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Moderna Stock Surges As It Swings For Pfizer, GSK With New RSV Vaccine Results

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Moderna (MRNA) stock surged early Wednesday after the company said its experimental RSV vaccine proved nearly 84% effective against respiratory symptoms in older adults.

The company tested its vaccine in people age 60 and older. It was 83.7% effective against mild respiratory syncytial virus, or RSV. The virus causes cold-like symptoms. It can be deadly in infants who have virtually nonexistent immune systems and older adults who have weakened immunity.

The results are competitive with Pfizer (PFE) and GSK (GSK), both of which are approaching Food and Drug Administration review dates for their RSV vaccines in May. Johnson & Johnson (JNJ) and Bavarian Nordic trail with potential vaccines.

Moderna is planning to file for approval of its RSV vaccine in the first half of this year. Needham analyst Joseph Stringer expects the FDA to approve the shot before year’s end.

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“We think Moderna’s profile is competitive and has the potential to capture a meaningful share of the multi-billion dollar RSV market,” he said in a note to clients.

Moderna Stock: A Battle Brewing In RSV

In premarket action on the stock market today, Moderna stock surged 6.3% near 202.70.

Moderna Chief Executive Stephane Bancel says the results further prove the capabilities of the company’s platform in messenger RNA, or mRNA. In the body, messenger RNA carries the genetic instructions for making proteins. Vaccines take advantage of this process, telling the body to make specific proteins in order to prompt an immune response.

“Today’s results represent an important step forward in preventing lower respiratory disease due to RSV in adults 60 years of age and older,”Bancel said in a written statement issued late Tuesday. “These data are encouraging and represent the second demonstration of positive Phase 3 (study) results from our mRNA infectious disease platform.”

Moderna tested its RSV vaccine in 37,000 adults age 60 or older in 22 countries, including the U.S. The company reported an interim analysis, examining the number of participants to develop two or more symptoms of RSV. Of the 64 people to develop symptoms, 55 received the placebo. Nine were vaccine recipients.

Another measure looked at participants to develop three or more symptoms of RSV. Moderna said there were 20 people in the study to hit that mark, including 17 placebo recipients and three vaccinated people. That put the effectiveness at 82.4% against so-called severe RSV.

An independent team of data monitors reviewed Moderna’s test results and said there have been no safety concerns.

The results help Moderna stock continue trending higher. Shares have turned around this month and have a strong Relative Strength Rating of 90 out of a best-possible 99, according to IBD Digital. This puts Moderna stock in the leading 10% of all stocks in terms of 12-month performance.

Comparing RSV Vaccines

Now, Moderna plans to submit the data to a peer-reviewed publication and present more data at a future infectious diseases conference.

By comparison, GSK has said its RSV vaccine was almost 83% effective overall and more than 94% protective against severe RSV in adults age 60 and older with underlying health problems. Pfizer’s shot was close to 67% protective overall and about 86% effective against severe disease.

“Based on high level comparison with vaccine effectiveness from RSV vaccines from competitors Pfizer, GSK and J&J, we see these results as likely approvable and plausibly competitive with those agents,” SVB Securities analyst Mani Foroohar said in a note. He noted the results are still early and comparing the various competitors’ studies “should consequently be taken with a grain of salt.”

Trailing, Bavarian Nordic plans to have its Phase 3 RSV vaccine results in the middle of the year. J&J is also in final-phase testing with results possible in the second half of 2024, Needham’s Stringer said.

Foroohar, the SVB analyst, expects Moderna to ask for a speedy review of its RSV vaccine.

This would allow “approval in time to give Moderna a more fulsome opportunity to participate in the 2023 contracting season,” he said. Foroohar boosted his price target on Moderna stock to 111 from 102, but kept his market perform rating.

Follow Allison Gatlin on Twitter at @IBD_AGatlin.

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GLP-1 Agonists Protected Kidneys in T2D With Advanced DKD – Medscape

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Researchers published the study covered in this summary on Research Square as a preprint that has not yet been peer reviewed.

Key Takeaways

  • In patients with advanced diabetic kidney disease (DKD; estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73m2), treatment with a glucagon-like peptide-1 (GLP-1) agonist had a neutral effect on cardiovascular outcomes but significantly linked with preservation of kidney function and improved survival in a propensity-score matched, retrospective analysis of observational data from more than 2000 people with type 2 diabetes in Taiwan.

Why This Matters

  • Cardiovascular disease is a leading cause of mortality in people with type 2 diabetes and among those with chronic kidney disease.

  • GLP-1 agonists reduce all-cause mortality and cardiovascular death in people with type 2 diabetes, but their role in patients with advanced DKD is controversial.

  • Research on the effect of GLP-1 agonists on cardiovascular outcomes in patients with advanced DKD is limited. Trials that have assessed GLP-1 agonists in people with type 2 diabetes have generally excluded those with advanced DKD and completely excluded those with end-stage kidney disease (eGFR < 30 mL/min/1.73m2).

  • Treatment with GLP-1 agonists has been associated with a significant reduction in composite cardiovascular outcomes in people with type 2 diabetes and relatively fair kidney function (eGFR > 30 mL/min/1.73m2), but among people with type 2 diabetes and lower levels of kidney function, research has shown neutral composite cardiovascular outcomes levels. However, limitations of previous studies include being mainly based on subgroup analysis or including a limited sample of patients.

Study Design

  • Retrospective analysis of observational data from nearly 9000 people in Taiwan with type 2 diabetes and an eGFR < 30 mL/min/1.73m2 who received a first prescription for a GLP-1 agonist or dipeptidyl peptidase 4 (DPP-4) inhibitor in 2012-2021 and had the data necessary for this analysis in their records.

  • The data came from the largest multi-institutional electronic medical record database in Taiwan, which includes two medical centers and five general hospitals and information on more than 11 million patients, from 2001 to 2019.

  • Researchers used propensity scoring to match 602 people treated with a GLP-1 agonist with 1479 people treated with a DPP-4 inhibitor.

Key Results

  • During a mean follow-up of 2.1 years, the rate of the composite cardiovascular outcome (cardiovascular death, myocardial infarction, and ischemic stroke) did not significantly differ between the GLP-1 agonist and DPP-4 inhibitor groups, with incidence rates of 13.0% and 13.8%, respectively, and a nonsignificant hazard ratio of 0.88. Rates of each of the three components of the composite endpoint also did not significantly differ between the two groups.

  • Progression to end-stage kidney disease with dialysis was significantly lower in those treated with a GLP-1 agonist compared with a DPP-4 inhibitor, with incidence rates of 23.4% and 27.5%, respectively, and a significant hazard ratio of 0.72.

  • The incidence of a greater than 50% drop in eGFR from baseline was 32.2% with GLP-1 agonist treatment compared to 35.9% with a DPP-4 inhibitor, with a significant hazard ratio of 0.74.

  • Median time until patients needed new-onset dialysis was 1.9 years with GLP-1 agonist treatment and 1.3 years with DPP-4 inhibitor treatment, which was a significant difference.

  • The rate of all-cause death was 18.4% with GLP-1 agonist treatment compared with 25.1% with DPP-4 inhibitor treatment, a hazard ratio of 0.71 that was significant.  

Limitations

  • Because the study was a retrospective analysis of observational data it cannot prove causality.

  • The study could be subject to residual confounding despite propensity-score matching.

  • The data came from health records that could have included coding errors.

  • Treatment compliance was unknown.

Disclosures

This is a summary of a preprint research study, “The cardiovascular and renal effects of glucagon-like peptide 1 receptor agonists in patients with advanced diabetic kidney disease,” by researchers in Taiwan on Research Square and provided to you by Medscape. This study has not yet been peer reviewed. The full text of the study can be found on researchsquare.com.

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Research by UBC professor lays groundwork for life-saving breast cancer treatment – UBC Faculty of Medicine

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A drug originally designed to prevent osteoporosis is now expected to save and improve the lives of millions of people with breast cancer, thanks in part to decades of foundational research by Dr. Josef Penninger, a professor in UBC’s Faculty of Medicine and director of the Life Sciences Institute.

The achievement highlights how UBC scientists are developing effective new treatments — and unlocking the full potential of existing drugs – through research into the fundamental biological principles behind disease. By advancing scientific discoveries from the lab to the clinic, UBC researchers are bringing life-changing treatments to patients everywhere.

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The drug, called Denosumab, was recently shown in a long-term Phase 3 clinical trial to improve survival among postmenopausal women with hormone receptor-positive early breast cancer receiving aromatase inhibitor treatment. Moreover, the drug markedly improved patients’ quality of life by reducing broken bones by 50 per cent, a common side effect of breast cancer treatment. The results of the trial were recently reported in The New England Journal of Medicine.

Denosumab is a monoclonal antibody developed by American biopharmaceutical company Amgen to prevent bone loss. In the early 2000s, research by Dr. Penninger and his team revealed the therapeutic potential of Denosumab, as well as the drug’s surprising connections with breast cancer.

“More than two decades ago we started the experimental groundwork that revealed Donosumab’s potential as a treatment for breast cancer patients,” says Dr. Penninger. “These results are incredibly exciting and will help improve the lives of millions of patients. I am very proud of all the people in my lab over the years who did that work and helped pave the way for this achievement.”

Discovering the link between osteoporosis and breast cancer

Denosumab works by binding to and inhibiting the activity of a protein called RANKL, which plays a key role in bone-resorbing cells called osteoclasts. By blocking RANKL, denosumab reduces the activity of osteoclasts and slows down bone resorption, helping to increase bone density and preventing osteoporosis.

Dr. Josef Penninger

Dr. Josef Penninger

Dr. Penninger and his team began to draw the connection between osteoporosis and HR-positive breast cancer when they generated the first RANKL “knock-out” mice in the late 1990s.

A knockout mouse is a laboratory mouse that has been genetically engineered to have certain genes deactivated, or “knocked-out”. Dr. Penninger’s team engineered mice that lacked the genes necessary to produce the RANKL protein in an effort to study the protein’s essential function in bone metabolism.

However, to the researchers’ surprise, they discovered that the RANKL-deficient mice failed to develop a lactating mammary gland in pregnancy – a process that depends on sex hormones.

“This proved an evolutionary link: showing how bone loss is regulated by sex hormones, and how pregnant mammals activate RANKL to form breast tissue for lactation among other functions,” says Dr. Penninger.

Based on this initial finding, Dr. Penninger’s team went on to show that RANKL played a key role in progestin-driven breast cancer, as well as breast cancer driven by BRCA1 mutations.

“Further researcher revealed how RANKL controls the stem cells in the breast that respond to sex hormones and thereby drives growth of the breast tissue at every menstruation cycle and in particular in pregnancy and lactation,” adds Dr. Penninger.

In the case of breast cancer, RANKL spurs mammary epithelial cells to divide, and helps to maintain the stem cells that give rise to breast tumours.

A dual benefit drug

One in eight Canadian women will be diagnosed with breast cancer in their lifetime according to the Canadian Breast Cancer Network. An estimated 70 to 80 per cent of these breast cancers are hormone receptor-positive (HR-positive), making it the most prevalent breast cancer subtype.

The current standard treatment for HR-positive breast cancer involves surgery and radiation, followed by treatment with aromatase inhibitors for 5 to 7 years. While aromatase inhibitors diminish sex hormones that drive new cancer growth, they can have serious adverse effects on bone health, including increased risk of osteoporosis and fractures.

The now-published clinical trial, led by the Austrian Breast and Colorectal Cancer Study Group, was conducted to see if Denosumab could help in two ways: by reducing these negative effects on bone health, while also improving breast cancer survival outcomes.

“These results are incredibly exciting and will help improve the lives of millions of patients.”
Dr. Josef Penninger

The results reveal that 6 mg of Denosumab every six months — the recommended treatment level for osteoporosis — improved disease-free survival, bone metastasis-free survival, and overall survival among participants. It also effectively reduced bone fractures over the long term.

“Blocking RANKL in breast cancer patients reduces broken bones by 50 per cent, massively improving their quality of life, and even at a very low treatment dose,” says Dr. Penninger. “We now know that RANKL drives breast cancer cell growth, is the critical mechanism behind bone loss, and has also an effect on anti-cancer immunity and immunological rewiring in pregnancy. These clinical results in patients show how blocking RANKL could save the lives of 50,000 women among one million women with the diagnosis of breast cancer.”

Based on the data, the researchers behind the trials are recommending that Denosumab be considered for routine clinical use in postmenopausal breast cancer patients receiving aromatase inhibitor therapy.

These trials were largely based on the foundational research published by the Penninger laboratory, including Kong et al. Nature 1999, Fata et al. Cell 2000, Jones Nature 2006, Schramek et al. Nature 2010, Sigl et al. Cell Research 2016, and Paolino et al. Nature 2021.

Dr. Penninger is now part of a large international prevention trial evaluating Denosumab in young women who carry BRCA1 mutations.

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Respiratory illness peaked in December at Chatham Kent Health Alliance: Suni – Chatham-Kent This Week

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Chatham-Kent Health Alliance officials are reporting a drop in patients visiting the emergency departments with respiratory illnesses between December and January, but admissions from the emergency rooms to the hospitals remain high.

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Caen Suni, the hospital group’s vice president of clinical programs and operations, said patients with illnesses like influenza, COVID-19 and respiratory syncytial virus dropped 50 per cent in January compared to December among children and by one-third among adults.

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“The community is I think essentially working its way through seasonal illness at this point,” he said during a media teleconference Monday.

December also showed a 25 per cent increase over December 2021 for pediatric admissions and of those, 77 per cent were for respiratory illnesses, Suni said.

“That’s impactful and I think that’s what we’ve seen across the health sector in our entire region at this point,” he said.

Suni said the number of people seeking treatment at the emergency departments – which includes patients not admitted – is not “historically high,” but admissions to the hospitals increased in December by three per cent over the previous month.

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This translates to an extra two to three extra patients a day who require a bed. The health alliance also experienced almost 2.5 per cent more admissions in December than any month in the previous year.

However, December also had the lowest daily average of visits to the emergency departments of any month during the Health Alliance’s current fiscal year.

This means a higher proportion of patients require admission to the hospital and patients presenting at the emergency departments are more ill, Suni said.

Since December, the trends are now “pointing towards a decrease,” Suni said, “which we’re thankful for, as the community bounces back from seasonal illness.”

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