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Phase I/II clinical trial indicates solid safety profile for Phynova’s PYN17
Phynova Group plc (AIM: PYN), the developer of prescription pharmaceuticals derived from Chinese botanical medicines, announced on 26 November 2007 that preliminary data from Phase I/II clinical trial successfully confirm safety and tolerability of PYN17 in chronic hepatitis C. The prospective, double-blind trial enrolled 39 patients at five hepatology centres in the USA, randomised to treatment for one month with either PYN17 or placebo.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 seen in the previously completed London study.
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. Many patients drop out or decline the treatment because of the side effects.
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.”
Phynova believes that 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. 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, with very little or no toxicity. PYN17 is not an anti-viral treatment for HCV, but a treatment for the symptoms of CHC.
According to the WHO, HCV is comparable to a 'viral time bomb'. The WHO estimates a global 170 million chronic suffers are at risk of developing liver cirrhosis and/or liver cancer which are the primary reasons for liver transplants. Only a minority of patients receive a long-term benefit from the treatments currently available. The market for treatments for hepatitis C is estimated to be US$9 billion by 2010. The unmet medical need remains very high and the market potential for a new effective treatment is substantial.
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