CBIO LODGES PRE-IND MEETING REQUEST WITH U.S. FDA
BRISBANE: Australian drug development company CBio Limited (ASX:CBZ) has lodged a request with the U.S. Food and Drug Administration (FDA) for a pre-Investigational New Drug (pre-IND) meeting regarding the development of Cpn10 in Systemic Lupus Erythematosus (SLE or lupus).
A “type B” pre-IND meeting request has been made. It is anticipated that a face-to-face meeting will be held with the FDA in Q4 2012.
At the meeting, the company will put forth to the FDA its suggested pathway for the development of Cpn10 in lupus. It is expected that prior to the meeting, a number of requests will be made by the FDA to the company for clinical, chemistry and toxicology information. The company will submit the IND when all questions have been resolved, including an FDA-approved clinical trial protocol.
Chairman Dr Ralph Craven said this is the first step in the new clinical development plan for Cpn10.
“The Board’s review of Cpn10 supports the drug’s continued investigation, and lupus was identified as the most promising development target in terms of clinical need, regulatory path and competitive landscape. We are focussed on this strategy and the further development of Cpn10 as one of the assets of the company following the merger with Inverseon Inc.,” he said.
CBio announced on 2 July 2012 that it will, subject to shareholder approval, merge with US-based drug developer, Inverseon Inc. to create a clinical-stage company that targets new anti-inflammatory treatments for a range of diseases including asthma, chronic bronchitis, cystic fibrosis and lupus.
The proposed name for the post-merger company is Invion Limited. The proposed merger will be put to shareholders at a General Meeting to be held at 3pm, Thursday 30 August 2012, at the offices of McCullough Robertson Lawyers, Level 11, 66 Eagle Street, Brisbane.
For and on behalf of the Board