Holding AG (OTC: RLFTF), VBI Vaccines Inc. (NASDAQ: VBIV), iBio, Inc. (NYSE: IBIO), Aytu BioScience, Inc. (NASDAQ: AYTU)
While biotech companies work on vaccines and possible treatments and medical device companies progress on patient monitoring, many others have been working on improving testing options. Experts warn, however, that vaccines are not going to be distributed quickly. According to a report by CNN, CDC Director Dr. Robert Redfield told a Senate Appropriations Subcommittee on Wednesday that, while a very limited supply of a vaccines might be ready in November or December, it will have to be prioritized. "It will be those first responders and those at greatest risk for death, and then eventually that will expand," he said. "If you're asking me when is it going to be generally available to the American public, so we can begin to take advantage of vaccine to get back to our regular life, I think we're probably looking at third, late second quarter, third quarter 2021."
Sunshine Biopharma Inc. (OTC: SBFM) just announced breaking news that, "it has screened and subsequently identified a lead compound from its library of Coronavirus protease inhibitors. The screening which pinpointed the lead compound was performed at the University of Georgia, College of Pharmacy under the leadership of Dr. Scott D. Pegan, Director of the Center for Drug Discovery and Interim Associate Head of Pharmaceutical and Biomedical Sciences. The Company is currently looking into expanding its collaboration with the University of Georgia and will be seeking the University's assistance in advancing the development of the newly identified lead compound.
The compounds which were screened are based on the technology described in Sunshine Biopharma's recently filed patent application covering small molecules which can be used to treat Coronavirus infections. Next, Sunshine's lead compound will be put through a battery of in vitro tests to evaluate its specific inhibitory activity against the SARS-CoV-2 papain-like protease (PLpro), one of two virus encoded proteases essential for viral replication. In addition to cleaving the virus encoded polyprotein at three different sites to generate mature virus proteins, PLpro also cleaves certain host proteins resulting in suppression of the host immune response and allowing virus replication to proceed unchecked which enhances the virus' ability to cause severe morbidity. Following the in vitro tests, the lead compound will be moved forward to the cell culture testing stage followed by mice studies before entering human clinical trials
About Sunshine Biopharma's Coronavirus Treatment Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) is the causative agent of COVID-19, the current ongoing pandemic that has claimed the lives of over 1,000,000 people worldwide since it first appeared in December 2019. There are currently no drugs that can effectively arrest replication of the virus in people who have contracted the illness. On May 22, 2020, Sunshine Biopharma filed a provisional patent application for a library of molecules which were designed to inhibit the Coronavirus proteases, thus shutting down the ability of the virus to multiply and cause illness."
RELIEF THERAPEUTICS Holding AG (OTCQB: RLFTF) and NeuroRx, Inc. have established supply chain agreements and ordered sufficient drug substance (RLF-100TM) to prepare to treat 1 million patients with COVID-19, should the pandemic continue. Dr. Raghuram (Ram) Selvaraju, Chairman of the Board of Relief said: "We are living in unprecedented times, which call for flexibility and innovative thinking, in and outside the clinic. Therefore, we have taken the necessary steps to match the rapid clinical development of RLF-100TM by establishing a supply chain capable of scaling up to meet the urgent medical needs of critical COVID-19 patients."
VBI Vaccines Inc. (NASDAQ: VBIV) subsidiary Variation Biotechnologies Inc. announced on August 5th, that it has been awarded up to a CAD$56 million contribution from the Strategic Innovation Fund of the Government of Canada to support the development of the company's coronavirus program, VBI-2900, through Phase 2 clinical studies. "We are grateful for the support of the Government of Canada and we share their public health commitment to providing an effective response to the ongoing COVID-19 pandemic," said Jeff Baxter, VBI's President and CEO. "VBI's coronavirus program is a differentiated approach, using a proven, scalable, and cost-effective technology to potentially broaden the immune response to SARS-CoV-2 and potentially other coronaviruses. This funding will help accelerate our vaccine candidates into and through clinical development, the first clinical studies for which are expected to initiate by the end of 2020."
iBio, Inc. (NYSE: IBIO) announced on September 9th, that it has selected IBIO-201, its LicKM™-ubunit vaccine, as its leading candidate for the prevention of SARS-CoV-2 infection. Mr. Isett said, "We plan to conduct more focused studies on each of IBIO-200 and IBIO-201, with the goal of advancing IBIO-201 to toxicology studies ahead of planned clinical development. Meanwhile, we intend to continue preclinical development of IBIO-200 and our virus-like particle platform as a potential 'plug-and-play' vaccine development system."
Aytu BioScience, Inc. (NASDAQ: AYTU), announced on September 8th, that the Company has signed an agreement to distribute the Pinnacle CovID RAD Rapid Antigen Detection Test worldwide. The rapid antigen test, which delivers results in fifteen minutes, tests for the presence of the SARS-CoV-2 virus antigen via a nasopharyngeal sample and can be conducted without the use of laboratory equipment. Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, "We continue to find ways to help in the COVID-19 fight. This high-performing antigen test - that directly detects the presence of the COVID-19 virus antigen - requires no laboratory equipment and enables medical professionals to deploy large-scale testing in a rapid and simple-to-use format. Antigen testing has become a primary screening tool as we seek to decentralize testing and speed up turnaround times."
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