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Monday, July 27, 2020

Unusual Early Recovery of Critical COVID-19 Patient After IV Vitamin C

Abstract

BACKGROUND Coronavirus disease 2019 (COVID-19) continues to spread, with confirmed cases now in more than 200 countries. Thus far there are no proven therapeutic options to treat COVID-19. We report a case of COVID-19 with acute respiratory distress syndrome who was treated with high-dose vitamin C infusion and was the first case to have early recovery from the disease at our institute. CASE REPORT A 74-year-old woman with no recent sick contacts or travel history presented with fever, cough, and shortness of breath. Her vital signs were normal except for oxygen saturation of 87% and bilateral rhonchi on lung auscultation. Chest radiography revealed air space opacity in the right upper lobe, suspicious for pneumonia. A nasopharyngeal swab for severe acute respiratory syndrome coronavirus-2 came back positive while the patient was in the airborne-isolation unit. Laboratory data showed lymphopenia and elevated lactate dehydrogenase, ferritin, and interleukin-6. The patient was initially started on oral hydroxychloroquine and azithromycin. On day 6, she developed ARDS and septic shock, for which mechanical ventilation and pressor support were started, along with infusion of high-dose intravenous vitamin C. The patient improved clinically and was able to be taken off mechanical ventilation within 5 days. CONCLUSIONS This report highlights the potential benefits of high-dose intravenous vitamin C in critically ill COVID-19 patients in terms of rapid recovery and shortened length of mechanical ventilation and ICU stay. Further studies will elaborate on the efficacy of intravenous vitamin C in critically ill COVID-19.

Pfizer, BioNTech rise as they start late-stage vaccine human trial

Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) have begun their late-stage human trials for their lead mRNA COVID-19 vaccine candidate.
Pfizer is up 1.9% postmarket; BioNTech is up 6%.
The candidate BNT162b2, a nucleoside-modified messenger RNA vaccine that encodes an optimized SARS-Cov-2 full-length spike glycoprotein, is starting a 2-dose regimen in a phase 2/3 safety/efficacy study.
The study is worldwide, except for China.
“Today, we are starting our late-stage global study, which will include up to 30,000 participants. We selected BNT162b2 as our lead candidate for this Phase 2/3 trial upon diligent evaluation of the totality of the data generated so far,” says Pfizer’s Head of Vaccine Research and Development Kathrin U. Jansen.
Assuming clinical success, the companies claim they are on track to seek regulatory review as soon as October – and pending approval, to supply up to 100M doses by the end of 2020 (and 1.3B doses by the end of 2021).

EU talks with Pfizer, Sanofi, J&J on COVID vaccines hit snags

European efforts to secure potential COVID-19 vaccines from Pfizer, Sanofi and Johnson & Johnson are mired in wrangles over price, payment method and potential liability costs, three EU officials told Reuters.

The bloc is in talks with at least six vaccine makers to acquire up front doses of potential shots against the novel coronavirus, officials told Reuters earlier in July, in a strategy meant to increase the chances of having COVID-19 vaccines for its population.
Despite the urgency to seal deals amid a global race to secure the most promising shots, the EU is struggling to reach swift agreements, said the officials, who are involved in the talks, and declined to be named because the negotiations are confidential.
The United States, meanwhile, has already inked two supply agreements with AstraZeneca and Pfizer among other major funding deals.
The EU’s negotiations with Johnson & Johnson are among the most advanced but have yet to conclude amid a back-and-forth over how to share liability costs if the potential vaccine showed unexpected side-effects, two of the officials told Reuters.
Johnson & Johnson had no immediate comment.
France’s Sanofi is negotiating to supply 300 million doses of the potential vaccine it is developing with British drugmaker GlaxoSmithKline Plc to the EU and wants an immediate upfront payment for the entire stock, two officials said.
But the EU wants to pay in tranches and delay some payments until the vaccine has passed large clinical trials, the officials said.
But the EU wants to pay in tranches and delay some payments until the vaccine has passed large clinical trials, the officials said.
This has caused “some hurdles,” one of the officials said.
A spokesman for Sanofi declined to comment.
A spokesman for the Commission, which is leading EU talks with drugmakers, declined to comment.
Aside from the Pfizer, Sanofi and Johnson & Johnson discussions, the EU is also in talks with biotech companies Moderna and Germany’s CureVac, officials told Reuters earlier in July.
Moderna and CureVac were not immediately available to comment.
A deal with AstraZeneca for its vaccine under development with Oxford University was struck by four large EU countries in June and is now about to be completed for the whole 27-nation bloc, officials said.
One official said the EU was seeking to seal three or four advance purchase deals.
“OVER BUDGET”
The most complex talks appear to be with Pfizer and BioNtech which are developing a vaccine using an experimental technology known as messenger RNA, or mRNA, which has not been approved for commercial use by medical authorities.
The two firms want the EU to pay them for 500 million doses only if their COVID-19 vaccine is authorised, one official told Reuters.
This might eliminate the EU’s risk of losing money should the shot prove unsuccessful. But the bloc fears that if it waits for the vaccine to be proved effective, the bill could be much higher and they risk going “over budget,” one of the officials said.
In a further potential complication, some EU negotiators have raised doubts about mRNA, which is also used in the potential COVID vaccines developed by Moderna and CureVac.
Pfizer and BioNtech are also discussing liability issues with EU negotiators, a fourth person familiar with the talks told Reuters.
Pfizer and BioNTech declined to comment.
The U.S. government last week agreed to pay nearly $2 billion to buy enough of the vaccine being developed by Pfizer and BioNTech to inoculate 50 million people, but with payments conditional on their vaccine being successful in large clinical trials.
The price agreed under that deal of nearly $40 per course of treatment is considered too high by the EU, officials told Reuters last week.
The EU is relying on about 2 billion euros ($2.3 billion) from an emergency fund to finance its possible deals with vaccine makers, which could be topped up with payments from EU governments.
For instance, the agreement with AstraZeneca initially negotiated by Germany, France, Italy and the Netherlands cost the four countries 750 million euros for 300 million doses of the potential shot, an Italian official said, with an option to buy a further 100 million doses.
That works out at 2.5 euros per dose.
It is not clear whether under ongoing talks that money will now be provided by the EU emergency fund.

Spectrum Pharma up big on positive poziotinib data in lung cancer

Spectrum Pharmaceuticals (NASDAQ:SPPI) announces positive results from cohort 2 in a Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations.
The 90-subject second cohort met the primary endpoint demonstrating a statistically significant proportion of treated patients who responded (27.8%). Mean duration of response was 5.1 months. The disease control rate (responders + stable cancer) was 70%.
The positive outcome was a reversal of fortune for the epidermal growth factor receptor kinase inhibitor. Cohort 1 failed to achieve the primary endpoint. 
The company plans to review the data with the FDA. Additional results from cohort 2 will be presented at an upcoming medical conference. Cohort 2 was designed to be a registrational study.
Management hosts a conference call today at 4:30 pm ET.

Medpace EPS beats by $0.28, beats on revenue

Medpace (NASDAQ:MEDP): Q2 GAAP EPS of $0.64 beats by $0.28.
Revenue of $205M (-4.3% Y/Y) beats by $23.83M.

Encompass Health EPS misses by $0.05, beats on revenue

Encompass Health (NYSE:EHC): Q2 Non-GAAP EPS of $0.31 misses by $0.05; GAAP EPS of $0.34 misses by $0.03.
Revenue of $1.07B (-6.1% Y/Y) beats by $20M.

Universal Health Services EPS beats by $1.25, beats on revenue

July 27, 2020

Universal Health Services (NYSE:UHS): Q2 Non-GAAP EPS of $1.90 beats by $1.25; GAAP EPS of $2.95 beats by $2.18.
Revenue of $2.73B (-4.5% Y/Y) beats by $260M.