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Eli Lilly says other COVID-19 antibody drug trials ongoing after study halted for safety concern

October 14, 2020

By Carl O’Donnell and Michael Erman

a large building: FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego

© Reuters/MIKE BLAKE
FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego

(Reuters) – Eli Lilly & Co on Wednesday said other trials of its experimental coronavirus antibody therapy remain on track after a government-run study testing the treatment in hospitalized COVID-19 patients was paused due to safety concerns.

Lilly said on Tuesday that an independent safety monitoring board requested a pause in the trial, called ACTIV-3, due to a potential safety issue.

The National Institutes of Health (NIH), which is collaborating with Lilly on the trial, said the advisory board paused the trial after seeing a “difference in clinical status” between patients on Lilly’s drug on those who received a placebo, without providing further detail.

Lilly on Wednesday said the paused trial is distinct from others it is conducting because it focuses on hospitalized patients who are

Eli Lilly pauses trial of antibody drug Trump touted as COVID-19 ‘cure’ over safety concern

October 14, 2020

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By Michael Erman and Carl O’Donnell

(Reuters) – Eli Lilly and Co said on Tuesday that the government-sponsored clinical trial of its COVID-19 antibody treatment similar to one taken by U.S. President Donald Trump has been paused because of a safety concern.

Trump touted the Lilly drug, along with the antibody treatment from Regeneron Pharmaceuticals Inc that he received for his COVID-19, as tantamount to a cure in a video he posted last week.

The announcement comes one day after Johnson & Johnson said it was forced to pause a large high-profile trial of its experimental coronavirus vaccine because a volunteer fell ill. J&J said it does not yet know if that person was given the vaccine or a placebo.

AstraZeneca Plc’s U.S. trial for its experimental COVID-19 vaccine has also been on hold for over a month after a volunteer in its UK study fell ill. Trials of that

CytRx Highlights Use of Licensed Drug Aldoxorubicin in ImmunityBio’s Expanded Phase 2 Study of Pancreatic Cancer Treatment

October 13, 2020

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Third-Line Cohort Added to Phase 2 Pancreatic Cancer Trial for Combination Immunotherapy That Includes Aldoxorubicin, ImmunityBio’s N-803 and NantKwest’s PD-L1 t-haNK

Three Trial Sites in California and South Dakota Will Initially Enroll 298 Patients Across the Cohorts, With 40 Patients Already Enrolled or Being Evaluated

CytRx Corporation (OTCQB:CYTR) (“CytRx” or the “Company”), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today highlighted that ImmunityBio, Inc. and NantKwest, Inc. (collectively, the “Companies”) have announced the addition of a third cohort to their ongoing Phase 2 study of a novel combination immunotherapy – which includes CytRx’s licensed drug aldoxorubicin – for locally advanced or metastatic pancreatic cancer (QUILT-88). According to the Companies, the third cohort will enable pancreatic cancer patients who have failed all approved standards of care to participate in the study.

As previously noted in CytRx’s October 7, 2020 press release regarding

South Korea’s Celltrion gets approval for Phase 3 trials of COVID-19 antibody drug

October 12, 2020

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By Sangmi Cha

SEOUL (Reuters) – South Korean drugmaker Celltrion Inc <068270.KS> said on Monday it has received regulatory approval for Phase 3 clinical trials of an experimental COVID-19 treatment.

The approval comes as the company plans to seek conditional approval for its antibody drug, CT-P59, for emergency use by the end of this year.

The treatment, the most advanced antibody drug in terms of research in South Korea, is directed against the surface of the virus and designed to block it from locking on to human cells.

The third stage trials will be conducted on some 1,000 asymptomatic coronavirus patients and those who have come into close contact with COVID-19 patients in Korea, Celltrion said in a statement.

The Ministry of Food and Drug Safety recently approved a Phase 2/3 study on patients with mild and moderate cases of COVID-19, Lee Sang-joon, Celltrion’s senior executive vice president, told Reuters.

Hong Kong scientists say anti-microbe drug successful against coronavirus

October 12, 2020

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An affordable anti-microbial drug used to treat stomach ulcers and bacterial infections has shown promise in combatting the coronavirus in animals, scientists in Hong Kong announced Monday.

Researchers set out to explore whether metallodrugs — compounds containing metal that are more commonly used against bacteria — might also have anti-viral properties that could fight the SARS-CoV-2 coronavirus.

Using Syrian hamsters as tests subjects, they found that one of the drugs, ranitidine bismuth citrate (RBC), was “a potent anti-SARS-CoV-2 agent”.

“RBC is able to lower the viral load in the lung of the infected hamster by tenfold,” Hong Kong University researcher Runming Wang told reporters on Monday as the team presented their study.

“Our findings demonstrate that RBC is a potential anti-viral agent for Covid-19.”

The coronavirus has killed more than a million people since it first emerged in China last December and then spread across the globe.

As scientists scramble

Lilly’s Rheumatoid Arthritis Drug, Combined With Remdesivir, Benefits Covid-19 Patients Who Need Oxygen

October 9, 2020

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This week, Eli Lilly and Company announced additional findings indicating that its rheumatoid arthritis drug, baricitinib, may improve the health of severe Covid-19 patients when used in combination with Gilead Science’s antiviral drug remdesivir.

Outcomes of the study, which the company had reported preliminary data from in September, suggest that the two drugs in combination reduce hospitalization stays by one day compared to the use of remdesivir alone. The data also indicates that the drug combination increases chances of severe Covid-19 patients surviving by about 35%. That increase was more pronounced in those patients who required supplemental oxygen.

“We’re obviously extraordinarily pleased that it has an impact on the mortality rate,” says Ilya Yuffa, president of Lilly Biosciences.

The findings come from a large study called the Adaptive Covid-19 Treatment Trial (ACTT-2), which is sponsored by the National Institutes of Health. The full data and study writeup will be

Pfizer’s breast cancer drug Ibrance fails late-stage study

October 9, 2020

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(Reuters) – Pfizer Inc said on Friday its cancer drug Ibrance did not meet the main goal in a late-stage trial in patients with a type of breast cancer, the latest setback in the company’s attempt to expand the use of the drug to treat early stages of the disease.

The latest development comes after an independent data monitoring committee said in May a similar trial comparing Ibrance plus an endocrine therapy to a standalone endocrine therapy to treat early-stage breast cancer was unlikely to meet the main goal.

Ibrance is already approved in the United States to treat certain adult patients with advanced breast cancer which has spread to other parts of the body. The drug has not yet been approved for treating early stages of the disease.

This puts the drug at a relative disadvantage to rival Eli Lilly and Co, which in June posted data showing that

Gilead Drug Shows Promising Results In Treating COVID, Ready For Distribution Says CEO

October 9, 2020

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KEY POINTS

Gilead’s coronavirus treatment redemsivir was found to reduce recovery time in patients by several days
Redemsivir and other drug treatments could serve as stopgap measures until a proper vaccine is ready and approved
The Trump administration and Congress re-entered negotiations about a stimulus package to help a U.S. economy hit hard by the pandemic

Final results from Gilead Sciences’ latest remdesivir trial showed the antiviral drug was effective in treating coronavirus patients and cutting recovery time by at least a week.

Gilead’s CEO said, given the positive results, the company was ready for mass production and distribution of the drug.

As of Friday, Johns Hopkins said the U.S. has over 7.6 million confirmed cases of coronavirus and 212,805 reported deaths from it. The latest trial was conducted for nearly a month and involved over 1,062 patients hospitalized for coronavirus. Half of the patients were given remdesivir while the

Health officials scrambling to produce Trump’s ‘last-minute’ drug cards by Election Day

October 9, 2020

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“The goal is to begin the test by distributing cards starting in October 2020,” according to a draft proposal circulated within the White House last week and obtained by POLITICO.

Career civil servants have raised concerns about the hasty plan and whether it is politically motivated, particularly after Verma pushed Medicare officials to finalize the plan before the Nov. 3 election, said two officials.

The plan to lower seniors’ drug costs comes as administration officials grapple with Trump’s falling support among older Americans, a significant threat to his re-election. Trump is currently lagging challenger Joe Biden by as much as 27 points in recent polls among Americans ages 65 and older, a major reversal from the 2016 campaign, with seniors now voicing concerns about Trump’s handling of the coronavirus pandemic and his chaotic leadership style.

“This has nothing to do with politics. It’s good policy and demonstrates the president is

Trump’s COVID drug was developed using aborted fetal tissue

October 9, 2020

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The antibody cocktail that President Trump received for his COVID-19 infection and touted on Wednesday evening as a “cure” for the deadly virus was developed using cells derived from aborted fetal tissue, a practice the White House and anti-abortion rights groups oppose.

Amanda Banks, Alveda King, Donald Trump standing in front of a crowd holding a sign: Anti-Abortion Activists Demonstrate In D.C. During Annual March For Life

© Mark Wilson / Getty Images
Anti-Abortion Activists Demonstrate In D.C. During Annual March For Life

Last week, Mr. Trump received Regeneron Pharmaceuticals’ cocktail of monoclonal antibodies, an experimental therapeutic for coronavirus that is still undergoing testing and is not FDA approved. In a nearly five-minute video posted to Twitter on Wednesday, the president lauded its effects, calling it “the key.”

“I think this was a blessing from God that I caught [the virus], I think it was a blessing in disguise,” Mr. Trump said in the video. “I caught it, I heard about this drug, I said, ‘Let me take it’ … and it was

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