HOME ABOUT CONTACT AVAILABLE ISSUES SUBSCRIBE MEDIA & ADS
LATEST UPDATES » Vol 22, No 06, June 2018 – Cancer - Therapies and strategies for better patient outcomes       » Gardasil 9 supply running short in Hong Kong       » China helps Tajikistan tackle grassland degradation       » Immuno-oncology trials in China surge more than 50 per cent       » Yeast for industrial biotechnology       » Uncontrolled hypertension in rural communities      
INSIDE INDUSTRY
Knopp Biosciences and NIH to collaborate in evaluating dexpramipexole in patients with hypereosinophilic syndrome
Knopp Biosciences LLC has entered a collaboration agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to conduct a clinical trial of dexpramipexole in hypereosinophilic syndrome (HES).

Under the Cooperative Research and Development Agreement (CRADA), NIAID will sponsor the Phase 2 proof-of-concept trial, while Knopp will provide the dexpramipexole study drug and will collaborate on trial design and study oversight.

The 24-week, open-label clinical trial in HES subjects receiving corticosteroid therapy is expected to initiate enrollment in the first quarter of this year at the NIH Clinical Center in Bethesda, MD. The principal investigator is Amy Klion, M.D., immediate past president of the International Eosinophil Society and chief of the Eosinophil Pathology Unit of NIAID's Laboratory of Parasitic Diseases.

The principal objective of the trial is to evaluate the potential of dexpramipexole to reduce long-term and acute treatment with corticosteroids in people with HES while maintaining or reducing eosinophil count. Data presented at the July 2013 meeting of the International Eosinophilia Society in Oxford, England, demonstrated that dexpramipexole safely and persistently reduced blood eosinophil counts by approximately 70% (p < 0.0001) in people with amyotrophic lateral sclerosis (ALS) enrolled in a large Phase 3 trial (n=943).

Evidence from multiple preclinical and ALS clinical studies showing that dexpramipexole reduces blood eosinophils is the basis for the hypothesis that the drug may be a potential treatment for HES, for which off-label corticosteroid administration remains first-line treatment. HES is a collection of rare disorders characterized by excess levels of circulating eosinophils, a type of white blood cell, eventually leading to tissue damage in end organs. Dr. Klion will evaluate the primary endpoint of minimally effective corticosteroid dose reduction after treatment with dexpramipexole.

"Knopp is very pleased to collaborate with a researcher of Dr. Klion's experience and leadership in evaluating investigational treatments for HES," said Michael Bozik, M.D., president and CEO of Knopp. "HES is a very serious orphan disease with limited treatment options, and we expect this collaboration to provide an important assessment of the drug's potential for benefiting patients with this aggressive immunological disease."

In addition to assessing the potential of dexpramipexole as a corticosteroid-sparing treatment for HES, the planned Phase 2 study will examine drug effects on bone marrow eosinophils and myeloid precursors prior to steroid taper; changes in tissue eosinophils; and measures of eosinophil activation, cytokine/chemokine profile, and other immunologic parameters.

Study objectives also include evaluating the safety of 150 mg of dexpramipexole administered twice daily in HES patients currently treated with corticosteroids. The selection of dose and regimen is based on the safety and tolerability of dexpramipexole in earlier clinical studies of healthy volunteers and ALS subjects receiving 50 mg, 150 mg, and 300 mg total daily doses and in a healthy volunteer study of 600 mg total daily dose.

Source: Business Wire

Click here for the complete issue.

NEWS CRUNCH  
news Shire, Microsoft and EURORDIS form Global Commission to accelerate time to diagnosis for children with rare diseases
news EmTech Asia explores future of life, humanity and economy
news Biology of Ageing II - Impactful Interventions
PR NEWSWIRE  
Asia Pacific Biotech News
EDITORS' CHOICE  
COLUMNS  
Click here to receive APBN e-newsletters once a month!

APBN Editorial Calendar 2018
January:
Obesity / Outlook for 2018
February:
Searching for the fountain of youth
March:
Women in Science - Making a difference
April:
Digestive health in the 21st century - Trust your guts
May:
Dental health - The root to good health
June:
Cancer - Therapies and strategies for better patient outcomes
July:
Water management / Vaccination
August:
Regenerative medicine / Biotech start ups
September:
Digital healthcare / 3D printing
October:
Bones / Breast cancer
November:
Liver health / Top science research nations & institutions
December:
AIDS / Breakthrough of the year/Emerging trends
Editorial calendar is subjected to changes.
MAGAZINE TAGS
About Us
Events
Available issues
Editorial Board
Letters to Editor
Instructions to Authors
Advertise with Us
CONTACT
World Scientific Publishing Co. Pte. Ltd.
5 Toh Tuck Link, Singapore 596224
Tel: 65-6466-5775
Fax: 65-6467-7667
» For Editorial Enquiries:
   biotech_edit@wspc.com or Ms Lim Guan Yu
» For Subscriptions, Advertisements &
   Media Partnerships Enquiries:
   biotech_ad@wspc.com
Copyright© 2018 World Scientific Publishing Co Pte Ltd  •  Privacy Policy