Donanemab | Jotup

Vaccinex Reports Completion of Last Patient Visit in Randomized, SIGNAL-AD Phase 1b/2 Study of Pepinemab Treatment for Alzheimer’s Disease

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星期四, 六月 6, 2024

ROCHESTER, N.Y., June 06, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of Semaphorin 4D (SEMA4D), today announced that the last patient completed their last visit in its randomized, placebo-controlled double-blind study of pepinemab treatment for Alzheimer’s disease.

Key Points:

Pepinemab targets astrocyte reactivity and neuroinflammation,
believed to be key drivers of neurodegeneration.
ROCHESTER, N.Y., June 06, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of Semaphorin 4D (SEMA4D), today announced that the last patient completed their last visit in its randomized, placebo-controlled double-blind study of pepinemab treatment for Alzheimer’s disease.
What can we expect to learn from this study?
Pepinemab has, to date, been well-tolerated in clinical trials that enrolled a total of more than 600 patients.

Weekly Recap: 11 Press Releases You Might Have Missed

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星期五, 六月 14, 2024

NEW YORK, June 14, 2024 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major stories from the week that shouldn't be missed.

Key Points:

The Fenty Hair collection is comprised of one shampoo, two conditioners, one treatment, four stylers and one tool.
These are just a few of the recent press releases that consumers and the media should know about.
To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists .
Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines , features regular media news roundups, writing tips, upcoming events, and more.

C2N Diagnostics Expands Into Japan Through Mediford Corporation Partnership With Precivity™ Blood Testing for Alzheimer’s Disease and Brain Research Market

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星期五, 四月 26, 2024

Hoshiko, who’s based in Kyoto, Japan, has a well-established background as a neuroscientist focused on the commercialization aspects of the field.

Key Points:

Hoshiko, who’s based in Kyoto, Japan, has a well-established background as a neuroscientist focused on the commercialization aspects of the field.
Other research has found that Japan has the highest proportion of people with dementia of any country.
We believe our partnership with Mediford Corporation will unlock many opportunities and possibilities.
Mediford Corporation is known for providing clinical and non-clinical analysis that supports each stage of drug research and development, including advanced treatment options.

How Do Companies Avert Further Frustration among Neurologists Due to Relyvrio’s (Amylyx) Phase 3 Failure and Donanemab’s (Lilly) FDA delay?

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星期二, 三月 12, 2024

Diagnosis, Lecanemab, Alzheimer's disease, ALS, Sodium phenylbutyrate/ursodoxicoltaurine, Caregiver, Patient, Amyotrophy, News, Hope, Life, Life expectancy, Lilly, FDA, Donanemab, Pharmaceutical industry

ALS strikes adults in the prime of their life, is fatal, and the life expectancy of patients is generally 15 years or less.

Key Points:

ALS strikes adults in the prime of their life, is fatal, and the life expectancy of patients is generally 15 years or less.
ALS patients maintain their cognitive functions while their muscle function deteriorates and eventually renders them bed-ridden, unable to swallow, and unable to breathe.
In an unusual decision the FDA conditionally approved Relyvrio based on the Phase 2 results as long as Phase 3 trial outcomes confirmed the results.
Only 40% of neurologists were initially aware of the FDA announcement regarding donanemab for Alzheimer's Disease (AD) when prompted.

FDA Delays Approval of Donanemab for the Treatment of Early-Stage Alzheimer’s

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星期五, 三月 8, 2024

Eli Lilly, FDA, Food, Donanemab, Disease, Patient, Pharmaceutical industry

About UsAgainstAlzheimer’sUsAgainstAlzheimer’s is engaged in a relentless pursuit to end Alzheimer’s, the sixth leading killer in America. Our work centers on prevention, early detection and diagnosis, and equal access to treatments regardless of gender, race, or ethnicity. To achieve our mission, we give voice to patients and caregivers while partnering with government, scientists, the private sector, and allied organizations -- the people who put the “Us” in UsAgainstAlzheimer’s.

Key Points:

WASHINGTON, March 08, 2024 (GLOBE NEWSWIRE) -- The maker of donanemab, Eli Lilly, announced today that the Food and Drug Administration (FDA) will convene an advisory committee to consider the drug’s safety and efficacy, further delaying approval of the promising drug.
UsAgainstAlzheimer’s issued the following statement in response:
“As patients, we’re obviously disappointed by any delay.
We know that about 2,000 people per day progress to more advanced stages of the disease, so we urge the FDA to schedule this advisory committee as soon as possible to discuss these important questions.”

Alzheimer's Drug Discovery Foundation (ADDF) Statement on FDA Decision to Convene Advisory Committee for Donanemab

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星期五, 三月 8, 2024

NEW YORK , March 8, 2024 /PRNewswire/ -- Drugmaker Eli Lilly & Company today announced the FDA expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to further review and discuss donanemab's efficacy and safety profile before making its final decision on whether to grant the drug approval. The advisory committee is scheduled to take place later this year.

Key Points:

The FDA plans to hold an advisory committee to glean more information on the TRAILBLAZER-ALZ 2 trial data and safety profile.
The advisory committee is scheduled to take place later this year.
"Today's FDA decision is not a setback, but another step forward in the drug approval process, with the regulatory agency doing its due diligence before the distribution of the drug to patients," says Howard Fillit, MD, Co-Founder and Chief Science Officer of the Alzheimer's Drug Discovery Foundation (ADDF).
"The decision to hold an advisory committee before granting approval follows the regulatory process that was used for the other drugs in this class, including Leqembi."

Neurophet introduces AI-powered brain imaging analysis technology at AD/PD 2024

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星期一, 三月 4, 2024

Myenteric plexus, Artificial intelligence, ARIA, Observation, Prognosis, Patient, Donanemab, DSM-IV codes, Fifth, Atrophy, WMH, PET, MRI, Brain, Medical imaging

SEOUL, South Korea, March 4, 2024 /PRNewswire/ -- Neurophet, an artificial intelligence (AI) solution company for brain disease, announced its participation in the international conference on Alzheimer's and Parkinson's diseases and related neurological disorders (AD/PD 2024).

Key Points:

At this conference, Neurophet will introduce Alzheimer's disease treatment related technologies planned to be commercialized such as analysis of the side effect and amyloid-positive prediction.
Neurophet AQUA analyzes brain atrophy and white matter hyperintensities (WMH) found in brain MRI of most Alzheimer's disease patients.
Neurophet SCALE PET provides quantitative regional amyloid beta deposition, known as the causative agent of Alzheimer's disease, using PET images.
Neurophet plans to launch total solution for Alzheimer's disease treatment including ARIA analysis, since Neurophet has the technology to analyze ARIA.

Breakthrough in Treating Alzheimer's Using Targeted Drug Delivery Reported in New England Journal of Medicine

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星期三, 一月 3, 2024

Anti-amyloid-beta (Aβ) monoclonal antibody therapies, such as aduncaumab, lecanemab, and donanemab, can reduce amyloid-beta plaques and slow the progression of Alzheimer’s.

Key Points:

Anti-amyloid-beta (Aβ) monoclonal antibody therapies, such as aduncaumab, lecanemab, and donanemab, can reduce amyloid-beta plaques and slow the progression of Alzheimer’s.
More than 98 percent of drugs do not readily cross the BBB, thus requiring systemic treatments with higher doses and more frequent therapies.
The FUS MRI-guided treatment helmet with more than 1,000 ultrasound transducers were directed to specific brain regions with high amyloid-beta plaques.
“We are hopeful that the work we are doing may lead to improvements in outcome for many other patients and their families coping with Alzheimer’s.”

Eisai to Present New Data from LEQEMBI (Lecanemab-Irmb) Phase 3 Clarity Ad Study and Other Alzheimer's Disease Pipeline Research at The Clinical Trials on Alzheimer's Disease (CTAD) Conference

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星期一, 十月 16, 2023

The conference will be held in Boston, Massachusetts, United States and virtually from October 24 to 27, 2023.

Key Points:

The conference will be held in Boston, Massachusetts, United States and virtually from October 24 to 27, 2023.
At the conference, Eisai will present data and research in five oral and ten poster presentations.
"We look forward to sharing the new LEQEMBI low-tau subgroup data and subcutaneous data at CTAD 2023."
The full list of presentations about Eisai assets and research, click the link: www.eisai.com/news/2023/news202365.html

Alzheimer's disease is partly genetic − studying the genes that delay decline in some may lead to treatments for all

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星期六, 九月 16, 2023

Others are risk genes that affect the body in a way that increases the chance someone will develop the disease.

Key Points:

Others are risk genes that affect the body in a way that increases the chance someone will develop the disease.
In Alzheimer’s disease, genetic mutations in any of three specific genes can cause the disease, and other risk genes either increase or decrease the risk of developing Alzheimer’s.
Some genetic mutations or variants interact with other genetic alterations that lead to Alzheimer’s disease.

The amyloid hypothesis

In the early 1990s, scientists proposed the amyloid hypothesis to explain how Alzheimer’s disease develops.
These findings added strength to the amyloid hypothesis explanation of the disease.
However, uncertainty and opposition to the amyloid hypothesis have developed over the past several decades.
But until a clinical trial based on the amyloid hypothesis could show definitive results, uncertainty would remain.

Genetic discoveries with treatment implications

However, a relatively small number of families have one of the three known genetic mutations that cause the disease to be passed down.
In familial Alzheimer’s, 50% of each generation will inherit the mutated gene and develop the disease much earlier, usually from their 30s to early 50s.
These mutated genes were found in a very large family in Colombia whose members tended to develop Alzheimer’s symptoms by their 40s.
A genetic analysis showed that she had an additional mutation in a variant of the gene that codes for a protein called apolipoprotein E, or ApoE.

Starts and stops

Although there is still discussion of how much slowing of decline is clinically significant, these successes provide support for the amyloid hypothesis.
They also suggest that other strategies will be needed for optimal treatment.
The U.S. Food and Drug Administration’s 2021 approval of the first antibody treatment for Alzheimer’s, aducanumab, sold under the brand name Aduhelm, was controversial.