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– AV-380 Phase 1 Clinical Study Initiated Following FDA’s IND Acceptance –
The capital and largest city in northern China’s Hebei province barred people from leaving on Thursday in an effort to curb the spread of the coronavirus as the country reported the biggest rise in daily infections in more than five months.
Hebei accounted for 51 of the 52 local cases reported by the National Health Commission on Thursday. This compared with 20 cases reported in the province, which surrounds Beijing, a day earlier.
Authorities in Shijiazhuang, home to 11 million people, have launched mass testing drives and banned gatherings to reduce the spread of the coronavirus.
In addition to barring people from leaving the city, people and vehicles from areas of the city considered high-risk were not allowed to leave their district, authorities said.
Hebei entered a “wartime mode” on Tuesday, meaning investigation teams would be set up at provincial, city and district levels to trace the close contacts of those who have tested positive.
Chinese state television earlier reported that Shijiazhuang had banned passengers from entering its main railway station. The city had previously required travellers to present a negative nucleic acid COVID-19 test result taken within 72 hours before boarding a train or a plane in the province.
Total new COVID-19 cases for all of mainland China stood at 63, compared with 32 reported a day earlier, marking the biggest rise in daily cases since 127 cases were reported on July 30.
The number of asymptomatic carriers, who have been infected with the SARS-CoV-2 virus that causes the disease but have yet to develop any symptoms, also rose, to 79 from 64 a day earlier.
The total number of confirmed COVID-19 cases in mainland China since the outbreak first started in the city of Wuhan in late 2019 now stands at 87,278, while the death toll remained unchanged at 4,634.
In the city of Dalian in Liaoning province in China’s northeast, which has reported local infections in recent days, residents in medium or high-risk areas have been barred from leaving the city. Residents in other areas were told to refrain from unnecessary trips out of Dalian.
Authorities in Guangdong province in southern China late on Wednesday reported a patient infected with a more transmissible variant of the coronavirus discovered in South Africa.
Some scientists worry that COVID-19 vaccines currently being rolled out may not be able to protect against this variant because of certain mutations that have been observed.
The pace of Britain's rollout of COVID-19 vaccines is being limited by the supply of shots, and the government is working with both Pfizer and AstraZeneca to increase supplies, health minister Matt Hancock said on Thursday.
The government must quickly ramp up the rate of vaccinations in order to meet an ambitious target to inoculate more than 13 million people who are elderly, vulnerable or frontline workers by mid-February.
"The rate limiting step is the supply of vaccine, and we're working with the companies, both Pfizer and of course AstraZeneca, to increase the supply," Hancock told broadcasters.
"The manufacturers are doing a brilliant job, and they're delivering to the schedule that's agreed, but that schedule is the amount of vaccine that we have ... we expect to see that amount of vaccine being delivered going up."
Hancock spoke after the COVID-19 vaccine developed by AstraZeneca and Oxford University was rolled out in doctors surgeries from Thursday.
More than 1.3 million people in the United Kingdom have received one shot of either AstraZeneca's or Pfizer's COVID-19 vaccine, but the government needs to be administering around 2 million doses a week to hit its February target.
In a sign of supply constraints, one doctor visited by Hancock on Thursday said she had not received the delivery of AstraZeneca's vaccine she had been expecting.
Birmingham City Council's leader and local lawmakers also wrote to Hancock saying no AstraZeneca vaccine was available in the central English city and that stocks of the Pfizer shot would run out on Friday.
Britain is prioritising the administration of an initial shot to more people, delaying second doses beyond a month after the first.
Just 20,000 people received their second shot of the Pfizer vaccine before the guidance was changed. Pfizer has said there is no data for the efficacy of the first shot beyond 21 days.
Prime Minister Boris Johnson has said that if the vaccine rollout goes to plan, new lockdown measures introduced this week could start to be eased in February.
Johnson, who will give a news conference later on Thursday, has previously cited the time it takes for the regulator to approve batches of AstraZeneca's vaccine as one limiting factor.
AstraZeneca's vaccine was first deployed in hospitals on Monday. It does not have the ultra-low temperature requirements that Pfizer's does, making it easier to roll out.
Initial boxes of the Pfizer vaccine contained nearly 1,000 doses, but the NHS said smaller boxes had also been approved for use that could be used in settings like care homes without wasting doses.
Last month, Sanofi and Britain's GlaxoSmithKline said a COVID-19 vaccine they are jointly developing had showed an insufficient immune response in older people, delaying its launch to late next year, in a setback for both companies.
Less than a third of Filipinos are willing to get inoculated against the coronavirus, an opinion poll showed on Thursday, as the government races to secure vaccines to give to as many as 70 million people this year.
The survey by Pulse Asia conducted between Nov. 23 and Dec. 2, found that 32% of 2,400 respondents would get a COVID-19 vaccine jab when available, while 47% would refuse it over safety concerns.
The remaining 21% were undecided, the poll showed.
Nearly all of the respondents said they knew vaccines were being developed, but 84% were unsure of their safety, highlighting the challenges the government may face in convincing its people to get vaccinated.
The Philippines has had difficulties with parents being reluctant to vaccinate their children after a high-profile scrapping of a dengue immunisation programme in 2017, following its links to child deaths. Sanofi's has insisted the vaccine used, Dengvaxia, is safe.
A separate poll on Thursday of 1,500 people by Social Weather Stations, conducted in late November, showed 91% of Filipinos were worried about being infected with the coronavirus, up from 85% in September.
The government on Wednesday said it was negotiating with seven vaccine manufacturers to procure at least 148 million COVID-19 shots to inoculate close to two-thirds of its population this year.
The Philippines has so far secured only 2.6 million doses, from AstraZeneca, and its regulators have yet to approve any COVID-19 vaccines. It is deliberating on emergency use applications filed by Pfizer and AstraZeneca.
The country, which has recorded more than 482,000 coronavirus cases, among the most in Asia, hopes to roll out the vaccines as early as the first quarter.
Pfizer Inc. on Thursday said it dosed the first patient in a Phase 3 study of its investigational gene-therapy candidate PF-06939926 in boys with Duchenne muscular dystrophy, or DMD.
The New York drugmaker on Thursday said the pivotal trial is the first Phase 3 gene-therapy program to begin enrolling eligible patients with DMD, a fatal neuromuscular genetic disease that occurs in roughly one in every 3,500 to 5,000 males.
There are currently no approved disease-modifying treatment options available for all genetic forms of DMD, which is caused by a change or mutation in the gene that encodes instructions for dystrophin, a protein found in muscle cells.
Pfizer said it expects the study to enroll 99 patients across 55 sites in 15 countries.
The U.S. Food and Drug Administration in October granted fast-track designation to PF-06939926, which had previously received orphan-drug and rare-pediatric-disease designations from the agency.
The findings, which have not yet been peer-reviewed, showed that the immunosuppressive drugs - Actemra, also known as tocilizumab, and Kevzara, also known as sarilumab - reduced death rates by 8.5 percentage points among patients hospitalised and severely ill with the pandemic disease.
That would mean that for every 12 patients treated with one of the two drugs, an extra life would be saved, said Anthony Gordon, an Imperial College London professor of anaesthesia and critical care who co-led the study.
The data will boost confidence that some existing drugs could be repurposed to help with the pandemic that has killed more than 1.87 million people and crushed global economies.
It also comes as countries struggle to contain two variants of the virus found in South Africa and Britain that are more transmissible and have driven a surge in infections.
Drug companies have been scouring their existing portfolios for possible therapies. So far the generic steroid dexamethasone and Gilead's antiviral drug remdesivir have been approved for treating patients with severe symptoms.
The United States has also authorised emergency use of some antibody drugs for non-hospitalised COVID-19 patients.
The data, from around 800 severely ill COVID-19 patients involved in an international study known as the REMAP-CAP trial showed that the two drugs reduced mortality rates from 35.8% in a control group to 27.3% among patients receiving either tocilizumab or sarilumab.
"That's a big change in survival," said Gordon. "They are both lifesaving drugs."
The results also showed that on average, patients treated with Actemra or Kevzara recovered more swiftly and were able to be discharged from intensive care units around seven to 10 days earlier than those who did not get these drugs, Gordon said.
"This ... could have immediate implications for the sickest patients with COVID-19," he added. "We're seeing the actual benefit in terms of survival and quicker recovery."
Until now, results for Actemra and Kevzara - both a type of drug known as IL-6 receptor antagonists - in treatment trials in patients with COVID-19 have been mixed.
Sanofi said in September that Kevzara - which it produces with partner Regeneron - failed to meet the main goals of a U.S. study testing it in critically ill COVID-19 patients.
In November, Roche said research showed Actemra helped the sickest COVID-19 patients, but it was unclear if it kept people alive or shortened how long they needed intensive care support such as mechanical ventilation, or both.
Gordon noted on Thursday that previous studies had found no clear benefit, but said those trials had included less severely ill patients and started treatment at different stages in the disease course.
"A crucial difference may be that in our study, critically ill patients were enrolled within 24 hours of starting organ support," he said. "This highlights a potential early window for treatment where the sickest patients may gain the most benefit from immune modulation treatment."
Thursday's trial data have not yet been peer-reviewed but were published in online on the medRxiv website.
