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Phynova announces completion of patient enrollment for Phase I/II clinical trial of PYN17 in chronic hepatitis C
Phynova Group plc
("Phynova")
Phynova announces completion of patient enrollment for
Phase I/II clinical trial of PYN17 in chronic hepatitis C
Phynova Group plc (AIM: PYN), the developer of prescription pharmaceuticals derived from Chinese botanical medicines, today announces that it has completed patient enrollment for its ongoing Phase I/II clinical trial of PYN17 in five hepatology centres in the USA. PYN17 is the only product currently in clinical development that is specifically aimed at treating the debilitating symptoms and impaired health related quality of life and liver inflammation in chronic hepatitis C. The double-blind trial, which commenced on 29 May 2007, has enrolled 39 patients as planned, randomised to treatment with either PYN17 or placebo and no serious adverse events have been reported to date.
Robert Miller, Phynova´s CEO, said "The completion of enrollment for this Phase I/II safety study of our lead clinical candidate marks an important landmark for Phynova. We have enrolled on time and results so far have shown that PYN17 has been well tolerated, with no serious adverse events. Dosing in this study should be completed by mid September, with interim clinical results available later this quarter. We look forward to working with the US Food & Drug Administration (FDA) at that time, as planned, to work towards commencing a Phase IIb study early in 2008."
- Ends -
For further information, please contact:
Phynova Group PLC +44 (0) 1993 880700
Robert Miller, Chief Executive Officer www.phynova.com
Nominated Adviser:
Nabarro Wells & Co. Limited +44 (0) 20 7710 7400
Marc Cramsie/Harry Stockdale
Broker:
Evolution Securities China Limited +44 (0) 20 7220 4878
Barry Saint
Media enquiries:
Abchurch Communications +44 (0) 20 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 is now in a Phase I/II trial in the US and the Phase IIb trial is scheduled to commence in early 2008. Two further products, for fatty liver disease and post-operative ileus, are targeted for entry to the clinic over the next six months 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 170 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.
For further information please visit www.phynova.com
12/09/2007
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