BRISBANE, 31 AUGUST 2012: Australian drug development company Invion Limited (ASX:CBZ) is pleased to advise that it has received a response from the US Food and Drug Administration (FDA) confirming the timing of its pre Investigational New Drug (pre-IND) meeting for initiating clinical trials of XToll as a treatment for systemic lupus (SLE). The meeting is scheduled to be held at the FDA offices in Silver Spring, Maryland on 14 December 2012. The FDA has assigned a pre-IND number for the application of 116156.
Chairman Dr Ralph Craven welcomed the response from the FDA. “We are delighted with this timely and positive response from the FDA. This significant step forward in the development of XToll has been made possible by the efforts and expertise of our new executive directors, Drs Mitchell Glass and William Garner. The entrepreneurial, clinical and regulatory expertise that William and Mitchell have brought to the table as part of the merger with Inverseon Inc is already delivering outcomes.”
Invion’s Executive Vice President of R&D and Chief Medical Officer Dr Mitchell Glass noted that Invion has a robust package of data to support testing the safety and efficacy of XToll in patients with systemic lupus, the vast majority of whom are inadequately treated by current therapies. “Following a successful pre-IND meeting, we anticipate initiating a phase II clinical trial in lupus in early 2013” said Dr Glass.
About Invion Limited
Invion Limited is a clinical-stage drug development company that targets inflammation. Invion exploits the patented use
of beta-2 adrenergic inverse agonism for the development of treatments for major market opportunities in inflammatory
conditions of the lungs such as asthma, chronic bronchitis and cystic fibrosis. INV102, also known as nadolol, has been used to treat more than 8 million people for high blood pressure, migraine and chest pain. Invion is now targeting INV102 for new indications. To date, two phase II clinical trials of INV102 have been completed which have demonstrated acceptable safety as well as dose-related activity showing a reduction of airway hyper-responsiveness. Two further phase II trials are due to commence in H2 2012. The larger of these two trials, a phase II $4.4 million study in asthma patients, is expected to be entirely funded by the US National Institutes of Health. Invion Limited is also progressing regulatory preparations to investigate its second compound Cpn10 to treat lupus and has requested a pre-
IND meeting with the US Food and Drug Administration (FDA) to discuss the proposed development path and regulatory strategy for this compound.
FOR MORE INFORMATION CONTACT:
Dr William Garner
Managing Director and CEO
03 9866 4722
(03) 9866 4722