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Phynova Obtains FDA Approval of its IND to Enter Into a Clinical Trial of PYN17 for the Treatment of Chronic Hepatitis C
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OXFORDSHIRE, England, Jan. 8, 2007-Phynova Group PLC (AIM: PYN), a developer of pharmaceuticals derived from Chinese botanical drugs targeting viral and metabolic diseases and cancer, is pleased to announce that its first drug candidate will shortly enter into clinical trials in the US.
The Group has received approval from the US Food and Drug Administration (FDA) for an Investigational New Drug (IND) application in respect of its lead drug candidate PYN17, to proceed to the clinical trial phase. This trial will evaluate 40 patients in the USA with chronic hepatitis C (CHC).
Phynova's trial is expected to begin in Q2 2007 and will investigate the effect of PYN17 on safety and efficacy parameters. These include the key symptoms associated with CHC such as fatigue, poor concentration and abdominal pain leading to a marked deterioration in an individual's quality of life. There are no treatments currently available to effectively manage these disease symptoms.
PYN17 is a botanical drug derived from Chinese medicinal plants with a long history of safe use in humans.
Hepatitis C is a major viral disease with over 200 million sufferers worldwide including over four million in the USA.
Phynova's drug pipeline includes PYN18, an anti-viral drug for the treatment of hepatitis C and PYN22, an anti-obesity drug. In both cases patents have been filed to support these drug programmes.
Robert Miller, the CEO of Phynova said "This is a major milestone for us, validating our business model to shorten the time it takes to progress new drug candidates into human trials by developing products derived from Chinese medicines which have a long history of use in humans. The US is the largest pharmaceutical market in the world and this approval sets us on the path to targeting that market."
For further information, please contact:
Phynova Group PLC
Robert Miller, Chief Executive
01865 784880
Buchanan Communications
Diane Stewart/ Tim Anderson
020 7466 5000
Nabarro Wells & Co. Limited
Marc Cramsie
020 7710 7400
Phynova
Phynova was founded in July of 2002 to develop drugs that satisfy unmet therapeutic needs in areas such as: infectious disease, metabolic disease and cancer. The Company's headquarters are located in the Long Hanborough near Oxford and it has a laboratory at Warwick Horticultural Research Institute.
Phynova is developing Drug Candidates which are mainly derived from botanical medicines and have proved effective and safe in clinical use in China. The Chinese have been using botanical medicines for thousands of years and over that time have built up a wealth of knowledge and expertise in the medicinal use of plants. In a number of areas these medicines are used in China in circumstances where there is an unmet therapeutic need in the West. Since all of Phynova's Drug Candidates are derived from plants, its drugs will be produced from sustainable resources.
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