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Lenzilumab: Proven Effective COVID Treatment

According to a Dartmouth-Hitchcock press release, Dartmouth-Hitchcock Medical Center (DHMC) was one of 18 sites that conducted patient trials with lenzilumab and found this drug to be a safe, well-tolerated, and highly effective treatment against COVID-19.

Lenzilumab works by preventing and treating “cytokine storms,” an immune hyper-response, which is a life-threatening, systemic inflammatory response in the body triggered by the COVID-19 virus. Results of the trials showed that patients who received lenzilumab and other treatments (including steroids and/or remdesivir), had  greater relative likelihood of survival (54%), without the intervention of a ventilator. 

Humanigen, Inc., is the biopharmaceutical company that makes lenzilumab. The Food and Drug Administration (FDA) is soon expected to review lenzilumab for treatment of COVID-19.

Read full Dartmouth-Hitchcock News Release here

Read more LDA Articles on COVID here




Missouri Tick Study: Citizen Tick Submissions Requested

Photo by J. Occi, PhD (cand.), Rutgers Univ.

The Missouri Department of Conservation (MDC) and A.T. Still University are partnering on a Missouri tick study. This two-year research study is designed to better understand the distribution and species of ticks as well as the pathogens that they carry throughout Missouri. The study will run from April 2021 through September 2022.

During that time, MDC and the University are asking for citizens of Missouri to collect, save, and mail ticks that they encounter to A.T. Still University. To learn more about the research, submission directions, or to submit questions online visit atsu.edu/ticks.

Read full MDC news release here.

For additional LDA articles on tick and tick-borne disease studies/clinical trials visit here.

NOTE: The Lyme Disease Association, Inc.(LDA) thanks Lyme Association of Greater Kansas City (LAGKC) for this information. LAGKC is an affiliate partner of the LDA.  




Patients Win! Columbia Gets $16M to Establish Treatment Center/Trials Network

Dr. Brian Fallon
Brian Fallon, MD

A new center at Columbia University will open this summer to patients. The Cohen Center for Health & Recovery from Tick-Borne Diseases has been established through a $16M grant from the Steven & Alexandra Cohen Foundation to Columbia. Brian Fallon, MD, will be Center Director, Shannon Delaney, MD, co-director. Patients at the Center will be invited to enroll in clinical trials, brain imaging and neuropsychiatric studies. Physicians will be invited to annually submit treatment study ideas to the trials network for consideration.

Lyme Disease Association Pat Smith had this to say:  “This is the best possible news for patients who have been neglected for decades by much of the medical community. Often unable to get a timely diagnosis and appropriate treatment, many patients have gone on to develop chronic Lyme disease, facing debilitating manifestations, which have prevented them from working or going to school and even causing death.  Having a Treatment Center, a Clinical Trials Network, and a Research Center in one institution will certainly provide a three prong attack on a disease causing 476,000 people annually to be diagnosed and treated in the U.S.–Lyme disease–and allows for other tick-borne diseases to be addressed at the same time. ”

Dr. Fallon is also Director of the Columbia Lyme & Tick-Borne Diseases Research center, which was established in 2008 by the Lyme Disease Association Inc. and Time for Lyme (now GLA).

Thanks to the Cohen Foundation!   Congratulations to Drs. Fallon and Delaney!
 
 
 



Researchers! CDMRP Funding Opportunities for Fiscal Year 2021

The FY21 Tick-Borne Disease Research Program (TBDRP) Program Announcements managed by the Department of Defense (DOD) office of Congressionally Directed Medical Research Programs (CDMRP) are now posted to the grants.gov (search grants by CFDA Number 12.420) and on the CDMRP website.

FY21 funding opportunities include the following:

· Career Development Award

· Idea Development Award

Detailed descriptions of the funding opportunity, evaluation criteria, and submission requirements can be found in the Program Announcements. The Program Announcements are available electronically for downloading from the Grants.gov website, the CDMRP website and the electronic Biomedical Research Application Portal (eBRAP) 

Pre-Applications are due May 26, 2021 and invited Applications due August 27, 2021.

Click here to view the Synopsis of FY21 TBDRP Award Mechanisms

Click here to view the CDMRP TBD flyer with program highlights.

Additional information about applying to CDMRP programs, as well as tips for successfully preparing applications for different types of CDMRP award mechanisms, are available in the CDMRP webinar series

All CDMRP funding opportunities, both recently and previously released, are available on the CDMRP website

For further information, please send e-mail to:

NOTE from Lyme Disease Association: Please do not contact us for information. Contact the CDMRP TBDRP directly. Thank you!

 




Pfizer Gets Priority Review for Tick-Borne Encephalitis Vaccine

Pfizer has received priority review for their vaccine, TicoVac, which protects against tick-borne encephalitis. This tick-borne virus can cause meningitis and trigger long-term neurological symptoms in humans. If approved, the vaccine would potentially protect travelers and members of the United States military that are deployed to regions where the virus is common, such as Europe and parts of Asia.

TicoVac is an inactivated virus vaccine that has been highly effective at preventing tick-borne encephalitis throughout Europe for four decades. With this FDA fast-pass, it is hoped that a US approval would occur by August and would simplify the process for US military members to get the vaccine. 

Pfizer is also developing a vaccine for another tick-borne illness: Lyme disease.

Read full article here.

Read more LDA posts on vaccines here




Phase 2 Study for Lyme Disease Vaccine Candidate Begins

Valneva and Pfizer announced that they have initiated a Phase 2 study for their Lyme disease vaccine candidate. This is currently the only active Lyme disease vaccine in clinical development. 

This new study builds on previous studies, including new dose regimens as well as being the first clinical study to include children between the ages 5-17 years. Advancement to Phase 3 studies will depend on the outcome of this study.

Six serotypes prevalent in both North America and Europe will be covered by this vaccine and the vaccine targets one of the most dominant surface proteins expressed by Borrelia the pathogen when present in a tick, the outer surface protein A (OspA). 

Note: The Lyme Disease Association Inc. has not taken a position on this vaccine but presents current information so consumers take actions relating to any information presented or can make informed decisions on issues presented. 

Read the full article here.
Read articles on vaccines from LDA here.




COVID Pre-Exposure Prophylaxis for Pregnant Women

COVID pre-exposure prophylaxis for pregnant women is a critical issue as pregnant women are at higher risk for developing severe complications of COVID infections including preterm delivery, fetal demise, respiratory failure and maternal death. As pregnant women initially may not be eligible to receive COVID-19 vaccines due to the unknown effects on mother and fetus, these women urgently need an option for protection from COVID when vaccine candidates are not available to them. 

A peer-reviewed report, co-authored by Melissa C. Fesler and Raphael B. Stricker, has been published in the International Journal of General Medicine which evaluates pre-exposure prophylaxis (PrEP) with medications approved for use in pregnant women to prevent gestational problems and severe illness in this high-risk population. 

This report evaluates pre-exposure prophylaxis medications with findings that hydroxychloroquine (HCQ) may provide the safest most effective means to reduce effects of or prevent SARS-CoV-2 infection in pregnancy. 

Read 24/7 press release here.

Read published study: Fesler MC, Stricker RB. Pre-Exposure Prophylaxis for COVID-19 in Pregnant Women. Int J Gen Med. 2021;14:279-284  https://doi.org/10.2147/IJGM.S295627   

Read other COVID related LDA posts here.




LDA Announces Lyme Project Webinar: Bransfield & Pat Smith Discuss IDSA Guidelines

UPDATE 12.22.20: Bransfield & P. Smith on What’s the Scoop on IDSA Guidelines?

Dr. Robert Bransfield and LDA President Pat Smith spent two hours discussing all aspects of the new IDSA Lyme Guidelines from how they were developed, differences from prior guidelines and how they impact patients and treating physicians. The Zoom program was hosted by Project Lyme, a NYC non profit who will be posting the entire program on You Tube soon. 

  • In response to the question asked by moderator Noah Johnson to Pat Smith “How do these guidelines affect clinicians and practitioners?,” she responded  

Doctors who treat using ILADS guidelines are often investigated by medical boards and charged with malpractice.

  • Over decades, treating doctors have lost licenses, have been fined, been monitored, or have not been allowed to diagnose and treat Lyme disease.
  • Hospitals have threatened their privileges, insurers have threatened them from removal from plans if they treated long-term.
  • Doctors who practice under IDSA guidelines have reported doctors treating with antibiotics long-term to medical boards and testified against them in insurance cases.
  • Many of the treating physicians are no longer in any insurance plans, and some have spent hundreds of thousands of dollars to defend their right to treat Lyme patients long-term when they determine it is necessary.
  • In response to the question asked by moderator Noah Johnson to Dr. Bransfield “How do these guidelines compare to standards of care?,” he responded 

Standard of care is established by the physicians who actually treat the illness, not the physicians who dismiss the illness. The disclaimer is critical in pointing out guidelines assist, but do not dictate assessment, treatment.

More information on content of program to follow soon!

View entire Zoom program hosted by Project Lyme with Noah Johnson as moderator.

______________________________________________________________
Project Lyme Presents Webinar: Expert Opinions IDSA Guidelines with Special Guests Robert Bransfield, MD and Patricia Smith, President, Lyme Disease Association, Inc.
Date: Thursday, December 17, 2020
Time:  5:30pm – 7:00pm
Where:  Online

Free Online Registration

Project Lyme will host renowned psychiatrist Dr. Robert Bransfield, M.D. (Bio) and well-known advocate Patricia Smith, President of Lyme Disease Association, Inc. (Bio)

They will offer opinions on the restrictive and selective nature of the updated Infectious Disease Society of America’s guidelines for treating Lyme disease and discuss key insights such as IDSA’s refusal to acknowledge persistent infection, lax treatment protocols that ignore patient’s needs, as well as maintaining outdated definitions for Lyme presentations.

Noah Johnston, Administrative Director of Project Lyme will moderate the discussion and take live Q&A from the virtual crowd.

Click here for more articles concerning IDSA Guidelines

 

 

 




New Direct Detection Test for Lyme

A new direct test for Lyme disease was announced by Galaxy Diagnostics Inc., the Nanotrap® Urine Test for Lyme Borreliosis.  This is a urine-based Lyme antigen test, that Galaxy states “provides the most sensitive direct detection of Borrelia burgdorferi infection at all stages of the disease.” The test is easily administered through collection of urine; and identifies positive cases missed by CDC-recommended two-tiered testing, reducing concern for false positive results via direct detection of OspA proteins. 

Published data shows that the Nanotrap® Urine Test is very effective for confirmation of early stage Lyme borreliosis in patients with EM rashes. Galaxy states that their unpublished validation data shows that the Nanotrap® Urine Test often confirms active infection in patients with negative CDC recommended Two-Tiered Testing results.

Clinical utility of this test for other presentations of Lyme, including Lyme arthritis, Lyme carditis, and neuroborreliosis, needs further research.

This information is provided by LDA for informational purposes only. The LDA does not recommend or endorse this test but provides it for informational purposes only.  Contact your health care provider for medical advice. 

Galaxy Diagnostics News Release: November 10, 2020

Application of Nanotrap technology for high sensitivity measurement of urinary outer surface protein A carboxyl-terminus domain in early stage Lyme borreliosis

 




New Tick Repellent Ingredient Registered by EPA

Protecting children from biting insects with repellent.

On July 20, 2020, the Environmental Protection Agency (EPA) registered a new active ingredient called nootkatone, which repels and kill ticks, mosquitoes, and other pests including bed bugs, and fleas. The Center for Disease Control (CDC) discovered and developed the new ingredient, a non-toxic chemical found in Alaska yellow cedar trees and grapefruit skin in minute amounts. Nootkatone smells and tastes like grapefruit, and is used in the fragrance industry for perfumes and food industry for flavoring. It can be used on humans and pets.

Nootkatone apparently kills bugs differently than previous classes of insecticides, including pyrethroids, organophosphates, carbamates, and cyclodienes. Since it is a new chemical — the first insecticide approved in 11 years — it can kill bugs that are resistant to currently available pesticides. It lasts on skin and clothing for several hours.

CDC’s exclusively licensed partner, Evolva, and HHS Biomedical Advanced Research Development Authority were crucial to nootkatone development. Evolva can produce large amounts of nootkatone for low-cost, as it takes several tons of grapefruit to produce 2.2 lbs of nootkatone.

Dr. Brian Fallon, director of the Lyme and Tick-Borne Diseases Research Center at Columbia University in New York City, said of nootkatone, “I think it’s a major contribution to our arsenal of repellents.”(nbcnews.com)

Tick-borne diseases represent almost 80 percent of reported vector-borne disease cases in the U.S.  Reported cases of vector-borne diseases doubled from 2004 to 2018.  Companies interested to develop brand name products will be required to submit a registration package to EPA for review, and products could be available in stores as early as 2022.

Current ingredients registered by the EPA as skin-applied insect repellents include Catnip oil, Oil of citronella, DEET, IR 3535, p-Methane-3,8-diol (pmd), Oil of lemon eucalyptus, Picardin, 2-undecanone, and now nootkatone.

LDA’s Tick-Insect Repellents: Check the Facts
LDA’s TBD & Prevention Page

CDC Press release
CDC Digital Press Kit
NY Times:  Citrus Flavoring Is Weaponized Against Insect-Borne Diseases
Nbcnews.com: First new insect repellent approved in 11 years smells like grapefruit