Category Archives: Neurology

EXTON, Pa., Jan. 27, 2022 /PRNewswire/ -- On January 11th, the Centers for Medicare and Medicaid Services (CMS)' proposed Medicare reimbursement of FDA-approved anti-amyloid monoclonal antibodies (mAbs) be limited to clinical trials under Coverage with Evidence Development (CED). Days later, Spherix surveyed 75 U.S. neurologists and Alzheimer's disease specialists (including five follow-up interviews) to evaluate their awareness of and opinions on this unprecedented event.

The resulting insights are part of a two-wave Special Topix: Impact of CMS Reimbursement Decision on Alzheimer's Disease Therapies service. The second wave will be fielded immediately following the publication of the final determination.

Key takeaways from the first wave of research include:

Indeed, according to an interviewed neurologist, "To pre-judge before the data is submitted on the other three products is unfair. I don't think that that's reasonable because one of them may show a significant clinical improvement."

One neurologist noted, "If Lilly had very strong data on clinical benefit [with donanemab], not just clearing of amyloid, and on the side effect profile, I hope that CMS would change its decision for that particular drug."

Positive cognitive and functional data with acceptable safety from at least one of the ongoing Phase III programs with anti-amyloid mAbs would positively impact neurologists' currently low willingness to participate in such trials.

As mentioned by one interviewed neurologist, "The FDA is very concerning. As you probably are aware, the advisory committee, which were all neurologists and memory disorder neurologists, almost unanimously recommended against it [Aduhelm's approval] and then the FDA went around and said yes, so you lose a lot of confidence right now. My confidence in CMS is much better, much improved. I think they did the right thing. I think this is necessary. Too expensive and too potentially harmful to just willy-nilly start using these medications. We need to know definitively that these are really beneficial."

While CMS' draft NCD decision is specific to anti-amyloid mAbs, the Special Topix report also captures insights on the potential impact that the proposal could have on emerging therapies for Alzheimer's disease with alternative mechanisms of action (i.e., non-amyloid-targeted).

About Special Topix

Special Topix: Impact of CMS Reimbursement Decision on Alzheimer's Disease Therapies (US)includes two waves of research, collecting feedback from U.S. neurologists and Alzheimer's disease specialists about their awareness of and opinions on CMS' draft and final National Coverage Determination (NCD) decision on FDA-approved mAbs targeting amyloid for the treatment of Alzheimer's disease. The waves of research will field immediately following the releases of the draft and final NCD decisions.

Therapies covered include:

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About Spherix Global Insights

Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

All company, brand or product names in this document are trademarks of their respective holders.

For more information, contact:

Virginia Schobel, Neurology Franchise Head

info@spherixglobalinsights.com

http://www.spherixglobalinsights.com

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Neurologists React to CMS' Proposed NCD Decision on Anti-Amyloid Monoclonal Antibodies for Alzheimer's Disease in the Latest from Spherix Global...

For a retrospective cohort study, researchers wanted to determine if there was a link between early decompressive surgery and the influence of transport time on traumatic spinal cord injury (tSCI) patients neurological outcomes. tSCI was a life-changing incident leaves a person permanently unable or unable to function. There was a lot of debate over when the best time is for surgical decompression in tSCI patients. The goal of the research was to compare the neurological results of tSCI patients who had early vs. late surgical decompression and the effect of transit time on neurological outcomes. A total of 84 patients with tSCI who required surgical decompression were studied. Time to decompression classification cutoffs was determined using regression analysis. The following subgroups of patients were identified: As a percentage of total or admitting hospital time to decompression, 0 to 12 or greater than 12 hours. It was discovered how the American Spinal Injury Association Impairment (AIS) Grade changed from admission to discharge. In addition, the influence of transport duration on AIS grade conversion was evaluated, with patients being divided into 2 groups: those who travelled for less than 6 hours and those who travelled for more than 6 hours. Confounding factors such as age, injury severity, and AIS grade had no significant differences (P>0.05) among the time to decompression subgroups. Patients who got decompression within 0 to 12 hours had considerably (P<0.0001) better average ASIA grade improvements (0.76). Patient transport periods of fewer than 6 hours were linked to a significantly larger conversion of AIS grade to less impaired states (P=0.004). According to the findings, decompression within 12 hours and short transport periods (<6 hours) are linked to significant improvements in neurological outcomes.

Link:journals.lww.com/spinejournal/Abstract/2022/01010/Early_Decompression_and_Short_Transport_Time_After.10.aspx

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Longer Decompression Time and Early Transport Time After Spinal Cord Injury Are Linked to Higher Impairment... - Physician's Weekly

Article In Brief

Neurology practices, hospitals, and academic institutions across the country are experiencing severe workflow disruptions as a result of hiring and recruitment challenges post-COVID-19.

Over the past 20 months, many sectors of the health care workforce have suffered extraordinary levels of stress and exhaustion due to the COVID-19 pandemic. This has resulted in massive departures of physicians, advanced practice providers (APPs), nurses1, technicians, medical assistants (MAs), research assistants, administrative assistants, and other employees.

According to a survey by Morning Consult, which polled 1,000 U.S. health care workers in early September, nearly one in five had quit their jobs during the pandemic, and one in five of those remaining had considered leaving. The exodus has placed downstream pressure on the remaining staff, who are often asked to bear an increased workload, creating a domino effect on the outflow of employees.

The causes for these departures are complex and multifactorial. They have been attributed to the effect of vaccine mandates on those unwilling to get vaccinated, illness related to COVID-19 or its sequelae, and severe burnout and other psychological consequences triggered by the pandemic. More broadly, COVID-19 has caused health care professionals to reevaluate what they find meaningful in life, to examine whether they feel sufficiently valued in their workplaces, and to consider alternative positions or even professions. Many ultimately end up leaving for higher pay and better opportunities.

As a result, neurology practices, hospitals, and academic institutions across the country are experiencing severe workflow disruptions. So ubiquitous is this crisis that one might ask who in our profession has not been impacted, rather than who has.

Neurology Today spoke to several neurologists and business administrators who provided examples of how the employment shortages have affected their departments and practices across the country.

Randolph W. Evans, MD, FAAN, a solo practitioner in Houston, who has practiced general neurology and headache medicine for the past 39 years was unable to find an MA after two left in April 2021. Prior to the pandemic, a listing in Indeed by his practice would have elicited a robust response of qualified assistants, but in April he received responses from 73 unqualified applicants, despite posting a two-year experience requirement. (Candidates included a canine coach, bus driver, waitress, sales associate, babysitter, school volunteer, housekeeper, security officer, music school coordinator, and a preschool teacher.)

Five people worked in the office for less than two weeks each and did not work out, said Dr. Evans, who tried to do the best he could by hiring nursing students who proved to be unreliable or left the position for better pay. Another new hire resigned due to the vaccine mandate and one person never showed up at all.

After I lost an MA due to illness and another due to a family relocation, it created big problems for me, but it was nothing compared to our regional hospitals, which have been very short-staffed and overwhelmed during waves of COVID over the last few months, he added.

Recruiting for nurses, APPs, and MAs is somewhat similar to the post-COVID housing marketa seller's marketwith owners receiving multiple offers that end up increasing the selling price, said Bryan Soronson, MPA, FACMPE, CRA, senior administrator in the department of neurology at the University of Maryland School of Medicine- in Baltimore, who has not previously witnessed such market forces in his 36 years of work in the department.

These job searchers are offered additional salary, benefits and other goodies, and usually take the highest offer.

Recently we had two vacancies for MAs; on two consecutive occasions, candidates accepted the position, gave notice, and two to three days before the start date contacted our clinic director stating that they decided to take another position that paid a higher salary, he said. We then went to a temporary agency that was supposed to send two new MAs but only one showed up, noting that the lack of consistent MA staffing is an ongoing challenge which is negatively impacting clinic operations and efficiency as well as patient satisfaction.

Many large medical systems are behind in providing competitive salaries and this is becoming an ongoing spiral, Soronson said. Once a market adjustment is made, other medical groups further increase their salaries, a treadmill that continues to be pushed faster.

There have been workplace shortages throughout the pandemic and our clinic and hospital, like many others, have been working very hard to cope, said neuromuscular specialist, Anne Louise Oaklander, MD, PhD, FAAN, director of the Massachusetts General Hospital Nerve Unit & Neuropathology Skin Biopsy Service in Boston, Massachusetts. But I hadn't expected to lose one of two histotechnologists in my neurodiagnostic skin biopsy lab with two weeks' notice, particularly with the workload becoming so heavy in 2021, explaining that the sudden resignation was a result of a hospital-wide vaccine mandate.

Clinical diagnostic labs still have specimens arriving even if the lab is short-staffed. My one remaining technologist has been working sometimes seven days a week and until midnight to try and catch up, Dr. Oaklander said. Clinical testing labs are disproportionately affected by loss of technologists as there isn't a pool of trained EEG, EMG, histotechnologists, and intra-operative monitoring techs looking for jobs..

Dr. Oaklander said the loss of their team members affected the remaining staff emotionally, herself included, because they worried about how departed staff members would support their families, given that mandated resignation makes employees ineligible for unemployment benefits.

We have not experienced this degree of personnel loss in any given year in my 14-year tenure, said Vinny Kaur, MPH, senior clinical department administrator in the department of Neurology at the Texas Tech University Health Sciences Center in El Paso. In Texas, no entity has allowed state-based institutions to mandate vaccines to date (although this may change on January 5) so we have not lost neurology personnel for this reason so far..

Kaur, who performed exit interviews on all departed staff, said, After a campus-wide restructuring in January 2021, a new centralized billing department lost more than half its billers and coders within ten months, including five of six neurology personnel.

One chose retirement, another with childcare issues decided to be a stay-at-home mother, and three changed their line of work and transferred to other departments. The clinic structure was also reorganized leading to the departures of a manager who decided to pursue an RN degree and a cashier and authorization personnel who left for jobs in the community. (MAs also left due to a variety of reasons.)

We used a combination of strategies to fill the positions, including utilizing interns and temporary agencies, outsourcing coding and billing, and turning to internal hires and promotions, said Kaur. But we experienced no shows for interviews and also ended up reopening positions for a long period of time, since we did not have a robust pool of candidates applying.

While staff had a multitude of other reasons for leaving, Kaur explained that the duration of unfilled positions has been compounded by a very lengthy hiring process at her institution.

The range of staff issues, which have impacted clinic operations, has included burnout due to overtime requirements, human error due to fatigue, and a pervasive inability to catch up with daily operations, she noted. In addition to permanent staff loss, the department of neurology has been struck by temporary staff losses due to FMLA [Family and Medical Leave Act] issues and illnesses, which has made this an extraordinarily challenging time. This unfortunately has hampered the provision of effective service to our patients.

The scientific community has been hard hit over the past year due to serial obstacles serving as impediments to research which could cripple science for some time to come. A perfect storm of adversities has ensued from the pandemic, including the loss of clinical coordinators and related personnel, supply chain shortages, and barriers to patient enrollment, including prolonged travel fears and telemedicine regulatory roadblocks.

Neuro-oncologist Maciej M. Mrugala, MD, PhD, MPH, FAAN, professor of medicine and director of the Comprehensive Neuro-Oncology Program at Mayo Clinic in Phoenix, has been witnessing difficulties with retention of research coordinators. It's hard to provide exact numbers, but we have been plagued by high turnover rate with departures from the clinical research core, he said.

He suspects that many left for better opportunities within the institution or elsewhere, with improved work schedule and/or pay. I think most feel overworked and underappreciated, he said. This is a high-stress work environment that calls for excellent navigation skills and an ability to multitask and meet tight deadlines.

The departures have impacted day-to-day operations with periodic halts in enrollment into trials due short staffing. This is concerning, particularly in my field, neuro-oncology, where clinical trials are a vital part of treatment strategy, and patients don't have time to wait as prognosis is poor and disease progresses rapidly, he explained. Situations like this can lead to potential problems providing appropriate follow up of study patients and may threaten protocol compliance and data integrity.

Dr. Mrugala pointed out that this is a nationwide problem. Clinical research specialists/coordinators are vital parts of the team and scientific progress can't be achieved without their involvement, he said. They must be recognized for their work and treated and compensated appropriately, so that their retention will improve.

To compound the dearth of research assistants, the pandemic has led to a loss of study patients who are averse to travel. Until now telemedicine filled the gap, said Bruce Cohen, MD, FAAN, director of the NeuroDevelopmental Science Center at Akron Children's Hospital in Ohio. But as states rescind the waiver for telemedicine licenses, it may no longer be legal for us to practice medicine across state lines without obtaining a license in that state, Dr. Cohen explained.

We went from a time prior to COVID-19 when patients got on a plane at the expense of a pharmaceutical sponsor to take part in a clinical trial to a pandemic when we learned how to conduct research safely by telehealth with the assistance of their local doctors, laboratories, and visiting nurses, he said. And although we have patients who are still reluctant to travel, state license waivers are being rescinded removing telemedicine as a viable alternative option.

Patients will be difficult to recruit for new trials if they continue to avoid getting on planes, he said, adding that this may slow development of new therapies for some time to come.

The worst-case scenario for patients currently enrolled in trials is that they will not be able to receive the drug/device and lose the opportunity entirely. To avoid that we are scurrying around trying to identify accredited visiting nurses in their communities who are research-qualified to assist us, Dr. Cohen said. Furthermore, if we are unable to complete trials, industry stands to lose years of work and millions of dollars of their investment, an especially dire situation for smaller pharma companies who may not be able to recover and for new treatments for serious illnesses.

Finally, supply chain shortage has impacted not only consumer household goods but laboratory supplies. Research labs across the country are running low on plastic lab materials such as gloves, pipette tips, reagents, centrifuge tubes and other essential items for which they are waiting longer and paying more. Several neuroscientists cited shortages in cryotubes, commonly used for cryogenic storage of biological materials using liquid nitrogen, including the preservation of serum, blood, and cells.

This six-month long shortage is impeding an NIH-sponsored multi-institutional trial at our institution, said Dr. Cohen. Two patients this week who wanted to participate in the trial were turned away due to shortages of these containers.

Justin T. Jordan, MD, MPH, who serves as clinical director of the MGH Pappas Center for Neuro-Oncology and director of the MGH Family Center for Neurofibromatosis (NF) in Boston, said that his current administrative assistant is pulled in more directions than ever, working with more physicians and doing additional non-secretarial work to support hospital and patient needs. Indeed, she is the fourth secretary he has had this past two years due to multiple departures.

During the pandemic, telemedicine opened a unique door to see NF patients during virtual visits, he said. But now that state license waivers have been rescinded, that door has been closed again.

This regulatory roadblock acutely affects people with rare diseases, who typically must travel a significant distance for care, he explained, having studied aggregate data on patient access to care reported by patients and specialty NF clinics between 2008 and 2015.

He found that geographic access to care is particularly limited for adults, patients with rarer conditions, and patients in the Western U.S.2

Dr. Jordan is currently applying for a license in New Hampshire so that he may continue to care for patients who reside there. The process has been laborious and disruptive and even with the available secretarial assistance he has, there were many things only he could do.

For example, I had to go out to get ink fingerprinted this week, he said. The administrative burden of completing an application for a new license is so high that it leaves me with little desire to accumulate licenses from other states, he said.

Neurology Today reached out to Paul B. Ginsburg, PhD, professor of health policy at the Sol Price School of Public Policy at the University of Southern California in Los Angeles, California, who also serves as vice chair of the Medicare Payment Advisory Commission, to understand what is happening to the labor market and to ask how long the current workforce departures may last.

Dr. Ginsburg, who has spent his career studying changes in the financing and delivery of health care and the evolution of health care markets is particularly intrigued by a behavioral economics explanation for the workforce resignations, particularly those in low-wage jobs.

It suggests that that the pandemic caused many employees, typically comfortable with the status quo, to look into alternative positions, he explained.

This gets reinforced when they see others changing jobs to get higher pay and possibly more satisfying work, he added.

People often have little information about employment alternatives, but the pandemic motivated them to look more, he said. The pandemic has also caused people to do serious rethinking about where they are in their lives, often triggering a move to make a change.

Dr. Ginsburg expects that as COVID-19 gets under control and the infection rates go down, some of the precipitants of departures will recede as people get used to a new status quo. A winding down of the pandemic will also allow more individuals to work; for example, when more children get vaccinated and schools are open more consistently, some parents will be able to return to work.

Medical facilities are responding to labor shortages by reducing services delivered and likely some will affect patient health, while others will not.

It is said that about a third of medical care does not produce value, so with pressure to do less due to workforce constraints, wasteful services may be abandoned, Dr. Ginsburg explained. Over time, this will lead to even faster consolidation in health care delivery.

Many economists believe that much of the economy-wide inflation is temporarycaused by large shifts in spending away from services towards goods.

People are already starting to shift back; they are rejoining gyms and acquiring less home exercise equipment, said Dr. Ginsburg.

But the higher wages that came from greater willingness of workers to look at alternatives will stay with usand this may be a good thing, he concluded.

Excerpt from:
The Great Resignation: The Workforce Exodus Hits Neurology... : Neurology Today - LWW Journals

BURNABY, British Columbia, Dec. 03, 2021 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced that it will provide updates on its proprietary, neurology programs at the Annual Meeting of the American Epilepsy Society (AES 2021).

Mr. Ian Mortimer, Xenons President and Chief Executive Officer stated, We continue to advance our portfolio of neurology-focused programs, and we have a number of scientific presentations scheduled at the AES 2021 meeting in Chicago. In addition, this year we are hosting a symposium focused on our XEN1101 program and the X-TOLE clinical trial results. We are also participating in a joint industry scientific exhibit related to rare genetically-defined epilepsies, with a particular focus on XEN496. We are grateful for the opportunity to meet with leading epileptologists, patient advocacy groups, and other key opinion leaders at this important meeting.

The following summarizes Xenons presentations at AES 2021 related to its proprietary, clinical stage programs as well as promising pre-clinical work:

Poster: Phase 2b Efficacy and Safety of XEN1101, a Novel Potassium Channel Modulator, in Adults with Focal Epilepsy (X-TOLE)

Poster: Electronic Seizure Diary Compliance in an Adult Focal Epilepsy Clinical Trial

Poster: XEN1101, a Differentiated Kv7 Potassium Channel Modulator, Impacts Depression and Anhedonia

Poster: Pathogenic and Likely Pathogenic Variants in KCNQ2 Underlie a Large Majority of Genetic Epilepsy in Neonates and Infants <6 Months of Age

Poster: Nav1.1 Selective Potentiators Normalize Inhibition/Excitation Imbalance and Prevent Seizures in a Mouse Model of Dravet Syndrome

On Sunday, December 5, 2021, Xenon is participating in a joint industry scientific exhibit related to rare genetically-defined epilepsies, and is presenting the following posters:

Conference Call InformationXenon will host a conference call and live webcast today at 9:00 am Eastern Time (6:00 am Pacific Time) to discuss the X-TOLE results presented at AES 2021. The webcast will be broadcast live on the Investors section of the Xenon website. To participate in the call, please dial (855) 779-9075, or (631) 485-4866 for international callers, and provide conference ID number 8639677.

About Xenon Pharmaceuticals Inc.

We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit http://www.xenon-pharma.com.

Safe Harbor StatementThis 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, and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN496, XEN1101, and other proprietary products; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101 and other proprietary product candidates; the anticipated timing of IND, or IND-equivalent, submissions and the initiation of future clinical trials for XEN496, XEN1101, and other proprietary products; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in XEN496, XEN1101, and other proprietary development programs; the timing and results of our interactions with regulators; anticipated enrollment in our clinical trials and the timing thereof; and the progress and potential of our other ongoing development programs. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators product candidates; promising results from pre-clinical development activities or early clinical trial results may not be replicated in later clinical trials; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; any of our or our collaborators product candidates, including XEN1101 and XEN496, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

Xenon and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.

Media/Investors Contact:Jodi RegtsXenon Pharmaceuticals Inc.Phone: 604.484.3353Email: investors@xenon-pharma.com

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Xenon Pharmaceuticals Provides Updates on Proprietary Neurology Pipeline Programs at the Annual Meeting of the American Epilepsy Society (AES 2021) -...

image:Katerina Akassoglou, senior investigator at Gladstone Institutes, is named a fellow of the National Academy of Inventors for her long track record of discovery and innovation. view more

Credit: Gladstone Institutes

Katerina Akassoglou, PhD, senior investigator at Gladstone Institutes, has been named a fellow of the National Academy of Inventors (NAI). Election to NAI is the highest professional distinction given solely to academic inventors.

This prestigious recognition is a testament to Akassoglous long track record of discovery and innovation. She has made seminal discoveries on the relationship between the brain, immune, and vascular systems. Her research has illuminated the toxic role of blood proteins in neurological diseases and has led to the development of therapeutics to treat these diseases.

Akassoglou holds 10 issued US patents and several pending patent applications, many of which have been licensed by biomedical companies. She co-founded the startup Therini Bio with technology spun out from her laboratory for the clinical development of these discoveries.

Katerina exemplifies Gladstones commitment to innovation, invention, and translational research that has the potential to benefit patients, says Gladstone President Deepak Srivastava, MD. We are incredibly proud that she has been recognized with this well-deserved honor.

Akassoglou was named an NAI Fellow for demonstrating a highly prolific spirit of innovation in creating or facilitating outstanding inventions that have made a tangible impact on the quality of life, economic development, and welfare of society.

I am truly honored to be elected to the National Academy of Inventors in recognition of our discoveries and grateful for the support of academic innovation, says Akassoglou, who is also director of the Center for Neurovascular Brain Immunology at Gladstone and UCSF, and professor of neurology at UC San Francisco. Election to the NAI further encourages us to pursue challenging problems in biology and medicine to develop urgently needed treatments for devastating human diseases.

Akassoglous research team discovered that blood proteins are toxic when they enter the brain in neurological diseases because they induce inflammation and inhibit repair. They showed that in neurodegenerative diseasesincluding multiple sclerosis and Alzheimers diseasethe blood-clotting protein fibrin leaks through the blood-brain barrier into the brain. There, it hijacks receptors on nervous system cells and can activate microglia (the brains resident immune cells), triggering inflammation and, eventually, nerve damage.

With this knowledge, Akassoglou invented an antibody to neutralize the toxic effects of blood in disease. This first-in-class immunotherapy targets fibrin and prevents it from activating immune cells, but doesnt impair its beneficial blood clotting function. In mouse models of Alzheimers disease, the antibody prevents neurodegeneration, even when administered after mice have already developed accumulations of amyloid proteins in the brain, a hallmark of disease. Similarly, in a mouse model of multiple sclerosis, the fibrin antibody prevented paralysis, nerve damage, and inflammation. Her lab also developed a fibrin therapeutics platform and, together with collaborators, discovered small molecule drugs to block the deleterious effects of fibrin on nervous system cells with potent protection from neurodegeneration.

Akassoglou is among 164distinguished academic inventors from 116universities and research institutes elected to the NAI this year. She becomes the second Gladstone researcher to be an NAI Fellow, with Senior Investigator Jennifer Doudna, PhD. An induction ceremony for newly elected NAI Fellows will be held at the organizations 11th annual meeting in June2022 in Phoenix, Arizona.

The program currently has 1,403Fellows worldwide representing more than 250 universities and research institutes. Collectively, fellows hold more than 42,700issued US patents, which the NAI estimates have generated more than $3trillion in revenue and created more than 1million jobs.

###

About the National Academy of Inventors

The National Academy of Inventors is a member organization comprising U.S. and international universities, and governmental and non-profit research institutes, with over 4,000 individual inventor members and Fellows spanning more than 250 institutions worldwide. It was founded in 2010 to recognize and encourage inventors with patents issued from the United States Patent and Trademark Office (USPTO), enhance the visibility of academic technology and innovation, encourage the disclosure of intellectual property, educate, and mentor innovative students, and translate the inventions of its members to benefit society. The NAI has a close partnership with the USPTO and is one of three honorific organizations, along with the National Medals and National Inventors Hall of Fame, working closely with the USPTO on many discovery and innovation support initiatives. The NAI publishes the multidisciplinary journal,Technology and Innovation.

About Gladstone Institutes

To ensure our work does the greatest good, Gladstone Institutes focuses on conditions with profound medical, economic, and social impactunsolved diseases. Gladstone is an independent, nonprofit life science research organization that uses visionary science and technology to overcome disease. It has an academic affiliation with the University of California, San Francisco.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Katerina Akassoglou elected to National Academy of Inventors - EurekAlert

Proprietary formulations include a range of liquids, capsules, powders, and controlled release tablets utilizing Avicannas self-emulsifying drug delivery systems (SEDDS) technology

The advanced formulations offer enhanced stability, bioavailability and controlled release of cannabinoids including (CBD, THC, CBG, CBN and THCv)

Avicanna intends to utilize the technology in its medical and pharmaceutical products and develop these formulations for treatment of neurological diseases and disorders

TORONTO, Dec. 06, 2021 (GLOBE NEWSWIRE) -- Avicanna Inc. (Avicanna or the Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing and commercialization of plant-derived cannabinoid-based pharmaceuticals is pleased to announce that it has filed a provisional patent application in the United States Patent and Trademark Office for a novel oral cannabinoid technology (the Formulation Candidates), which is intended to be commercialized globally for medical and pharmaceutical applications including treatment of various neurological diseases and disorders.

Oral administration of cannabinoids is the most convenient route for non-invasive drug delivery. However, due to the highly lipophilic nature and poor water-solubility of cannabinoids the elementary formulations currently available on the market generally have poor bioavailability and lack consistent drug delivery. Avicannas proprietary compositions have been specifically designed to alter the hydrophobic nature of cannabinoids, resulting in enhanced drug solubility which leads to better absorption and bioavailability either sublingually or orally, thereby increasing efficacy of cannabinoids.

Our novel formulations overcome the current limitations of cannabinoid finished products in the market today and offer enhanced absorption of varying cannabinoid profiles with controlled delivery. We expect this will yield better patient outcomes and clinical results, stated Dr. Frantz Le Devedec, Executive Vice President of Research and Product Development at Avicanna.

Story continues

The patent application entitled "Oral cannabinoid compositions and methods of treating neurological diseases and disorders" claims formulations that have been developed through Avicanna's R&D platform utilizing the companys proprietary self-emulsifying drug delivery systems (SEDDS) technology and include a range of drug delivery formats with varying release and absorption profiles including:

Sustained and controlled release tablets designed for linear release of the drug over time and thereby maximizing pharmacological properties and reducing side effects particular to cannabinoids.

Oral capsules c self-emulsifying cannabinoid technology designed to enhance absorption through a fast and effective dispersion mechanism.

Sublingual tablets designed to provide rapid absorption of cannabinoids through the sublingual membrane to reduce first pass metabolism and provide a solution for acute symptom management and

Water-soluble formulations nano-emulsion technology designed for instant dispersion and dissolution of cannabinoids which can be utilized for convenient titration in drug delivery and beverages.

This patent submission is another example of our drug delivery platforms used to develop industry leading products as we continue to innovate and lead the path with advanced, standardized and evidenced based cannabinoid solutions. We are optimistic about the potential of these formulations across several of our commercial and clinical platforms globally, stated Aras Azadian, Chief Executive Officer of Avicanna.

Avicanna intends to conduct further pre-clinical studies in the coming months in order to formalize this provisional application and will incorporate the technology into its clinical pipeline in 2022. If granted, this patent application will provide Avicanna with protection on the use of the Formulation Candidates for neurological diseases, alone or in combination with other therapies.

About Avicanna

Avicanna is a Canadian commercial-stage biopharmaceutical company established in cannabinoid research, development, and evidence-based products for the global consumer, as well as medical and pharmaceutical market segments. In leading global cannabinoid advancements, Avicanna conducts most of its research in Canada at its R&D headquarters in the Johnson & Johnson Innovation Centre, JLABS @ Toronto, located in the MaRS Discovery District. The company actively collaborates with leading Canadian academic and medical institutions. Avicanna has established an industry-leading scientific platform including advanced R&D and clinical development which has led to the commercialization of over twenty products across four main market segments:

Medical Cannabis & Wellness Products: Marketed under the RHO Phyto brand, or Magisterial Preparations, these medical and wellness products are an advanced line of pharmaceutical-grade cannabis products containing varying ratios of cannabidiol (CBD) and tetrahydrocannabinol (THC). The product portfolio contains a full formulary of products including oral, sublingual, topical, and transdermal deliveries that have controlled dosing, enhanced absorption and stability studies supported by pre-clinical data. The advanced formulary is marketed with consumer, patient and medical community education and training. Avicannas medical and wellness product portfolio also forms the foundation of the Companys pharmaceutical pipeline with the contribution of the formulations that form the basis of the products as well as the data generated from sales and participation of the products in real world evidence studies.

CBD Derma-Cosmetic Products: Marketed under the Pura H&W or Pura Earth brands, these registered, clinically tested, derma-cosmetic products include a portfolio of functional CBD topical products.

Pharmaceutical Pipeline: Leveraging Avicannas scientific platform, vertical integration, and real-world evidence, Avicanna has created a pipeline of patent-pending drug candidates which are indication-specific and in various stages of clinical development and commercialization. These cannabinoid-based drug candidates provide solutions for unmet medical needs in the areas of dermatology, chronic pain, and various neurological disorders. Avicannas first pharmaceutical preparation (Trunerox) is in the drug registration stage in South America.

Cannabis Raw Materials, Seeds, and Bulk Formulations: Marketed under the Aureus brand, the Companys raw material business has successfully completed sales to 11 countries. Aureus offers cannabis dried flower, standardized seeds, full spectrum extracts, and cannabinoid distillates, isolated cannabinoids (CBD, THC, cannabigerol (CBG) and other rare cannabinoids), and bulk formulations derived from hemp and cannabis cultivars through its sustainable, economical, and industrial-scale subsidiaries based in Colombia. The majority of the Aureus products are produced at Santa Marta Golden Hemp S.A.S. (SMGH), the Companys majority-owned subsidiary, which is also Good Agricultural and Collection Practices (GACP) certified and has United States Department of Agriculture (USDA) National Organic Program certification for its hemp cultivar.

SOURCE Avicanna Inc.

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For more information about Avicanna, visit http://www.avicanna.com, contact Ivana Maric by email at info@avicanna.com or follow us on social media on Linkedin, Twitter, Facebook or Instagram.

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Cautionary Note Regarding Forward-Looking Information and Statements

This news release contains "forward-looking information" within the meaning of applicable securities laws. Forward-looking information contained in this press release may be identified by the use of words such as, "may", "would", "could", "will", "likely", "expect", "anticipate", "believe", "intend", "plan", "forecast", "project", "estimate", "outlook" and other similar expressions and includes statements with respect to the Companys ability to generate data to support a final patent application, the Companys ability to conduct further research on the Formulation Candidate, the grant of any patent for the Formulation Candidate. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management in light of management's experience and perception of trends, current conditions and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment, the availability of licenses, approvals and permits, and the utility and application of certain drugs and products. Although the Company believes that the expectations and assumptions on which such forward looking information is based are reasonable, undue reliance should not be placed on the forward looking information because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to current and future market conditions, including the market price of the common shares of the Company, and the risk factors set out in the Company's annual information form dated September 3, 2021 and final short form prospectus dated November 27, 2020, filed with the Canadian securities regulators and available under the Company's profile on SEDAR at http://www.sedar.com. The statements in this press release are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

See more here:
Avicanna Files a Patent to Protect its Advanced Oral Cannabinoid Platform and its Applications for Neurological Diseases - Yahoo Finance