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Preliminary Phase I/II data
Press Release 26 November 2007
Phynova Group plc
("Phynova")
Preliminary data from Phase I/II clinical trial successfully confirm
safety and tolerability of PYN17 in chronic hepatitis C
Phynova Group plc (AIM: PYN), the developer of prescription pharmaceuticals derived from Chinese botanical medicines, today announces preliminary data from the Phase I/II trial of its lead drug candidate PYN17 for treating the symptoms of chronic hepatitis C (CHC). The primary objective of this double-blind, placebo-controlled study was to evaluate the safety and tolerability of PYN17.
The preliminary results show that PYN17 was well tolerated, with a low level of relatively minor adverse events identical to that seen with placebo. This preliminary outcome confirms the good safety profile of PYN17 in patients with CHC seen in the completed London study, previously reported. 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 CHC.
The prospective, double-blind trial commenced on 29 May 2007 and enrolled 39 patients at five hepatology centres in the USA, randomised to treatment for one month with either PYN17 or placebo. There were no serious adverse events whatsoever. For the group treated with PYN17, 11/26 (42.3%) patients reported adverse events of some kind during treatment against 10/13 (76.9%) in the group receiving placebo. For drug-related adverse events, the incidence was 6/26 (23.1%) on PYN17 compared with 3/13 (23.1%) on placebo.
Robert Miller, Phynova´s CEO, said: "We are delighted that this study confirms that PYN17 is well tolerated with a good safety profile. This is a very important attribute for patients suffering from this serious chronic condition since current treatments for Hepatitis C have a notoriously high level of drug-related toxicity. We expect to commence the pivotal, Phase IIb study for PYN17 in the first half of 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 4850
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 has now completed a Phase I/II trial in the US and the Phase IIb trial is scheduled to commence in the first half of 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;
26/11/2007
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