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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.

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 in the development of these individuals.

SOURCE AFMR

Related Links

https://afmr.org/

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TLC Announces Acceptance of Manuscript on Anti-COVID-19 Program by Clinical and Translational Science Journal

Technology can be quickly translated and applied to other drugs for direct, extended release delivery to the lungs and is open for collaboration

SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Nov. 03, 2020 (GLOBE NEWSWIRE) — TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, today announced that the manuscript describing how inhalable liposomal hydroxychloroquine (TLC19) may provide clinical benefit and serve as a potential treatment for COVID-19 has been peer-reviewed and accepted by Clinical and Translational Science (CTS) journal. CTS highlights original research that helps bridge laboratory discoveries with the diagnosis and treatment of human disease and is an official journal of the American Society of Clinical Pharmacology and Therapeutics (ASCPT).

“We are honored to be sharing this peer-reviewed manuscript in an internationally acclaimed journal,” said George Yeh, President of TLC. “CTS has a collection of clinical pharmacology research from various potential treatments such as remdesivir, favipiravir, and lopinavir/ritonavir. Acknowledgment of our work by CTS further fortifies the soundness of our strategy of preferential delivery to the lungs. In these unprecedented times, we wish to do all that we can to help, and we openly welcome partnerships to re-formulate drugs with high potency against SARS-CoV-2 virus but low bioavailability utilizing our proprietary inhalable liposomal formulation in order to create more potential remedies to address this global pandemic.”

The accepted manuscript titled “A Strategy to Treat COVID-19 Disease with Targeted Delivery of Inhalable Liposomal Hydroxychloroquine: A Pre-clinical Pharmacokinetic Study” can be found on the ASCPT website using the following link: https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1111/cts.12923. The research, which was previously available as pre-print on bioRxiv.org, is a collaborative work by TLC in conjunction with key opinion leader in respiratory therapies – Dr. Huey-Dong Wu, Senior Pulmonologist at the Department of Integrated Diagnostics and Therapeutics at National Taiwan University Hospital – and the leading authority in infectious diseases – Dr. Yee-Chun Chen, Professor of Medicine at National Taiwan University Hospital and College of Medicine, Investigator of the National Institute of Infectious Diseases and Vaccinology, National Health Research Institutes of Taiwan, and Board Member and Vice President of the International Society for Human and Animal Mycology (ISHAM).

“There is an unmet medical need for a therapy that is accessible and affordable for everyone affected by the COVID-19 pandemic,” said Dr. Chen. “Altering the route of administration of hydroxychloroquine from oral to inhalation substantially increases exposure in the airways and lungs while decreasing exposure in the system, and a liposomal formulation allows sustained residence of the drug in the lungs. I am happy to see these principles reflected in the results of this preclinical study and look forward to seeing more encouraging data from the clinical trials.”

A Phase I randomized, vehicle-controlled, blinded study evaluating the safety, tolerability, and pharmacokinetics of inhaled TLC19 in healthy volunteers is ongoing.

About TLC19
TLC19 is a liposomal suspension of hydroxychloroquine (HCQ) for inhalation. HCQ has shown potential in prophylaxis and/or treatment for COVID-19 in in vitro and

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medicine

Emmes Employees Co-Author COVID-19 Vaccine Report for the New England Journal of Medicine

ROCKVILLE, Md., Nov. 2, 2020 /PRNewswire/ — Emmes today announced that it provided the data and statistical analysis support for a Phase 1 clinical trial of an investigational COVID-19 vaccine, mRNA-1273, that enrolled adult volunteers.   The results of this clinical trial were published in the New England Journal of Medicine (NEJM) on September 29.

Three Emmes employees were among the co-authors of the recent report, “Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults.”  The employees are Jim Albert, lead project manager; Dr. Mat Makowski, senior biostatistician; and Kaitlyn Cross, senior biostatistician.

In its role as the statistical and data collection and coordination center, Emmes managed development of the statistical analysis plan and performed all data analysis. 

The recent NEJM publication focused on the immune response to the vaccine and whether the vaccine produced any adverse effects in two groups of older adults (56 to 70 years or ≥ 71 years). An earlier report in NEJM described findings from a Phase 1 trial of the mRNA-1273 candidate vaccine in adults ages 18 to 55 years old.

According to Albert, “It’s an honor to contribute to a study targeted on finding a vaccine for COVID-19 and to participate in writing two articles published in the prestigious New England Journal of Medicine during the same year.”

He added, “The whole world is watching the results of this and other vaccine trials, as we move closer to finding safe, effective ways to address this devastating disease.”

The first part of the Phase 1 trial, which began in March, tested 45 adults, while the subsequent portion enrolled 40 older adults during April and May.  As described in the Preliminary Report published in NEJM in July, this was a dose-escalation, open-label trial to assess the safety of the mRNA-1273 vaccine and its ability to induce an immune response.  Both papers concluded that adverse effects were predominantly mild or moderate in severity.  The side effects, such as fatigue, chills and headache, were found to be dose-dependent and were more common after the second immunization. According to this Sept. 29 report, volunteers receiving the 100 mcg dose produced a stronger antibody response than the 25 mcg dose. This observation supported the use of the 100 mcg dose vaccine in a Phase 3 trial of the candidate.

The trial was conducted at Kaiser Permanente Washington Health Research Institute in Seattle, the Emory University School of Medicine in Atlanta and the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center in Bethesda, Maryland.  The vaccine was co-developed by researchers at the Vaccine Research Center, NIAID and at Moderna, Inc.  Moderna, Inc. manufactured and provided the vaccine candidate.

“COVID-19 is the latest in a long history of infectious disease research that Emmes has supported,” noted Dr. Christine Dingivan, Emmes president and chief executive officer.  “This includes H1N1 influenza, SARS, Ebola and Zika.  Our team has spent many long hours – nights and weekends – collecting and evaluating the statistical data,

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medicine

Data for Lilly’s bamlanivimab (LY-CoV555) in COVID-19 outpatients published in New England Journal of Medicine

INDIANAPOLIS, Oct. 28, 2020 /PRNewswire/ — The New England Journal of Medicine has published data from the monotherapy arms of BLAZE-1, a Phase 2 study assessing the efficacy and safety of Eli Lilly and Company’s (NYSE: LLY) bamlanivimab (LY-CoV555) – a neutralizing antibody – in the COVID-19 outpatient setting. This study focused on ambulatory COVID-19 patients being treated in the outpatient setting, whose symptoms did not require hospitalization at the time of enrollment. The publication, which can be found here, follows Lilly’s proof-of-concept data announcement for bamlanivimab as monotherapy in September 2020.

“The publication of these data in a peer-reviewed journal adds to the growing body of evidence for the potential utility for neutralizing antibodies as therapeutics for people recently diagnosed with mild to moderate COVID-19, particularly high-risk patients,” said Ajay Nirula, M.D., Ph.D., vice president of immunology at Lilly and co-first author of the study. “These data show bamlanivimab may be effective in treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in outpatients.”

“It is important to treat people with COVID-19 as soon as possible after diagnosis in order to forestall development of more severe disease,” said Peter Chen, M.D., director of Pulmonary and Critical Care Medicine at Cedars-Sinai and co-first author of the study. “Our findings indicate that neutralizing antibodies may have the potential to be useful in this early-stage intervention.”

These data were submitted as part of Lilly’s request for an emergency use authorization from the U.S. Food and Drug Administration for bamlanivimab in higher-risk patients who have been recently diagnosed with mild to moderate COVID-19.

About BLAZE-1

BLAZE-1 ( NCT04427501 ) is a randomized, double-blind, placebo-controlled Phase 2 study designed to assess the efficacy and safety of bamlanivimab alone or in combination with a second antibody for the treatment of symptomatic COVID-19 in the outpatient setting. To be eligible, patients were required to have mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than three days prior to drug infusion.

The monotherapy arms of the trial enrolled mild to moderate recently diagnosed COVID-19 patients, studying three doses of bamlanivimab (700 mg, 2800 mg, and 7000 mg) versus placebo.

The primary outcome measure for the completed arms of the BLAZE-1 trial was change from baseline to day 11 in SARS-CoV-2 viral load. Additional endpoints include the percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.

The study is ongoing with additional treatment arms. Across all treatment arms, the trial will enroll over 800 participants.

Data from the BLAZE-1 study show bamlanivimab may be effective in treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in patients recently diagnosed with mild to moderate COVID-19. In the BLAZE-1 trial, rates and types of adverse events were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity and with no drug-related serious adverse events reported thus

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