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New HCV Therapy PYN17
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Start of US Phase II Clinical Trial for Lead product PYN17
Phynova Group plc (AIM: PYN), the developer of prescription pharmaceuticals derived from Chinese botanical medicines, today announced the commencement of a Phase IIa clinical trial with PYN17 in the United States.
PYN17 is Phynova's lead candidate for the relief of inflammation and other symptoms suffered by patients with chronic hepatitis C infection. It is based on a novel formulation of extracts of four plants which individually have been used to treat liver diseases in Asia and Europe. There are no treatments currently available to effectively manage the debilitating disease symptoms suffered during chronic hepatitis C infection such as fatigue, muscle aches, anorexia and abdominal pain.
The randomised, double-blind, placebo controlled study in five sites in the USA will evaluate safety and efficacy in 36 patients suffering with chronic hepatitis C, for whom approved treatments such as pegylated interferon and ribavirin have either failed or are not appropriate. Patients will be dosed over a period of a month and symptoms monitored using a recognized and well validated assortment of quality of life (QoL) scores and liver function tests to evaluate patient response and alleviation of disease symptoms. Preliminary safety and efficacy results will be available by the end of the year and are expected to confirm and extend promising observations already made with PYN17 in a physician sponsored (DDX) safety and efficacy study carried out in the UK.
Robert Miller, Managing Director of Phynova, commented: "This news represents the achievement of an important goal in the development of PYN17 and in the quest to find the first effective treatment for the debilitating symptoms suffered by chronic hepatitis C patients. Establishing clinical activities in the US, one of the world's largest prescription drug markets also represents a significant corporate milestone for Phynova."
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For further information, please contact:
Phynova Group PLC 07775 920 963
Robert Miller, Chief Executive Officer www.phynova.com
Nominated Adviser:
Nabarro Wells & Co. Limited 020 7710 7400
Marc Cramsie/John Wilkes
Broker:
J M Finn & Co. Limited 020 7628 9688
Sam Smith
Media enquiries:
Abchurch Communications 020 7398 7700
Peter Laing/Ashley Tapp/Stephanie Cuthbert
Stephanie.cuthbert@abchurch-group.com
www.abchurch-group.com
Notes to editors:
About Phynova
Phynova is a UK company developing prescription pharmaceuticals derived from Chinese botanical medicines. Phynova is focused on viral and metabolic diseases and cancer. Phynova's lead product for hepatitis C will enter Phase II trials in the first half of this year. Two further products, in fatty liver disease and post operative ileus are targeted for entry to the clinic in 2007 and there are a further four products in preclinical development.
About Hepatitis C and Phynova's clinical candidate PYN17
Hepatitis C is a liver disease caused by the hepatitis C virus ("HCV"). Hepatitis C is usually transmitted by injections of illicit drugs, or through exposure to contaminated blood or blood products. Symptoms include fatigue, abdominal discomfort or tenderness, muscle and joint pain, nausea and loss of appetite. Symptoms may persist in patients, even after viral clearance following interferon-ribavirin therapy. Chronic hepatitis C can result in cirrhosis of the liver, which can lead to liver failure and other serious complications, and liver cancer.
Hepatitis C affects over 200 million people world wide, including over four million people in the US. Currently available treatments with pegylated interferon and ribavirin are only effective in approximately 50% of patients treated, often with significant associated toxicity and side effects. The market for treatments for hepatitis C is estimated to be US$9 billion by 2010.
Phynova believes that PYN17 is the only drug in clinical development specifically designed to treat the debilitating symptoms of chronic hepatitis C. It is based on a novel formulation of four plant extracts that have a long history of safe and efficacious use in the treatment of liver ailments in Asia and the West.
29/05/2007
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