A new rapid expert consultation from a standing committee of the National Academies of Sciences, Engineering, and Medicine.

Rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United States.; Credit: /AP

Updated at 4:59 p.m. ET

The Food and Drug Administration has given emergency use authorization to the antiviral drug remdesivir to treat hospitalized patients with the coronavirus, President Trump on Friday told reporters at the White House.

Gilead CEO Daniel O'Day said remdesivir maker Gilead Sciences is donating 1.5 million vials of the drug and will work with the federal government to distribute it to patients in need.

The news comes days after preliminary results from a study of the drug showed it can help patients recover faster. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, hailed the findings earlier this week as "quite good news."

The authorization means remdesivir can be distributed in the U.S. and given intravenously to treat COVID-19 patients — both adults and children — who are hospitalized with severe disease, the FDA says. The agency defines that category as "patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator."

Discussing the findings about the drug's ability to help COVID-19 patients, O'Day cautioned earlier Friday that remdesivir is used to treat advanced cases, in which people are already hospitalized. The recent positive findings, he said, are a starting point in the fight against the respiratory disease.

"We want to continue to see how we can expand remdesivir to more patient populations," O'Day said on NBC's Today show. "Clearly with other medicines and vaccines to come, this is part, I think — the beginning of our ability to make an impact on this devastating virus."

This content is from Southern California Public Radio. View the original story at SCPR.org.

Source: Streetwise Reports   04/24/2020

Mesoblast Ltd. (MESO:NASDAQ; MSB:ASX) today announced that it had achieved an "83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated during the period March-April 2020 with two intravenous infusions of Mesoblast's allogeneic mesenchymal stem cell product candidate remestemcel-L within the first five days." The company stated that of the 12 patients treated, 75% (9/12) successfully came off ventilator support after a median timeframe of 10 days. The firm advised that all of the patients were treated under an emergency Investigational New Drug (IDA) application or expanded access protocol at Mt. Sinai hospital in New York City and so far seven of the patients have been discharged from the hospital. The company noted that each of the patients had received a variety of experimental agents prior to being treated with remestemcel-L.

The firm explained that until now only about 9% (38/445) of ventilator-dependent COVID-19 patients at a major referral hospital network in New York City were able to come off ventilator support when treated with existing standard of care treatments during March and April 2020. The company reported that at a second major referral hospital network in New York City over the same period, there was 88% mortality with only 12% survival (38/320) among ventilator-dependent COVID-19 patients.

The company's CEO Dr. Silviu Itescu commented, "The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled Phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients."

Dr. Fred Grossman, Mesoblast's Chief Medical Officer, added, "There is a significant need to improve the dismal survival outcomes in COVID-19 patients who progress to ARDS and require ventilators. We have implemented robust statistical analyses in our Phase 2/3 trial as recommended by the US Food and Drug Administration (FDA) in order to maximize our ability to evaluate whether remestemcel-L provides a survival benefit in moderate/severe COVID-19 ARDS."

Mesoblast Ltd. is headquartered in Melbourne, Australia, and is a developer of industrial-scale, cryopreserved, off-the-shelf allogeneic cellular medicines. The company utilizes its proprietary mesenchymal lineage cell therapy technology platform in order to create a wide portfolio of commercial products and late-stage product candidates. The firm indicated that "the Biologics License Application to seek approval of its product candidate RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease has been accepted for priority review by the U.S. Food and Drug Administration." The company has offices in Australia, the U.S. and Singapore.

Mesoblast began the day with a market capitalization of around $687.9 million with approximately 106.7 million shares outstanding. MESO shares opened nearly 142% higher today at $15.59 (+$9.14, +141.71%) over yesterday's $6.45 closing price and reached a new 52-week high price this morning of $20.57. The stock has traded today between $13.01 and $20.57 per share and is presently trading at $14.76 (+$8.30, +128.76%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: MESO:NASDAQ; MSB:ASX, )

Source: Streetwise Reports   04/29/2020

Biopharmaceutical company Chimerix Inc. (CMRX:NASDAQ), which focuses on developing medicines to treat cancer and other serious diseases, today announced that it will initiate a Phase 2/3 study of dociparstat sodium (DSTAT) in COVID-19 patients suffering from acute lung injury (ALI).

The firm explained that "DSTAT is a glycosaminoglycan derivative of heparin with robust anti-inflammatory properties, including the potential to address underlying causes of coagulation disorders with substantially reduced risk of bleeding complications compared to commercially available forms of heparin.^"

Joseph Lasky, M.D., Professor of Medicine, Pulmonary and Critical Care Section Chief, John W. Deming, M.D. Endowed Chair in Internal Medicine at Tulane University Medical School commented, "Given the severity of the COVID-19 pandemic, we have evaluated many potential targets to address the clinical manifestations associated with severe COVID-19...Based on the literature, we believe DSTAT has the potential to reduce the excessive inflammation, immune cell infiltration and hypercoagulation associated with poor outcomes in patients with severe COVID-19 infection."

The company's CEO Mike Sherman remarked, " DSTAT is well-suited to unlock the anti-inflammatory properties of heparin as it may be dosed at much higher levels than any available form of heparin without triggering bleeding complications...We had planned to evaluate DSTAT in several indications of high unmet need, including ALI from different causes. The pandemic intensified our focus on ALI associated with COVID-19. Our team has worked closely with critical care physicians treating COVID-19 patients and with the U.S. Food and Drug Administration (FDA) to develop a Phase 2/3 protocol to determine if DSTAT can reduce the need for mechanical ventilation and improve the rate of survival in patients with severe COVID-19 infection."

The company outlined its plans for the study indicating that it will be a randomized, double-blind Phase 2/3 trial to determine the safety and efficacy of DSTAT in adults with severe COVID-19 who are at a high risk of respiratory failure. The study subjects will be confirmed COVID-19 patients who require hospitalization and supplemental oxygen therapy. The primary endpoint established in the study is the percentage of subjects who survive and do not require mechanical ventilation through 28 days. Several secondary endpoints listed include time needed for showing improvement, time to hospital discharge, time to resolution of fever, number of ventilator-free days, all-cause mortality and changes in several key biomarkers.

The study will begin by enrolling 24 subjects in Phase 2 to first establish dosage levels and then expand to 74 total patients. The firm advised that if Phase 2 results are positive, it would enroll approximately 450 subjects in the Phase 3 portion of the study.

The company reported that "the clinical manifestations of COVID-19 range from mild, self-limited respiratory tract illness to severe alveolar damage and progressive respiratory failure, multiple organ failure, and death. Mortality in COVID-19 is associated with severe pulmonary disease and coagulation disorders such as disseminated intravascular coagulation." The firm indicated that the mechanisms of action of DSTAT may address overactive inflammatory response including underlying causes of blood coagulation disorders associated with COVID-19.

Chimerix is a development-stage biopharmaceutical company based in Durham, N.C. which is engaged in advancing medicines in the areas of cancer and other serious diseases. The company listed that it presently has two active clinical-stage development programs. The first is dociparstat sodium (DSTAT) which is a glycosaminoglycan compound derived from porcine heparin that has low anticoagulant activity. The second pipeline candidate is brincidofovir (BCV) which is an antiviral drug being developed as a medical countermeasure for smallpox.

Chimerix began the day with a market capitalization of around $93.2 million with approximately 61.74 million shares outstanding. CMRX shares opened 30% higher today at $1.97 (+$0.46, +30.46%) over yesterday's $1.51 closing price. The stock has traded today between $1.82 to $2.62 per share and is currently trading at $2.27 (+$0.76, +50.33%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: CMRX:NASDAQ, )

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