26th Feb 2008 07:00
VERONA PHARMA PLC ("Verona Pharma" or the "Company") Clinical trial planning underway for RPL554 as experimental inhalation toxicity studies near completion
The AIM-quoted drug discovery company, Verona Pharmao is preparing to obtain regulatory approval for clinical trials of RPL554, its potential ground-breaking treatment for allergic respiratory diseases including asthma and hay fever.
It has initiated preliminary advisory discussions with European regulatory authorities and is preparing the submissions that will be needed in support of the planned application.
The Company views RPL554 as a potential major step forward in the treatment of such respiratory ailments since it involves neither the administration of steroids nor beta agonists that are found in current treatments and which cause serious side effects such as anxiety and tremors in many patients. RPL554 is the invention of Sir David Jack, the former GlaxoSmithKline Research Director who pioneered many of the leading respiratory drugs.
Verona Pharma Chief Executive, Dr Michael Walker, said: "We are still waiting for the final toxicology analysis from our inhalation studies. However, results so far suggest that there are no major toxicity impediments to our plan to seek regulatory approval as early as possible."
As part of its regulatory submissions, Verona Pharma will apply to carry out a combined and contiguous Phase 1/ Phase IIa trial in healthy people with stable mild asthma as a means of establishing as rapidly as possible that RPL554 is both safe and effective in asthma sufferers.
For further information contact:
Professor Clive Page, Chairman, Verona Pharma plc: 07971 504931
David Youngman, WH Ireland Ltd: 0161 832 2174
Allan Piper, First City Financial Public Relations: 020 7242 2666
Background information follows:
About Verona Pharma plc (www.veronapharma.com )
Verona Pharma plc (AIM:VRP) is an AIM-quoted drug discovery company that is focused on finding new therapeutic drugs for the treatment of allergic rhinitis (hay fever) and other chronic respiratory diseases, such as asthma and chronic obstructive pulmonary disease (COPD), as well as chronic inflammatory diseases.
Globally, these diseases are costing an estimated US$20 billion per annum to treat, and while they are among the most prevalent diseases in the industrialised world, many of the available treatments have unwanted side effects, and/or limited effectiveness.
Verona Pharma was admitted to AIM in September 2006, and is run by two of the world experts in pharmacology and drug discovery. Dr Michael Walker is Emeritus Professor of Anesthesiology, Pharmacology and Therapeutics at the University of British Columbia, and a founder of other biotech, and biotech related companies. Chairman Dr Clive Page is a Professor of Pharmacology at King's College London, and an internationally-recognised authority in lung diseases and inflammation.
Verona Pharma's compound RPL554 is a long-acting bronchodilator/ anti-inflammatory drug (belonging to a class of drugs known as mixed phosphodiesterase (PDE) 3/4 inhibitors) that could be rapidly brought to clinical proof-of-concept for the treatment of hay fever and asthma.
RPL554 was invented by Sir David Jack, the former GlaxoSmithKline Research Director who pioneered many of the leading respiratory drugs already in use. As a PDE3/4 inhibitor, RPL554 targets the underlying cause of respiratory diseases by dilating the bronchial passages and blocking inflammation through a non-steroid or beta agonist receptor.
To complete the inhalation studies needed ahead of the planned application for clinical trials, Verona Pharma used LAB Research Inc of Hungary.
Verona Pharma is also seeking to develop an anti-tussive drug that works to suppress the generation of a cough signal at the nerve endings in the lungs. The Company's longer term focus is to develop novel polysaccharides (NAIPS) as potential anti-inflammatory drugs for the treatment of respiratory allergies, asthma and other inflammatory diseases.
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