clinical trials Archives - Page 9 of 11

Why the pandemic is forcing oncology clinical trials to evolve

Photo by Markus Spiske from Pexels

COVID-19 has complicated oncology trials and oncology care in general, slowing down the success seen against cancer.

The cancer death rate fell 29% between 1991 and 2017, according to the American Cancer Society. Novel treatments such as immunotherapy helped, but the coronavirus pandemic has created challenges.

Researchers have had to adapt and innovate, with AI playing an important role.

COVID-19’s disproportionate impact on oncology

“Cancer patients have been disproportionately negatively affected by COVID-19,” said Jeff Elton, CEO of ConcertAI, an AI company specializing in oncology. Immunocompromised patients with hematological malignancies such as multiple myeloma, in particular, face outsized risks from COVID-19 infection.

To reduce the risk for patients, many oncology clinics in 2019 limited capacity while making significant treatment chang…

Improving clinical trial ROI with medication adherence management

Photo by Elsa Olofsson on Unsplash

Study power is the holy grail of clinical trials, setting drug developers on the quickest path to market — but nonadherence causes costly detours.

When participants do not take their medication as specified in the study protocol, it can result in underestimated drug efficacy, delay the approval of investigational products, and contribute to rising costs.

Without mitigation, then, medication nonadherence can have a significant impact on clinical trial return on investment (ROI).

The scale of the problem

A staggering 80% of clinical studies fail to finish recruitment on time, and 20% of these are delayed for at least six months1 – and every single day of delay to market can cost between $600,000 and $8 million in lost revenue.2

Taking control of adherence is one way to recoup costs and improve ROI. Studies show that each patient involved in a Phase 3 tria…

Pfizer-BioNTech COVID-19 vaccine 91.3% effective after six months

The first COVID-19 vaccine to win emergency use authorization in the U.S. is highly effective for at least six months after the second dose. Developed jointly by Pfizer (NYSE: PFE) and BioNTech (NSDQ: BNTX), the BNT162b2 vaccine

The durability of COVID-19 vaccines had been something of an open question, although early clinical data suggested that Moderna’s mRNA-1273 COVID-19 vaccine was effective for at least 90 days after the second dose.

Pfizer plans on releasing more data related to the long-term vaccine immunogenicity in the coming weeks.

Pfizer and BioNTech plan on doing two years of follow-up for their Phase 3 vaccine trial.

Earlier this year, the two companies released data indicating that their vaccine also remains effective against a highly-transmissible SARS-CoV-2 variant first identified in South Africa.

Pfizer and BioNTech are also testing the vaccine on adolescents. Recent data suggest that the vaccine is 100% effective in ad…

Study: Remdesivir supports clinical improvement in hospitalized COVID-19 patients

Remdesivir diagram

A multicenter study involving a substantial number of minorities indicated that remdesivir supported clinical improvement in the majority of patients.

The hospitalized remdesivir group had an average time to clinical improvement of five days versus seven days for those not receiving the drug. Remdesivir recipients had a 28-day mortality rate of 7.7% compared with a 14% rate for matched controls. The study authors note, however, that this finding was not statistically significant in the time-to-death analysis

Combining remdesivir with corticosteroids did not appear to provide additional benefit.

The study, which was recently published in JAMA, involved 2,483 patients in a five-hospital system in Baltimore, and Washington, D.C.

From that patient pool, 342 participants received remdesivir, with 184 of those individuals also receiving corticosteroids. More than 80.0% of th…

BioNTech and Moderna set their sights on treating cancer

Nodular melanoma. Image courtesy of Wikipedia.

COVID-19 vaccines launched BioNTech and Moderna into the limelight, making these once little-known companies prominent companies. But neither wants to be pigeonholed as a COVID-19 vaccine company.

BioNTech cofounder Özlem Türeci stressed in a recent interview with AP that the mRNA vaccine technology that is its focus could be a powerful weapon against cancer. “We have several different cancer vaccines based on mRNA,” said Türeci, BioNTech’s chief medical officer.

Such therapy could be available to people within a “couple of years,” Türeci said, stressing that it is difficult to predict regulatory timelines involving emerging therapies.

BioNTech is currently working on several novel immunotherapies for oncology targeting melanoma, prostate cancer and cancers associated with human papillomavirus.

Moderna is also exploring the possibility of…

AstraZeneca vaccine offers little protection against South Africa SARS-CoV-2 variant

The ChAdOx1 COVID-19 vaccine jointly developed between AstraZeneca and the University of Oxford is not effective against the B.1.351 variant first identified in South Africa, according to a recent study published in NEJM.

In a five-month study involving HIV-negative adults, 23 of 717 placebo recipients developed mild-to-moderate COVID-19 while 19 of 750 vaccine recipients did. Based on that data, the vaccine has an efficacy of 22% in protecting against mild-to-moderate disease in South Africa more than 14 days after the second dose. Efficacy against the B.1.351 variant specifically was 10.4%.

Last month, South Africa decided to pause its rollout of the vaccine based on the data points, which hadn’t then been peer-reviewed.

The B.1.351 variant has three mutations in the receptor-binding domain portion of the virus, which enhance transmissibility.

The AstraZeneca remains 75% effective against the B.1.1.7 variant, which was first identified in the U.…

Study: Pfizer-BioNTech vaccine dramatically reduces risk of death from COVID-19

Recent real-world data from the Israel Ministry of Health found that unvaccinated individuals were 29 times more likely to die as a result of COVID-19 complications than those who received two doses of the BNT162b2 Pfizer-BioNTech vaccine.

In addition, those who were unvaccinated were 44 times more likely to contract symptomatic COVID-19.

The data also suggest that the vaccine prevents the spread of asymptomatic COVID-19 and is 94% effective against symptomatic disease.

Researchers from the U.K. have also published a preprint that suggested that a single dose of the BNT162b2 vaccine provided a 43% risk of hospitalization and a 51% reduction in risk of death in individuals 70 or older.

In addition, the BNT162b2 vaccine was 89% effective at least 14 days after the second vaccination. The U.K. study also found that a single dose of the vaccine resulted in an 85% reduction in the risk of death from COVID-19.

The Israeli data came from Jan…

Lilly’s bamlanivimab and etesevimab cut COVID-19 hospitalization and deaths in study

A recent Phase 3 trial found that bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) administered jointly led to an 87% reduction in hospitalization and deaths in high-risk patients recently diagnosed with COVID-19.

The randomized, double-blind, placebo-controlled trial administered 700 mg of bamlanivimab (LY-CoV555) and 1400 mg of etesevimab (LY-CoV016) to 511 patients in the treatment arm. FDA granted emergency use authorization to the dosing regimen, which is also supported by the European Medicines Agency’s Committee for Medicinal Products for Human Use. A total of 258 patients in the cohort of the BLAZE-1 study received a placebo.

There were no deaths in the treatment arm but four deaths in the placebo arm. All of the deaths were considered related to COVID-19.

The BLAZE-1 trial has been ongoing for several months, giving Lilly the ability some indication that its monoclonal antibodies are effective against a range of SARS-CoV-2 varia…

Why intranasal vaccines confer immunity where it matters

Mucosa and relevant structures. [Image from Wikipedia]

The COVID-19 vaccine landscape is gradually becoming more diverse. And it could grow more so, as several companies work on intranasal vaccines.

Intranasal vaccines offer potential advantages over traditional intramuscular vaccines. They can stimulate immunoglobulin A production, which can avert infection, as a recent Scientific American article noted.

“It’s not insignificant to go from a needle-based delivery to nasal delivery,” said Dr. C. Buddy Creech, who is the director of the Vanderbilt Vaccine Research Program.

Buddy Creech, MD. Photo by Joe Howell

The approach has several clear advantages. Intranasal vaccines would likely generate mucosal immunity, reducing the virus’s odds to take root in the respiratory tract.

And once pediatric COVID-19 vaccines are available…

Ivermectin not supported for mild COVID-19, study says

Ivermectin image courtesy of Wikipedia.

The antiparasitic drug ivermectin does not appear to be an efficacious COVID-19 treatment for mild COVID-19 cases, based on a randomized study recently published in JAMA.

Ivermectin — which is widely used in veterinary medicine to get rid of worms and other parasites— emerged as a potential COVID-19 treatment, owing to its ability to inhibit replication of the SARS-CoV-2 drugin in vitro and animal studies.

Similar research elevated hydroxychloroquine as a potential COVID-19 therapeutic agent, but the drug also has disappointed in human studies. The World Health Organization now cautions against its use as a COVID-19 treatment.

The ivermectin recipients in the Colombian study had a slightly faster resolution of symptoms than the placebo arm. The median time to resolution was 10 days in the ivermectin group versus 12 for placebo recipients. The number of …

Brilacidin inhibits SARS-CoV-2 in cell culture

The investigational drug brilacidin showed promise in a recent study published in the peer-reviewed journal Viruses.

Researchers conclude that the synthetic small molecule from Innovation Pharmaceuticals exhibited “potent antiviral activity.”

The scientists tested the drug in a human lung cell line and a monkey cell line.

The researchers tested brilacidin against COVID-19 variants from Washington and Italy. The manufacturer plans to test the drug’s antiviral effect with other variants.

Because the antimicrobial compound brilacidin works by disrupting viral integrity, it could be effective against so-called SARS-CoV-2 “variants of concern.” The manufacturer also believes the drug has potential in fighting secondary bacterial infections while also serving as an anti-inflammatory agent.

The drug was based on host defense peptides that are part of the immune system.

Effects of the drug were amplified when used with remdesivir, th…

Is there a link between Bell’s palsy and COVID-19 vaccines?

Image from Nataliya Vaitkevich via Pexels

One adverse event common to clinical trials for currently authorized COVID-19 vaccines is Bell’s palsy, an asymmetrical weakness or paralysis of the face that is often temporary.

Two vaccine recipients in the Johnson & Johnson Phase 3 clinical trial developed Bell’s palsy, as did two people in the placebo group. Another patient developed facial swelling and “droopiness” without facial asymmetry. A clinical trial investigator concluded that this event was unrelated to the vaccine.

Three vaccine recipients in the Moderna Phase 3 clinical trial developed Bell’s palsy, as did one in the placebo group. In the corresponding Pfizer-BioNTech study, four vaccine recipients developed Bell’s palsy, but no participants in the placebo group did.

The three Phase clinical trials involved some 30,000 to 40,000 volunteers.

The numerical imbalance between the …