Category Archives: Anti-Aging Medicine

Essential oils have been around for thousands of years, but some still do not understand what they are and if they should use them.Whether you're dropping them onto your body or filling a room through a diffuser, essential oils can be used for a range of ailments. "Every single body system that you could possibly imagine neurological, digestive, pain management, immune function, anti-aging. There is a plant for everything," holistic practitioner Roxanne Foura said.Foura said essential oils are distilled or cold-pressed from various plants, but they're not all created in the same way. "That's the deep dark secret of essential oils. Because it's an unregulated industry, there is a lot of filthy ingredients in non-therapeutic grade essential oils," she said.She said if you plan to use them, do your homework. Make sure they've been tested by a third party with published results. She suggested going to aromaticscience.org if you want to learn more.LG Health statementWGAL also reached out to Penn Medicine Lancaster General Health.Debra Dower, the manager of holistic health, provided the following statement:"Essential oils offer many health and wellness benefits and can be valuable in supporting a multitude of health conditions. However, before using essential oils, it is important to check with a trusted and knowledgeable health-care provider as to which oils might be appropriate for you. "Because essential oils are a concentrated byproduct of the volatile oils of plants, it is important to limit usage to the appropriate dosage. Due to possible interactions and contraindications, individuals with certain medical conditions, including pregnancy, cardiac or pulmonary conditions, or seizure disorders, or those taking certain medications should exercise special caution and consult with their health-care provider before using essential oils."Skin irritation is the most common side effect of essential oil overuse. Essential oils in the citrus family should not be used prior to sun exposure, as they may cause photosensitivity of the skin. Pet safety can be another concern when essential oils are used heavily in small spaces."

Essential oils have been around for thousands of years, but some still do not understand what they are and if they should use them.

Whether you're dropping them onto your body or filling a room through a diffuser, essential oils can be used for a range of ailments.

"Every single body system that you could possibly imagine neurological, digestive, pain management, immune function, anti-aging. There is a plant for everything," holistic practitioner Roxanne Foura said.

Foura said essential oils are distilled or cold-pressed from various plants, but they're not all created in the same way.

"That's the deep dark secret of essential oils. Because it's an unregulated industry, there is a lot of filthy ingredients in non-therapeutic grade essential oils," she said.

She said if you plan to use them, do your homework. Make sure they've been tested by a third party with published results.

She suggested going to aromaticscience.org if you want to learn more.

WGAL also reached out to Penn Medicine Lancaster General Health.

Debra Dower, the manager of holistic health, provided the following statement:

"Essential oils offer many health and wellness benefits and can be valuable in supporting a multitude of health conditions. However, before using essential oils, it is important to check with a trusted and knowledgeable health-care provider as to which oils might be appropriate for you.

"Because essential oils are a concentrated byproduct of the volatile oils of plants, it is important to limit usage to the appropriate dosage. Due to possible interactions and contraindications, individuals with certain medical conditions, including pregnancy, cardiac or pulmonary conditions, or seizure disorders, or those taking certain medications should exercise special caution and consult with their health-care provider before using essential oils.

"Skin irritation is the most common side effect of essential oil overuse. Essential oils in the citrus family should not be used prior to sun exposure, as they may cause photosensitivity of the skin. Pet safety can be another concern when essential oils are used heavily in small spaces."

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Essential oils: What they are and how they're used - WGAL Susquehanna Valley Pa.

Leading scientists in the field of tea research recently met virtually at the Sixth International Scientific Symposium on Tea and Human Health to discuss the current state of knowledge and the gaps in understanding about the benefits of tea. Researchers discussed many topics at the symposium, which included the potential beneficial effects of tea on cardiovascular health, cognitive function, and the prevention of cancer.

The conference was organized by the Tea Council of the USA, the public relations arm of the Tea industry whose primary aim is to encourage greater tea consumption. It accomplishes this by furthering tea science and establishing tea as a healthy, good for you beverage.

Here is a breakdown of the main findings, and why it may be too early to draw definitive conclusions.

Tea is the second most consumed beverage in the world, after water. The four primary types of tea include white, green, Oolong, and black. All four teas are derived from the same plant, Camellia sinensis, but differ in how they are processed after harvesting.

Tea contains a wide array of components that have biological activity, including flavonoids, L-theanine, and caffeine. Many of the beneficial effects of tea are due to the high levels of flavonoids, such as catechins, which have antioxidative and anti-inflammatory properties.

The differences in the manufacturing process can influence the chemical composition and the beneficial effects of the different tea types. For instance, green tea is roasted before it can oxidize and hence, contains higher levels of catechins. In contrast, black tea is allowed to oxidize and has lower levels of catechins. Meanwhile, black tea contains larger amounts of other flavonoids called thearubigins and theaflavins, which also possess antioxidant properties.

A number of observational studies suggest that tea consumption is associated with improvements in cognitive function. A few small randomized controlled trials have suggested tea intake may result in short-term improvements in attention.

Each cup of tea contains about 35-60 mg of caffeine, which may contribute to the increase in attention and improvements in mood some people experience after consuming tea. Tea also contains theanine, which has been suggested to enhance attention while reducing anxiety and stress.

Researchers think that the presence of theanine and caffeine may potentially produce a simultaneous feeling of calmness while improving attention. In addition, limited evidence suggests that the intake of theanine and caffeine together may result in a greater increase in attention than either component alone.

The flavonoids present in tea may also exert protective effects against common age-related cognitive decline and dementia. Dr. Jonathan Hodgson, a professor at the University of Western Australia, told Medical News Today:

Several recent large long-term prospective cohort studies have explored the relationships of tea intake and intake of flavonoids found in tea with dementia outcomes. The two main types of dementia are Alzheimers disease and vascular dementia. Flavonoids are components of tea that are believed to play an important role in the prevention of vascular diseases.

[S]tudies have shown that higher intakes of tea, starting at as little as 1 cup and up to 5-6 cups [a day], are associated with reduced risk for dementia, moderate intakes of flavonoids present in ~2-4 cups of tea are associated with reduced risk for dementia, and for both tea and its flavonoids, maximal benefit may be obtained from moderate intakes of ~2-4 cups[ a day]. Dr. Jonathan Hodgson

However, Dr. Hodgson said high intakes may not be needed to see teas full benefits.

Finally, these studies indicate that the protection provided may be strongest for vascular dementia, he added.

A higher intake of dietary flavonoids is associated with a lower risk of cardiovascular diseases and metabolic conditions, including diabetes.

According to a meta-analysis synthesizing data from 39 studies, the daily intake of each additional cup of tea was associated with a 2% lower risk of a cardiovascular event, a 4% decline in the risk of stroke, and a 4% lower risk of mortality due to cardiovascular disease. These positive effects of flavonoids on cardiometabolic health are associated with lower inflammation and oxidative stress, improved regulation of blood glucose and lipid levels, healthier gut microbiome, and protective effects on blood vessels.

Thus, consumption of tea could be especially beneficial for individuals whose diets are deficient in other sources of flavonoids, including whole grains, fruits, and vegetables.

Dr. Taylor Wallace, a professor in the Department of Nutrition and Food Studies at George Mason University, says, Adding two cups of unsweet tea to the diet can be a simple and cost-effective [preventive] healthcare approach for cardiovascular diseases.

After cardiovascular disease, cancer is the second leading cause of mortality. Modifying lifestyle factors such as diet, physical inactivity, smoking, and obesity can prevent 30-40% of all cancers.

Thus, adopting healthier lifestyle choices that increase levels of flavonoids could reduce the risk of cancer incidence, although the evidence for tea reducing cancer remains limited.

Commenting on the evidence, Dr. Raul Zamora-Ros, a professor at IDIBELL Bellvitge Biomedical Research Institute, told MNT:

There is a lot of plausible preclinical evidence showing anticarcinogenic properties of tea, and mainly its bioactive compounds (flavonoids), against cancer initiation promotion and progression.

However, he pointed out that more research was needed to confirm these benefits in humans.

In humans, there is limited-suggestive evidence showing that tea consumption may reduce the risk of biliary tract, breast, endometrial, liver, and especially, oral cancer. The evidence for the rest of cancer sites is still inconclusive, he said.

Dr. Zamora-Ros noted that larger observational studies and clinical trials are needed to further assess the association between tea consumption and cancer incidence. Moreover, some of the studies have not distinguished between the effects of green and black tea, and future studies must address this shortcoming.

Tea consumption may also improve immune health, with studies suggesting a potential role of green tea in preventing bacterial and viral infections. For instance, a number of human studies, including randomized controlled trials, suggest that green tea consumption could reduce the risk of incidence of influenza infection.

Dr. Dayong Wu, a professor at Tufts University, Massachusetts, said the health benefits of consuming tea on the immune system fell into two categories.

First is the protective effect against infection. Current research shows that tea/tea catechins may directly act on a variety of viruses and bacteria to prohibit them from attaching to and thus blocking their entry into the host tissues, inhibit their replication, and limit their spread. Tea/tea catechins may also enhance the anti-pathogen response of the host immune cells to help fight pathogens and clear the infection, he explained.

Second, the antioxidant and anti-inflammatory properties of green tea may also help prevent tissue damage caused by excessive inflammation in response to an infection. Given its anti-inflammatory properties, green tea could also help alleviate symptoms of autoimmune diseases, such as inflammatory bowel disease and rheumatoid arthritis.

Autoimmune disease represents a disrupted immune balance, and it is characterized by immune cells of a host attacking its own tissues. Tea/tea catechins have been shown to modulate complex immune cell function in a way to help correct this disorder, perhaps by suppressing overactive response and promoting tolerance, Dr. Wu elaborated.

However, he also cautioned that most of these results are based on cell culture and animal studies, and more studies assessing the impact of green tea on immune function in humans are needed.

The studies discussed at the symposium suggest that tea consumption is associated with a multitude of health benefits. However, before changes are made to dietary guidelines, more research may be needed on individual compounds within tea to negate the negative effects.

Addressing some of the key areas of future research in tea science, Dr. Johanna Dwyer, a professor of medicine and senior scientist at Tufts University, said, she believes it would be profitable [..] to pin down the continuing puzzle of why it is that some green tea supplements seem to be associated with liver toxicity and what compounds are responsible for these effects.

Tea has also been associated with side effects such as reduced iron absorption as well as increased anxiety, and restlessness, largely owing to the caffeine it contains.

Experts point out that there are caffeine-free ways to consume the beneficial flavonoids present in tea, such as by eating vegetables and fruits, which also contain fiber.

On a more basic level, it is still important to study the health-related properties of the various compounds in tea, added Dr. Dwyer.

There is growing research examining the health benefits of green tea extracts enriched in flavonoids and other components.

Dr. Mario Ferruzzi, professor and chief of the section of Developmental Nutrition in the Department of Pediatrics at the University of Arkansas for Medical Sciences, touched on teas place in current dietary guidelines.

Currently, dietary bioactive compounds like flavan-3-ols are not part of food-based dietary guidance. Polyphenols make up 30 to 40 percent of the solids in a cup of green and black tea. The dietary guidelines have mentioned phytochemicals as a beneficial part of fruit and vegetables, but not beverages.

To rectify these shortcomings, Dr. Feruzzi noted that current guidelines on healthy beverages need to be expanded to include tea and coffee as a source of bioactive components, such as flavonoids.

Moreover, dietary guidelines should include an adequate intake value for dietary flavonoids to ensure sufficient intake of these nutrients that can help reduce the risk of chronic diseases.

Dr. Feruzzi cautioned that ready-to-drink products tend to have lower levels of flavonoids, and hence, consumers should favor brewed tea over these products.

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Can tea prevent cancer and improve overall health? - Medical News Today

TOKYO and CAMBRIDGE, Mass., May 9, 2022 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today that Eisai has completed the rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (A) protofibril antibody lecanemab (BAN2401) for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. As part of the completed rolling submission, Eisai has requested Priority Review. If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set. While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase 3 confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Dependent upon the results of the Clarity AD clinical trial, Eisai may submit for full approval of lecanemab to the FDA during fiscal year 2022.

The BLA submission for lecanemab is based on clinical, biomarker and safety data from the proof-of-concept Phase 2b (Study 201 Core) in 856 people with early AD with confirmed presence of amyloid pathology, biomarker and safety data from the Study 201 OLE (open-label extension study, 180subjects), and blinded safety data from the confirmatory Clarity AD Phase 3 study (1,795 subjects). The large number of participants across these studies provides the FDA with extensive safety data. Study 201 explored the impact of treatment with lecanemab on reducing amyloid plaque and clinical decline. At 18 months of treatment, 10 mg/kg biweekly lecanemab reduced brain amyloid by a mean of 0.306 SUVr units (from a baseline mean of 1.37), and over 80% of subjects became amyloid negative by visual read. Furthermore, the extent of reduction in amyloid was correlated with slower clinical decline on ADCOMS (Alzheimer's Disease Composite Score), CDR-SB (Clinical Dementia Rating-Sum-of-Boxes), and ADAS-cog (Alzheimer Disease Assessment Scale-Cognitive Subscale) at the treatment group and patient level. In the Core study, the overall rate of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an adverse event associated with anti-amyloid beta antibodies therapies was 9.9% (16/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 0.8% (2/245) of placebo patients.The results from Study 201 were published in a peer-reviewed journal Alzheimer's Research and Therapy in April 2021.

"We would like to thank the people living with early AD and the healthcare professionals who participated in the lecanemab 201 study for their cooperation allowing completion of this BLA to the U.S. FDA. Alzheimer's disease is a progressive and devastating disease with few treatment options," said Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. "Eisai employees have spent time with people living with Alzheimer's disease and their families to truly understand their feelings and challenges and have been working to create new treatments for many years. Our comprehensive medicine creation approach along the Alzheimer's disease continuum reflects Eisai's long-term commitment to providing innovative treatments to the people living with AD, their families and healthcare professionals who urgently need new treatment options."

"With Alzheimer's disease, patients and their loved ones don't have the luxury of time. There is an enormous unmet need in this space, and we continue to make progress in advancing additional treatment options for people living with this devastating disease," said Michel Vounatsos, Chief Executive Officer at Biogen. "Anti-amyloid antibodies are a new wave of important medicines, which could provide patients and their physicians more options in addressing this complex disease."

Lecanemab was granted Breakthrough Therapy and Fast Track designations by the FDA in June and December 2021, respectively. In March 2022, Eisai initiated submission of application data to the Pharmaceuticals and Medical Devices Agency (PMDA) under the prior assessment consultation system in Japan with the aim of obtaining early approval for lecanemab, and aims to file for the manufacturing and marketing approval based on the results of Clarity AD during Eisai's fiscal year 2022.

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Contacts

MEDIA CONTACT:

MEDIA CONTACT:

Eisai Co., Ltd.

Biogen Inc.

Public Relations Department

Ashleigh Koss

TEL: +81-(0)3-3817-5120

+ 1-908-205-2572

[emailprotected]

Eisai Inc. (U.S.)

Laura DiBenedetto

INVESTOR CONTACT:

+ 1-551-815-9468

Biogen Inc.

[emailprotected]

Mike Hencke

+ 1-781-464-2442

INVESTOR CONTACT:

[emailprotected]

Eisai Co., Ltd.

Investor Relations Department

TEL: +81-(0)70-8688-9685

[Notes to editors]

1. About Lecanemab (BAN2401)Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (A) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Currently, lecanemab is being developed as the only anti- A antibody that can be used for the treatment of early AD without the need for titration. With regard to the results from pre-specified analysis at 18 months of treatment, Study 201 demonstrated reduction of brain A accumulation (P<0.0001) and slowing of disease progression measured by ADCOMS* (P<0.05) in early AD patients. The study did not achieve its primary outcome measure** at 12 months of treatment. The Study 201 open-label extension was initiated after completion of the Core period and a Gap period off treatment of 9-59 months (average of 24 months, n=180 from core study enrolled) to evaluate safety and efficacy, and is underway.

Currently, lecanemab is being studied in a confirmatory Phase 3 clinical study in symptomatic early AD (Clarity-AD), following the outcome of the Phase 2 clinical study (Study 201). Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing. Furthermore, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007.

* Developed by Eisai, ADCOMS (AD Composite Score) combines items from the ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale), CDR (Clinical Dementia Rating) and the MMSE (Mini-Mental State Examination) scales to enable a sensitive detection of changes in clinical functions of early AD symptoms and changes in memory. The ADCOMS scale ranges from a score of 0.00 to 1.97, with higher score indicating greater impairment.

** An 80% or higher estimated probability of demonstrating 25% or greater slowing in clinical decline at 12 months treatment measured by ADCOMS from baseline compared to placebo.

2. About the Collaboration between Eisai and Biogen for Alzheimer's DiseaseEisai and Biogen are collaborating on the joint development and commercialization of AD treatments. Eisai serves as the lead in the co-development of lecanemab.

3. About the Collaboration between Eisai and BioArctic for Alzheimer's DiseaseSince 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD. The commercialization agreement on the lecanemab antibody was signed in December 2007, and the development and commercialization agreement on the antibody lecanemab back-up for AD, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD. BioArctic has no development costs for lecanemab in AD.

4. About Eisai Co., Ltd.Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai's corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

Leveraging the experience gained from the development and marketing of a treatment for Alzheimer's disease, Eisai aims to establish the "Eisai Dementia Platform." Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a "Dementia Ecosystem," by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com.

5. About BiogenAs pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has aleading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer's disease. Biogen is also commercializing biosimilars and focusing on advancing the industry's most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need.

In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives aims to eliminate fossil fuels across the company's operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities.

The company routinely posts information that may be important to investors on our website at http://www.biogen.com. To learn more, please visitwww.biogen.comand follow Biogen on social media Twitter,LinkedIn,Facebook,YouTube.

Biogen Safe Harbor This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the expected data readout for the Clarity AD study; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies, including the Clarity AD clinical trial and AHEAD 3-45 study; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

SOURCE Eisai Inc.

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EISAI COMPLETES ROLLING SUBMISSION TO THE US FDA FOR BIOLOGICS LICENSE APPLICATION OF LECANEMAB FOR EARLY ALZHEIMER'S DISEASE UNDER THE ACCELERATED...

Novel drugs are being designed to treatunique genetic mutations.

Heres a definition of a hopeless case: a child with a fatal disease so exceedingly rare that not only is there no treatment, theres not even anyone in a lab coat studying it. Too rare to care, goes the saying.

Thats about to change, thanks to new classes of drugs that can be tailored to a persons genes. If an extremely rare disease is caused by a specific DNA mistakeas several thousand aretheres now at least a fighting chance for a genetic fix.

One such case is that of Mila Makovec, a little girl suffering from a devastating illness caused by a unique genetic mutation, who got a drug manufactured just for her. Her case made the New England Journal of Medicine in October, after doctors moved from a readout of her genetic error to a treatment in just a year. They called the drug milasen, after her.

The treatment hasnt cured Mila. But it seems to have stabilized her condition: it has reduced her seizures, and she has begun to stand and walk with assistance.

Milas treatment was possible because creating a gene medicine has never been faster or had a better chance of working. The new medicines might take the form of gene replacement, gene editing, or antisense (the type Mila received), a sort of molecular eraser, which erases or fixes erroneous genetic messages. What the treatments have in common is that they can be programmed, in digital fashion and with digital speed, to correct or compensate for inherited diseases, letter for DNA letter.

How many stories like Milas are there? So far, just a handful.

But more are on the way. Where researchers would have once seen obstacles and said Im sorry, they now see solutions in DNA and think maybe they can help.

The real challenge for n-of-1 treatments (a reference to the number of people who get the drug) is that they defy just about every accepted notion of how pharmaceuticals should be developed, tested, and sold. Who will pay for these drugs when they help one person, but still take large teams to design and manufacture?

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2020 | MIT Technology Review

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Novus Anti-Aging Center Los Angeles | Erectile Dysfunction ...

SEATTLE If it werent for squirrels, Bagel probably wouldnt be here today at Washington State Universitys College of Veterinary Medicine. The yellow Labrador was destined to be a guide dog for the blind but flunked out because she was distracted by small animals. Now, this otherwise very good girl has a second chance to be of service by participating in the most comprehensive study ever conducted of health and aging in dogs.

Bagels owner, Brenda Voght, volunteered her to join a research pack that already includes more than 37,000 pet dogs across the country and is expected to swell to 100,000. Called the Dog Aging Project, the ambitious undertaking seeks to answer many of the questions dog owners ask and often anguish over: Why do some breeds live longer than others? How do genetics, environment and lifestyle affect longevity and the risk of disease? And, above all: How can we ensure our beloved companions stay healthy, happy and active for as long as possible?

I would like to know if there is something we can do as humans, as their partners, to extend their lives a little longer, says Voght. After her last dog died, it was a year before she was able to open her heart to another puppy.

She fostered Bagel for about a year, then adopted her after the canines career change the gentle euphemism used when guide dogs dont make the cut.

On average, yellow Labs live 10 to 12 years.

Bagel is 9.

The project welcomes dogs of all types and ages and plans to track them for at least 10 years, says Daniel Promislow, an evolutionary geneticist at UW Medicine who co-founded the initiative and helped assemble a national team of more than 80 researchers, veterinarians and data scientists to coordinate the massive undertaking.

No one has ever investigated such a large number of dogs over such a long period of time, especially at the level of detail Promislow and his colleagues envision. One branch of the study is sequencing the genomes of at least 10,000 dogs. Another zeros in on the oldest dogs in the pack the supercentenarians to look for keys to their longevity.

All of us are really excited about what will come out of it, says Elaine Ostrander, who pioneered genetic analysis of dogs more than two decades ago in Seattle at the Fred Hutchinson Cancer Research Center. She now works at the National Human Genome Research Institute.

Its long been clear that big dogs have shorter lifespans than small dogs, and that different breeds are predisposed to different ailments, says Ostrander, who is not involved in the project. Golden retrievers are prone to cancers. German shepherds often develop hip dysplasia. Doberman pinschers have a high prevalence of heart disease. The Dog Aging Project will help reveal more about the mechanisms behind those links, she says.

Theyre going to be able to make those connections pretty tightly because their data set is the biggest one out there.

The researchers also hope to gain insights into normal aging, along with the entire spectrum of ailments that plague older dogs, from arthritis and hearing loss to cataracts and cognitive decline. Discovering ways to help dogs live longer would be wonderful, says Promislow. But the primary goal is to prolong health span that golden period of well-being when dogs can leap and dive and fetch and snuggle free from pain or disability.

We want to help each dog live the longest, healthiest lifespan that it can, he says.

The findings could be relevant to human health as well.

Dogs suffer from many of the same diseases we do. And unlike mice and other animals used in laboratory studies, dogs are genetically diverse. They live in our homes, breathe the same air and experience the same conditions.

The sad fact that dogs lives are shorter than ours means its possible to gain that knowledge more quickly by focusing on humanitys best friends.

Most of the animals enrolled in the Dog Aging Project never have to leave their home turf. Owners fill out an annual, 116-page questionnaire that covers everything from diet and mobility to temperament, favorite types of toys, bowel habits, pesticide exposure, health status and sleeping arrangements. Environmental data, like air and water quality, is correlated to each dogs geographic location. Participants also can upload their dogs veterinary records, and more than 15,000 already have done so.

Dog owners are integral to the project, which keeps them in the loop with blog posts and a dedicated social media platform called the Dog Park. Its the kind of science that cuts across politics, demographics and geography because so many Americans are crazy about dogs, Promislow says.

Im really excited about the ability to bring science to the lives of people in a way thats fun and informative and educational.

A small subset of canines are candidates for more intensive study, which is why Voght made the drive from her home in Bothell to the other side of the state. Bagel is being evaluated for the most high-profile arm of the project: a clinical trial of a potential anti-aging drug.

Called rapamycin, the medication is used in human transplant patients to prevent organ rejection. But studies in yeast, worms and mice show that low doses can extend lifespan by up to 25%. Rapamycin also delays age-related maladies such as cognitive decline and cancer, and boosts heart health in mice.

Dr. Kate Creevy, chief veterinary officer for the project, is optimistic it might do the same for dogs. In one small trial, dogs who got the drug showed improved heart function. In another, owners said their dogs seemed more active.

Now, the team is recruiting 500 senior dogs for a year of treatment and two years of follow-up. Half the dogs will get rapamycin, and half will get a placebo. Neither owners nor scientists will know which until the end.

Even if we dont actually change lifespan, if we improve the experience of aging, that will be really, really valuable to dogs and the people who love them, says Creevy, of Texas A&M University.

The dogs in the study need to be healthy, so Bagel is getting the type of checkup available only in a veterinary teaching hospital such as WSUs. Staff leads her into an exam room, where she obligingly hops on the table and rolls onto her side.

Technicians shave a small patch of fur for analysis, draw blood, measure blood pressure and attach electrodes to monitor her heartbeat. Dr. Ryan Baumwart, a veterinary cardiologist, checks Bagels eyes and probes her heart with ultrasound, displaying the image of the beating organ on a wall-mounted computer screen.

The study is just getting started, and, so far, only about half of dogs examined have qualified. Bagels scans look promising, Baumwart says. Now, its a matter of waiting on the blood tests.

The dog aging project reflects a new approach to the most common causes of death in canines and people, says co-director and UW Medicine pathologist Matt Kaeberlein, who studies the basic biology of aging. Most research focuses on specific diseases, such as cancer or Alzheimers. But nearly all of the major killers are strongly linked with age, so Kaeberlein argues that it makes sense to focus on the aging process itself.

If we can understand aging biology and what it is at a cellular, molecular, mechanistic level, then maybe it will be feasible to target that biology with interventions, he says. Those might be nutritional strategies, drugs or gene therapy, with the goal of lowering the risk of all age-related diseases.

For example, rapamycin seems to work at least in part by reducing inflammation, which increases with age and impairs immune function. Older animals also accumulate more cellular debris, and rapamycin revs up the process of clearing it away.

Another arm of the project, called the Precision Cohort, will delve in unprecedented detail into biochemical changes and shifts in gene expression over time in 1,000 dogs.

We will know more about the biology and physiology of those dogs than probably anybody has ever known about dogs before, Kaeberlein says. We will be collecting very high-resolution data to try to understand the relationship between their unique genetic makeup and their unique environment thats influencing the aging process.

One of those dogs is Hana, a 3-year-old Cavalier King Charles spaniel with long, silky ears who lives on Bainbridge Island. Her owner, Masami Shimizu-Albergine, is a researcher herself and was eager to help.

Once a year, Hanas vet collects blood, urine, feces and hair samples for analysis at specialized labs. Its a level of medical monitoring few humans receive, and it will help pin down the role of gut microbes, metabolic function, toxin exposure and a host of other factors.

Theres really no end to what we can discover, Promislow says.

Analyzing the genomes of 10,000 dogs will uncover the genetic basis for a large swath of canine diseases, says Joshua Akey, a geneticist who started working on the dog project at the University of Washington and is now at Princeton Universitys Lewis-Sigler Institute for Integrative Genomics.

As in humans, though, its not likely to be simple. Most diseases result from multiple genes and environmental factors. But Akey says it should be possible to develop risk scores to alert owners to their dogs genetic predispositions. One UW researcher is focused on dogs with lymphoma, looking for a genetic biomarker for early diagnosis.

The link between a dogs size and lifespan appears to have a strong genetic basis. Big breeds have higher levels of a protein called IGF-1 (insulin-like growth factor), which is involved in regulating growth. In mouse studies, dialing down that protein can extend life and improve health.

So even though it might be possible to improve health for all dogs, a 150-pound Great Dane likely will never match the longevity of a 15-pound Chihuahua, Creevy says.

Distinct breeds were developed only in the past few centuries, and the trove of genetic information compiled for the project will help retrace that process. It could even settle the debate over when wolves were first domesticated and morphed from Canis lupus to Canis familiaris.

Some people say it was 10,000 years ago, and others have argued it was much longer, Akey says. I think well have a data set that can definitively answer some of these evolutionary questions.

Promislow, Creevy and Kaeberlein started kicking around the idea of a major dog study more than a decade ago. It took years to lay the groundwork and convince federal funders of its worth. Their first major grant $25 million from the National Institutes of Aging was awarded in 2018. The team also has funding from foundations, tech entrepreneurs and small donors such as the Irish wolfhound Association of New England.

All of the data will be freely shared online. The first batch, from about 25,000 dogs, was recently posted and already is showing some intriguing correlations. For example, dogs fed once a day appear to have higher cognitive scores and fewer health problems than dogs who eat multiple times a day.

That doesnt prove cause and effect, Kaeberlein cautions, but its a place to start digging deeper.

The project also has the potential to provide some of the best comparisons of dog diets, which now come in a dizzying array, from dry kibble to small-batch artisan concoctions. Promislow, who never imagined he would be cooking for a dog, started preparing a mix of sweet potatoes, oats, ground chicken and kibble for Frisbee, his 16-year-old mixed-breed female, after she was stricken with severe diarrhea.

We can do the careful science to evaluate the effects of raw-food diets, home-cooked diets, et cetera, he says. We will soon have more data than any other study on the consequences of a grain-free diet.

The project is nonprofit, but entrepreneurs are keen to apply the information it generates. Americans spent almost $104 billion on pet care in 2020, and the trendline points up, according to the American Pet Products Association.

Startups already are chasing more sophisticated genetic testing and anti-aging drugs for dogs. But they cant generate the massive amounts of data or conduct large-scale clinical trials like the Dog Aging Project does, says Celine Halioua, founder and CEO of Loyal. Kaeberlein is a scientific adviser to the Bay Area biotech, which is testing two drugs to increase health span in dogs.

The dog-aging database will be an invaluable resource, Halioua says.

Its a gift to the aging field for them to be doing this.

A week after the visit to WSU, Voght got the news: Bagel qualified for the rapamycin trial. Shell get a once-a-week dose, either real or placebo, for the next year, and physical exams every six months through 2025. Voght wont know until then whether Bagels pills are real. Either way, shes willing to keep making the trip to Pullman in hopes that the project will benefit Bagel, other dogs or even people.

Shes not expecting miracles, though.

Bagel is already slowing down a bit, and her face is frosted with white. If Labs can make it into the double digits, youre lucky, Voght says.

So she recently adopted what she calls her transition dog a 2-year-old black Lab named Delray.

Its nice to have another dog in the house to help you a little bit, she says. For when that time comes.

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The Dog Aging Project digs deeper than ever to help our best friends live better longer and the findings could help us, too - The Spokesman Review