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Phynova Secures Funding
Phynova Group plc
("Phynova")
Phynova secures funding to progress the US Phase IIb clinical trial
of lead product PYN17 and to advance drug pipeline development
Phynova Group plc (AIM: PYN), the developer of prescription pharmaceuticals derived from plants used in Chinese medicines, today announces that it has successfully obtained commitments to provide in excess of £1.1 million through a placing of new ordinary shares at 40 pence per share with existing investors and private investors who will benefit from the tax reliefs offered by the UK Government´s Enterprise Investment Scheme ("EIS"). Its financial adviser on the transaction was Merchant Securities Group Ltd. Final details of the new ordinary shares placed will be announced shortly, at which point an application will be made to admit the new ordinary shares to trading on AIM.
Phynova will use part of the new funds to initiate a multicentre, double-blind, placebo-controlled Phase IIb efficacy trial of its lead drug candidate, PYN17, for treating the debilitating symptoms and impaired liver function associated with Chronic Hepatitis C. This follows the successful confirmation of the safety and tolerability of PYN17 in a 39 patient Phase I/II study completed in November 2007 and extensive interaction with the US Food and Drug Administration (FDA) to discuss the trial design, clinical end points and the overall development plan. The primary objective of the trial is to evaluate the efficacy of PYN17 in improving the symptoms, impaired health-related quality of life (HRQoL) and liver inflammation associated with Chronic Hepatitis C. The Company expects the results of this study in the second half of 2009.
Hepatitis C affects over 170 million people world wide, including over four million people in the US. PYN17 is the only drug currently in development specifically for the treatment of the debilitating symptoms, impaired HRQoL and liver inflammation associated with the disease. Currently available antiviral treatments with pegylated interferon and ribavirin are only effective in approximately 50% of patients treated, often with significant associated toxicity and side effects. As a result, it is estimated that the market for treatments for Hepatitis C will grow to around US$9 billion by 2010.
Robert Miller, Phynova´s CEO, said: "This successful financing will allow Phynova to progress clinical development with PYN17, a drug that represents real hope for Chronic Hepatitis C sufferers, who are often left with the debilitating symptoms of the disease even after it has apparently been successfully treated with antiviral drugs. Progress on PYN17 is currently being monitored by several potential pharma partners. As well as supporting PYN17´s clinical development, Phynova will continue to fund its other pipeline candidates, all of which have progressed significantly in development over the last 12 months. It is especially pleasing that we have attracted commercial interest right across the pipeline at such comparatively early stages of development.
Key pipeline developments include:
- PYN22, for the treatment of non alcoholic fatty liver disease, is Phynova´s
next clinical candidate. A regulatory dossier is now in preparation and
commercial due diligence and licensing discussions are taking place with
several companies. - PYN6, the novel antibacterial agent active against MRSA and acne, has shown better activity against MRSA than the most commonly used topical antibiotic, mupirocin.
Phynova is now preparing a topical formulation and a preclinical package; a new patent
application has been filed; and commercial discussions are underway with several acne
treatment companies. - PYN18, the novel antiviral agent has been shown in studies carried out at the Rega Institute in Belgium (one of the world´s leading virology centres) to have activity
against hepatitis C virus and against dengue virus, the virus which causes Dengue
Fever. New patent applications have been filed and PYN18 has attracted interest from
several companies in the antiviral field. - PYN9, the candidate treatment for post-operative ileus, i.e. bowel blockage that can follow abdominal surgery. An IND has been applied for by Phynova´s Chinese partner, Botanic Century Ltd and a Chinese clinical study is expected to begin in 2008. Phynova is preparing a preclinical development plan for Europe and the Company is already in commercial due diligence for PYN 9 with a mid cap European speciality pharma company.
- PYN7, the cancer drug candidate, has shown promising activity against a range of cancer cells. Work is continuing with collaborators in Birmingham (UK) and Hong Kong to explore the mechanisms of action and activity against tumour grafts.".
- Ends -
For further information, please contact:
Phynova Group plc +44 (0) 1993 880700
Robert Miller, Chief Executive Officer www.phynova.com
Merchant Securities Group Ltd +44 (0) 20 7375 9060
Anthony Fabrizi
Nominated Adviser:
Nabarro Wells & Co. Limited +44 (0) 20 7710 7400
Marc Cramsie
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
ashley.tapp@abchurch-group.com
www.abchurch-group.com
Notes to Editors:
About Phynova
Phynova is a UK company developing prescription pharmaceuticals derived from plants used in Chinese 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. For further information please visit www.phynova.com.
About Hepatitis C and Phynova´s clinical candidate PYN17
Hepatitis C is a liver disease caused by the Hepatitis C virus. 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. These symptoms commonly persist in patients even after viral clearance following interferon-ribavirin therapy and may be so severe as to prevent patients from working so the economic impact is considerable. Furthermore 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 antiviral treatments with pegylated interferon and ribavirin are only effective in approximately 50% of patients treated, often with significant associated toxicity and side effects.
Phynova believes that PYN17 is the only drug currently 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;
27/03/2008
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