Category Archives: Epigenetics

New study shows that race does not influence outcomes from immunotherapy for aggressive triple-negative breast cancer.

Black and non-Black patients who take durvalumab (Imfinzi) and chemotherapy before surgery have positive outcome for triple-negative breast cancer (TNBC), according to a phase 1/2 clinical trial published in Clinical Cancer Research.

Black patients continue to be underrepresented in investigational therapies and clinical trials, according to Lajos Pusztai, MD, DPhil, professor of medicine, and co-leader of the Genetics, Genomics, and Epigenetics Program;1 however, they are the ones most affected by TNBC.1,2

TNBC does not test positive for estrogen receptors, progesterone receptors, or the human epidermal growth factor receptor 2 (HER2) protein, which are indicators of other forms of breast cancer.2

TNBC makes up 10%-15% of all breast cancers, differing from other breast cancers because it grows and spreads faster, has less treatment options, and has a worse outcome.2 It also tends to afflict women younger than 40 years of age.2

The low accrual of ethnic minorities, particularly Black Americans, in clinical trials is problematic for several reasons, Pusztai said in a press release. For one, it means Black patients are not given equitable access to potentially lifesaving new treatments very early on. Secondly, it limits our ability to study potential differences in drug metabolism, toxicity, and efficacy between populations with different ancestries.1

The immunotherapeutic durvalumab targets the PD-1/PD-L1 immune checkpoint pathway. Other studies done by these study authors indicated that durvalumab benefited patients with non-metastatic TNBC when combined with chemotherapy and administered before surgery.1

This study was limited, however, because the participants were not an accurate reflection of the racial or ethnic makeup of the disease population in the surrounding neighborhood, according to the authors.1

Pusztai and colleagues decided to enter more patients into this original trial. This could help them understand the efficacy of durvalumab and chemotherapy (pre-surgery) on Black patients who make up the majority of TNBC patients.1

The trial incorporated 67 new patients21 people identified as Black,40 as non-Hispanic white patients, 3 as Hispanic/Latino, and 3 as Asian. The local community was better reflected with 31% of participants identifying as Black. Race did not differ across baseline tumor features.1

The pathologic complete response (pCR) to neoadjuvant durvalumab and chemotherapy was not significantly different with race. Of the 31 patients who had a positive pCR and no sign of cancer, 43% of patients were Black and 48% were non-Black patients.1

Rates of metastatic recurrence were also not significantly different between Black and non-Black patients, at 14% and 17%, respectively. Further, there were not significant differences observed in the 3-year overall survival (OS) Black and non-Black patients (81% and 87%, respectively) or 3-year event-free survival (71.4% and 78.3%, respectively).1

Patients with a pCR had significantly longer event-free survival and OS in Black and non-Black patients. With a pCR, the 3-year OS rate was 96.8% and the event-free survival rate was 90.3%, compared to 81.8% and 66.7% for those without a pCR, respectively.1 The study was limited by a small sample size and single institution location, according to the authors.1

Our study demonstrates that if patients are given similar treatment and similar follow-up, the differences in outcomes between Black and non-Black patients are reduced, Pusztai said. By improving health care access and delivery, we could mitigate some of the health care disparities that exist in our society.1

Reference

Benefits of pre-surgical immunotherapy were independent of race in patients with aggressive breast cancer. EurekAlert! July 29, 2022. Accessed on July 29, 2022. https://www.eurekalert.org/news-releases/960058

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Efficacy of Neoadjuvant Immunotherapy on Breast Cancer is Independent of Race - Pharmacy Times

You know the old expression: Youre only as old as you feel, right? Well, its wrong. Youre actually only as old as your epigenetic age, or, in other words, youre as old as the methylation of your DNA. Dont worry, well unpack the terminology in a moment, but first lets talk about thing in broader strokes.

In simpler terms, a better measurement than chronological age, which is literally the amount of time that you have been alive, is your biological age. That is to say biological age is the better metric when it comes to matters of health, predictions of longevity, and the potential for you to avoid various diseases and age-related conditions.

For a visual representation of biological age vs. chronological age and we make this comparison with nothing but respect, please note look at a picture of President Franklin D. Roosevelt in the last year of his life, then look at a picture of actor Vigo Mortensen. FDR died at 63, the age of Mortensen is at the time of this writing. Yes, the years on the books may be the same, but the aging process clearly weighed on those two quite differently.

How can peoples biological age be so different from one another even when chronological ages line up? While certain factors, such as congenital diseases, accidents, and exposures to harmful substances can cause issues for anyone, generally speaking, a healthy, active lifestyle will lead to a biological age that is younger than your birthday might suggest. Living well really will help you live a longer, better life.

As is usually the case in life, however, there is a flip side to this coin: many peoples biological age is actually notably older than their chronological age.

Epigenetic age acceleration is when your DNA has aged more rapidly than would be expected based on your chronological age. According to a study published by the JAMA Network, people who were found to have a lower epigenetic age were much more likely to reach age 90 with intact cognitive function and mobility, while those of more advanced biological age were more likely to be physically and cognitively impaired if they did reach that age, and also, of course, were much less likely to reach that advanced age.

It must be noted that this study was only focused on women, so while the results may apply to all genders universally, take the findings in their context or with a grain of salt.

Epigenetic age is calculated by looking at DNA methylation, which is a natural process wherein methyl groups bind to DNA. Some methylation is necessary is required for the proper function of DNA molecules, but if an abundance occurs, it can begin to restrict proper expression of the DNA. In people of advanced epigenetic age, more DNA methylation is presented.

You probably wont be shocked by the factors that lead to epigenetic age acceleration. According to Oxford Academics publication Environmental Epigenetics: DNA methylation can be influenced by environmental factors such as diet, hormones, stress, drugs, or exposure to environmental chemicals. In other words, an unhealthy lifestyle leads to less health right down to your very genes.

The choices you make in life, such as whether or not you smoke, regularly consume alcohol, take drugs, and eat heavily processed foods will take a toll on your DNA. So too can where you live, as pollution is terrible for health, as well as factors in your life like a high-stress job, poor sleep habits, and more.

There is a silver lining to be found for anyone who learns that their epigenetic age is older than their chronological age: unlike your actual age based on year and birthdate, your epigenetic age can be lowered again.

With a healthy diet and regular cardio exercise, ideally both of which are initially supported by a nutrition and fitness expert, you can effectively turn back the clock on genetic aging. In fact, according to a study shared by the National Library of Medicine, switching to a proper diet and committing to regular exercise can reduce genetic age by more than 3.2 years. And not only will eating well and getting exercise help you live longer and feel better later in life, but it will help you feel better now, as well.

Advances in medicine, better access to food and water, and, for many people around the world, safer, cleaner living conditions are already seeing a dramatic increase in life expectancy. Focusing in only on America for the sake of an apples-to-apples comparison, consider the average life expectancy for a person living in America in the middle of the 19th century.

The average life expectancy then was 40 years, per Statista. By the year 1900, life expectancy in America was still a bit under 50 years. In 1950, the average American could expect to live to 67. By the year 2000, it was 76, and today it is around 78 years. Were already living longer than ever, in terms of our chronological lives. And again, we have no control over how old we are based on the calendar, but we can take some measure of control over our genetic age.

So, what can you do, specifically, to ensure your biological age is as young as possible? For starters, you need to remove as many of those negative factors noted before (smoking, excessive alcohol, stress, and so forth) from your life as you can.

Certain diets, used intermittently, may be able to increase the efficiency of the mitochondria in your cells, and that can do wonders for reducing your biological age. Intermittent fasting, a ketogenic diet, and other approaches can be tried from time to time, though overall the best diet is one that is balanced.

Stress reduction techniques like mindful meditation or sensory deprivation can have lasting effects in your wellness, reducing cortisol levels in your body and helping increase your physical health along with your mental wellbeing.

And of course, exercise is a must. A study cited by Eat This Not That noted higher intensity exercise, engaged in multiple times per week, is the best way to turn back the clock on epigenetic aging. But any exercise is better than none, so even if you cant get to an Orange Theory class or a kickboxing lesson, a walk or jog around the neighborhood will still help.

More here:
Your True Age Might Not Be Your Birthdate And Thats Good News - Goalcast

NEW YORK, July 22, 2022 /PRNewswire/ -- According to the market research report published by P&S Intelligence, the epigenetics market was worth around $1,563.8 million in 2021, which is predicted to touch $6,460.5 million value by 2030, advancing at a 17.1% CAGR between 2021 and 2030. The field of epigenetics involves research on how the environment and behavior affect gene function. It is expected that increasing the usage of epigenetics in non-oncology applications would present a lucrative potential for market expansion.

Moreover, it has long been assumed that epimutations, which are epigenetic changes brought on by epigenetic silencing and hypermethylation, play a role in the development of cancer. Numerous R&D efforts are focusing on epimutations, particularly those related to the activation of oncogenes and the deactivation of tumor suppressor genes.

Get the sample pages of this report at: https://www.psmarketresearch.com/market-analysis/epigenetics-market/report-sample

Key Points of Epigenetics Market Report

Browse detailed report on Epigenetics Market Size, Share, and Demand Forecast Report 2030

For pharmaceutical and biotechnology companies, players in the field of epigenetics have been continually developing a wide range of products. These key players are PerkinElmer Inc., F. Hoffmann-La Roche Ltd., New England Biolabs Inc., QIAGEN N.V., Bio-Rad Laboratories Inc., Active Motif Inc., Abcam plc, Pacific Biosciences of California Inc., Illumina Inc., Merck KGaA, and Thermo Fisher Scientific Inc.

Epigenetics Market Report Coverage

By Product

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By End User

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Generic Drugs Market Analysis and Demand Forecast to 2030

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Epigenetics Market is Predicted to Hit $6460.5 Million Value by 2030, says P&S Intelligence - PR Newswire UK

Oryzon Genomics, S.A.

MADRID and BOSTON, July 26, 2022 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today the start of a preclinical collaboration with the CMT Research Foundation (CMTRF), a U.S.-based patient-led, non-profit organization focused on delivering treatments and cures for Charcot-Marie-Tooth (CMT) disease, to explore Oryzons histone deacetylase 6 (HDAC6) inhibitors.

CMT is a progressive, degenerative disease involving the peripheral nerves. It affects one in 2,500 people (about the same prevalence as multiple sclerosis), including 150,000 Americans and more than 3 million people around the world. It is one of the most prevalent conditions among rare diseases and currently lacks effective treatments or cures. CMT is caused by a variety of genetic mutations. CMT1A is the most prevalent of all, accounting for approximately half of all people with CMT.

HDAC6 inhibitors have been previously described as potentially effective treatments for CMT. Oryzon has recently completed an HDAC6 discovery program leading to the selection of two potential preclinical candidates with promising efficacy, selectivity and safety. Under this collaboration, CMTRF will be financing a series of in vivo tests with Oryzons HDAC6 candidates in a murine model of CMT1A, which reliably recapitulates many of the symptoms of this condition in humans.

Dr. Jordi Xaus, Oryzons CSO, said: CMT is the most promising indication for our HDAC6 precandidates. CMTRF is the perfect ally to explore our compounds in this indication, as it has a strong connection with the CMT patient community, a very experienced Scientific Advisory Board and a strong commitment to finding treatments for CMT. We are delighted to start this collaboration. If the results are positive, our HDAC6 program would be closer to clinical development and to offering hope to CMT patients. This program would become our second epigenetic program in nervous diseases.

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"We are excited to collaborate with Oryzon on this important project," said Cleary Simpson, CEO of the CMT Research Foundation. "HDAC6 inhibitors are promising as potential therapeutics for several forms of CMT, including the most common formCMT1A. With funding from the CMT Research Fountation, Oryzon will be able to rapidly test their newly discovered HDAC6 inhibitors in CMT1A model mice, paving the pathway for further development. People with CMT currently have no effective treatments or cures, and we believe this project has the potential to change that for millions of families.

The CMT Research Foundation (CMTRF) is focused solely on delivering treatments and cures for CMT. Founded by two patients who are driven to expedite drug delivery to people who live with CMT globally, the organization funds research for drug development. The 501(c)(3) federal tax-exempt organization is supported by personal and corporate financial gifts.

About OryzonFounded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European leader in epigenetics. Oryzon has one of the strongest portfolios in the field, with two LSD1 inhibitors, iadademstat and vafidemstat, in Phase II clinical trials, and other pipeline assets directed against other epigenetic targets. In addition, Oryzon has a strong platform for biomarker identification and target validation for a variety of malignant and neurological diseases. For more information, visit http://www.oryzon.com

FORWARD-LOOKING STATEMENTS This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words expects, anticipates, believes, intends, estimates and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisin Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forwardlooking statements, whether as a result of new information, future events or otherwise. This press release is not an offer of securities for sale in the United States or any other jurisdiction. Oryzons securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of Oryzons securities to be made in the United States will be made by means of a prospectus that may be obtained from Oryzon or the selling security holder, as applicable, that will contain detailed information about Oryzon and management, as well as financial statements.

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ORYZON Collaborates with the CMT Research Foundation in the US - Yahoo Finance

In England, approximately one adult in every 100 lives with a schizophrenia diagnosis. Despite this, there are several myths and misconceptions surrounding the mental health condition

Image: Getty Images)

Society has evolved in many ways, but certain things continue to remain taboo. Schizophrenia is one mental health condition that's been stigmatised and misunderstood.

Every year on National Schizophrenia Awareness Day, which is marked on July 25, the charity Rethink Mental Illness aims to break the stigma around the diagnosis and raise awareness on what it's like to live with the illness.

Dr John Read , professor in clinical psychology at the University of East London and editor of the scientific journal Psychosis and author of Models of Madness: Psychological, Social and Biological Approaches to Psychosis (Routledge), explains the most common myths and misconceptions around schizophrenia.

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Schizophrenia is a severe long-term mental health condition which causes a range of psychological symptoms.

Some symptoms of the condition including hallucinations - hearing or seeing things that do not exist outside of the mind - delusions, muddled thoughts, disinterest in everyday activities, withdrawing from people and social isolation.

Doctors often describe the illness as a type of psychosis, which means a person may not always be distinguish their own thoughts and ideas from reality.

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Here are six common myths and misconceptions about schizophrenia, according to expert Dr John Read.

There is a common perception that those with schizophrenia have a tendency towards violence. Dr Read explains that having schizophrenia does not make someone more violent than other people.

However, they are more at risk of harming themselves, he says: "It does make them more likely to commit suicide and be the victims of violent crimes."

It's often believed that there is a strong genetic component for schizophrenia. However, Dr Read reveals there's little evidence to back up this theory.

He explains: "Researchers have been looking for "schizophrenic" genes for 50-years. What they should be focussing on is epigenetics, the science of how our social environment turns our genes on and off."

Though a common belief suggests that schizophrenia is not related to adverse events in childhood, many studies have proven otherwise.

Studies show that child abuse and bullying are strongly predictive of psychosis in later life. Dr Reads adds:"Adults diagnosed with schizophrenia have often experienced some form of trauma as a child and or adult."

Having schizophrenia doesn't mean that someone has split personality - that is dissociative identity disorder. Both of these are two different mental health conditions.

Schizophrenia is a form of psychosis, usually characterised by hallucinations and/or delusion and other symptoms of psychosis.

There is no evidence for the theory that schizophrenia is caused by an overactive dopamine system, except for those people who might be on antipsychotic drugs, which can cause overactivity.

In most cases, schizophrenia is caused by adverse life experiences, both in childhood and adulthood.

Schizophrenia is a long-term condition, but it is treatable and many people can recover from the condition - even if they may have relapses of symptoms occasionally - if given proper psychological therapy and social support.

If schizophrenia is well managed, it's even possible to reduce the chance of severe relapses.

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What is schizophrenia? Common myths and misconceptions around the mental illness - The Mirror

Irvine, Calif., July 14, 2022 The role of gene alterations resulting from childhood adversity in adults addicted to heroin and a search for blood tests to predict addiction vulnerability are part of sweeping research that scientists are launching at the University of California, Irvine.

The nearly $3.5 million five-year project to understand the opioid crisis is a collaboration of the School of Biological Sciences and the School of Medicine, as well as the Irvine Center for Addiction Neuroscience. The National Institute on Drug Abuse is funding the work through an initiative to encourage research innovation.

Researchers will examine how early-life adversity influences epigenetics, or experience-induced changes in gene expression, and how they affect the likelihood of adult addiction.

We want to see how these epigenetic alterations interact with the heroin experience and if there are sex differences in these processes, said lead principal investigator Stephen Mahler, associate professor of neurobiology & behavior and a fellow in the Center for the Neurobiology of Learning and Memory.

For example, what happens upon using opioid drugs might be different between people who had scarcity of resources or chaotic environments as children and those who didnt, Mahler said. This could account for why some people become addicted to these drugs, while others dont.

He noted that earlier research shows opioid-addicted women were more likely than men to have experienced stressful circumstances as children, such as those resulting from growing up amid early-life adversity.

Examining the bloods capacity for revealing the propensity for addiction and other mental disorders is also part of the study. This work centers on extracellular vesicles, which are cell-produced droplets containing proteins and microRNAs. Researchers will compare these vesicles in blood samples and cerebral spinal fluid of rodents to learn if those in the blood hold clues about an individuals risk of addiction or other mental disorders. If so, it could mean blood screening can provide information about the brain that helps prevent and treat addiction and related conditions.

Gaining a better understanding of an individuals epigenetics and brain activity opens up powerful new possibilities, said Mahler. As an example, if someone suffers a broken leg and it is determined they are susceptible to addiction, they can be given an alternative treatment for pain. For people already dependent on opioids, we may be able to develop precise treatments that target the genetic activity causing the addiction.

Numerous other inquiries will also take place as part of the research project. Serving as principal investigators are Christie Fowler, associate professor of neurobiology & behavior and fellow, CNLM; Vivek Swarup, assistant professor of neurobiology & behavior; and Dr. Tallie Z. Baram, distinguished professor of pediatrics, anatomy & neurobiology and neurology, Danette Shepard Professor of Neurological Sciences, and fellow, CNLM. Marcelo Wood, professor of neurobiology & behavior and fellow, CNLM, is co-investigator.

Nearly 50,000 people nationwide died from opioid-related overdoses in 2019, according to the National Institute on Drug Abuse. It calls opioid misuse and addiction a serious national crisis that affects public health as well as social and economic welfare.

If you can tie the event through a quote or anecdote to our values or to research, academic, character or leadership excellence or entrepreneurial spirit, research, education or community service, so much the better.

About UCIs Brilliant Future campaign:Publicly launched on Oct. 4, 2019, the Brilliant Future campaign aims to raise awareness and support for UCI. By engaging 75,000 alumni and garnering $2 billion in philanthropic investment, UCI seeks to reach new heights of excellence instudent success, health and wellness, research and more. TheSchool of Biological Sciences and School of Medicine play a vital role in the success of the campaign. Learn more by visiting https://brilliantfuture.uci.edu/school-of-biological-sciences/ andhttps://brilliantfuture.uci.edu/uci-school-of-medicine/.

About the University of California, Irvine:Founded in 1965, UCI is the youngest member of the prestigious Association of American Universities and is ranked among the nations top 10 public universities byU.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UCI has more than 36,000 students and offers 224 degree programs. Its located in one of the worlds safest and most economically vibrant communities and is Orange Countys second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.For more on UCI, visitwww.uci.edu.

Media access: Radio programs/stations may, for a fee, use an on-campus ISDN line to interview UCI faculty and experts, subject to availability and university approval. For more UCI news, visit news.uci.edu. Additional resources for journalists may be found at communications.uci.edu/for-journalists.

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What gene changes and blood could tell us about the opioid crisis - UCI News

Written by: James Carnell

Dr. Nirmalya Saha

If all the DNA molecules that make up a single person were lightbulbs, epigenetic modulators would be the light switch. While it is factual that our DNA plays a large role in our personal makeup, overall health, and body functionality, the picture is much more complex. Even while in utero, developing fetuses can experience epigenetic changes that play a major role in what that future persons makeup will be. While many of these changes are a normal part of development and will continue to happen over time, epigenetic modulators can also trigger internal changes that are linked to serious diseases, such as cancer.

As a molecular biologist, Dr. Nirmalya Saha has dedicated his career to understanding the role epigenetic changes play in Leukemia and how these complex factors present themselves throughout the course of specific cancers. While his work is largely focused on the oncology space, Dr. Saha recognizes just how powerful epigenetics can be. If these light switches can cause disease in an otherwise healthy person, they might just be the secret to fighting a disease once it has become a reality.

Dr. Sahas Impact on the Epigenetics Space

Though the importance of epigenetics is becoming more widely known, often emphasized by new studies and medical research advancements, many professionals in the molecular biology field have begun to examine its role in certain body functions. For Dr. Saha, the focus has been on developing an understanding of how important the epigenetic regulator PRMT5 is in Acute Myeloid Leukemia as well as unpacking the dynamic between SETDB1 and suppressing Leukemia. These studies are about more than understanding a complex relationship; they are about finding a solution for diseases that take lives.

Acute Leukemia with MLL rearrangement makes up about 5-10% of cases in adults and a shocking 70% of cases in infants. This disease straps those affected with a devastating prognosis and low chances of survival. With Dr. Sahas research, its becoming more likely that science can create a novel inhibitor molecule to treat the disease and offer patients a better outlook. Even if his work stopped here, with this subset of patients, it would be extraordinary, but it goes much further.

The Future of Epigenetics

Epigenetic therapies can fight against many forms of cancer, completely revolutionizing the toolkit doctors and patients have access to when battling different types of the disease. If these therapies are effective for one subset of diseases, there is so much potential to develop similar therapies for a plethora of disease categories. The work Dr. Saha and other molecular biologists are doing right now will be the difference between a future patient living and dying, growing old to see their families flourish or being taken too soon.

Aside from treating diseases, epigenetics plays a large role in understanding how each body works on an individual level, almost providing a fingerprint of each person. Armed with this knowledge, epigenetic researchers are making leaps and bounds in the space of personalized medicine. If we can determine how a persons body will react to different factors, its possible to mitigate potential dangers and get ahead of medical problems before they even start.

The Future of Dr. Saha

Though he has already provided astounding research, advancing the molecular biology field and propelling medical capabilities, Dr. Saha does not seem to be slowing down. As his research uncovers more powerful information, he is reminded of why he started this career to begin with: to help people.

Today, Dr. Saha is a committed teacher and mentor, working in the Department of Pathology at the University of Michigan, Ann Arbor. His work has been featured in renowned publications such as BBA-Reviews on Cancer, Stem Cell Reports, and BMC Genomics. As an active member of the American Association of Cancer Research and the Sigma Xi Honor Society, Dr. Saha will continue on his path to saving lives through research.

This article does not necessarily reflect the opinions of the editors or management of EconoTimes

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Epigenetics Is The Key To Treating Complex Diseases; Dr. Nirmalya Saha Is Using It To Unlock Cancer Treatment And More - EconoTimes

This summer, huge swaths of the U.S. have already faced record-breaking heat waves. Heat kills more people than any other extreme weather event, and deadly heat waves are getting longer and hotter as the climate warms.

Staying cool and informed is essential. So we spoke with Thomas Clanton, a professor of applied physiology and kinesiology at the University of Florida and an expert in the effects of heat on the body, about how to recognize heat illness and the long-term consequences of this kind of stress.

Heatstroke is a medical emergency. If you notice signs of heatstroke in a person, call 911 immediately.

It's a really broad spectrum. At the lowest end is heat exhaustion, and on the more extreme end we have heatstroke. The difference is really the presence of neurological symptoms in heatstroke. Throughout the spectrum, mild to severe injury to liver, heart, kidney and muscle can be present. So, you can have heat exhaustion and you're probably still thinking pretty well, but you know you're hot. You try to get out of the heat and you're functional. However, heatstroke victims can go unconscious, lose motor control or become delirious, so their ability to respond is limited.

Clinically, a person would be diagnosed with heatstroke if they have a temperature above 40 degrees centigrade (104 degrees Fahrenheit) and also exhibit central nervous system symptoms.

Other signs that people notice include pallor (paleness) of the skin. Whereas profuse sweating is a normal reaction to heat, at the extremes of heatstroke the sweat response doesn't work as well, and the skin can become dry. If you begin to notice these signs, get into the shade, drink plenty of water and move to a reclined position. If ice bags or wet towels are available, place them under the arms, on the neck and along the groin regions. If any unusual neurological symptoms develop, get medical assistance immediately.

A lot of times people in the heat exhaustion range may not know they are getting heat illness. I think that's one of the concepts worth emphasizing. Besides just feeling hot, an individual may feel a little woozy or just not themselves. When this occurs, and they are not well hydrated, they can move quickly to conditions of heatstroke. Heatstroke can develop rapidly and it often mistaken for just normal overheating and exhaustion, so it pays to be aware of the clinical symptoms and to act quickly.

Absolutely. A buddy can get help, call the ambulance, right? And you can help each other stay healthy. Coaches can play this role during workouts and team players up. I play golf in the summer, and my partner and I make sure each other drinks plenty of water and stays in the shade whenever possible. We bring wet towels for our shoulders. These techniques are really effective and pretty simple.

We rightfully worry about people dying from heatstroke. But the evidence in the last few years is extremely good that some people who experience heatstroke may have medical consequences that can affect them the rest of their life.

The field has documented changes in the immune system of humans and animals years after a heatstroke. Heatstroke victims also have a greater frequency of developing chronic heart disease and kidney diseases later in life.

In the animals I study,we see evidence of epigenetic changesthat likely explain some of these long-term effects. Epigenetics is kind of cellular memory. So at a cellular level, cells have their own way of remembering if they've been exposed to severe stresses in the environment, which can help them respond over time by altering their cellular responsiveness. Cells imprint this memory by using enzymes that chemically tag their DNA. This memory is often helpful and can be adaptive, but can also be maladaptive if the stress is severe.

We certainly see strong epigenetic signals in the hearts, immune cells and skeletal muscle of mice one month after heatstroke. The mice look fine, their hearts look fine, but later they begin to develop metabolic disorders and other secondary effects. We believe that many of these epigenetic changes are maladaptive and make the animals less able to withstand additional stresses in their environment or to fight off other chronic forms of disease. Once we understand this in our animal models, we hope to develop approaches in humans that will help them ward off the development of these long term consequences to severe heat exposures.

Eric Hamilton July 18, 2022

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Heatstroke stresses the body years after the original heat illness - University of Florida

CAMBRIDGE, Mass., July 14, 2022 /PRNewswire/ -- Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2, first-in-human, clinical study of OTX-2002 for the treatment of hepatocellular carcinoma (HCC). OTX-2002, an Omega Epigenomic Controller (OEC), is designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation.

"We are thrilled to obtain clearance to advance OTX-2002 into the clinic and are excited about the prospects of what this new class of medicines may mean for patients in need," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "This is an important milestone for our company, representing our first program to receive FDA clearance to enter the clinic and the first ever clinical trial to evaluate an epigenomic controller. This new class of programmable mRNA therapeutics leverages our groundbreaking science and has broad potential applicability in many therapeutic areas."

About OTX-2002

OTX-2002 is a first-in-class Omega Epigenomic Controller in development for the treatment of HCC. OTX-2002 is an mRNA therapeutic delivered via lipid nanoparticles (LNPs) and is designed to downregulate MYC expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. The MYC oncogene is associated with aggressive disease in up to ~70% of patients with HCC. An IND application for OTX-2002 has been cleared by the FDA.

About Omega Therapeutics

Omega Therapeutics, founded by Flagship Pioneering, a clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines. The company's OMEGA Epigenomic Programming platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth, and differentiation to cell death. Using a suite of technologies, paired with Omega's process of systematic, rational, and integrative drug design, the OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's modular and programmable mRNA medicines, Omega Epigenomic Controllers, target specific epigenomic loci within insulated genomic domains, EpiZips, from amongst thousands of unique, mapped, and validated genome-wide DNA-sequences, with high specificity to durably tune single or multiple genes to treat and cure diseases through Precision Genomic Control. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases, including alopecia.

For more information, visit omegatherapeutics.com, or follow us on Twitter and LinkedIn

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our product candidate pipeline, including efficacy, trial design, regulatory submissions, approvals and timing thereof, the launch of a clinical trial of OTX-2002 and timing thereof, and the filing of future IND applications and timing thereof. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the novel technology on which our product candidates are based makes it difficult to predict the time and cost of preclinical and clinical development and subsequently obtaining regulatory approval, if at all; the substantial development and regulatory risks associated with epigenomic controller machines due to the novel and unprecedented nature of this new category of medicines; our limited operating history; the incurrence of significant losses and the fact that we expect to continue to incur significant additional losses for the foreseeable future; our need for substantial additional financing; our investments in research and development efforts that further enhance the OMEGA platform, and their impact on our results; uncertainty regarding preclinical development, especially for a new class of medicines such as epigenomic controllers; the fact that our product candidates may be associated with serious adverse events, undesirable side effects or have other properties that could halt their regulatory development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences; the impact of increased demand for the manufacture of mRNA and LNP based vaccines to treat COVID-19 on our development plans; difficulties manufacturing the novel technology on which our OEC candidates are based; our ability to adapt to rapid and significant technological change; our reliance on third parties for the manufacture of materials; our ability to successfully acquire and establish our own manufacturing facilities and infrastructure; our reliance on a limited number of suppliers for lipid excipients used in our product candidates; our ability to advance our product candidates to clinical development; and our ability to obtain, maintain, enforce and adequately protect our intellectual property rights. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

Contacts

Investor contact: Kevin MurphyArgot Partners212.600.1902[emailprotected]

Media contact: Jason BracoLifeSci Communications646.751.4361[emailprotected]

SOURCE Omega Therapeutics

Link:
Omega Therapeutics Announces FDA Clearance of IND Application for OTX-2002, First Omega Epigenomic Controller, for MYC Driven Hepatocellular Carcinoma...

CALGARY, Alberta, June 21, 2022 (GLOBE NEWSWIRE) -- Zenith Epigenetics Ltd. (Zenith or the Company) announced today that the data from its Phase 2 Metastatic Triple Negative Breast Cancer (mTNBC) clinical trial combining ZEN-3694 + Pfizer Inc.s Talzenna (talazoparib) was highlighted at an oral session Optimizing Targeted Therapies in Advanced Breast Cancer: Building on Past Success. The discussant presented the novel concept of administering ZEN-3694, a bromodomain and extraterminal (BET) inhibitor (BETi), to sensitize resistant mTNBC tumors to talazoparib, a poly (ADP-ribose) polymerase (PARP) inhibitor (PARPi), and the clinically meaningful response rate and manageable safety profile of the combination from the Phase 2 study. Selection of an abstract for an oral discussion is a very competitive process with only 24 of the more than 125 accepted abstracts selected for this presentation format. The poster can be viewed on Zenith Epigenetics website (Poster) and the discussion can be viewed on the ASCO website (Discussion).

The data from the Phase 2 trial demonstrate that the ZEN-3694 plus talazoparib combination regimen, with a clinically meaningful response rate of 32% in a defined population, has the potential for treating patients whose tumors do not harbor germline mutations in BRCA1/2, said Dr. Philippe Aftimos, a principal investigator and medical oncologist at The Institut Jules Bordet in Brussels, Belgium. This combination is active with a manageable safety profile and warrants continued clinical evaluation. Zenith has expanded the Phase 2 trial to continue to evaluate the combination in an additional 120 mTNBC patients (NCT03901469).

In conjunction with ASCO, Zeniths TNBC poster was also awarded the GRASP Advocate Choice Award and selected to be discussed at theGRASPPoster Walkthroughs. GRASP, which standsfor Guiding Researchers and Advocates for Scientific Partnerships,is a patient-led organization that brings together patients, clinicians, and researchers to exchange ideas and learn from each other to accelerate scientific breakthroughs. GRASP Poster Walkthroughs are small group discussions of selected posters presented at scientific conferences such as ASCO.

We are very pleased that the data from our mTNBC clinical study, conducted in collaboration with Pfizer, was well received and recognized at ASCO, said Don McCaffrey, CEO of Zenith Epigenetics. The combination regimen of ZEN-3694 + talazoparib has shown promising clinical activity in a mTNBC patient population with significant unmet need. We continue to advance this program toward registration and are committed to bring an important therapy to these patients.

About Zenith and ZEN-3694

Zenith Epigenetics Ltd., a wholly-owned subsidiary of Zenith Capital Corp., is a clinical stage biotechnology company focused on the discovery and development of novel therapeutics for the treatment of cancer and other disorders with significant unmet medical need. Zenith Epigenetics is developing various novel combinations of BET inhibitors with other targeted agents. The lead compound, ZEN-3694, is in clinical development for various oncologic indications, specifically:

About Triple Negative Breast Cancer (TNBC)

TNBC is an aggressive form of breast cancer with low survival rates. TNBC accounts for about 10-15%of all breast cancers and it differs from other types of invasive breast cancer in that it tends to grow and spread faster, has fewer treatment options, and tends to have a worse prognosis. The termtriple-negative breast cancerrefers to the fact that the cancer cells have only low or no amount of the receptors ER, PR, and HER2. Approximately 75,000 women in the US, Japan and the major EU countries are diagnosed with TNBC each year.

About ZEN-3694 + Talazoparib Combination

In the United States, talazoparib is currently approved under the brand name TALZENNA, which is a PARP inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. ZEN-3694, in combination with talazoparib, is being developed for targeting tumors that do not have a germline BRCA mutation which represent approximately 89% of TNBC tumors. Preclinical and clinical data has shown that BET inhibition may reduce the levels of DNA repair proteins such as BRCA1/2 and RAD51 and thus create synthetic lethality in wildtype BRCA1/2 TNBC tumors when combined with PARP inhibition.

For further information, please contact:

Investor Relations & Communications

Zenith EpigeneticsPhone: 587-390-7865Email: info@zenithepigenetics.comWebsite:www.zenithepigenetics.com

This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts" and other similar expressions. In particular, this news release includes forward looking information relating to the Companys development activities involving ZEN-3694 in combination with Pfizers PARP inhibitor Talzenna, and other targeted agents used in precision oncology, as well as other planned PARPi based combination therapy clinical trials in other tumor types. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our most recent MD&A which are incorporated herein by reference and are available through SEDAR at http://www.sedar.com. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. Zenith disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Read more:
Zenith Epigenetics Triple Negative Breast Cancer Clinical Data Highlighted in an Oral Discussion at the American Society of Clinical Oncology...