Unproven Stem Cell Therapy Gets OK for Testing in Coronavirus Patients – The New York Times

At least one outside expert said the approach could present safety risks. Paul Knoepfler, a stem cell researcher at the University of California, Davis, said that patients with coronavirus can develop severe reactions where their immune systems go too far in attacking cells in their lungs, causing damaging inflammation. Other cell therapies tested in China are designed to dampen the immune response. He said one risk with the natural killer cells is they could go in the other direction, exacerbating respiratory problems by massive killing of the patients respiratory cells.

Despite the scant evidence, Mr. Giuliani has become an early booster, interviewing Dr. Hariri on a podcast published on his website Saturday, and praising the treatment on Twitter, saying, this therapy has real potential. In a tweet on Saturday, he added, Lets hope F.D.A. can recognize that their cumbersome process designed to keep us safer, if it is not altered dramatically in times of great need, can result in unimaginable loss of human life.

Around the same time, Twitter deleted a post by Mr. Giuliani that it said violated its rules. The tweet, from March 27, made unfounded claims about the malaria drug hydroxychloroquine, one of the treatments that Mr. Trump has supported.

Dr. Hariri said that he has known Mr. Giuliani for years and that the appearance on his podcast was a friendly chat between people who know each other and who share a common interest in this particular response to this disease.

He said that he has no business relationship with Mr. Giuliani, and that Mr. Giuliani is not representing him in any way, either paid or unpaid. I dont have anything to do with what the mayor tweets or whatnot, and I dont agree or disagree with anything, he said.

Dr. Hariri said the company would follow the established process for testing whether a drug works. We have waited for the F.D.A. to complete their review, which they did in a heroic and quick fashion, he said.

On Wednesday evening the same day the F.D.A. approved his trial Dr. Hariri praised the appearance by the agencys commissioner, Dr. Stephen Hahn, on the conservative Fox News talk show The Ingraham Angle.

We are fortunate to have Dr. Hahn at the helm, he tweeted.

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What You Need to Know About the FDA’s Approval of Opdivo-Yervoy for Hepatocellular Carcinoma – Curetoday.com

The Food and Drug Administration approved the dual immunotherapy of Opdivo and Yervoy for the treatment of patients with advanced hepatocellular carcinoma. Heres what you need to know.

This is the only dual immunotherapy approved by the FDA in this setting of patients with HCC and was based on the results of the phase 1/2 CheckMate-040 trial. The overall trial was to look at Opdivo in patients with advanced HCC, with the Opdivo and Yervoy cohort showing a duration of responses that lasted from 4.6 to 30.5 months with 88% of responses lasting at least 6 months, 56% at least 12 months and 31% at least 24 months, according to a Bristol Myers Squibb spokesperson.

HCC is an aggressive disease in need of different treatment approaches, Dr. Anthony B. El-Khoueiry, lead investigator and phase 1 program director at the Keck School of Medicine, University of Southern California (USC) and the USC Norris Comprehensive Cancer Center, said in the original press release regarding the approval. As the incidence of liver cancer rises in the United States, HCC has become the most common and aggressive from of the disease with relapsed patients in need of new treatments after the first line of treatment fails. This is why the FDA granted accelerated approval to the Opdivo and Yervoy combination for this patient group previously treated with Nexavar, a chemotherapy for liver cancers.

The CheckMate-040 trial is a phase 1/2, dose-escalation/dose expansion, open-label study of Opdivo in patients with advanced hepatocellular carcinoma with or without chronic viral hepatitis C or B. Researchers envaulted the Opdivo-Yervoy combination in 49 patients with advanced HCC, 33% of these patients responded to this treatment with 8% demonstrating a complete response and 24% exhibiting a partial response after a minimal follow up of 28 months. Overall response was reported in 35% of patients.

According to a Bristol Myers Squibb spokesperson, the Opdivo-Yervoy combination acts on the CTLA-4 and PD-1 immune checkpoints that while beneficial alone there is evidence that the mechanisms can work together to produce a greater effect in patients. In the case of Yervoy, it may help the patients immune system to activate more T cells that help fight cancer cells while Opdivo assists in already active T cells discovering cancer cells. The researchers believe the combination can work to discover and then deploy newly activated T cells in the fight against cancer.

However, according to a Bristol Myers spokesperson, this combination therapy can cause the immune system to attack normal organs and tissues which can lead to serious complications and may happen more often on this combination therapy.

In the CheckMate-040 trial serious side effects were seen in 59% of patients on the treatment, including pyrexia, diarrhea, anemia, increased aspartate aminotransferase, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin and pneumonitis in more than 4% of patients. The most common of these side effects was rash, pruritus, musculoskeletal pain, diarrhea, cough, decreased appetite, fatigue, pyrexia, abdominal pain, headache, nausea, dizziness, hypothyroidism and weight decrease reported in more than 20% of patients.

The approval for the Opdivo-Yervoy combination was granted on March 10th, 2020.

Read CUREs original coverage of the approval.

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Mesoblast’s remestemcel-L receives FDA IND clearance for treating COVID-19 patients with acute respiratory distress – Small Caps

Regenerative medicine company Mesoblast (ASX: MSB) has received US Food and Drug Administration Investigational New Drug (IND) clearance for its remestemcel-L treatment to be used in COVID-19 patients presenting with acute respiratory distress syndrome.

According to Mesoblast chief medical officer Dr Fred Grossman, the FDA IND approval now enables US-based COVID-19 patients with poor prognosis to be treated with remestemcel-L under compassionate usage grounds and in a planned randomised controlled trial.

Remestemcel-L is an anti-inflammatory treatment that has been developed for use in various inflammatory conditions including steroid-refractory acute graft versus host disease.

Mesoblast claims the drug works by counteracting the inflammatory processes in these diseases by down-regulating the production of pro-inflammatory cytokines, while boosting production of anti-inflammatory cytokines and enabling recruitment of the ant-inflammatory cells to the involved tissues.

To-date, the safety and therapeutic impact of remestemcel-L intravenous infusions have been evaluated in over 1,100 patients in clinical trials.

In a phase 3 trial, remestemcel-L was found useful in treating acute graft versus host disease, which Mesoblast claims produces a similar cytokine storm process as seen in COVID-19 patients with acute respiratory distress syndrome.

Additionally, post hoc analysis of a previous study involving 60 patients with chronic obstructive pulmonary demonstrated remestemcel-L significantly improved respiratory function in patients with the same elevated inflammatory biomarkers that are also seen in COVID-19 acute respiratory distress syndrome patients.

COVID-19 patients most at risk of developing acute respiratory distress syndrome include the elderly and those with co-morbidities such as diabetes.

According to Mesoblast, patients with COVID-19 that have developed acute respiratory distress syndrome have an almost 50% fatality rate.

Remestemcel-L is an allogeneic mesenchymal stem cell product, with preliminary data from China indicating allogeneic mesenchymal stem cells have either cured or significantly improved functional outcomes for seven patients with COVID-19 in the small trial.

By mid-morning trade, Mesoblasts shares were up almost 30% to $1.74.

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COVID-19 Tips for Patients with Myelodysplastic Syndromes and Acute Myeloid Leukemia – Curetoday.com

The COVID-19 pandemic has created a unique challenge for patients with myelodysplastic syndromes and acute myeloid leukemia, creating many questions that experts tried to answer in a recent webinar from The Aplastic Anemia and MDS International Foundation.

The Aplastic Anemia and MDS International Foundation (AAMDSIF) recently hosted a webinar to address the questions of this patient population by connecting them with Dr. Gail J. Roboz, professor of medicine and director of the clinical and translational leukemia program at the Weill Medical College of Cornell University in the New York Presbyterian Hospital in New York City.

Over the course of the webinar, Dr. Roboz, also a member of the AAMDSIF Medical Advisory Board, answered questions from the audience about the various ways that COVID-19 is impacting patients, from treatment delays to transplant and beyond.

Audience: If a patient with MDS were to be diagnosed with COVID-19, what are the most important things that they should let their medical team know, as they may not be familiar with MDS?Roboz: I think that it's important that if you're being seen in a facility where they don't know you very well or they don't know much about MDS, you can tell them that MDS is a is a bone marrow failure problem. You can tell them about your own blood counts, do I usually run low neutrophils or low hemoglobin or low platelets or all three, so you can tell them about what your specific experience is. But with respect to therapy, it is not completely clear that the underlying diagnosis, in this case MDS, is going to change what they do.

I think one of the questions is going to be about potential interactions with any medications that you're taking for MDS. And that's, of course, something that would be discussed if you're hospitalized.

If you are not getting hospitalized and you are patient with MDS, I certainly think it's reasonable to have, if at all possible, a daily or every other day telemedicine visit, either by video or by phone or by email, or however you're communicating with your doctor as a check in to just see how you're doing, see how your symptoms are evolving.

Should I continue with routine blood tests under the conditions or should I hunker down and not leave the house? If the previous blood test that the patient has had is looking absolutely perfect, and if there is a track record over a period of time that we know that this patient is tolerating the drug well and hasn't had any issues, I would be willing to consider skipping a routine blood test.

That said, I think it's really important to discuss this individually with the physician. First of all, depending on where you are, I'm hearing that in some parts of the country, you can actually drive to the doctor's office and they have a check in system that's allowing you to check in from your car, so that you could actually get into the office, get a lab check and get out without seeing really anybody.

Is there a change in patient protocol for when patient should be concerned about a fever?That is a really important question, especially for neutropenic patients. I think that if you are neutropenic and running a fever, neutropenic fevers do have to be evaluated, especially in hematologic malignancy patients.

If you don't feel too bad, and you're not having shaking chills and you think you can get your doctor's office on the phone quickly, it's not unreasonable to try that. That said, most of the time, it's really tough to get seen urgently in an office at this point. Again, it depends on where you are.

If you're going into the ER, you have to be very specific with them and say, hey, listen, I have leukemia, or I have MDS. This is my doctor. I'm neutropenic. I'm coming in with neutropenic fever, and they will evaluate you simultaneously for all of the routine things for neutropenic fever, as well as for coronavirus.

What are the recommendations regarding patients moving forward with transplant?I think that the issue is that the intensive care units in many areas, and the infectious disease doctors and many of the pulmonary specialists and other supportive specialties that are so critical to get patients safely through transplant, are very occupied at the moment.

But we want to make sure that when you come in for a procedure with curative intent, that all of the backup that we need to get you through the procedure safely is 100% available. So, it is definitely the case that patients are being delayed in their transplant. However, there are situations in which people might proceed. And I think again, this has to be a very individual discussion with the physician.

In the New York area, we are anticipating a surge in mid-April. So we definitely have been making decisions for our transplant patients that we don't want to bring you in here literally at the moment when they're predicting that things are going to get much worse, because maybe things will be better at the end of the month or at the beginning of the next month. And then we can hopefully start breathing a sigh of relief and bring you in much more safely.

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Stem Cell Therapy for Colon Cancer – The Ritz Herald

An article published in Experimental Biology and Medicine(Volume 245, Issue 6, March 2020)examines the safety of stem cell therapy for the treatment of colon cancer.The study, led by Dr. J. Liu in the State Key Laboratory of Bioreactor Engineering and Shanghai Key Laboratory of New Drug Design at the East China University of Science and Technology in Shanghai (China), reports that mesenchymal stem cells from a variety of sources promote the growth and metastasis of colon cancer cells in an animal model.

Mesenchymal stem (MSCs), a category of adult stem cells, are being evaluated as a therapy for numerous cancers.MSCs are excellent carriers for tumor treatment because they migrate to tumor tissues, can be genetically modified to secrete anticancer molecules and do not elicit immune responses.Clinical trials have shown that MSCs carrying modified genes can be used to treat colon cancer as well as ulcerative colitis. However, some studies have demonstrated MSCs can differentiate into cancer-associated fibroblasts and promote tumor growth.Therefore, additional studies are needed to evaluate the safety of MSCs for targeted treatment of colon cancer.

In the current study, Dr. Liu and colleagues examined the effects of mesenchymal stem cells (MSCs) from three sources (bone marrow, adipose, and placenta) on colon cancer cells.MSCs from all three sources promoted tumor growth and metastasis in vivo. In vitro studies demonstrated that MSCs promote colon cancer cell stemness and epithelial to mesenchymal transition, which would enhance tumor growth and metastasis respectively.Finally, the detrimental effects of MSCs could be reversed by blocking IL-8 signaling pathways. Dr. Ma, a co-author of the study, said that Mesenchymal stem cells have a dual role: promoting and/or suppressing cancer. Which effect is dominant depends on the type of tumor cell, the tissue source of the MSC and the interaction between the MSC and the cancer cell. This is the major issue in the clinical application research of MSCs, and additional preclinical experimental data will be needed to evaluate the safety of MSCs for colon cancer treatment.

Dr. Steven R. Goodman, Editor-in-Chief of Experimental Biology & Medicine, said: Lui and colleagues have performed elegant studies on the impact of mesenchymal stem cells (MSCs), from various sources, upon the proliferation, stemness, and metastasis of colon cancer stem cells (CSCs) in vitro and in vivo. They further demonstrate that IL-8 stimulates the interaction between colon CSCs and MSCs, and activates the MAPK signaling pathway in colon CSCs.This provides a basis for the further study of MSCs as a biologic therapy for colon cancer.

Experimental Biology and Medicine is a global journal dedicated to the publication of multidisciplinary and interdisciplinary research in the biomedical sciences. The journal was first established in 1903. Experimental Biology and Medicine is the journal of the Society of Experimental Biology and Medicine. To learn about the benefits of society membership, visit sebm.org.

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What does the public know about COVID-19? – University of Miami

Survey aims to shed light on any misconceptions so that public agencies can address them.

Two University of Miami researchers are investigating how much people truly know about COVID-19and whether they would be willing to take a drug to prevent themselves from getting the disease, if one existed.

Dr. Dushyantha T. Jayaweera, a professor of medicine in the infectious disease research unit at the Miller School of Medicine, and public health graduate student Russell Saltzman often work together on clinical trials. Recently, they were brainstorming ways to help slow the spread of coronavirus, and Saltzman thought it would be helpful to find out if people are receiving the correct information about the virus that has prompted a global pandemic.

Ive heard people say that there has been a lot of inconsistent messaging by the authorities about COVID-19, so we wanted to figure out where the misconceptions lie, said Saltzman, who is also a clinical research coordinator at the Interdisciplinary Stem Cell Institute at the Miller School.

Both Saltzman and Jayaweera acknowledged the constant government advisories are a lot to keep up witheven for health care professionalsbut said it is their goal to ensure that the public has as much information as possible to stay healthy.

Things are moving so fast that its easy to be out of the loop, so its important to know what people know to inform the policymakers, Saltzman said. If we can identify gaps in knowledge, that can help focus efforts for disseminating information about the disease.

After about a month of data collection, the two will publish their research, making it accessible to government agencies and state health departments, Jayaweera said.

To gather the information, Saltzman created a 10-minute electronic survey and made it available through social media and several email listservs. The researchers hope participants will share it with friends so they can gain 10,000 participants from around the country.

Also through the survey, Jayaweera and Saltzman hope to gauge public attitudes toward a study that would examine the use of a drug called hydroxychloroquine (HCQ) as amedication topreventor slow the transmission of COVID-19. In two to three weeks, Jayaweera will begin a clinical trial funded by the National Institutes of Health examining whether the drug can help prevent infection in health care providers and shorten the disease course in general.

To participate in the survey, visit https://umiami.qualtrics.com/jfe/form/SV_blNe3xhV8Xx4uGN.

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Column: Scientific advancements in the time of COVID-19 and what they offer us – The Daily Tar Heel

The coronavirus, otherwise known as COVID-19, has dramatically transformed the lives of people around the globe. It has decimated economies, overwhelmed health care systems and affected families in unimaginable ways. However, in spite of the havoc that it has caused, COVID-19 has furthered our understanding of pandemic control beyond anything that we've known before. Most importantly, it has proven the resilience of the scientific and healthcare communities.

Data sharing is a huge aspect of how epidemiologists can begin to understand diseases. It provides insight in terms of the populations that the conditions affect, as well as the speed and extent of transmission. This is something that health care professionals at UNC and the Icahn School of Medicine at Mount Sinai are attempting to address with the establishment of SECURE-IBD.

SECURE-IBD is a project that is focused on collecting disease-specific COVID-19 data, with an emphasis on patients with inflammatory bowel disease, such as Crohns disease and colitis, who contract the virus.

The registry takes patients with varying disease symptoms and hospitalizations and connects them with specialists and healthcare professionals. The tool has inspired other disease-specific registries, and can be used to identify things like potential drugs and treatments. It also connects doctors and scientists in a way that hasnt been this widely done in the past.

Data sharing has also allowed researchers to collaborate on projects in order to study coronavirus at an expedited pace. The virus was sequenced within a week of discovery and has been made publicly available. Courses at UNC, such as Computer Science 555 (Bioalgorithms), have even integrated the genome into everyday classwork. And although academic life has generally been branded with the 'publish or perish' mindset for decades, publishing is the last thing on anyones minds at the moment.

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Metrion Biosciences and International Scientific Consortium Publish Data and New Recommendations for in Vitro Risk Assessment of the Cardiac Safety of…

CAMBRIDGE, England--(BUSINESS WIRE)-- Metrion Biosciences Limited (Metrion), the specialist ion channel CRO and drug discovery company, today announced it has contributed to two new peer-reviewed papers under the U.S. Food and Drug Administrations (FDA) CiPA (Comprehensive in vitro Proarrhythmia Assay) initiative. The papers, in Nature Scientific Reports1 and Toxicology and Applied Pharmacology2, focus on application of improved cardiac safety testing protocols and recommendations for best practice for the drug discovery industry.

The CiPA Initiative (www.cipaproject.org), which began in July 2013 following a workshop at the US FDA, has the objective to revise and enhance the regulatory framework assessing cardiac safety of new chemical entities. Under current guidelines, new therapeutics undergo initial assessment of proarrhythmic risk by measuring activity against the hERG cardiac ion channel, before progressing to studies in preclinical animal models and ultimately, a Thorough QT interval study in the clinic. The CiPA initiative aims to extend the use of advances in early electrophysiology-based cardiac ion channel screening, in silico predictive modelling, and human induced pluripotent stem cell derived cardiomyocytes to improve the accuracy and reduce the cost of predicting the cardiac liability of new drug candidates. Metrions research forms part of the first stage of the proposed harmonisation work, to provide clarity on how to standardise cardiac ion channel assays to ensure they deliver consistent data for in silico models of clinical cardiac arrythmia risk.

The first paper1, published in Nature Scientific Reports on 27th March 2020 by an international group of authors drawn from 20 different commercial and academic laboratories, including Metrion Biosciences, was coordinated by the Health and Environmental Sciences Institute (HESI). It reviews data from a multi-year, multi-site collaboration across industry, academia and the FDA regulatory agency to optimize experimental protocols and reduce experimental variability and bias. The goal of the study was to guide the development of best practices for the use of automated patch clamp technologies in early cardiac safety screening. High quality in vitro cardiac ion channel data is required for accurate and reliable characterisation of the risk of delayed repolarisation and proarrhythmia in the human heart and to guide subsequent clinical studies and regulatory submissions.

The second paper2, to be published formally in Toxicology and Applied Pharmacology paper on 1st May 2020 but currently available online, uses automated patch clamp data from the CiPA consortium to address the lack of statistical quantification of variability, which hinders the use of primary hERG potency data to predict cardiac arrhythmia. The consortium establishes a more systematic approach to estimate hERG block potency and safety margins.

Dr Marc Rogers, CSO, Metrion Biosciences, said: The Metrion team has been a participant in the international CiPA Initiative since inception and we are now pleased to be able to announce the publication of our data from this global collaborative scientific effort. We believe these projects will make a significant contribution to the eventual revision of cardiac safety testing guidelines by the FDA and other international regulatory agencies. They also contribute to deepening our knowledge of the underlying causes of proarrhythmia, which will help prevent early attrition of potentially promising drugs.

Contributing organisations to the Nature Scientific Reports CiPA study include: Charles River Laboratories; Bayer AG; Sophion Bioscience A/S; Nanion Technologies; GlaxoSmithKline PLC; Pfizer; Sanofi R&D; Astra Zeneca; BSYS GmbH; Bristol-Myers Squibb Company; Eurofins Discovery; Merck; Metrion Biosciences Ltd.; Natural and Medical Science Institute at the University of Tbingen; Northwestern Feinberg School of Medicine, Chicago; Roche Innovation Center Basel; Novoheart; Health and Environmental Sciences Institute, Washington, DC; AbbVie.

Contributing organisations to the Toxicology and Applied Pharmacology hERG study include: Center for Drug Evaluation and Research, Food and Drug Administration; Eli Lilly and Company; AstraZeneca; CiPA LAB; NMI-TT GmbH; Sophion Bioscience A/S; B'SYS GmbH; The Ion Channel Company; F. Hoffmann-La Roche AG; Eurofins Discovery; Bristol-Myers Squibb; Merck & Co., Inc; Metrion Biosciences Ltd.; Nanion Technologies; Charles River Laboratories; Bayer AG; University of Nottingham; Universit de Lille.

For more information on Metrions fully integrated Cardiac Safety Screening / CiPA Screening service, please visit: https://www.metrionbiosciences.com/services/cardiac-safety-screening/

Merion Biosciences comprehensive cardiac safety testing White Paper The changing landscape of cardiac safety will also be available on the Companys website from 13th April 2020.

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Dr. Bart Rademaker Offers Free Classes On Stem Cell Therapy And The Coronavirus – PR Web

Dr. Bart Rademaker Stem Cell Therapy Info, Coronavirus

TAMPA, Fla. (PRWEB) April 02, 2020

Dr. Bart Rademaker, the long-time plastic surgeon who has branched out into stem cell therapy, is offering online classes to patients and doctors who are interested in learning more about regenerative medicine and the potential benefits on health in particular during this time with the coronavirus or COVID-19. Rademaker, has offered the therapy in his office for years and has been contacted by physicians and patients who wish to find out more information on the benefits it could have for those combating the virus as clinical trials are proceeding in many parts of the world.. The classes will be available beginning in April 2020 and include podcasts, blogs and other forms of information that are available online.

The coronavirus has turned the world upside down and people are trying to gather any information they can. Ive heard medical experts tell people to drink warm tea or water every 20 minutes. Ive heard patients say they read that you can kill the virus with stem cell therapy. There is too much information going out there right now and I want to help patients and medical professionals get the facts on it. Based on my experience and my communication with experts in the field of regenerative medicine, I feel that I can offer some assistance. Dr. Bart Rademaker

One of the main things the doctor wishes to stress to people who are unsure how to minimize exposure is that they need to follow the guidelines put in place by their government and information provided on personal hygiene and safety. This includes washing hands thoroughly with water and soap rather than rely on hand soap. Trying to avoid contact with your eyes and mouth unless youve recently washed your hands. Taking vitamins to strengthen your immune system. Staying away from people and avoiding areas like grocery stores as long as possible are other good recommendations provided that people should follow.

People are not sure what to do because the information comes at them so quickly. Even doctors are not sure when their patient asks them if stem cell therapy is a safe option to prevent or treat the coronavirus. When I have doctors calling me just because they saw that I offer regenerative medicine information online, I knew it was time to start getting aggressive with these classes and offer my assistance to everyone.

For more information you can call our team at: 727-748-7389

About Dr. Bart Rademaker

Dr. Bart Rademaker is based in Tampa, Florida and has over 20 years of experience as a well-respected medical professional. He has affiliations with several hospitals including Morton Plant and Mease Countryside. His degree is from Erasmus University Rotterdam Faculty of Medicine and added regenerative medicine to his practice four years ago.

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