Melokinex™ is a preclinical candidate for the treatment of post operative ileus ('POI'), developed in China by Botanic Century (Beijing) Ltd ('BCCL'), a botanical drug development company in which Phynova has a 45% equity stake. POI is a form of bowel obstruction/hypomotility associated with surgery and/or the use of opiate painkillers that is widely seen after abdominal surgery and is an important cause of post-operative morbidity and delayed hospital discharge. BCCL’s candidate has shown promising efficacy in preclinical studies targeting increased bowel movement in conditions where the bowel motility has been impaired. BCCL has an IND to conduct clinical studies in China and a Phase IIa study is currently underway.  The study aims to investigate the safety and efficacy of Melokinex™ and to establish an optimum dosing regime.  Results of this study are expected in H1 2010.  Phynova is currently exploring the potential for Melokinex™ in markets outside China.

An estimated 100,000 patients in the UK contract an antibiotic resistant infection while in hospital each year. The reported cost to the NHS of treating these infections is in excess of £1 billion. With the sharp increase of so-called "super-bugs" such as MRSA in hospitals, there is a major need for new anti-bacterial treatments. Phytobacx™ is a topical formulation isolated from a single plant and has been shown in preclinical screening assays conducted both in China and in the UK to have significant activity against clinical isolates of MRSA and against various other gram-positive bacteria, including the bacterium associated with the development of acne, Propionobacterium acnes. Laboratory studies of resistance extending over three weeks showed that cultures of MRSA were unable to develop resistance to Phytobacx™, and it is hypothesized that due to the inherent polymolecular nature of botanical drugs omit formation of resistance is more difficult due to the number of potentially active molecules.  Formulation studies have shown that Phytobacx™ retains its anti-MRSA activity in a variety of gel formulations.

According to the WHO, HCV is comparable to a 'viral time bomb'. The WHO estimates that about 200 million people are infected with HCV with a global 170 million chronic sufferers 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. Many drop out or decline the treatment because of side effects. The unmet medical need remains very high and the market potential for a new effective treatment is substantial.

PYN17 is not an anti-viral treatment for HCV, but a treatment for the symptoms of CHC. It is based on a novel formulation of one European and three Chinese plants that individually have been used to treat liver diseases in Asia and Europe. The plants selected have a long-established use in hepatic protection and hepatic stimulation. All four plants have a long history of safe use in humans with very little or no toxicity.

A Phase IIa clinical trial was completed in May 2005 by Professor Graham Foster of the Royal London Hospital on PYN17, and showed a clean safety profile and decreases in liver inflammation in patients with CHC. It suggests that PYN17 could be developed both as a stand alone treatment and an adjunct treatment alongside established drugs for viral hepatitis, and also more broadly as a treatment for other inflammatory liver diseases such as alcoholic cirrhosis and fatty livers associated with metabolic disorders.

PYN22 is a drug candidate for the treatment of obesity and other metabolic disorders such as non-alcoholic fatty liver disease (NAFLD). Obesity is a common and increasing problem world wide, and treatment of it and its associated morbidities is a large drain on healthcare services worldwide.  Current treatments for obesity are centred around life-style changes, pharmaceutical treatment, and in extreme circumstances, surgery.

Often associated with obesity is NAFLD.  NAFLD encompasses a spectrum of liver disorders ranging from fatty liver to non-alcoholic steatohepatitis (‘NASH’), the latter being associated with liver inflammation and fibrosis. NAFLD may progress through NASH to cirrhosis and heptocellular carcinoma. Currently there is no effective drug therapy in use for NAFLD/NASH. Treatment focuses on reducing body weight by diet and exercise and for more severe cases associated with morbid obesity, bariatric surgery.

PYN22 is a single plant extract that has been selected as a candidate for the treatment of NAFLD/NASH, based on preclinical work in both China and the UK that suggests PYN22 may have a direct effect on body weight, liver and blood fat levels.

PYN18 is a single plant extract that has shown considerable antiviral activity in laboratory assays against both the Hepatitis C Virus and against the virus that causes Dengue Fever (both Flaviviruses). There is a clear need for new drug candidates for the treatment of hepatitis C, given the low viral clearance rates seen using the combination approach of interferon with ribavarin and the continuing disappointing side effects that are emerging with some of the newer clinical candidates that include protease and polymerase inhibitors. Likewise, there is an outstanding need for drugs that could treat Dengue Fever, which is endemic in many (particularly) southern hemisphere countries infested with the virus-carrying Aedes aegypti mosquito. There are no current effective treatments for Dengue Fever and control measures largely comprise attempting to reduce mosquito populations.

Traditional Herbal Medicinal Products
The European market for herbal supplements and herbal medicines is currently estimated to be worth US$ 7.4 billion. However, under the new EU Traditional Herbal Medicinal Product Directive (THMPD) Directive 2004/24/EC, by April 2011 many of these products will no longer be able to be sold.  After April 2011, no industrially produced herbal product may remain on the market unless it has been registered or licensed. Registration of THMPs has many advantages, foremost is the ability to add label-claims to the product. 

Phynova has identified a great opportunity to launch a range of registered traditional Chinese herbal products that will not only help fill the gap that will be created in the market by the removal of most TCM products in 2011, but also offer an appealing alternative to the few registered Western herbs that have currently been registered.  TCM is arguably the oldest and most famous traditional herbal medicine system in the world, and with the ability to add label claims to THMPs, the marketing opportunities are considerable.

Phynova is developing products across a number of OTC indications including colds and flu; stress, fatigue, joint care, pain relief, diarrhoea, and women’s health.  These THMP products are being developed primarily for the European market.

Relivergen™
Relivergen™ is a patented formulation consisting of a number of plant extracts selected for their detoxifying activity on the liver.  The liver is a vital organ and an intrinsic part of the body's detoxification, metabolism and digestion processes. There is currently no way to compensate for the absence of liver functions.  Poor diet, excessive alcohol, and a number of other factors and diseases can place a high level of stress on the liver and may result in fatty liver disease, steatohepatitis, cirrhosis, and even hepatocellular carcinoma.  Clinical studies have shown that Relivergen™ effectively lowers the levels of liver enzymes associated with liver inflammation, often a precursor to many liver morbidities.  Phynova is looking to commercialise Relivergen™ in the USA, Asia, and some European countries for use as a nutraceutical for promoting general liver health.

Phynova is developing several active ingredients for use in the cosmetic market. 

PhynoRadiance™
PhynoRadiance™ is a novel cosmetic ingredient with skin-lightening properties.  In vitro studies have shown that low concentrations of PhynoRadiance™ effectively prevents the formation of melanin through inhibition of the enzyme tyrosinase.  Although melanin is indispensible for the absorption of free radicals generated in cells, and plays an important role in blocking various types of radiation (such as UV), the increased production and accumulation in the skin characterizes a large number of skin diseases, including acquired hyperpigmentation.

PhynoRadiance™ is water soluble and easily formulated into a suitable cream.  Phynova is currently promoting and marketing PhynoRadiance™ for worldwide use in the cosmetic industry.