A Blog by Jonathan Low

 

Oct 14, 2020

Eli Lilly Covid Antibody Trial Paused, Following Johnson and Johnson, AstraZeneca

Advanced trials at three of the major pharma companies working on vaccines or antibodies to fight Covid have now been paused. 

While these pauses may not be significant in themselves, they do reveal that not every solution is going to work for every patient or potential recipient, meaning that a 'cure' to the virus is probably still some ways off. JL

Berkeley Lovelace and Christina Farr report in CNBC:

Eli Lilly’s late-stage trial of its leading monoclonal antibody treatment for the coronavirus has been paused by U.S. health regulators over safety concerns. The news comes less than 24 hours after Johnson & Johnson confirmed that its late-stage coronavirus vaccine trial was paused after a participant reported an “adverse event” the day before. “When a small number of patients have received a compound, it’s hard to tell what’s a real problem and what is noise. That’s why patience and prudence are always warranted before doling out experimental treatments.”

Eli Lilly’s late-stage trial of its leading monoclonal antibody treatment for the coronavirus has been paused by U.S. health regulators over potential safety concerns, the company confirmed to CNBC on Tuesday.

“Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” spokeswoman Molly McCully told CNBC. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

The company’s shares closed down 2.9%.

The news comes less than 24 hours after Johnson & Johnson confirmed that its late-stage coronavirus vaccine trial was paused after a participant reported an “adverse event” the day before.

Dr. Mathai Mammen, global head of the Janssen research and development arm at J&J, told investors on a conference call Tuesday that the company still has “very little information” on the reason for the holdup, including if the patient received the vaccine or the placebo. Preliminary information has been sent to the data safety monitoring board for review, he added.

Medical experts note that pauses in large clinical trials are not uncommon. They added it’s possible the bad reaction could be the result of an unrelated illness, and not the drug itself. The review from the data and safety monitoring board will help determine that.

The ACTIV-3 trial is designed to test a monoclonal antibody developed by Eli Lilly in combination with Gilead Sciences’ remdesivir, an antiviral with emergency use authorization for the virus. It’s one of several ongoing trials that are part of the National Institute of Health’s “Activ” program, which is designed to accelerate the development of Covid-19 vaccines and treatments. It is also backed by Operation Warp Speed, the Trump administration’s effort to manufacturer and distribute vaccines to fight Covid-19.

Eli Lilly’s drug is part of a class of treatments known as monoclonal antibodies, which are made to act as immune cells that scientists hope can fight the virus. The treatment was developed using a blood sample from one of the first U.S. patients who recovered from Covid-19. AstraZeneca and Regeneron, among other companies, are also working on so-called antibody treatments.

Monoclonal antibody treatments hit the headlines this month after news broke that President Donald Trump received an antibody cocktail from Regeneron. As Trump’s health improved, he touted it as a “cure.” But Regeneron’s CEO, Leonard Schleifer, has stressed that more testing is required.

Trump has previously touted Eli Lilly’s treatment and others. Earlier this month, when he was sick with Covid-19, he said, “We have these drugs, Eli Lilly and the others that are so good.”

“They are in my opinion, remember this, they’re going to say that they’re therapeutic. And I guess they are therapeutic. Some people don’t know how to define therapeutic. I view it different. It’s a cure,” Trump said in a video posted Oct. 7 on Twitter. “For me, I walked in. I didn’t feel good. A short 24 hours later, I was feeling great. I wanted to get out of the hospital. And that’s what I want for everybody. I want everybody to be given the same treatment as your president because I feel great.”

No details regarding Eli Lilly’s safety concern are yet known.

“When scientists test promising treatments, sometimes unexpected side effects occur,” said Jeremy Faust, a health policy expert and emergency medicine doctor at Brigham and Women’s Health in Boston.

Faust was part of the group of scientists that first reported the news via the research site Brief19.

“When only a small number of patients have received a compound, it’s hard to tell what’s a real problem and what is noise,” he told CNBC. “That’s why patience and prudence are always warranted before doling out experimental treatments.”

1 comments:

Robert Earl said...

HAVE YOU LOST YOUR HARD EARNED FUNDS TO THE WRONG HANDS?
MEET THE PROFESSIONAL HACKERS FOR HIRE TODAY.
⏱️ 3min Read
�� Hiring a professional hacker has been one of the world's most technical valued navigating information.
Regarding:
•Recovery Of Lost Funds,
•Mobile Phone Hack.(Catching A Cheating Spouse).
•Credit Score Upgrade,
VARIOUS HACKTIVITIES via
leroysteckler@gmail.com
High prolific information and Priviledges comes rare as it has been understood that what people do not see, they will never know. The affirmative ability to convey a profitable information Systematically is the majoy factor to success.
Welcome to the Global KOS hacking agency where every request on hacking related issues are fixed within a short period of time.
When you wonder “which hacking company should I hire, the first aspect that should concern you is Sincerity. Secondly, Rapid response. Clearly, you want to embark for services that povides swift response, With our astonishing Hackers, you will be glad to find out that our services Implies precision and action.
This post is definitely for those who are willing to turn their lives around for the better, either financial-wise, relationship-wise or businesses.
The manual Operation of this hackers is to potentially deploy a distinguished hacking techniques to penetrating computers.
If your shoe fits in any of the services below, you will be assigned to a designated professional hacker who is systematically known for operating on a dark web V-link protocol.
Providing value added services to clients as a hacker has been our sustaining goal.
Are you faced with cyber challenges like
��Recovery of lost funds:✅(BITCOIN INVESTMENTS, BINARY OPTIONS, LOAN AND TRADING FOREX WITH FORGERY BROKERS.) ��️I would try my possible best to shortly explain this in particular.
This shocking study points to one harsh reality we all face today. It saddens our mind when client expresses annoyance or dissatisfaction of unethical behaviours of scammers. We have striven to make tenacious efforts to help those who are victims of this flees get off their traumatic feeling of loss. The cyber security technique used to retrieving back the victims stolen funds is the application of a diverse intercall XX breacher software enables you track the data location of a scammer. Extracting every informations on the con database. Every information required by the Global KOS would be used to tracking every transaction, time and location of the scammer. This is acheived using the systematic courier tracking base method•
However, there are secret cyber infiltrators called brokers and doom. The particular system used by this scammers permeates them to manupulate targets digital trading system or monetary fund based accounts. Strictly using a dark web rob to diverting successful trades into a negative outcome. This process bends to thier advantage while investors results to losing massive amount of money. An act of gaining access to an organization or databased system to cause damages. We have worked so hard to ensure our services gives you a 100% trading success to recover all your losses•
�� HACKING A MOBILE PHONE:.✅ Do you think you are being cheated on? Curious to know what your lover is up to online? This type of hack helps you track every movement of your cheater as we are bent on helping you gain full remote access into the cheater's mobile phone using a Trojan breach cracking system to penetrate their social media platforms like Facebook, whatsapp, snapchat etc.
The company is large enough to provide comprehensive range of services such as•
• Email hacks��
• Hacking of websites.��
• Uber free payment hacks.��
Our strength is based on the ability to help fix cyber problems by bringing together active cyber hacking professionals in the GlobalkOS to work with.
Contact:
✉️Email: theglobalkos@gmail.com
Leroysteckler@gmail.com
®Global KOS™
2020.

Post a Comment