BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Invion Announces Successful Pre-Ind Meeting on INV103 (Cpn10) for the Treatment of Lupus


12/17/2012 11:10:18 AM

17 December 2012 -- Clinical-stage drug development company Invion Limited (ASX:IVX) today announced that a pre-IND meeting with the Pulmonary, Allergy and Rheumatology Products Division of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) took place on 14 December 2012.

Invion requested the meeting with the FDA to seek guidance on the proposed clinical development path for INV103 (Cpn10) – a modified version of the naturally occurring human protein, chaperonin10.

Four representatives of the company led by CMO Dr Mitchell Glass met with 10 representatives of the CDER led by Director Badrul Chowdhury, MD PhD.

Final minutes of the meeting will be prepared by the Division, however a summary of the meeting is as follows:

? The FDA agreed to Invion’s proposed indication for INV103 (Cpn10) as a drug for the treatment of systemic lupus erythematosus (“SLE” or “lupus”) and confirmed that the clinical target of SLE is an important unmet medical need

? The FDA accepted Invion’s clinical strategy, subject to the review of the final clinical trial protocol which will be provided in the investigational new drug (IND) submission

? The FDA has accepted the company’s animal and human safety data to support dosing in a proof-of-concept study in subjects with SLE

Stocks of INV103 (Cpn10) have been transferred to Laureate Biopharmaceutical Services USA (Princeton, NJ) where they will be tested (qualified), formulated and filled for release to support a proof-of-concept clinical trial in lupus.

"Our meeting with the FDA represents an important step in our clinical development plan for INV103. Our strategy to bring this drug into human clinical trials for patients suffering from lupus is now clear, and we aim to submit an IND early in 2013. If granted this will be the second IND that Invion is working under to develop its assets," said Dr William Garner, Chief Executive Officer.

"INV103 is a fascinating protein. We believe the clinical, safety and biological data obtained to date demonstrate characteristics which warrant investigation of this drug as a therapy for lupus, and we are very pleased to have achieved clear FDA support for our plan as well as acceptance of our rationale for our strategies in chemistry, pharmacology, toxicology, and clinical development," said Dr Mitchell Glass, Chief Medical Officer.

About INV103 (Cpn10)

Chaperonin10 is a naturally occurring protein present in all cells. Chaperonin10 is thought to function as a natural regulator of the innate immune system: it is released locally by activated or damaged cells in response to “danger” signals, and down-regulates inflammatory immune responses. It is hypothesized that in disease states, levels of chaperonin10 may not be high enough to control inflammation; however, administration of pharmacological levels of chaperonin10 may overcome ongoing inflammatory signals and result in therapeutic benefit. INV103 (Cpn10) is a minimally modified version of this naturally occurring protein. Mirroring its endogenous counterpart, INV103 appears to work in a way which distinguishes it from current registered therapies for the treatment of inflammatory diseases, including rheumatoid arthritis and lupus. By down-regulating rather than ablating excessive inflammatory responses, INV103 (Cpn10) shows the potential to restore a balanced immune response.

About Invion Limited

Invion Limited is a clinical-stage drug development company that targets chronic inflammation. Focussed on the development of treatments for major market opportunities in inflammatory diseases including asthma, chronic bronchitis and lupus, Invion has two phase II proprietary therapeutic candidates: INV102 – a repurposed beta adrenergic inverse agonist; and INV103 (Cpn10) – a modified natural immunomodulator.

FOR MORE INFORMATION CONTACT:

Corporate

Dr William Garner

Managing Director and CEO

Invion Limited

investor@invion.com.au

Investor Relations

Rebecca Wilson

Buchan Consulting

03 9866 4722

rwilson@buchanwe.com.au

Media

Tom Donovan

Buchan Consulting

(03) 9866 4722

tdonovan@buchanwe.com.au



Read at BioSpace.com

 
 

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES