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Escalating Doses of Nexvax2 Avoids Adverse Symptoms, Raises Patient Tolerance


Image: CC--NIAID

Celiac.com 01/04/2018 - Nexvax2 is a peptide-based, epitope-specific immunotherapy intended to reduce reactions to natural gluten exposure, and ultimately restore tolerance to gluten in patients with celiac disease.

Celiac disease patients who received fixed intradermal doses of Nexvax2 lost their sensitivity to the HLA-DQ2·5-restricted gluten epitopes in Nexvax2, but their tolerance was limited to 150 μg, due to gastrointestinal symptoms and cytokine release, mimicking gluten exposure, that accompany the first dose.

A team of researchers recently set out to test whether small doses in steps might reduce the first dose effect of Nexvax2 in celiac disease patients.

The research team included James M. Daveson, Hooi C. E, Jane M. Andrews, Timothy King, Kaela E. Goldstein, John L. Dzuris, James A. MacDougall; Leslie J. Williams, Anita Treohan, Michael P. Cooreman, and Robert P. Anderson.

They are variously associated with the Faculty of Medicine, University of Queensland, QLD, Australia b Department of Gastroenterology, Sir Charles Gairdner Hospital, WA, Australia; Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, SA, Australia; Department of Gastroenterology, Auckland City Hospital, Auckland, New Zealand; PROMETRIKA, LLC, Cambridge, MA, USA; and ImmusanT Inc., Cambridge, MA, USA.

The team conducted a randomized, double-blind, placebo-controlled trial at four community sites in Australia (3) and New Zealand (1) in HLA-DQ2·5 genotype positive adults with celiac disease who were on a gluten-free diet.

By using doses escalated from 3 μg up to 300 μg in HLA-DQ2·5 homozygotes or to 900 μg in HLADQ2.5 non-homozygotes the team was able to eliminate the adverse events and cytokine release that had limited the previous maximum dose to 150 μg.

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Administration of Nexvax2 at dose levels from 150 μg to 900 μg preceded by dose escalation was not associated with elevations in plasma cytokines at 4 h.

Otherwise, the most common treatment-related side effects in the Nexvax2 participants were headache (52%), diarrhea (48%), nausea (37%), abdominal pain (26%), and abdominal discomfort (19%).

This study shows that antigenic peptides recognized by CD4-positive T cells in an autoimmune disease can be safely administered to patients at high maintenance dose levels without immune activation when preceded by gradual dose escalation.

These findings help further these efforts to develop a successful immunotherapy drug to treat celiac disease.

Read more at Ebiomedicine.com

This completed trial is registered with ClinicalTrials. gov, number NCT02528799.

 

Celiac.com welcomes your comments below (registration is NOT required).












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2 Responses:

 
Laura
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said this on
08 Jan 2018 5:13:32 PM PST
Defense cells use "cytokines" to communicate with one another or with other body cells. They are needed as a defense against infected or cancerous cells. Cytokines are released by many cells of the immune system. Cytokines stimulate the growth and maturity of cells. This form of immunotherapy might prevent triggering a gluten response. Ask yourself; Is it worth the risk of developing a raging infection or cancer in order to once again consume wheat products? Wheat contains gluten and gliadin that are known to be the underlying cause of many inflammatory and endocrinological diseases. Is it worth the risk? Judge for yourself; Are these immunologists concerned more with cashing in on the almighty pharmaceutical drug dollars or you?

 
coloradosue
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said this on
11 Jan 2018 2:33:07 PM PST
I watched my younger spend the last 14 years of her life dying from lymphoma from undignosed celiac disease. I was diagnosed in 2004 with celiac disease. I just had another ER visit from ingesting gluten. This theraphy sounds promising but not enough to try it. I will continue being gluten free. Besides, there have been so much advancement in quality of gluten free products in just the past 10 years that I can't see changing back over to wheat products. Enough said!




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