Invion Limited (ASX: IVX) is pleased to announce that the US Food and Drug Administration (FDA) has removed the clinical hold on Invion’s phase II ‘smoking cessation’ clinical trial of INV102 (nadolol) in patients with pre-existing chronic obstructive pulmonary disease (COPD).
On 20 December 2013, Invion announced that the FDA had requested changes to the ‘smoking cessation’ clinical trial protocol that resulted in a halt to enrolment (clinical hold). Subsequent to Invion’s prompt and full response to FDA requests, the Division of Anesthesia, Analgesia and Addiction Products (DAAAP) accepted Invion’s amendments and has lifted the clinical hold.
While the changes were sufficient to require a re-launch of this study, Invion has expanded the number of sites to minimise the impact on timing and reporting. New sites have been selected for their expertise in smoking cessation, COPD, and analysis capabilities of biochemical markers of inflammation and healing.
Invion Chief Medical Officer, Dr Mitchell Glass said, “The FDA took the unusual step of changing our reviewing division to DAAAP after study initiation, which then placed us on clinical hold. Questions raised by the DAAAP were resolved by aligning titration criteria and dosing with our asthma study. These changes will enable sites to recruit and treat our targeted COPD patient population which is in dire need of successfully quitting smoking.”
About Invion Limited
Invion is a life sciences company focussed on the development of treatments for major opportunities in respiratory disease and autoimmune disease. The Group has three drug assets in development, and three phase II clinical trials, regulated by the Food & Drug Administration (FDA), currently underway in the United States. INV102 (nadolol) a beta blocker (beta adrenergic inverse agonist) currently used to treat high blood pressure and migraine, is being repurposed to treat chronic inflammatory airway diseases, including asthma and chronic obstructive pulmonary disease (COPD). INV104 (zafirlukast) is a leukotriene receptor antagonist (LTRA) or anti-leukotriene that reduces inflammation, constriction of the airways, and the build-up of mucus in the lungs. INV103 (ala-Cpn10) is a modified, naturally occurring human protein which has been proposed as a founding member of the Resolution Associated Molecular Pattern (RAMPs) family hypothesised to maintain and restore immune homeostasis. Invion is an ASX listed company (ASX:IVX), with operations in Brisbane, Australia and Delaware, USA.