From 15 years of heroin addiction to becoming a neuroscience lecturer – The Irish Times

Every morning psychology lecturer and author Brian Pennie wakes up very early and does five things: meditation, affirmation, visualisation, inner child work and gratitude. It makes up an acronym mavig and he swears by it. He does these things every morning, he says, whether itsWorld War III orthe coronavirus.

Seven years ago, when he was in the throes of a serious heroin addiction, Pennies mornings looked quite different. He would awake to an overly loud alarm playing In the Morning by Razorlight, after which a couple of benzos and some gear would get him out of bed. I had no emotional world. I had no spiritual world. That was all gone . . . My brother, who I lived with, says he still gets shivers when he hears that song.

Pennies memoir, Bonus Time, tells the story of his journey through a 15-year heroin addiction on to a post-recovery career as a speaker, neuroscience lecturer and PhD student.

All addiction, Pennie says, has its roots in trauma. His own trauma, he now believes, stems from an operation he had as a baby. In those days, operations on infants were misguidedly carried out without anaesthetic and, with what he knows now about psychology, Pennie reckons this might explain the feelings of unease and anxiety he carried with him through his childhood and into adulthood.

I still have weird feelings around bodily sensations, he says. Thats my Everest. If you said to me, Ill give you a million euros, Brian, if you can feel your pulse for a minute, Id probably do it for a million quid but I stillhave negative associations around my heartbeat and my pulse. He rubs his side. Im rubbing my scar as I talk about it . . . I imagine for the first year of my life I had horrible bodily sensations; I imagine that as a baby I could feel my heartbeat, I could feel the pulse and I associated that with pain.

Throughout his childhood he was restless and agitated. I had sirens in my head, he says. I was just such a worrier. I worried about my parents dying. I had huge fear of death and a huge fear of losing people close to me.

Drugs offered him relief from this. His first drug, he says, was a cigarette. He remembers it very clearly. All my friends were smoking and I remember thinking they were idiots . . . but something just shifted one day and one of my mates said, I love the head buzz you get off that and that piqued my interest. And within weeks I was smoking hash.

Pennie grew up in working-class Ladyswell in Blanchardstown, but went to a posher school than many of his friends, St Declans in Cabra. He never felt he fitted in there, he says, and in an attempt to do so he styled himself as a drug dealer. They called me Penpusher. I was such a mediocre drug dealer. I wasnt hard enough to be a drug dealer in [Ladyswell], but I was hard enough for St Declans. He laughs. Which is pathetic and I see that now.

He wanted to be cool. He and his best friends were obsessed with the music and poetry of Jim Morrison. Jim was into a drug called Peyote so we thought we have to do as much acid as we can to be like Jim Morrison and expand our minds.

Did it expand their minds? He laughs. I was completely deluding myself. I just liked the idea of expanding my mind . . . We were into Kurt Cobain as well . . . We wanted to join the 27 Club [musicians who died at the young age of 27], me and my friend Barry. Wed actually say that to each other . . . Were going to burn out, not fade out. Losers fade out. It was just a rationalisation to do more drugs.

When he was 16, Pennie tried methadone. He didnt even know that it was a heroin substitute, he says, though after I wrote the book the friend that I did it with said, You f***ing did know, you mad thing. Memories are crazy.

When he was 17, he did heroin. It was amazing, he says. Even talking about it now I feel a sense of calm. I got a lovely stillness in me . . . It was amazingly powerful and beautiful. I revered it like a god from the heavens.

Since getting clean, he says, he has discovered he can conjure up a purer less artificial version of that still and timeless feeling he got from heroin from meditation. At the time, however, he and his friend Barry (not his real name) fell into serious addictions. Barry, he tells me, is still in addiction and is homeless.

Pennie never saw himself as a real addict. He managed to keep a job in the graphics department of a printing company, and to keep a veneer of a functionality for 15 years while maintaining a serious addiction and a second job as a not particularly competent drug dealer. I wasnt as unusual as I thought I was. People stereotype the addict as someone on the dole, but a lot of people turn up [at methadone clinics] in vans and have jobs.

The fact Pennie managed to keep his job for so long feels miraculous given the reality of his addiction. He was liked by his colleagues and good at his job when he did it, he says, and he thinks some of them mistook his issues for a more socially acceptable addiction to alcohol. But his problems were increasingly obvious.

He describes his typical workday: I would wake up in the morning and there was always stress from the night before. I owed out money. I didnt get paid. I didnt have enough drugs for the day. I would always have a little bit of something to keep me out of the sickness, so I wouldnt be overly anxious at work. Id be frantically making phone calls during the day, and I would probably make up some story to say I had to go to thecredit union or something . . . I had a lot of bulls**t happening to give me excuses to get out of place and go and score some gear. Id come back and smoke it in the industrial estate, come back into the job. Id be looking a lot better now, because I wasnt struggling with anxiety anymore, but I would look stoned. I would probably goof off, on the chair.

He regularly fell asleep at work. After work Id go and try to collect some money, pay the dealers. In the earlier stages, it would have been just about getting more heroin, more benzos just to get nicely stoned. But in the latter years, no matter how many drugs I did, it just brought me to baseline or below baseline.

When the heroin stopped giving him a high, he formulated a plan to move to Afghanistan where he thought it would be stronger. Seriously. I was looking up flights and all, he says. From a neuroscience perspective my body was just in a state of agitation, my nerve endings were always agitated. I just wanted to ease the agitation that was in my body but the more drugs I did, the more agitated I became. I was like a snake trying to eat its own tail.

When his mother discovered piles of old methadone bottles under his bed, he managed to convince everyone he was nearly recovered from addiction rather than supplementing a long-standing methadone prescription with heroin and tablets. He likens himself to a chameleon, changing to fit whatever world he was in. At one point he might play golf with colleagues. At another he might watch a man who had just extracted heroin from his rectum, hand it to him with his faeces-covered hands. I thought, this is not who I am. I dont belong here. Hes a dirt ball, Im not a dirt ball.

It was only when he was finally suspended from work that he sought help. He was told by his doctor that he needed to wean himself off benzodiazepine before hed be allowed into a heroin detox centre and, against all advice, he decided to stop taking the tablets overnight. This is not recommended by the experts for good reason.

After a trip to AA with his sister I fell asleep on her shoulder, smelling of vodka he returned to his flat where, a few nights later, he had a withdrawal related seizure. He bit his tongue down the middle and ended up in hospital. That was the moment when the world completely changed. I was never really going to get clean until I had a seizure . . . My self identity was, I cant cope with anxiety, I need to take heroin. The seizure cracked that shell, and it just opened the door to look at the world in another way. It just broke me mentally, emotionally and physically. It was like I was dead inside afterwards. There was nothing inside of me.

He didnt even have the strength to score drugs at that point, which meant that several weeks later, the benzodiazepine was out of his system and he was in a detox centre coming off heroin and methadone. While there he began reading about mindfulness and psychology and eastern philosophy. He kept a diary, and wrote several overly earnest letters to his family. I genuinely believe the most clarity I ever had in my life was when I was in detox, he says.

This was difficult for some members of his long-suffering family to take. The addict mind kicked in and I thought I was a sage, he says. I told my sister, I have a secret. Ill tell you about when I get out, not realising that I had put them through torture for years. A few weeks after they thought I was dead Im sending them letters [saying things like], eat strawberries and really feel the strawberry.

Nonetheless, he embraced learning and never let go of it. From a neuroscience perspective, if we have that dopamine hit drug, drug, drug, drug, drug and you get clean and dont hook that little dopamine hit on to something else, you are going to feel crap. And what do you do when you feel like crap? You use drugs. I think what saved me was I hooked my dopamine receptors on to a new drug and that drug was learning. I think its really important to try to find what is the positive new drug for someone, and over time help them find balance. Ive never found balance. Im still obsessed about learning. Thats okay. We call it drive. We dont call it addiction anymore.

Since then, Pennie has completed a degree in psychology in NUI Maynooth, is studying for a fully-funded PhD at the institute of neuroscience in TCD, and slowly building a reputation as a speaker and a lecturer. Hes interested in the space where eastern philosophies of mind intersect with western psychology, and over the course of our chat, he quotes thinkers like Anthony de Mello, Eckhart Tolle and Viktor Frankl.

Things havent always gone smoothly, he says, but he insists that hes the happiest person I know. He is very close with his family. He has come up with 200 tools for life, at first to help himself, but which he now imparts to clients in one-on-one sessions and to rooms full of people as a speaker. He lectures in the neuroscience of mindfulness at UCD and the neuroscience of addiction in TCD. In his spare time, he has been interviewing business leaders and public figures about their own strategies for life, and is hoping to turn his findings into another book.

He talks about the importance of affirming your own values (his include boldness, connection, open mindedness), and visualising the things you want to achieve. When he got a box of his books from the publisher, he tells me he was so excited he hurt his hand opening the box. Ive been as honest as I could. My main mantra in life is, be true to your wonderfully weird self. I just let the truth out.

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From 15 years of heroin addiction to becoming a neuroscience lecturer - The Irish Times

IMMERSION NEUROSCIENCE INDEX REVEALS THE PUBLIC CRAVES DIRECTION FROM ITS ELECTED LEADERS, NOT CELEBRITIES, DURING A CRISIS – Broadcasting & Cable

Immersion Neuroscience, the worlds most advanced predictive software company unlocking neuroscience to measure what people love, recently announced a new Immersion Index revealing people's reaction to celebrities vs. elected officials communications about the current COVID-19 pandemic.

Immersion researched the most effective way to share information with the public about coronavirus. This new study compares celebrities and their social media messages with elected officials.

The best way to determine if communication is effective is to measure how well it "sticks" in the brain. Science has established that when the brain is immersed in information, it is remembered, shared with others, and acted on. Highly immersive information is what will reduce the spread of the coronavirus and save lives, said Dr. Paul J. Zak, Founder of Immersion.

The research study: Immersion asked participants to turn on their Apple watches or other wearable sensors and emailed them six videos to view online. The videos ran for one-and-a-half to two minutes and featured President Trump; Vice President Pence, who leads the White House Coronavirus Task Force; Dr. Anthony Fauci, who leads the National Institute of Allergy and Infectious Diseases and is a member of the Coronavirus Task Force; Georgia Governor Brian Kemp; singer Cardi B; and actor and former governor of California Arnold Schwarzenegger, all speaking about the coronavirus outbreak.

The study revealed that communication about coronavirus by government leaders is significantly more effective than a celebrity rant or an offbeat video with miniature horses, for example.

The Immersion platform aggregated neurologic responses and returned an average Immersion value from 1-10 for each video.

Immersion Index results for communication effectiveness are:

Vice President Pence generated neurologic immersion that was 48% higher than the next most immersive speakers, a tie between President Trump and Governor Kemp. Dr. Fauci was a close third at 53% less immersive, while Arnold and Cardi B were at the bottom of the list at 61% and 64% less immersive than Mr. Pence.

The results show that fact-based videos from elected officials, delivered without theatrics were significantly more immersive, meaning these are more likely to motivate actions by citizens.

We salute celebrities for reminding the public to be safe. But, when times are tough, this study shows that brains know that experts provide the most valuable information. If you ask people which videos they "like" or find "entertaining," they will choose the stars over the experts. Extensive research has shown that "liking" has no relationship to what people do. In this time of crisis, action is what matters. That is why measuring neurologic immersion is so important, said Immersion CEO Scott Brown.

Fifteen years of peer-reviewed research has proven that when the brain produces a specific set of unconscious responses called "immersion," it identifies an experience as valuable.

Immersions proprietary solution and software is the world's most accurate way to measure the brain's unconscious emotional responses to virtually any type of content whether its video, music, live events, training, educational resources and more. Developed by distinguished research scientists, Immersions simple to use and scalable predictive SaaS platform democratizes neuroscience so that anyone can measure what people love at scale.

The Immersion platform is unique in its ability to perform distributed neuroscience which becomes essential at a time when the world is sheltering in place. Immersion measures brain responses any place that people are using a mobile app that sends data to cloud servers. Algorithms developed by Immersion scientists infer brain activity from a small wearable sensor.

To learn more about Immersion, visit http://www.getimmersion.com.

For more information, contact:

Andrew Laszacs

Bob Gold & Associates

310-320-2010

immersion@bobgoldpr.com

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IMMERSION NEUROSCIENCE INDEX REVEALS THE PUBLIC CRAVES DIRECTION FROM ITS ELECTED LEADERS, NOT CELEBRITIES, DURING A CRISIS - Broadcasting & Cable

Neuroscience Antibodies & Assays Market Trends, Strong Application Scope, Key Players, Growth Overview and Forecast by 2027 – Jewish Life News

The latest Neuroscience Antibodies & Assays market study offers an all-inclusive analysis of the major strategies, corporate models, and market shares of the most noticeable players in this market. The study offers a thorough analysis of the key persuading factors, market figures in terms of revenues, segmental data, regional data, and country-wise data. This study can be described as most wide-ranging documentation that comprises all the aspects of the evolving Neuroscience Antibodies & Assays market.

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Neuroscience Antibodies & Assays Market Trends, Strong Application Scope, Key Players, Growth Overview and Forecast by 2027 - Jewish Life News

A New Drug May Be Able to Ease the Side Effects of Medication Against Severe Depression – Technology Networks

About one in five Danes are affected by depression at some point in their lives. The severe depressions may be treated with the so-called tricyclic antidepressants, an antidepressant drug that is more effective than the drugs used for mild and moderate depressions.

But unfortunately, the tricyclic antidepressants also have a downside: significantly more and more serious side effects. So serious that many people stop taking the drug and thus receive no treatment for their depression.

Now, researchers from the Faculty of Health and Medical Sciences at the University of Copenhagen, in collaboration with Lundbeck A/S and the National Institutes of Health in Baltimore, have discovered a substance that may solve that problem.

We have discovered a substance, Lu AF60097, that works in a different way from the ones presently in use. If the new substance works, it may help the existing drugs get rid of the serious side effects, says Professor at the Department of Neuroscience at the Faculty of Health and Medical Sciences, Claus Juul Lland.

Therapeutic effect without side effects

Serotonin is a so-called neurotransmitter, a chemical substance found in the brain. In a person with severe depression, the level of serotonin is very low. Antidepressant drugs make adjustments to get a higher level of active serotonin.

The antidepressants we use today work by going in and binding to the same site as serotonin on the serotonin transporter (SERT). The antidepressants block the return transport of serotonin and thereby also the removal of the active serotonin. But such blockage requires a relatively large dose of the antidepressant substance. And with the tricyclic antidepressants, that causes some serious side effects, says Claus Juul Lland.

The side effects can be anything from life-threatening heart problems to severely dry mouth, visual disorders, development of mania, weight problems and digestive challenges.

The substance discovered by the researchers binds to another site on SERT: the allosteric site. When a substance binds to the allosteric site rather than the same site as serotonin, it is possible to regulate the function of the serotonin transporter instead of completely blocking it.

In this case, we have shown that when we bind this substance to the allosteric site while giving the tricyclic antidepressant, we can amplify the binding of the antidepressant substance. Therefore, we can use a much smaller concentration of the antidepressant substance. It might cause fewer side effects, but have the same therapeutic effect, says Claus Juul Lland.

From concept to drug

The researchers have, over a long period of time and in several rounds, screened a number of substances from Lundbecks drug library to find a substance that had a sufficiently strong link to the allosteric site to make it possible to study the pharmacological effect. With Lu AF60097, they finally succeeded.

But there is still a long way to go before the substance can be used as an actual drug. The researchers have shown that a substance that binds to the allosteric site can have this pronounced, pharmacological effect in cells and in rats. From here, it is up to the pharmaceutical companies to develop substances that may have the same effect in humans.

We have taken the first step. But perhaps also the biggest. We have shown that the concept works. If it also works in practice, hopefully in the future it can be used to treat people with severe depression.The study The mechanism of a high-affinity allosteric inhibitor of the serotonin transporter has been published in Nature Communications.

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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A New Drug May Be Able to Ease the Side Effects of Medication Against Severe Depression - Technology Networks

Ahead of switch to online classes, the future of hands-on curricula remains unclear – The Daily Northwestern

Following University President Morton Schapiros email announcing the switch to online classes until further notice, many students with hands-on majors said they were confused as to how the transition will take place.

Unlike lectures for humanities classes, which can be held more easily over Zoom, the lesson plans for many music, theater, dance and art classes, as well as STEM classes requiring labs, remain unclear. Few students said they have received concrete plans from their schools and professors yet.

Bienen, Communications students have to get creative

Bienen sophomore Josh Kuhn said he wasnt surprised by the Universitys choice but he was disappointed with their decision to cancel classes. For Kuhn, a voice major, online instruction poses a major problem.

All of us voice majors, instrumentalists, orchestra, band we are all here for the specific lessons with professional teachers and were here for the ensemble, said Kuhn. We cant take those online.

The Bienen School of Music announced the cancelation of all concerts and chamber music activities scheduled through April 27 on their coronavirus site. However, individual lessons will be taught remotely through Zoom, according to the website. If the University decides to allow students to return to campus for the later portion of Spring Quarter, the major ensembles will offer one concert each, as currently scheduled.

Still, Kuhn said the decision to host individual lessons concerns him.

You cant hear the sounds correctly for individual lessons it just isnt going to work out, Kuhn said.

Moving onward, Kuhn said he is going to talk to his parents over Spring Break about what to do but that he is considering taking a quarter off school and then re-enrolling during the summer.

Kuhn is not alone in his confusion. Other students taking Art Theory and Practice studio classes will also have to content with new online learning requirements.

Within the School of Communication, students in their second and third years of study are required to take a two-year acting sequence classes that are expected to be particularly impacted by the transition. The school has yet to announce a detailed contingency plan on their coronavirus website.

Communication junior Saidie Stone is registered to take the final class in that theater sequence. However, she said she doesnt know how students are going to put any of their skills into practice.

Stone explained that her concerns largely depend on whether students are coming back for the second half of the quarter a decision that wont be reassessed by administrators until April 17.

From my perspective as an actor, I can work by myself its not like I wont be able to grow or learn new things but I think the process would be stunted and not as efficient, Stone said.

Previously, Stone had spent Fall and Winter Quarters studying Greek plays and Shakespeare productions, and she said she was supposed to focus on works by Russian playwright Anton Chekhov during the spring.

I think well gain an analytical background but its impossible to get the same thing out if were having the entire quarter online, Stone said.

In order to address the concerns of theater students, the acting faculty have asked students to email their professors stating whether they can access certain technologies or have the space to move around while remote so they can formulate remote learning plans, according to the School of Communication coronavirus website.

Acting faculty will then use this information to create a learning plan, which will be emailed to students before Spring Break ends. However, some School of Communication professors have already started brainstorming ideas to deliver instruction and performance feedback online.

I think the camera work will be very exciting, especially since many of the available acting jobs will be on camera, wrote Theater Prof. Cindy Gold in a news release statement. Id say at least 50 percent of my own auditions in the last year were video submissions, so its terrific that our undergraduates will get early experience with this.

In regards to Checkohv, Gold also described her excitement of seeing intimacy and a focus on subtext closely on camera.

The STEM dilemma

The switch to online classes also poses specific challenges for students in STEM classes with labs as well.

In a Friday email to neuroscience majors, Director of Undergraduate Studies in Neurobiology Valerie Kilman said all spring neuroscience classes will operate online, with the exception of Neuroscience 399, a credit earned through independent research.

Faculty will be working busily over break to adapt their spring courses to online learning platforms, Kilman wrote. Expect to be contacted by your instructor(s) to explain how things will be run.

Still, Weinberg College of Arts and Sciences has yet to send out detailed information to students regarding the format of hands-on classes, despite launching a website dedicated to coronavirus information, and has left individual departments to make announcements.

Similarly, students participating in the final class in the Biology 222 laboratory sequence received notification from their professor Friday morning.

According to the email, students in the laboratory sequence will watch videos of the professor and the lab manager performing the initial steps of the experiments. If students return to campus, they can pick where the lab manager and professor left off, completing the experiments for themselves. The email did not include a contingency plan for the experimental portion of the course if students do not return to campus.

Medill students face in-person reporting restrictions

Specific reporting-based classes in Medill are also working toward overcoming the challenge of not being able to meet in person. Students in Winter Quarter reporting classes have already been impacted by the ban on all in-person reporting put forth by the school ahead of finals week.

This ban is expected to continue into Spring Quarter as classes transition to being conducted online.

In line with other schools, Medill dean Charles Whitaker said in a Tuesday email to The Daily, The faculty who will teach reporting classes in the spring are working as a group to develop a framework for conducting those classes and guidelines for acceptable reporting techniques that do not require face-to-face contact.

Despite these limitations, students will be expected to do reporting, according to the email.

We are in a field where the professionals are doing the same thing, Medill Professor Patti Wolter said. We are dealing with this in class but they are reporting in the world some places going out and putting reporters in hazmat suits; were not doing that.

Wolter explained that Medill had already been discussing digital learning before the University made their universal announcement and continues working on adapting to the situation at hand.

McCormick dean Julio Ottinos Saturday email to The Daily reiterated the theme of considering each class on an individual basis.

No single approach will work across the board, wrote Ottino. We all understand that some courses will provide unique challenges and we are working through those issues now.

Email: cbuchaniec@u.northwestern.eduTwitter: @caty_buchaniec

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Ahead of switch to online classes, the future of hands-on curricula remains unclear - The Daily Northwestern

New Insights to How the Brain Controls the Voice of Bats – Technology Networks

A particular neuronal circuit in the brains of bats controls their vocalisations. This was recently discovered by biologists at Goethe University Frankfurt. Based on the rhythm with which the circuit oscillated, the Frankfurt researchers were able to predict the kind of sounds the bats were about to make. These research results could contribute to a better understanding of human diseases in which language is impaired such as Parkinsons or Tourette syndrome.

Bats are famous for their sonar-based navigation. They use their extremely sensitive hearing for orientation, emitting ultrasound noises and receiving an image of their surroundings based on the echo. Sebas short-tailed bat (Carollia perspicillata), for example, finds the fruits that are its preferred food using this echolocation system. At the same time, bats also use their voices in a somewhat deeper frequency range to communicate with other members of their species. Sebas short-tailed bats employ a vocal range for this purpose that is otherwise only found among songbirds and humans. Like humans, they produce sound through the larynx.

Together with his team, neuroscientist Julio C. Hechavarria from the Institute for Cell Biology and Neuroscience at Goethe University investigated brain activity preceding vocalisation in Sebas short-tailed bats. The scientists were able to identify a group of nerve cells that create a circuitry from the frontal lobe to the corpus striatum in the interior of the brain. When this neural circuit fires off rhythmic signals, the bat emits a vocalisation about half a second later. The type of rhythm seemed to determine whether the bats were about to utter echolocation or communication vocalisations.

Since it is nearly impossible to make a prediction within half a second, the Frankfurt researchers trained a computer to test their hypothesis: The computer analysed the recorded sounds and the neural rhythm separately and attempted to make prognoses using the various rhythms. The result: in its predictions of echolocation versus communication vocalisations, the computer was correct about 80 percent of the time. Predictions were particularly accurate when considering signals from the frontal lobe, an area that in humans has been linked to action planning, among other functions.

The Frankfurt scientists argue that the rhythms they observed in the bat brain are similar to neural rhythms often recorded from the human scalp, and concluded that brain rhythms could be linked to sound production in mammals in general.

Julio Hechavarria: For over 50 years, bats have served as an animal model for studying how the brain processes auditory stimuli and how human language develops. For the first time, we were able to show how distant brain regions in bats communicate with each other during vocalization. At the same time, we know that the corresponding brain networks are impaired in individuals who, for example, stutter as a result of Parkinsons disease or emit involuntary noises due to Tourette syndrome. We therefore hope that by continuing to study vocal behaviour in bats, we can contribute to a better understanding of these human diseases.

Reference:

Kristin Weineck, Francisco Garca-Rosales, Julio C. Hechavarra. Neural oscillations in the fronto-striatal network predict vocal output in bats. PLOS Biology, 2020; 18 (3): e3000658 DOI: 10.1371/journal.pbio.3000658

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New Insights to How the Brain Controls the Voice of Bats - Technology Networks

CEL-SCI to Develop LEAPS COVID-19 Immunotherapy in Collaboration with University of Georgia Center for Vaccines and Immunology – BioSpace

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation(NYSE American: CVM) announced today it has signed a collaboration agreement with the University of Georgias Center for Vaccines and Immunology to develop LEAPS COVID-19 immunotherapy. CEL-SCIs immunotherapy candidate aims to treat patients at highest risk of dying from COVID-19. The collaboration will commence with pre-clinical studies based on the experiments previously conducted with LEAPS immunotherapy in collaboration with the National Institutes for Allergies and Infectious Diseases (NIAID) against another respiratory virus, H1N1, involved in the 2009 H1N1 flu pandemic. Those successful studies demonstrated that LEAPS peptides, given after virus infection has occurred, reduced morbidity and mortality in mice infected with H1N1.

It is suggested, based on studies with H1N1, that a LEAPS coronavirus - SARS-CoV-2 immunotherapy may reduce or arrest the progression of the SARS-CoV-2 virus infection and prevent tissue damage from inflammation resulting from lung infection by the virus. By stimulating the correct immune responses to the COVID-19-causing virus without producing unwanted inflammatory responses associated with lung tissue damage, LEAPS immunotherapy may be particularly beneficial in those patients who are at highest risk of dying from COVID-19.

We are eager to commence these studies, which if successful, may lead to clinical trials in humans to address the immediate and critical need to treat COVID-19 in the most vulnerable patients. We are very pleased and honored to partner with Dr. Ted M. Ross and his team and the University of Georgia Center for Vaccines and Immunology. Their world-renowned expertise and world-class facilities will accelerate the development of LEAPS COVID-19 immunotherapy, stated CEL-SCI CEO Geert Kersten.

The University of Georgia (UGA) Center for Vaccines and Immunology (CVI) brings together a diverse, world-renowned team of experts in the areas of infectious disease, veterinary medicine, ecology and public health. The universitys world-class biocontainment research resources are coupled with the expertise of CVI investigators who focus on translational studies to test and assess the efficacy of vaccines and immunotherapies in development by industry, governmental and academic institutions. CEL-SCIs COVID-19 studies at UGA will be led by Principal Investigator Ted M. Ross, PhD, Director of the Center for Vaccines and Immunology, Georgia Research Alliance Eminent Scholar, and Professor of Infectious Diseases at the University of Georgia. Dr. Ross is a world renowned key opinion leader in new vaccine technologies intended to protect against all strains for influenza and life threatening viruses. Dr. Ross has published more than 160 papers and book chapters on infectious disease and vaccine development. He has been an invited speaker at more than 130 national and international conferences, and he participates in several vaccine working groups, including at the U.S. National Institutes of Health, U.S. Centers for Disease Control and Prevention and the World Health Organization.

Dr. Ross commented, LEAPS has the potential to be a powerful tool against SARS-CoV-2, the causative agent of COVID-19, based on its dual anti-viral and anti-inflammatory properties. Combining the prior pre-clinical data of LEAPS against H1N1 with our advancing knowledge of COVID-19, we aim to rapidly evaluate this technologys potential to meet the urgent need to treat patients at greatest risk of dying from this global pandemic. The University of Georgias biocontainment labs at the Center for Vaccines and Immunology are ideally suited for these studies, and will serve as critical assets in this collaboration with CEL-SCI.

CEL-SCIs studies will utilize the LEAPS peptide approach that is unique in its proven ability in animals to elicit both a cell mediated antiviral response and an anti-inflammatory immunomodulating response by activating CD8 T lymphocytes. Previous studies showed that LEAPS immunogens can prevent lethal infection by herpes simplex virus (HSV) and influenza A (H1N1) and stop the inflammatory disease progression of rheumatoid arthritis in animal models. LEAPS peptides against HSV demonstrated that the T cell response was sufficient to prevent viral disease, and if there was residual virus production, anti-viral antibody was generated to further control the spread of the virus.

The proposed LEAPS peptides for the COVID-19 study are directed towards antigens within the NP protein of SARS-Cov-2 virus that elicit cytolytic T cell responses. Unlike the viral glycoprotein spike antigens which are important for antibody-based vaccines, these NP-antigens are less variable between viral strains and less likely to change in response to antibodies elicited by prior infection or other vaccines. Cytolytic T cell responses attack the virus infected cellular factories within the infected host in order to eliminate the source of virus and help subdue the infection.

About LEAPS

The Ligand Antigen Epitope Presentation System (LEAPS) platform technology has demonstrated in several animal models the ability to design antigen-specific immunotherapeutic peptides that preferentially direct the immune response to a cellular (e.g., T-cell), humoral (antibody) or mixed response and are also capable of enhancing important T-regulatory (Treg) responses. Therefore, the LEAPS technology provides the opportunity to develop immunotherapeutic products for diseases for which disease associated antigenic peptide(s) sequences have already been identified, such as: a number of infectious diseases, some cancers, autoimmune diseases (e.g., RA), allergic asthma and allergy, select CNS diseases (e.g., Alzheimer's) and the COVID-19 associated virus.

The Company's LEAPS technology is currently also being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by $1.5 million grant for IND enabling studies from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study CEL-SCI treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with Multikine* first, BEFORE they received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

CEL-SCI's Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the study's protocol, newly diagnosed patients with advanced primary squamous cell carcinoma are treated with the Multikine treatment regimen for 3 weeks prior to the Standard of Care (SOC) which involves surgery, chemotherapy and/or radiation. Multikine is designed to help the immune system "see" the tumor at a time when the immune system is still relatively intact and thereby thought to better able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the body's immune system prior to SOC. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 events have occurred among the two main comparator groups.

The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K/A for the year ended September 30, 2019. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.

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CEL-SCI to Develop LEAPS COVID-19 Immunotherapy in Collaboration with University of Georgia Center for Vaccines and Immunology - BioSpace

Gossamer Bio Announces Fourth Quarter and Full-Year 2019 Financial Results and Provides Business Update – BioSpace

SAN DIEGO--(BUSINESS WIRE)-- Gossamer Bio, Inc. (Nasdaq:GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced its financial results for the fourth quarter and year ended December 31, 2019 and provided a business update.

Our hearts are with the patients, families, caregivers and medical professionals suffering and sacrificing in the ongoing Covid-19 viral pandemic. We are monitoring the situation on a daily basis to understand the impact on Gossamer and our programs and are taking the necessary actions now to do what is best for our patients, employees and company, said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer Bio.

2019 was a year of execution for Gossamer Bio, as we continued to advance all four of our clinical-stage product candidates in our target areas of immunology, inflammation and oncology. Notwithstanding the Covid-19 pandemic, we expect to continue our momentum in 2020, with data from all of our candidates expected this year. We are committed to advancing our product candidates and the field of medicine for the betterment of patients and their families, and we look forward to providing updates on these efforts throughout the year.

Clinical-Stage Product Candidate Updates

GB001: Oral DP2 Antagonist for Eosinophilic Asthma and Chronic Rhinosinusitis (CRS)

GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)

GB004: Oral HIF-1 Stabilizer for Inflammatory Bowel Disease

GB1275: Oral CD11b Modulator for Oncology Indications

Financial Results for Quarter and Full Year Ended December 31, 2019

About Gossamer Bio

Gossamer Bio is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology. Its goal is to be an industry leader in each of these therapeutic areas and to enhance and extend the lives of patients suffering from such diseases.

Forward-Looking Statements

Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Companys current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the anticipated timing of initiation and enrollment of clinical trials for our product candidates; plans to rapidly advance our product candidates; expectations on the timing of data readouts from our clinical studies; the potential clinical benefits of our product candidates; the indications we intend to pursue and our related business strategies; the expected timeframe for funding our operating plan with current cash, cash equivalents and marketable securities; and access to the Companys senior debt facility. The inclusion of forward-looking statements should not be regarded as a representation by Gossamer that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Gossamers business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; disruption to our operations from the recent global outbreak of the Covid-19 pandemic; the Companys dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Gossamers clinical trials and preclinical studies for its product candidates; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of the Companys product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Gossamers ability to obtain and maintain intellectual property protection for its product candidates; Gossamers ability to comply with its obligations in collaboration agreements with third parties or the agreements under which it licenses intellectual property rights from third parties; the risk that the funding under the senior debt facility may not be completed on the timeframe Gossamer expects, or at all, including as a result of Gossamer's failure to meet the conditions required for such funding or failure to comply with the affirmative and negative covenants under the credit facility; and other risks described in the Companys prior press releases and the Companys filings with the Securities and Exchange Commission (SEC), including under the heading Risk Factors in the Companys annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Gossamer undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

GOSSAMER BIO, INC.

CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA

(UNAUDITED; IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)

Three months ended December 31,

Year Ended December 31,

STATEMENTS OF OPERATIONS DATA:

2019

2018

2019

2018

Operating expenses:

Research and development

$

42,596

$

25,872

$

143,403

$

55,283

In process research and development

1,600

-

3,600

49,659

General and administrative

11,591

13,935

39,136

44,051

Total operating expenses

55,787

39,807

186,139

148,993

Loss from operations

(55,787

)

(39,807

)

(186,139

)

(148,993

)

Other income, net

1,089

1,013

5,832

2,024

Net loss

$

(54,698

)

$

(38,794

)

$

(180,307

)

$

(146,969

)

Net loss per share, basic and diluted

$

(0.89

)

$

(4.92

)

$

(3.29

)

$

(22.59

)

Weighted average common shares outstanding, basic and diluted

61,282,084

7,878,824

54,740,170

6,504,871

December 31,

BALANCE SHEET DATA:

2019

2018

Cash, cash equivalents, and marketable securities

$

401,829

Go here to see the original:
Gossamer Bio Announces Fourth Quarter and Full-Year 2019 Financial Results and Provides Business Update - BioSpace

‘This thing has taken off like wildfire’: Mayo races with high-powered alliance to produce plasma treatment for coronavirus – Duluth News Tribune

With vaccines 18 months away at best, and with coronavirus-targeting antivirals travelling in a clinical trial pipeline that could extend into next year, the results of the so-called convalescent plasma treatment for coronavirus could potentially put a critical bridge therapy into healthcare workers' hands in one month's time.

"There's many if's here," said Mayo Clinic research physiologist and project participant Dr. Michael Joyner. "There's many potential barriers. There's many things that could go wrong or could delay it. But hopefully we would be in a position in a month or so to deliver it to people who can benefit from it."

The project is spearheaded by Dr. Arturo Casadevall, a professor of molecular immunology at the Bloomberg School of Public Health at Johns Hopkins University in Baltimore. "Deployment of this option requires no research or development," Casadevall has recently stated. "It could be deployed within a couple of weeks since it relies on standard blood-banking practices."

"Arturo came up with the idea that as we get more and more people recovered from COVID-19, two or three weeks after they are asymptomatic they are going to have very high levels of antibodies against COVID-19 in their blood or plasma," Joyner said. "We want to collect some of that plasma and use it either for post-exposure prophylaxis (prevention), or to treat people who are sick early in their hospitalization, with the goal of shortening the duration of the disease and keeping them out of the ICU, thus decompressing the healthcare system."

"If we can get these dominoes lined up, and they fall correctly," Joyner said, "as large numbers of people start to recover in the United States, we can harvest plasma from them and give it to patients safely in a way that shortens the course of their disease, or prevents them from getting it in the first place if they've been exposed."

Convalescent plasma is a time-tested pathogen treatment first used against diphtheria in the late 19th century, later against the 1918 influenza, measles, mumps, chickenpox, MERS, SARS, H1N1 and Ebola. Though the immunology of convalescent plasma is well known, its effectiveness with coronavirus is still being determined.

It's limitations involve a small risk of enhanced infection and the necessity of carefully timing the treatment, but otherwise come down to a modest handful of safety issues that apply to the use of all blood products in transfusion medicine, a category of care that has been well-tolerated for decades.

While the biology and safety of passive immunity is well-known, a nation-wide roll out of coronavirus antibody serum poses an administrative and public health challenge like no other. Following an expedited approval of the project via the investigational new drug pathway at the FDA, the campaign will require the wide-scale identification of persons with antibodies for coronavirus, followed by a uniform, population-scaled screening process of potential donors.

That's just for the gathering of plasma. Quickly delivering it to the nation's hospitals will require another set of Herculean logistical and clinical challenges, including the need to quickly communicate to a disparate sea of clinicians an entirely-new protocol for delivering the antibody-containing transfusions. Joyner says this is an area where an infrastructure has already been created, thanks to well-developed supply-chains behind the nation's commercial plasma centers.

"Because of the great skill and capacity of our blood banks across the country, we know how to obtain plasma, prepare it and give it safely," Joyner says. "So if we can give patients plasma that's rich in these antibodies, that can help us hold us off the illness until the biotech cavalry arrives with vaccine and medicines."

Reached for a midday call last week during a break in helping to write the study design "this isn't exactly my wheelhouse but it's close enough that I figured I could take a stab at it" Joyner said his lab had cleared out and begun working from home out of the need for social distancing. "It's like Christmas day, here," he said of his empty surroundings, inactivity that belied the broad and frenetic institutional effort to move the therapy through review and into practice.

Others within Mayo working on the project include an interdisciplinary team of immunology, transfusion medicine, pulmonology, radiology, infectious disease and IRB-affiliated participants, a list Joyner said included Drs. Elitza Theel, Camille van Buskirk, Andrew Badley, Jeff Winters, Jim Stubbs, Philippe Bauer, Jack OHoro, Rickey Carter, numerous fellows, and the clinic's institutional review board staff.

Nationally, the project is utilizing the expertise of participants from 20 institutions, a short list of the nation's research braintrust that includes Johns Hopkins, Washington University of St. Louis, Alfred Einstein University, Duke, the University of Pittsburgh, Michigan State, Stanford and the University of California system. "This thing has taken off like wildfire," Joyner said. "The scientific community has really rallied around Arturo's ideas, and see this as where we can help the fastest."

"What's been amazing is, we had this large conference call yesterday with people that are very well known, and a lot of those people have pretty healthy egos 'I discovered this or I did that.' We had none of that. Everybody is just trying to focus on what's in front of them. We've got people who are the top virologists and experts in transfusion medicine from across the country and all over the world involved. We have commercial partners who are excellent at collecting plasma at sites all over the county reaching out to us."

Even the world's online retailer is said to be chipping in, by building a website to centralize the initiative's internal and external communications. As of press time, Amazon had not responded to a request to clarify their participation. Currently the IRB committee at Johns Hopkins is studying a plan to test coronavirus plasma for preventive use, while Mayo is reviewing a treatment protocol for hospitalized patients who have yet to reach a severe state of sickness.

At the time of the call last week, Joyner had already participated in two nationwide group conference calls, had two more scheduled in the coming days, and was midway through a 20-hour workday. "I took my first call at 4:37 this morning from a colleague at Einstein in New York," he said before brushing aside the topic. "I'll be getting emails about this until midnight but I'm getting some rest. The people on the front lines are the clinicians the nurses, the first responders, the people in the ICU."

How does it feel to fight the worst outbreak in modern times with an old-fashioned method?

"Washing of hands is an old fashioned method too," he said.

As a public service, we've opened this article to everyone regardless of subscription status.

The CDC COVID-19 symptom checklist is here.

MDH COVID-19 hotline: (651) 201-3920. 2,300 calls yesterday

Business impacts hotline: (651) 297-1304 or (800) 657-3504.

School and childcare hotline: (651) 297-1304 or (800) 657-3504.

MDH COVID-19 website: Coronavirus Disease (COVID-19) website.

See original here:
'This thing has taken off like wildfire': Mayo races with high-powered alliance to produce plasma treatment for coronavirus - Duluth News Tribune

What Will Drive Bristol-Myers Squibbs $42 Billion Revenue In 2020? – Forbes

PHILADELPHIA, PA - OCTOBER 06: View of the Bristol-Meyers Squibb booth in the exhibit hall before ... [+] guests arrive at the Pennsylvania Conference for Women 2016 at Pennsylvania Convention Center on October 6, 2016 in Philadelphia, Pennsylvania. (Photo by Marla Aufmuth/Getty Images for Pennsylvania Conference for Women)

Bristol-Myers Squibbs (NYSE: BMY) revenue grew from $19.4 billion in 2016 to $26.1 billion in 2019, and it is estimated to top $42 billion in 2020. This growth will primarily be driven by its oncology drugs portfolio, which will likely get over a 2x boost in 2020, due to the impact of the Celgene acquisition. Bristol-Myers Squibbs oncology drugs segment is expected to be the single-biggest revenue driver with $27.7 billion in revenues (66% of total revenues), which is over 3x the size of Cardiovascular, Bristol-Myers Squibbs second largest business segment, in 2020. Oncology drugs, which includes blockbuster drugs Revlimid and Opdivo, among other drugs, will be the fastest-growing segment adding $19.2 billion over 2017-20 (90% of the $21.3 billion in incremental revenues). Cardiovascular, which includes Eliquis, will add about $4.1 billion over 2017-20 (19% of the $11.5 billion in incremental revenue), and immunology drugs will add $1.0 billion (5% of incremental revenues). This will likely be offset by an expected decline of $3.0 billion (-14% of incremental revenue) in all other drugs segment. In this analysis, BMY Revenues: How Does Bristol-Myers Squibb Make Money?, we focus on Bristol-Myers Squibbs business model, its revenue segments, their historical performance, forecast for 2021, and peer comparison, parts of which are highlighted below.

Bristol-Myers Squibb 2020 Revenues To Surge After Celgene Acquisition

Comparing BMS Sales Growth To Its Peers

BMS Has A Large Oncology Drugs Portfolio, Courtesy of Celgene

BMS Is Gaining Market Share In Cardiovascular Drugs Market

Immunology Portfolio Could See Biosimilar Competition In 2021

All Other Drugs Sales Will Continue To Decline

Impact of Coronavirus

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What Will Drive Bristol-Myers Squibbs $42 Billion Revenue In 2020? - Forbes