BioIVT, a leading provider of research models and services for drug
and diagnostic development, today announced the opening of its new blood
donor center on the Tufts University campus in Medford, MA to support academic and pharmaceutical researchers involved in COVID-19, cell and gene therapy research.
“BioIVT wants to play a leading role in supporting COVID-19 research
efforts and blood donations are a vital resource for the research and
development of new therapies, vaccines, and diagnostics. We have many
years’ experience developing blood products, including blood-derived
immune cells for cell and gene therapy research, and we want to make
that expertise count,” said BioIVT CEO Jeff Gatz.
“Researchers recognize and appreciate BioIVT’s rapid response and
commitment to high quality, fresh blood products and this new donor
center will allow us to offer those attributes and services to
additional US clients.”
BioIVT’s new Boston blood donor center is its seventh. The company has similar facilities located in California, Tennessee and Pennsylvania to serve US clients and in London, UK for EU-based clients.
“While the initial focus at our Boston
donor center will be on delivering fresh blood, leukopaks and buffy
coats within hours of collection, we plan to add more capabilities and
donors over time,” said Jeff Widdoss, Vice President of Donor Center Operations at BioIVT.
Leukopaks, which contain concentrated white blood cells, are used to
help identify promising new drug candidates, assess toxicity levels, and
conduct stem cell and gene therapy research. They are particularly
useful for researchers who need to obtain large numbers of leukocytes
from a single donor.
BioIVT blood products can be supplied with specific clinical data,
such as the donor age, ethnicity, gender, BMI and smoking status. Its
leukopaks are also human leukocyte antigen (HLA), FC receptor and
cytomegalovirus typed. HLA typing is used to match patients and donors
for bone marrow or cord blood transplants. FC receptors play an
important role in antibody-dependent immune responses. COVID-19-related Precautions
Blood donor centers are considered essential businesses and will remain
open during the COVID-19 quarantine. BioIVT is taking additional safety
measures to protect both blood donors and its staff during this
difficult time. It has instituted several social distancing measures,
including increasing the space between chairs in the waiting room and
between donor beds, and limiting the entrance of non-essential
personnel. The screening rooms are disinfected between donors and all
areas of the center continue to be cleaned at regular intervals.
As soon as each blood donor signs their informed consent form, their
temperature is taken. If they have a fever, their appointment is
postponed, and they are referred to their physician. Any donor who
develops COVID-19 symptoms after donating blood is required to inform
the center immediately.
All BioIVT blood collections are conducted under institutional review
board (IRB) oversight and according to US Food and Drug Administration
(FDA) regulations and American Association of Blood Banks (AABB)
guidelines.
Those who would like to donate blood at BioIVT’s new Boston-area donor center should call 1-833-GO-4-CURE or visit www.biospecialty.com to make an appointment.
Further information about the products available from BioIVT’s new donor center can be found at https://info.bioivt.com/ma-donor-ctr-req. https://www.biospace.com/article/releases/bioivt-opens-new-blood-donor-center-to-support-boston-area-research-into-covid-19-therapies-vaccines-and-diagnostics/
Apeiron Biologics has been cleared to start a European phase 2
trial of a drug that it says could stop COVID-19 entering cells,
blocking the infection.
The drug – called APN01 – is already in an investigator-led clinical
trial in China in 24 patients with severe coronavirus infections that
started in February.
Now, Austria-based Apeiron has been given a green light to run its
own trials in Austria, Germany and Denmark, with the Austrian government
providing “significant” funding, according to the company.
APN01 is a recombinant form of human angiotensin-converting enzyme 2
(ACE2) that has previously been tested in phase 1 and 2 trials for acute
lung injury (ALI) and pulmonary artery hypertension (PAH) involving 89
patients.
It was licensed by GlaxoSmithKline in a $330 million deal in 2010, but the big pharma dropped the programme last year.
The drug is thought to work against SARS-CoV-2, the virus that causes
COVID-19, in two ways. Firstly, it mimics ACE2 – which is used by the
virus to enter cells – acting as a decoy that binds to the virus and
renders it inactive.
At the same time, it reduces harmful inflammatory reactions in the
lungs that occur in some patients with COVID-19 and lead to ALI and
acute respiratory distress syndrome (ARDS), according to Apeiron.
The mechanism of action means it could be the first drug approved to
treat COVID-19 that specifically targets the new SARS-CoV-2 virus,
according to Apeiron’s chief executive Peter Llewellyn-Davies.
“We look forward to dosing the first patient in our phase 2 trial
shortly, with the goal of providing a safe and effective treatment
option for severely infected COVID-19 patients in urgent need of help,”
he said.
Apeiron’s European trial will compare the drug to placebo in up to
200 patients, with the main efficacy measure being the need for invasive
mechanical ventilation – in other words intubation with an endotracheal
tube or in desperate need via a tracheostomy. Secondary objectives will
be based on biomarker changes.
A study published
in the journal Cell has provided laboratory evidence that ACE2 is a key
receptor for SARS-CoV-2 infections, building on earlier research
showing that it is also the point of entry for SARS-CoV, which caused an
outbreak in 2002/2003 and killed 8,000 people.
It also found that APN01 was able to “significantly block early stages of SARS-CoV-2 infections,” according to the authors.
Cases of SARS-Cov-2 have now swept well above the one million mark, with more than 60,000 deaths at the time of writing.
“Importantly, the novel coronavirus strain SARS-CoV-2 is a very close
relative of the first SARS-CoV virus,” said Prof Josef Penninger of the
University of British Columbia, a co-inventor of APN01 and founder of
Apeiron.
“There is significant scientific evidence suggesting that treatment
with the dual action recombinant human ACE2 can be used to treat
patients with COVID-19,” he added.
“We are blocking the door for the virus and, at the same time, protecting tissues, which is what ACE2 normally does.”
GlaxoSmithKline has announced plans to collaborate with
China’s Xiamen Innovex on a potential vaccine to treat the COVID-19
coronavirus.
The companies are testing a recombinant protein-based coronavirus vaccine candidate, known as COVID-19 XWG-03, which is being developed by Innovax with Xiamen University.
GSK will provide Innovax with the adjuvant need for a preclinical
test of the vaccine which is based on a series of truncated S (spike)
proteins from the novel coronavirus SARS-CoV-2 that causes the
respiratory disease known as COVID-19.
Like many of the other vaccines in development the vaccine uses a
version of the spike proteins seen on the surface of the coronavirus to
prime the body’s immune system.
GSK said that preclinical data from one of its collaborations has suggested that the adjuvant may have a benefit.
Adjuvants are important in vaccines as they boost the body’s reaction
to the vaccine and reduce the amount of antigen needed to produce a
therapeutic effect.
In the case of COVID-19, this would help the manufacturer of a successful vaccine keep pace with demand.
GSK expects data to be reported from the various collaborations over
the next 3 months and these data will inform next steps for clinical
development of the candidate vaccines.
CEO Emma Walmsley said the company is looking at further collaboration opportunities with companies and institutions.
It is also exploring options to share manufacturing capacity and
provide large-scale manufacturing for any vaccine that makes it through
the clinical development process.
At the beginning of February GlaxoSmithKline joined with the
not-for-profit organisation, the Coalition for Epidemic Preparedness
Innovations (CEPI) to supply adjuvants in the effort to find a vaccine
against the coronavirus.
According to the latest information published by the World Health Organization, there are two vaccines in clinical trials against coronavirus.
These are an adenovirus vector-based vaccine being developed in China
by CanSino Biologics and the Beijing Institute of Biotechnology, and
Moderna’s mRNA vaccine that is being developed in partnership with the
US-government backed NIAID.
There are 60 more vaccine candidates in preclinical testing, using a
variety of different approaches including DNA, viral vectors, protein
subunits, and live attenuated viruses.
After President Trump said Friday Americans can wear face masks (if they want to) — and experts now say they can help stop the coronavirus — people are going DIY, making their own face protectors in droves.
But a small clothing manufacturer in Los Angeles says not to use
T-shirt material, as the government suggested, but blue shop towels
instead.
Using blue shop towels in homemade face masks can filter particles
two to three times better than cotton, according to Lindsay Medoff, the
CEO of Suay Sew Shop.
Medoff and her pal Chloe Schempf were appalled that all the
instructions for DYI face masks called for porous cotton weaves which
couldn’t filter microscopic pathogen particles, and became obsessed with
finding a fabric better suited for the job.
They built a lab that could test particle filtration down to 0.3
microns and tested every fabric they could find, from coffee filters to
industrial materials.
Medoff was even more disgusted at the recommendations to use a bandana.
“The recommendation of a bandana made me ill,” Schempf told Business Insider. “I couldn’t understand how we can go from a 2020 N95 mask to a 1918-era cotton mask with a variable filtration of 20% to 60%.”
The ideal material turned out to be stretchy blue shop towels made from a polyester hydro knit.
So Schempf, Medoff, and Medoff’s business partner, Heather Pavlu, a
co-owner of Suay Sew Shop, researched proper materials and found “by
adding two blue shop towels and using a design that produces a
tighter-fitting mask, they could make a mask that could block up to 95%
of the particles, while the cotton masks blocked 20% to 60% of the
particles,” according to Business Insider.
The women are currently sewing their new masks and giving them (and the design) away while raising money to pay their workers. https://nypost.com/2020/04/04/shop-towels-filter-better-than-t-shirts-for-diy-coronavirus-masks/
Councilman Mark Levine (D-Manhattan) wrote in a series of tweets:
“This likely will be done using a NYC park for burials (yes you read
that right). Trenches will be dug for 10 caskets in a line.”
“It will be done in a dignified, orderly–and temporary–manner. But it
will be tough for NYers to take,” Levine wrote, adding in another
tweet, “The goal is to avoid scenes like those in Italy, where the
military was forced to collect bodies from churches and even off the
streets.”
He later clarified his tweets, saying this “is a contingency NYC is
preparing for BUT if the death rate drops enough it will not be
necessary.”
Mayor Bill de Blasio was asked about the grim matter during a coronavirus press briefing Monday at the Brooklyn Navy Yard.
“We may well be dealing with temporary burials, so we can deal with
each family later,” the mayor said. We will have the capacity for
temporary burials – that’s all I’m going to say.”
“I’m not going into details,” de Blasio said. “I don’t think it’s a great thing to be talking about.”
However, Hizzoner did mention city-owned Hart Island — the city’s
longtime potter’s field and nation’s largest public burial ground, which
sits just off The Bronx’s southeast coast in the Long Island Sound.
“We’re going to try and treat every family with dignity, respect
religious needs of those who are devout, and the focus now is to try and
get through this crisis and obviously also put all of our energy and
resources into saving those we can save,” he added.
A spokeswoman for the city’s Medical Examiner’s office, Aja
Worthy-Davis, told The Post there are no plans currently to begin
temporary burials and that the freezers at agency facilities in
Manhattan and Brooklyn have “adequate space.”
“We have no plans right now to bury anyone in city parks,” said
Worthy-Davis, noting that the disturbing scenario is mentioned in a
previous OCME disaster plan, but “it’s not in the works at this time.”
Levine explained that city hospital morgues have filled up and the
Office of the Chief Medical Examiner has sent out 80 refrigerated
tractor-trailers with a capacity to hold 100 bodies to hospitals around
the city.
“These are now mostly full too,” Levine said. “Some hospitals have had to add a 2nd or even 3rd trailer.”
According to Levine, “Grieving families report calling as many as
half a dozen funeral homes and finding none that can handle their
deceased loved ones” and that “cemeteries are not able to handle the
number of burial requests and are turning most down.”
More than 2,470 people have died in the city as a result of
coronavirus and more than 64,900 people in the city have tested positive
for the virus.
“[T]he number of bodies continues to increase,” Levine tweeted. “The
freezers at OCME facilities in Manhattan and Brooklyn will soon be
full.” https://nypost.com/2020/04/06/nyc-to-begin-temporarily-burying-coronavirus-victims-in-local-parks/
The American Thoracic Society issued guidelines suggesting Covid-19
patients with pneumonia get doses of the antimalarial drug
hydroxychloroquine if all of the following apply: a) shared
decision-making is possible, b) data can be collected for interim
comparisons of patients who received hydroxychloroquine (or chloroquine)
versus those who did not, c) the illness is sufficiently severe to
warrant investigational therapy, and d) the drug is not in short
supply,” the Thoracic Society said
The use of hydroxychloroquine has been hotly debated.
President Trump has promoted its use on an experimental basis and Gov. Andrew Cuomo has agreed to provide it to thousands of seriously ill patients in New York hospitals in combination with Zithromax.
Critics have criticized the promotion of using the drug based on limited or anecdotal evidence.
The Thoracic Society said its guidelines are based on input from an
international task force comprised of doctors from medical centers that
are currently treating COVID-19 patients.
The medical group said evidence about the impact of
hydroxychloroquine is “contradictory” but it is worth experimenting with
during a public health crisis to treat very sick patients.
“We believe that in urgent situations like a pandemic, we can learn
while treating by collecting real-world data,” said Dr. Kevin Wilson,
chief of Guidelines and Documents at the American Thoracic Society.
“There are in vitro studies that suggest that hydroxychloroquine and
chloroquine have activity against SARS-CoV-2019, the virus that causes
COVID-19,” Wilson said.
But he also said several controlled trials from China and France “all
have serious flaws and inconsistent findings. ….Thus, the bottom line
is, whether hydroxychloroquine and chloroquine confer benefits to
patients with COVID-19 are unanswered questions.” https://nypost.com/2020/04/06/medical-group-backs-giving-hydroxychloroquine-to-coronavirus-patients/
Prisma Health said Monday it would work with Ethicon Inc., part of
the Johnson & Johnson Medical Devices Companies, to make and
distribute the VESper Ventilator Expansion Splitter.
Ethicon said system is authorized for emergency use during the
Covid-19 pandemic and allows a single ventilator to be used for two
rescuable patients. The system would be used until individual
ventilators are available, Prisma said.
“Due to the predicted dire ventilator shortage, Prisma Health
received an Emergency Use Authorization from the U.S. Food and Drug
Administration for the device in response to the urgency for more
ventilators as a result of the pandemic,” the company said.
Ethicon will use 3D printing technology to manufacture the devices
and distribute them at no cost to healthcare providers in the U.S. “The
initial distribution of the device will be limited to the United States
as Prisma Health and Ethicon are developing strategies to navigate
various regulatory pathways and fulfill orders world-wide,” Prisma said. https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-Prisma-Health-Ethicon-to-Build-Ventilator-Split-Device-for-Emergency-Use-30346159/
