November 1, 2014     Japanese 
  JCN 
	  Network - Home
JCN Newswire
  Home  |  Companies  | Annual Reports  |  CSR  | News Alerts     
 
Share:
Takara Bio Submits IND Application for HIV-1 Gene Therapy to the FDA
 

Tokyo, Mar 23, 2012 (JCN) - Takara Bio and collaborator University of Pennsylvania have jointly submitted an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) dated March 17, 2012 in order to conduct a ribonuclease MazF based gene therapy phase I clinical trial for HIV-1 infection disease in the United States.

Takara Bio has been developing a novel retroviral technology for HIV-1 gene therapy, in which MazF, an endoribonuclease from Escherichia coli, confers resistance to a broad-spectrum of HIV-1 strains on CD4+ T cells.

The compnay has demonstrated that human T cells transduced with MazF can significantly inhibit the replication of HIV-1 in vitro without affecting cellular functions.

It has also demonstrated a promising result that MazF is similarly effective against multi-drug resistant HIV-1 clinical isolates in collaboration with Kagoshima University.

Furthermore, it has confirmed the safety of the MazF-transduced T cells in vivo animal experiments using macaques in collaboration with Tsukuba Primate Research Center of National Institute of Biomedical Innovation (Tsukuba, Japan).

Takara Bio entered into a collaboration research agreement with University of Pennsylvania on March 11, 2010 and has been pursuing an IND application with a group headed by Carl H. June, MD, Professor of Pathology and Laboratory Medicine at the University of Pennsylvania School of Medicine, and has now completed a series of preparations such as; preclinical translational studies, GMP manufacturing of MazF retroviral vector, GMP manufacturing of MazF-transduced CD4+ T cells, and has finally submitted the documents for the IND application.

After the IND review by the FDA, followed by protocol reviews by academic/additional regulatory committees including IRB, Takara Bio will initiate a phase I clinical trial in the U.S.. The study will be conducted by Dr. Jeffrey Jacobson, Professor of Medicine, Microbiology and Immunology, and Chief of the Division of Infectious Diseases and HIV Medicine at Drexel University College of Medicine.

By Chris Lui Staff Writer

Copyright © 2014 JCN. All rights reserved. A division of Japan Corporate News Network KK.


 Company Profile |   Print  |   Alerts
ACN Newswire

 Recent  Takara Bio  News  
  Takara Bio Submits IND Application to FDA for HF10 Anti-cancer Therapy  (May 12, 2014)
  Takara Bio Completes Enrollment for Phase I Clinical Trial in the US for HF10 Anti-Cancer Therapy  (Apr 10, 2014)
  Takara Bio to Distribute ZENOAQ's Cell Cryopreservation Medium in Japan, Europe, and North America  (July 26, 2013)
  Takara Bio launches Nippi's iMatrix-511 Worldwide  (July 12, 2013)
  Takara Bio Grants Cellular Dynamics a Commercial License to Use RetroNectin for iPSC Production  (June 24, 2013)
  Takara Bio Licenses Mushroom Production Technology to Sun Toward Tech  (June 13, 2013)
  Takara Bio Initiates Phase 1 HIV Gene Therapy Clinical Trial  (Jan 7, 2013)
  Takara Bio Submits IND Application for HIV-1 Gene Therapy to the FDA  (Mar 23, 2012)
  Takara Bio and Tianjin Medical University in Gene Therapy Project  (Aug 3, 2011)
  Takara Bio RetroNectin to UCLA for TCR-gene Therapy Clinical Trials in Advanced Melanoma  (Dec 18, 2008)



 Recent  Biotech News   
Otsuka's 'QuickNavi-Flu' Diagnostic Kit to Provide Additional Diagnosis-Related Information (Oct 14, 2014)
Nitto Denko Anti-fibrosis Drug Starts Phase-1b Dosing for Cirrhosis Patients in the US (Oct 10, 2014)
Mitsui to Participate in KIFMEC Specific Purpose Company (Aug 18, 2014)
Yokogawa Technology Selected for JSTA's Next-generation Technology Transfer Program (Aug 8, 2014)
Sysmex, Toppan Printing to Collaborate in Genetic Analysis Testing (June 9, 2014)
Takara Bio Submits IND Application to FDA for HF10 Anti-cancer Therapy (May 12, 2014)
Nitto Denko Anti-fibrosis Drug with Molecular Targeting DDS Completes Phase-1a Dose Escalation (Apr 24, 2014)
Kaneka, RIKEN Synthesize Bioplastic from Non-food Plant Resources
 (Apr 14, 2014)
Takara Bio Completes Enrollment for Phase I Clinical Trial in the US for HF10 Anti-Cancer Therapy (Apr 10, 2014)
Dainippon Sumitomo Pharma Establishes Anti-Cancer Drugs Sales Company in the U.S. (Oct 10, 2013)

More Biotech news...
 
CSR Report Download
Annual Reports

  More >>    
Most Popular


About JCN | Privacy Policy | Terms of Use | JCN Network (日本語)