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:
Dr William Garner
Managing Director and CEO
03 9866 4722
(03) 9866 4722