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Researchers get to the roots of chronic stress and depression

A study in mice provides clues about the common molecular origins of chronic stress and depression. The discovery could inform new treatments for mood disorders.

Millions of years ago, our ancestors evolved the physiological responses needed to survive in the face of sudden threats from rivals and predators.

The release of hormones, including epinephrine (adrenaline), noradrenaline (norepinephrine), and the steroid hormone cortisol, trigger these “fight-or-flight” stress responses.

However, sustained or chronic stress that does not resolve when the immediate threat passes is a major risk factor for the development of mood disorders such as anxiety and depression.

Traumatic experiences, for example, in military combat, can also damage the body’s ability to regulate its stress responses, causing post-traumatic stress disorder.

People with these mood disorders have abnormally high and sustained stress hormone levels, which puts them at an increased risk of developing cardiovascular disease.

Researchers at the Karolinska Institutet in Stockholm, Sweden, suspected that a protein called p11 plays a pivotal role in damping down stress responses in healthy brains after an acute threat has passed.

Their previous research found that p11 enhances the effect of the hormone serotonin, which regulates mood and has a calming effect.

Unusually low levels of p11 have been found in the brains of people with depression and in individuals who died by suicide.

Mice with reduced p11 levels also show depression and anxiety-like behaviors. In addition, three different classes of antidepressants that are effective in humans increase levels of this protein in the animals’ brains.

Now the Karolinska researchers have discovered that reduced p11 levels in the brains of mice make the animals more sensitive to stressful experiences.

The scientists also demonstrated that the protein controls activity in two distinct stress signaling pathways in the brain. It reduces not only the release of cortisol via one pathway but also adrenaline and noradrenaline via the other.

“We know that an abnormal stress response can precipitate or worsen depression and cause anxiety disorder and cardiovascular disease,” says first author Vasco Sousa. “Therefore, it is important to find out whether the link between p11 deficiency and stress response that we see in mice can also be seen in patients.”

The study, which appears in the journal Molecular Psychiatry, was a collaboration between the Karolinska Institutet and researchers at VU University in Amsterdam, The Netherlands.

To investigate the role of p11 in stress responses, the scientists bred “knockout” mice that lack the gene that makes this protein.

They compared their behavior with normal mice using a variety of standard tests. These suggested that those without p11 experienced heightened stress and anxiety.

For example, in one test, mice pups were separated from their mothers for 3 hours a day. The researchers found that pups lacking p11 produced more high-pitched distress calls, known as ultrasonic vocalizations, compared with normal pups.

In another test of anxiety-like behavior, the team gave the adult mice a choice of spending time in a brightly lit area or a dark space. Mice that were deficient

Gossamer Bio Announces Topline Results for Phase 2 Trials of Oral GB001 in Asthma and Chronic Rhinosinusitis

– Primary endpoint of asthma worsening not met in LEDA Study, however consistent numeric reductions ranging from 32-35% observed across all three GB001 groups –

– Statistically significant improvements in key secondary endpoint of time to first asthma worsening of 28% and 30% observed for 20 mg and 60 mg doses of GB001, respectively; 23% improvement observed in 40 mg group –

– TITAN Study in chronic rhinosinusitis did not meet primary or secondary endpoints –

– Gossamer to hold webcast to discuss trial results at 8:00 am EDT –

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 topline results from its Phase 2b LEDA trial in patients with moderate-to-severe eosinophilic asthma and its Phase 2 TITAN trial in patients with chronic rhinosinusitis.

“While we did not achieve statistical significance on the primary endpoint in the LEDA Study, we are encouraged by the consistent results observed for all three doses of once-daily, oral GB001 therapy across the primary and secondary endpoints,” said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer. “We believe these data provide important information for designing a well-powered Phase 3 program for GB001 in severe asthma. We plan to engage in global regulatory discussions in order to inform our thinking around potential partnerships or strategic alternatives for this program.”

“The results of the robust LEDA Study are meaningful and help us to further understand the DP2 pathway in asthma,” said Bruce Levy, M.D., Chief, Division of Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School. “I believe GB001 as an oral treatment has the potential to serve the high unmet need of patients with uncontrolled severe asthma.”

LEDA Phase 2b Trial Design

The LEDA trial enrolled 480 patients with uncontrolled, moderate-to-severe eosinophilic asthma and assessed the effect of oral GB001 add-on therapy to standard of care over 24 weeks, comparing three dose groups of once-daily, oral GB001 (20 mg, n=120; 40 mg, n=118; and 60 mg, n=122) to placebo (n=120).

The primary endpoint, asthma worsening, included five components and was chosen for its sensitivity in detecting deterioration in clinical outcome measures known to be correlated with exacerbations. A patient was considered to have experienced asthma worsening if they met any of the five components by Week 24. This endpoint has previously been used in the context of steroid withdrawal studies, including a prior Phase 2 trial of GB001.

LEDA Primary and Secondary Endpoint Results

The primary endpoint of the trial was not met, though consistent and meaningful numeric reductions in the odds of asthma worsening as compared to placebo were observed across all GB001 groups: 33% (p=0.1425), 32% (p=0.1482), and 35% (p=0.1086), for the GB001 20 mg, 40 mg, and 60 mg groups, respectively. In addition, statistically significant improvements in the key secondary endpoint of time to first asthma worsening as compared to placebo

Regenerative Medicine Market | Increasing Prevalence of Chronic Diseases to Boost the Market Growth

The global regenerative medicine market size is poised to grow by USD 9.55 billion during 2020-2024, progressing at a CAGR of over 20% throughout the forecast period, according to the latest report by Technavio. The report offers an up-to-date analysis regarding the current market scenario, latest trends and drivers, and the overall market environment. The report also provides the market impact and new opportunities created due to the COVID-19 pandemic. Download a Free Sample of REPORT with COVID-19 Crisis and Recovery Analysis.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201009005293/en/

Technavio has announced its latest market research report titled Global Regenerative Medicine Market 2020-2024 (Graphic: Business Wire)

The increasing prevalence of various chronic diseases is one of the primary factors which will drive regenerative medicine market growth during the forecast period. The incidence of many musculoskeletal disorders and bone injuries such as arthritis, osteoporosis, and severe limb trauma injuries requiring hospitalization is also increasing. Regenerative medicine opens the possibility of overcoming previously untreatable diseases using new treatment methods like processed cells for reconstructing tissues. It has the unique capability of altering the fundamental mechanisms of disease and also helps in reducing healthcare costs by eliminating the need for long-term hospitalization or drug regimes. This is leading to the increased adoption of regenerative medicine for the treatment of chronic diseases.

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Report Highlights:

  • The major regenerative medicine market growth came from the cell and tissue-based segment. Cell therapy is used to administer living cells into an individual’s body to restore the functioning of the diseased or damaged body organ. This therapy uses somatic cells and stem cells, such as embryonic stem cells, progenitor cells, hematopoietic stem cells, and mesenchymal stem cells.

  • North America had the largest regenerative medicine market in 2019, and the region will offer several growth opportunities to market vendors during the forecast period. The increasing prevalence of chronic and acute diseases, the rapidly rising aging population, and high awareness about regenerative therapies will significantly influence regenerative medicine market growth in this region.

  • The global regenerative medicine market is fragmented. Allergan Plc, Amgen Inc., Hitachi Chemical Co. Ltd., Integra LifeSciences Holdings Corp., Medtronic Plc, MiMedx Group Inc., Organogenesis Holdings Inc., Smith & Nephew Plc, Takeda Pharmaceutical Co. Ltd., and Zimmer Biomet Holdings Inc. are some of the major market participants. To help clients improve their market position, this regenerative medicine market forecast report provides a detailed analysis of the market leaders.

  • As the business impact of COVID-19 spreads, the global regenerative medicine market 2020-2024 is expected to have Neutral and At par growth. As the pandemic spreads in some regions and plateaus in other regions, we revaluate the impact on businesses and update our report forecasts.

Buy 1 Technavio report and get the second for 50% off. Buy 2 Technavio reports and get the third for free.

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Increasing Number of Clinical Trials

Reflow Medical Receives Approval in Japan for the Wingman Catheter to Cross Chronic Total Occlusions (CTOs) in Peripheral Artery Disease

Reflow Medical, Inc., a California-based medical device company, announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved the Wingman™ CTO Catheter. Reflow Medical has partnered with Century Medical, Inc. (CMI), a leading medical device distributor based in Tokyo, to introduce the Wingman CTO Catheter in Japan.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201008005741/en/

Wingman CTO Catheter (Photo: Business Wire)

The Wingman Catheter crosses peripheral CTOs using an extendable beveled tip. The physician controls the advancement and activation of the tip to create a channel to help penetrate, or cross, the occlusion with a guidewire, enabling further treatment of the lesion with therapeutic devices. The catheter is compatible with the physician’s preferred guidewire and procedural technique.

Approval by Japan’s PMDA follows the completion of the Wing-IT CTO clinical trial, a prospective, international, multicenter study that treated 85 patients and followed them for 30 days. The Wingman Catheter was able to demonstrate a 90% crossing rate when up to two previous guidewires could not cross the CTOs, meeting its primary safety and efficacy endpoints.

“We are very excited to launch the Wingman CTO catheter in the Japanese market,” said CMI President and CEO Takahiko Motani. “This product should have a significant impact on the Japanese peripheral market by helping physicians address specific treatment challenges within a growing patient population. We look forward to providing this new and unique device in partnership with Reflow Medical, Inc.”

“Reflow Medical focuses their efforts on developing technologies based on physicians’ needs,” said John R. Laird, MD, of Adventist Heart and Vascular Institute in St. Helena, California. Dr. Laird was the principal investigator for the study. “We rely on Reflow for real clinical evidence when utilizing the technology.”

“It is an honor for our device to have gained approval by Japan’s PMDA,” noted Reflow Medical Co-founder and CEO Isa Rizk. “We are grateful for the opportunity to partner with a fantastic organization like Century Medical.”

Reflow’s Wingman Crossing Catheter received clearance from the U.S. Food and Drug Administration for the expanded CTO indication for the Wingman Crossing Catheter in March 2020 after completing the Wing-IT clinical trial.

About Reflow Medical, Inc.

Reflow Medical, Inc. is a private company focused on empowering physicians through the design and development of innovative and effective technologies for cardiovascular disease. Reflow is developing a family of products to treat cardiovascular disease.

About Century Medical, Inc.

Century Medical, Inc. (CMI) is one of the largest independent medical device distributors in Japan, with more than 40 years of experience marketing medical devices. CMI has been a pioneering force, successfully introducing many new technologies to the Japanese healthcare community. Century Medical, Inc, is a wholly owned subsidiary of ITOCHU Corporation.

About Chronic Total Occlusions (CTO) in Peripheral Artery Disease (PAD)

Chronic total occlusions (CTO) of the lower extremities are found in 40% of symptomatic peripheral artery disease (PAD) patients. Endovascular options for the treatment of a CTO can be complex; conventional wire and catheter technique have a

Knopp Biosciences NIH-Funded Pain Program Advances to Second Year of HEAL Award to Discover Non-Opioid Treatments for Chronic Pain

Knopp Biosciences LLC today announced that it entered the second year of research funded by the National Institutes of Health (NIH) to utilize its Kv7 platform to discover and develop non-opioid therapies for the treatment of chronic pain. The project is funded by the NIH program called Helping to End Addiction Long-term (the NIH HEAL Initiative), which aims to improve treatments for chronic pain, curb the rates of opioid use disorder and overdose, and achieve long-term recovery from opioid addiction.

Knopp has developed a discovery platform of proprietary molecules directed to a non-opioid biological target linked to chronic pain caused by damage to nerves. The drug target is a cellular membrane potassium channel called Kv7.2/7.3, which regulates the flow of electrically charged ions required to modulate the excitability of cells. Growing scientific evidence suggests that selectively activating key Kv7 channel subtypes can control nerve-cell hyperexcitability associated with chronic pain.

“Knopp is pleased that the achievement of year one milestones positioned the company to continue research on solutions for this public health crisis,” said Michael Bozik, M.D., Chief Executive Officer of Knopp. “In year two, we expect to identify a molecule from our Kv7 platform that is suitable for further development as a potential non-opioid treatment for patients suffering from certain types of chronic pain.”

The grant funding of as much as $8 million is contingent upon the attainment of milestones over five years. Knopp’s HEAL award was one of 375 grants made across 41 states in fiscal year 2019 to apply scientific solutions to help reverse the national opioid crisis.

Knopp’s Kv7 research is supported in part under Award Number U44NS093160 and Award Number U44NS115732 of the National Institute of Neurological Disorders and Stroke of the NIH. The content of this announcement is solely the responsibility of Knopp and does not necessarily represent the views of the NIH.

ABOUT KNOPP BIOSCIENCES LLC

Knopp Biosciences is a privately held drug discovery and development company focused on delivering breakthrough treatments for immunological and neurological diseases of high unmet need. Knopp’s clinical-stage oral small molecule, dexpramipexole, is in Phase 2 clinical trials in moderate-to-severe eosinophilic asthma. Knopp’s preclinical Kv7 platform is directed to small molecule treatments for developmental and epileptic encephalopathies, other rare epilepsies, neuropathic pain, and tinnitus. Please visit www.knoppbio.com.

ABOUT THE NIH HEAL INITIATIVE

The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, is an aggressive, trans-NIH effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. For more information, visit: https://heal.nih.gov.

This press release contains “forward-looking statements,” including statements relating to planned regulatory filings and clinical development programs. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including the uncertainties inherent in clinical trials and product development programs, the availability of funding to support continued research

Expert looks at how COVID-19 problems can turn into lifelong chronic diseases

Once a patient is finished fighting COVID-19, their battle might not be over, as some effects could linger and even be worse than the virus itself.

Long-haulers are starting to realize the long-term effects are no joke. The effects could stay with a person for months, years or possibly the rest of a person’s life.

A long-hauler and an expert who studies the new part of the coronavirus fight spoke with sister station KOCO about the lingering effects.

“It’s important to know COVID is not an all or nothing, you die or you’re fine. There’s a whole lot in the middle ground that could impact lives for a very long time,” said Eliza Chakravarty, with the Oklahoma Medical Research Foundation.


That’s what Brad Benefield, of Moore, Oklahoma, is now realizing.

“I feel like I have the energy to go do stuff and then, whenever I start, it’s like, ‘Oh no. You don’t have the energy,’” Benefield said.

He tested positive for COVID-19 in March.

“Started feeling a little tickle in my throat at night,” Benefield said. “Like, you have this virus and people are dying from it.”

He said symptoms and panic immediately set in. Benefield recovered from active COVID-19 months ago, but now he’s seeing something else and is becoming a coronavirus long-hauler.

Chakravarty said COVID-19 long-haulers can have lung issues, brain fog, shortness of breath, inflammation of the heart – all affecting younger, healthy people.

“Interspersed in a lot of cells where they’re inflamed so they’re not functioning properly, so the heart is not beating as well as it should,” she said. “People running 7 miles a day now are struggling going down the driveway, so it can really take you out from the knees.”

Chakravarty added that these problems can turn into lifelong chronic diseases.

“Just because you don’t die from COVID doesn’t mean that you’re OK,” she said. “There’s no telling what it’s done long term. It’s scary.”

The virus is too new to know for sure how many patients will become long-haulers, but OMRF officials said a study in Europe showed that 43% of COVID-19 patients had shortness of breath months after the virus ran its course.

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