Lobe Sciences Announces Launch of Preclinical Study in Collaboration with the University of Miami Miller School of Medicine

(MENAFN – Newsfile Corp) Lobe Sciences Announces Launch of Preclinical Study in Collaboration with the University of Miami Miller School of Medicine

Vancouver, British Columbia–(Newsfile Corp. – November 30, 2020) – Lobe Sciences Ltd. (CSE: LOBE) (OTC Pink: GTSIF) (” Lobe ” or the ” Company “) is pleased to announce the launch of preclinical research studies using psilocybin and N-Acetylcysteine (” NAC “) for the treatment of mild traumatic brain injury/concussion (” mTBI “) with post-traumatic stress disorder (” PTSD “). The study is in collaboration with a multidisciplinary team of scientists and physicians at the University of Miami Miller School of Medicine under the lead of Michael E. Hoffer, M.D., professor of otolaryngology and neurological surgery.

NAC has been shown to be safe and efficacious in a phase I human clinical study in treating military personnel who had suffered mTBI. The initial research focus is to demonstrate the safety and efficacy of the combination of psilocybin and NAC using broadly accepted rodent models. Final results are expected in 2021. Once this is established, more specific work can examine dose response, medicine uptake, and medicine levels. The research team at the Miller School of Medicine has conducted prior studies involving NAC with mTBI and has a license from the United States Drug Enforcement Administration to conduct research using Schedule I controlled substances, which includes psilocybin.

The Miller School of Medicine is an internationally recognized leader in medical research, ranked No. 39 among the top medical schools in the nation by Blue Ridge Institute for Medical Research. In 2019, the medical school submitted 1,968 research proposals and was awarded $149 million in research funding from the National Institutes of Health (NIH).

Advances in neuro-diagnostic assessment have revealed mild traumatic brain injury (concussion) is more common than previously thought and potentially associated with a host of negative health outcomes. The Centers for Disease Control (” CDC “) estimates that there are 3 million emergency room visits and over 230,000 hospitalizations due to TBI in any given year in the United States alone. Also, at the same time there are 5.3 million Americans living with the effects of mTBI (a 53% increase over ten years ago). The World Health Organization calls traumatic brain injury a “silent epidemic” that affects over 70 million individuals across the world. The United States Department of Defense estimates that over 345,000 individuals are affected by mTBI and that 20% of all service members who deploy suffer mTBI. mTBI and PTSD are significant health care issues that often co-occur and impact each other.

Dr. Hoffer, the principal investigator on the study, said, “This a very important extension of our work with NAC and other medicines to identify new treatments for mTBI and PTSD. We are hopeful that this new combination of psilocybin with NAC will lead us to better solutions for those suffering from mTBI and/or PTSD.”

Maghsoud Dariani, Chief Science Officer of Lobe said, “We are very excited to begin the preclinical studies in collaboration with Dr.

Read more

Ionis announces AstraZeneca’s initiation of the Phase 2b clinical study of its antisense medicine targeting PCSK9 to lower LDL-cholesterol

CARLSBAD, Calif., Nov. 30, 2020 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) today announced that the biopharmaceutical company AstraZeneca has initiated a Phase 2b clinical trial of ION449 (AZD8233), an investigational antisense medicine designed to reduce blood cholesterol levels in patients with dyslipidemia by targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), an important regulator of low-density lipoprotein cholesterol (LDL-C). PCSK9 is an enzyme that controls the number of LDL receptors on the surface of cells. People with genetic variations that reduce PCSK9 function have lower LDL-C levels in the blood and a lower risk for major cardiovascular events. ION449 is a LIgand Conjugated Antisense (LICA) medicine being developed by AstraZeneca as part of a collaboration between Ionis and AstraZeneca.


(PRNewsfoto/Ionis Pharmaceuticals, Inc.)

The Phase 2b, randomized, double-blind, placebo-controlled trial will enroll approximately 108 participants, aged 18-75, who have LDL-C levels between 70 and 190 mg/dL and are receiving moderate- or high-intensity statin therapy as defined by the American College of Cardiology/American Heart Association (ACC/AHA) guidelines on blood cholesterol management. The primary objective is to assess the effect of different doses of ION449 on LDL-C compared to placebo at Week 12 in patients taking baseline statin therapy.  The study will evaluate three dose levels of ION449 versus placebo, all administered once a month by subcutaneous injection. Safety and tolerability will be evaluated along with a number of secondary endpoints. Learn more about the trial at: https://clinicaltrials.gov/ct2/show/NCT04641299. 

In a Phase 1 study reported at the American Heart Association (AHA) Scientific Sessions on November 13, single subcutaneous doses of ION449 (AZD8233) demonstrated dose-dependent mean reductions in circulating plasma PCSK9 and LDL-C levels of >90 percent and up to 70 percent, respectively, in subjects who had a baseline LDL-C between 100 and 190 mg/dL without concomitant statin therapy.Doses up to 120 mg were evaluated. ION449 was observed to be safe and well-tolerated at all dose levels. 

“Results from the Phase 1 study showed that ION449 potently reduces PCSK9 and LDL cholesterol. ION449 demonstrated best-in-class potential for PCSK9 inhibition and LDL-C reduction, supporting larger clinical trials that are now underway to further evaluate efficacy and safety,” said Sotirios “Sam” Tsimikas, M.D., senior vice president, clinical development and cardiovascular franchise leader at Ionis. “The growing evidence supporting Ionis’ advanced LICA technology in cardiovascular disease holds promise for more effective approaches to lower LDL-C and to address cardiovascular disease, the leading cause of death worldwide.”

Dr. Tsimikas will provide an update on Ionis’ cardiovascular programs during Ionis’ Virtual Investor Day, Dec. 7, 2020, beginning at 12 p.m. EST.

Ionis earned a milestone payment of $20 million from AstraZeneca for the Phase 2b clinical trial initiation of ION449. Ionis and AstraZeneca are collaborating on potential treatments for kidney disease, cardiometabolic disease and cancer.

About Ionis Pharmaceuticals, Inc.

As the leader in RNA-targeted drug discovery and development, Ionis has created an efficient, broadly applicable, drug discovery platform called antisense technology that can treat diseases where no other therapeutic approaches have proven effective. Our drug

Read more

Study and Editorial on Cannabinoid Hyperemesis Syndrome (CHS) Published in The Journal of Investigative Medicine (JIM)

BEVERLY, Mass., Nov. 30, 2020 /PRNewswire/ — The December issue of The Journal of Investigative Medicine (JIM), the journal of the American Federation for Medical Research (AFMR), is publishing both a study and editorial on the important topic of Cannabinoid Hyperemesis Syndrome (CHS).

The research is entitled Cannabinoid Hyperemesis Syndrome: Definition, Pathophysiology, Clinical Spectrum, Insights into Acute and Long-Term Management.

The Study: Although cannabinoid hyperemesis syndrome (CHS) was first reported more than 15 years ago, it still remains an unfamiliar clinical entity among physicians worldwide. With the legalization of marijuana in many states, CHS will become an increasingly prevalent clinical entity, so educating about CHS is an important goal, particularly for emergency department physicians who generally first encounter these patients.

Authors: Mahesh Gajendran MD, Joshua Sifuentes, MD, Mohammad Bashashati, MD and Richard McCallum, MD of Texas Tech University Health Sciences Center, El Paso.

The editorial, Cannabinoid Hyperemesis Syndrome: The Conundrum Is Here to Stay, is authored by Ron Schey, MD, University of Florida Health, Jacksonville.

Other December highlights include:

  • Review: Advances in the management of atrial fibrillation with a special focus on nonpharmacological approaches to prevent thromboembolism: A review of current recommendations.
    Authors:Harsha S. Nagarajarao, MD, Richard McCallum, MD, Chandra Prakash Ojha, MD, Adriana Camila Mares, MD and Ahmed Ibrahim, MD of Texas Tech University Health Sciences Center El Paso; Malini Riddle, MD of Paul L. Foster School of Medicine, Texas Tech University Health Sciences Center El Paso; Timir Kumar Paul, MD of East Tennessee State University; Vineet Gupta, MD of University of California San Diego; David Alan Baran, MD of Sentara Healthcare; Bharat Ved Prakash, MD of Texas Tech University Health University Health Sciences Center El Paso, Transmountain Campus; Amogh Misra, MD of The University of Texas at Austin; Moeen Abedin, MD and Venkatachalam Mulukutla, MD of University Medical Center of El Paso; Archana Kedar, MD of University of Louisville School of Medicine.
  • Faculty Development & Education:Academic Collaborations with Industry — Lessons for the Future.
    Authors: S. Sethu K. Reddy, MD of Central Michigan University College of Medicine, Mount Pleasant; Shing Chao, MD of College of Medicine, Central Michigan University, Saginaw.

About the Journal of Investigative Medicine: The Journal of Investigative Medicine (JIM) is the official publication of the American Federation for Medical Research. The journal is peer-reviewed and publishes high-quality original articles and reviews in the areas of basic, clinical, and translational medical research.

About the American Federation for Medical Research: The American Federation for Medical Research (AFMR) is an international, multidisciplinary association of scientists engaged in all areas of biomedical and patient-oriented research — from the laboratory to translational to clinical. It works to foster the development of future generations of clinical scientists and investigators through its own initiatives, as well as encouraging public, private, and governmental investment

Read more

UChicago Medicine and UIC researchers to study expanded access to rapid COVID-19 testing

Researchers at the University of Chicago Medicine and the University of Illinois at Chicago (UIC) are launching an investigational study to determine the effects of increased education and access to rapid, FDA-approved COVID-19 testing on community perceptions, access, and use of COVID-19 testing resources.

The study will be funded by $2M in support from the National Institutes for Health RADx-UP program. A part of the Rapid Acceleration of Diagnostics (RADx) initiative, the RADx Underserved Populations (RADx-UP) program supports research that aims to better understand COVID-19 testing patterns among underserved and vulnerable populations; strengthen the data on disparities in infection rates, disease progression and outcomes; and develop strategies to reduce the disparities in COVID-19 testing.

The research will be led by Ayman Al-Hendy, MD, professor of obstetrics and gynecology at UChicago Medicine, and Renee Taylor, PhD, professor of occupational therapy and Nahed Ismail MD, PhD, D(ABMM), D(ABMLI), professor of pathology and medical director of clinical microbiology at the University of Illinois at Chicago. The investigators plan to leverage existing university-community partnerships and expertise in clinical microbiology, community engagement, and epidemiological infrastructures to expand access to rapid COVID-19 testing.

“There are testing deserts in Chicago, where many people don’t have easy or affordable access to testing,” said Taylor. “We can reach individuals who maybe don’t have health insurance or are concerned about having a COVID-19 test on their medical record and provide them with an easy and private opportunity to get tested.”

The project includes collaboration with community members to co-create advertisements to recruit other participants into the trial as well as a mobile health web app, called the mHealth Literacy and Outreach Suite, that will allow individuals to not only privately order testing, but also learn how to prevent the spread of COVID-19 and care for themselves if they fall ill.

Investigators are also sending out kits so participants can collect their own samples and send them to be tested at UIC. Sample collection can be performed rapidly at home with a nasal swab, without the discomfort of the typical nasopharyngeal swab, before sending the sample to the central lab for testing.

The team hopes that the privacy offered by these options, as well as the community advocacy, will help improve the public perception of receiving a COVID-19 test.

“Many people don’t trust the test, are concerned about the expense, or are worried that they’ll be forced out of work or forced to isolate if they have a positive test, which is creating a lot of stigma,” said Ismail. “We need to expand our testing in a community setting where people have some privacy, and the mHealth Suite provides that, as well as overcoming issues of cost.”

Al-Hendy credits the skills of the interdisciplinary team and their pooled community networks for making this collaborative effort possible. “The collaboration between UIC and UChicago Medicine will allow this project to reach many underserved populations,” he said. “Our two institutions already both have robust relationships within our local communities, which will help expand the

Read more

Another Study Finds COVID Usually Mild in Kids | Health News

By Robert Preidt, HealthDay Reporter

(HealthDay)

MONDAY, Nov. 23, 2020 (HealthDay News) — COVID-19 is mild is most children, a new study says, but certain children have a higher risk of severe illness.

Of more than 135,000 children tested for the new coronavirus (SARS-CoV-2) at seven children’s hospitals in the United States up to September, 4% were found to be infected.

Those most likely to test positive included children from ethnic minorities, teens, those with history of public insurance, and those with certain underlying medical conditions.

Similar risk factors were noted in the 6.7% of infected children who developed severe COVID-19 and were hospitalized with respiratory, cardiovascular or COVID-19-specific symptoms. Of those, 27.6% required intensive care and 9.2% required mechanical ventilation.

Eight of the children who tested positive died, a fatality rate of 0.15%. The risk of death was strongly associated with having numerous complex preexisting medical conditions.

Children with a progressive long-term medical condition were nearly six times more likely to develop severe illness, and the risk was 1.5 to three times higher among Black children, those younger than 1 and older than 12, and those with a history of public insurance.

The researchers also found that Black, Hispanic and Asian children were less likely to get tested, but were two to four times more likely to test positive than white children.

“While the overall risk is low in this group of children, we see significant disparities in those who are testing positive and developing severe disease, which follows what we see in adults,” said study author Hanieh Razzaghi, assistant director of the PEDSnet Data Coordinating Center at Children’s Hospital of Philadelphia.

PEDSnet is national pediatric health network that includes more than 7 million patients.

“Future studies need to evaluate to what extent the higher rate of positive test results reflects different testing strategies across patient groups, as well as different social determinants of risk, like exposure to air pollution and likelihood of family continuing to work at in-person essential jobs,” Razzaghi said in a hospital news release.

“Similarly, it is important to understand differences in the biology of infection that cause different rates of symptoms between patients, so we can best protect children at higher risk,” she added.

The study was published Nov. 23 in the journal JAMA Pediatrics.

SOURCE: Children’s Hospital of Philadelphia, news release, Nov. 23, 2020

Copyright © 2020 HealthDay. All rights reserved.

Source Article

Read more

‘Hidden’ Prostate Cancer on Biopsy Usually Means Good Outcome: Study | Health News

By Robert Preidt, HealthDay Reporter

(HealthDay)

MONDAY, Nov. 23, 2020 (HealthDay News) — Negative biopsies among early-stage prostate cancer patients who’ve chosen active surveillance are associated with a low risk of disease progression, but they aren’t a sign that their cancer has completely vanished, a new study indicates.

Active surveillance refers to close monitoring for signs of cancer progression — what’s often called “watchful waiting.” Patients sometimes get regular prostate-specific antigen (PSA) testing, prostate exams, imaging and repeat biopsies.

The objective of active surveillance is to avoid or delay treatment and its side effects without putting patients at risk of cancer progression and death.

Sometimes, active surveillance patients have negative biopsies that show no evidence of prostate cancer. While some of these patients may believe that their cancer has “vanished,” they most likely have low-volume or limited, hidden areas of prostate cancer that weren’t detected in the biopsy sample, according to the authors of the study published recently in The Journal of Urology.

“While a negative biopsy is good news, the long-term implications associated with such ‘hidden’ cancers remain unclear,” said study author Dr. Carissa Chu, from the University of California, San Francisco.

For the study, Chu and colleagues analyzed data from 514 men undergoing active surveillance for early-stage prostate cancer between 2000 and 2019. All of them had at least three surveillance biopsies after their initial prostate cancer diagnosis. Median follow-up time was nearly 10 years.

Of those patients, 37% had at least one negative biopsy, including 15% with consecutive negative biopsies, according to the report.

Men with negative biopsies had more favorable disease characteristics, including low PSA density and fewer samples with cancer at the initial prostate biopsy. Negative biopsies were also associated with good long-term outcomes, the researchers said.

After 10 years, rates of survival with no need for prostate cancer treatment (such as surgery or radiation) were 84% for men with consecutive negative biopsies, 74% for those with one negative biopsy and 66% for those with no negative biopsies.

After adjusting for other factors, the researchers concluded that men with one or more negative biopsies were much less likely to have cancer detected on a later biopsy.

“For men undergoing active surveillance, negative biopsies indicate low-volume disease and lower rates of disease progression,” Chu said in a journal news release. “These ‘hidden’ cancers have excellent long-term outcomes and remain ideal for continued active surveillance.”

SOURCE: The Journal of Urology, news release, Nov. 17, 2020

Copyright © 2020 HealthDay. All rights reserved.

Source Article

Read more

Over-45s at greater risk of STIs, new study finds

Middle-aged adults face a greater risk of catching sexually transmitted infections than ever before — because society is unwilling to talk about older people having sex, a new study has found.



a hand holding a baby on a bed: Social stigma was a key barrier to sexual health in the over-45s, researchers said.


© Shutterstock
Social stigma was a key barrier to sexual health in the over-45s, researchers said.

Negative attitudes toward sexual health and limited knowledge of the needs of over-45s mean some older people are unaware of the dangers of unprotected sex, researchers from the UK, Belgium and the Netherlands have warned.

Experts associated with the SHIFT sexual health initiative surveyed 800 adults across the south coast of England and northern regions of Belgium and the Netherlands — with some 200 respondents identified as facing socioeconomic disadvantage.

Almost 80% of respondents in the general population group were aged between 45 and 65, while 58% of those considered socioeconomically disadvantaged were aged 45-54.

Researchers said “major changes” in sexual behavior in recent decades have seen rising numbers of sexually active older people — but many barely consider the possibility of STIs.

The most cited reason for not using contraception was that participants deemed themselves to be monogamous, exclusive to one relationship, experts said, followed by participants believing they were not at risk of pregnancy.

“Over-45s at most risk are generally those entering new relationships after a period of monogamy, often post-menopause, when pregnancy is no longer a consideration, but give little thought to STIs,” Ian Tyndall, senior lecturer at Britain’s University of Chichester, one of the project’s partner organizations, said in a statement.

Researchers found that more than 50% of respondents in both the general population and in the socioeconomically disadvantaged group had never been tested for a sexually transmitted infection.

Video: When can I get vaccinated? (CNN)

When can I get vaccinated?

UP NEXT

UP NEXT

Stigma and shame were identified as the greatest barriers to adults accessing sexual healthcare services, with many participants indicating that they felt that sexual health was a “dirty” term, discouraging people from seeking regular health checks.

“A big barrier to people accessing services is societal stigma, and assumptions that older people are asexual and that sex is no longer part of their lives. This really limits the awareness of sexual health services among this group,” Tess Hartland, research assistant with the SHIFT project, told CNN.

A “significant number” of survey respondents were also unaware of the risks of sexually transmitted infections, researchers said, while 42% of general respondents in the UK and the Netherlands did not know where their nearest sexual health service was located.

“A lot of services and sexual health promotion is really tailored towards young people,” Hartland told CNN, noting that some people in the over-45 age category may have received limited sexual health education at school, affecting their attitudes today.

Participants also reported that their healthcare professionals, such as doctors and nurses, lacked appropriate sexual health knowledge.

“A lot of respondents preferred to go to their GP or their doctor rather than a specific sexual health service,” Hartland

Read more

Rise in nighttime blood pressure increases heart disease risk, study finds

Nov. 2 (UPI) — People who have high blood pressure at night are at increased risk for heart disease, even if their blood pressure is within normal ranges during the day, according to a study published Monday by the journal Circulation.

A nighttime systolic blood pressure — the “top” number — that is 20 millimeters of mercury — or mm. Hg, the unit of measure for blood pressure — above daytime readings raises a person’s risk for heart disease by 18%, the data showed.

That same rise in nighttime blood pressure also increases a person’s risk for heart failure by 25%, the researchers said.

“Nighttime blood pressure is increasingly being recognized as a predictor of cardiovascular risk,” study co-author Dr. Kazuomi Kario said in a statement.

“This study provides much more in-depth information about the cardiovascular risk associated with high nighttime blood pressure,” said Kario, a professor of cardiovascular medicine at Jichi Medical University in Japan.

Nearly half of all adults in the United States — or 108 million people — have high blood pressure, the Centers for Disease Control and Prevention estimates.

Research suggests that up to 40% of people experience rises in systolic blood pressure at night, whether or not their blood pressure is considered normal or healthy — between 90 mm. Hg and 120 mm. Hg — during the day.

For this study, researchers measured daytime and nighttime systolic blood pressure in 6,359 adults from across Japan between 2009 and 2017, using an at-home, wearable, ambulatory monitor.

Blood pressure was recorded during daily activities and sleep for at least 24-hours at a time, and device data were periodically downloaded at a healthcare clinic, the researchers said.

Nearly half of the study participants were male, and more than half were aged 65 years and older, according to the researchers.

All of the study participants had at least one risk factor for heart disease — although none had been diagnosed with it — and 75% of them were taking blood pressure medications when the study began, the researchers said.

The study participants were instructed to rest or sleep during nighttime hours and maintain their usual daytime activities, and they recorded their daily activities and sleep and wake times in a diary.

Nearly every participant recorded 20 daytime and seven nighttime automated blood pressure measurements.

By the end of the study period, participants experienced a total of 306 cardiovascular events, including 119 strokes, 99 diagnoses of coronary artery disease and 88 diagnoses of heart failure.

Those with a disrupted circadian blood pressure rhythm — or higher blood pressure at night than during the day — had a 48% higher risk for heart disease and were nearly three times as likely to experience heart failure, the data showed.

Circadian rhythms are the body’s natural, internal process that regulates a person’s sleep-wake cycle and repeats with each rotation of the Earth, or roughly every 24 hours, according to the American Heart Association.

Blood pressure typically fluctuates with a pattern that follows the

Read more

A Rapid Virus Test Falters in People Without Symptoms, Study Finds

Mr. Bryant, of Quidel, who received an early copy of the University of Arizona study, praised the results as “very, very good,” citing the Sofia’s ability to root out “people who are infectious.”

Quidel, which is running several studies of its own, does not yet have definitive results that show the Sofia works in people without Covid-19 symptoms. But “based on the data so far, it seems to be applicable to that population,” Mr. Bryant said of his company’s results.

Other experts advised caution.

Although C.T. values do tend to increase as virus levels diminish, exceptions to this trend exist — and there is no universal “magic-number cutoff” for infectiousness, Dr. Dien Bard said.

Failing to grow the coronavirus out of a person’s sample also does not guarantee that individual is not contagious to others, said Omai Garner, the associate director of clinical microbiology in the UCLA Health System, who was not involved in the study.

Several experts noted that the University of Arizona study did not track transmission among its participants, making it impossible to draw conclusions about how, and from whom, the virus spread.

Dr. Harris said that some of the concerns about the Sofia’s accuracy could be overcome with repeat testing. Screened frequently enough with a rapid test, infected people missed by one Sofia would probably be detected with the next, especially if the levels of virus in their bodies were rising, Dr. Harris said. He and his colleagues are now gathering data on University of Arizona athletes, who are tested daily, to investigate this possibility. Quidel has also partnered with the Pac-12 and Big Ten Conferences to conduct daily tests.

People with symptoms or known exposures to the coronavirus should still get the most precise and reliable tests available — those that use P.C.R., said Susan Butler-Wu, a clinical microbiologist at the University of Southern California who was not involved in the study. More data, she added, would be needed to figure out how rapid tests fit into the larger diagnostic landscape.

Source Article

Read more