HOME ABOUT CONTACT AVAILABLE ISSUES SUBSCRIBE MEDIA & ADS CONFERENCE CALENDAR
LATEST UPDATES » Vol 21, No 05, May 2017 – Insights Into the Brain & microRNAs       » Omega-3 Therapy May Help Reverse Type 1 Diabetes       » The Potential of Saving Human Lives with Hibernation       » Scientists Unlock TCM Drug's Role in Weight Loss       » Medical Reforms in Beijing       » Fruits and Vegetables' Latest Superpower? Lowering Blood Pressure      
BIOBOARD - AUSTRALIA & THAILAND
Commencement of BIT225 Phase 2 HIV-1 Clinical Trial

Sydney, AUSTRALIA — The Directors of Biotron Limited are pleased to announce that the Company has commenced a Phase 2 human clinical trial (BIT225-009) with its lead antiviral drug BIT225.

The trial is a Phase 2, multi-centre, randomised, placebo-controlled, double-blind study of BIT225 and Combination Antiretroviral Therapy (cART): Atripla® in patients with Human Immunodeficiency Virus (HIV-1) infection. HIV-1-infected patients will not have previously been on anti-HIV-1 treatment (i.e. treatment naïve) and who will be commencing a cART regimen (approved anti-HIV-1 drugs). Patients will receive cART in addition to 12 weeks with BIT225 or placebo.

The trial includes a dose escalation, with an initial group of 9 patients receiving 100 mg BIT225 once daily, or placebo, together with cART. A second group of 27 patients will receive 200 mg BIT225 once daily, or placebo, together with cART.

At the conclusion of the trial, patients will remain on cART as per standard treatment protocols.

The trial will be undertaken at HIV-NAT, Thai Red Cross AIDS Research Centre in Bangkok, Thailand. HIV-NAT is affiliated with the Kirby Institute for Infection and Immunity in Society located at the University of New South Wales (UNSW), Sydney, Australia, and with the Amsterdam Institute for Global Health and Development in Amsterdam (AIGHD), The Netherlands. HIV-NAT is an internationally recognised research organisation and its core research areas include pharmacokinetics of HIV-1 therapy, co-infections with Hepatitis B, tuberculosis and HPV, new drug development and strategic studies.

An additional trial site is expected to commence recruitment shortly once appropriate ethics and regulatory approvals are in place at that second site.

The primary objectives of the study are to:

  • Determine the efficacy of 12 weeks of BIT2 25 treatment in HIV-1 infected subjects receiving cART: Atripla® by measuring plasma viral load decay and modelling HIV-1 decay.
  • Determine the safety and tolerability of BIT225 administered once daily for 12 weeks in HIV-1 infected subjects on cART: Atripla®.

The secondary objectives of this study are to:

  • Determine if 12 weeks of BIT225 treatment in addition to cART: At ripla® will impact levels of sCD163, a primary biomarker of monocyte immune activation.
  • Evaluate the pharmacokinetics of 100 mg BIT225 administered once daily for 12 weeks in combination with cART: Atripla® in subjects infected with HIV-1.

The Company is aiming to demonstrate:

  • Accelerated reduction of HIV-1 in patients treated with BIT225 in combination with cART, indicating that BIT225 can significantly improve current standard of care anti-HIV-1 treatment; and
  • Reduction in HIV-1-induced immune activation, indicating that BIT225 is targeting viral reservoirs not impacted by cART.

The commencement of the BIT225-009 clinical trial builds on the recent announcement by Biotron of successful results with BIT225 in a humanised mouse study of HIV-1 infection.

Biotron’s Managing Director, Dr. Michelle Miller said, “Initiating this clinical trial is an important step towards demonstrating the clinical benefit that BIT225 could bring to the treatment of HIV-1. BIT225 has the potential to play a key role in the eradication of HIV-1 by targeting and clearing HIV-1 from cellular reservoirs. We expect to see early results from the trial in late Q3 this year.”

Source: Biotron Ltd. & Monsoon Comms

Click here for the complete issue.

NEWS CRUNCH  
news Healthcare Sustainability in Asia: Now is the Time to Act — FT Asia Healthcare & Life Sciences Summit 2017
news Philip Morris International and British American Tobacco receive award from PETA science group for AOP developments
news 6th Asia-Pacific Breast Cancer Summit to take place in Hong Kong
PR NEWSWIRE  
Asia Pacific Biotech News
EDITORS' CHOICE  

Lady Ganga: Nilza'S Story
COLUMNS  
Subscribe to APBN E-Newsletter
Find us under 'Others' option to receive APBN e-newsletters thrice a month!

APBN Editorial Calendar 2017
January:
Healthcare Focus: LUNGS
February:
War on CANCER
March:
Get to Know TCM
April:
Diabetes: The Big Picture
May:
The Piece of Your Mind - Brain Health/Science
June:
Rare Diseases
July:
Food Science & Technology
August:
Eye Care/ Eye Health
September:
No. 1 Killer - Heart Diseases, Diagnosis and Treatment
October:
Skin Diseases/Allergic Reactions
November:
Diseases threatening our Children
December:
Liver Health & Treatment/Technology
Editorial calendar is subjected to changes.
– Editor: Carmen, Jia Wen Loh
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 Carmen
» For Subscriptions, Advertisements &
   Media Partnerships Enquiries:
   biotech_ad@wspc.com
Copyright© 2017 World Scientific Publishing Co Pte Ltd  •  Privacy Policy