Ixico Regulatory News (IXI)

30 Sep 2005 07:01

Phytopharm PLC30 September 2005 Company Contact: U.K. Investor Relations ContactPhytopharm, plc Financial DynamicsDr Richard Dixey David Yates/Ben Atwell+44 7867 782000 +44 207 831 3113Dr Wang Chong+44 1480 437 697www.phytopharm.com Completion of subject dosing and follow-up in phase II proof of principle studyin Alzheimer's disease Preliminary trial results expected December 2005 GODMANCHESTER, Cambridgeshire, U.K. (30 September 2005) - Phytopharm plc (LSE:PYM; NASDAQBB: PHYOF; PHYOY) ("Phytopharm") announces today that all subjectshave now completed their participation in the phase II proof of principleclinical study of PYM50028 (CoganeTM). The compound is an orally active,synthetic, neuroprotective and neurotrophic product that is under development asa treatment for Alzheimer's disease. Two hundred and fifty six subjects with Alzheimer's disease were randomlyallocated to receive either CoganeTM or a placebo orally once daily for twelveweeks. The patients were monitored for a further six weeks following thecompletion of dosing, with measurements taken during the study to determine thesafety, efficacy and pharmacokinetic profile of CoganeTM compared to placebotreatment. These data are now being collected for analysis. It is anticipatedthat the results of the study will be announced early in December 2005. In January 2005 an interim safety review was carried out by an independentconsultant physician on the first 60 subjects to complete the study andconcluded that the data available did not raise any safety concerns associatedwith CoganeTM. Dr Richard Dixey, Chief Executive of Phytopharm, said: "A substantial body ofwork is being conducted on all aspects of the CoganeTM programme. The results ofthis clinical study are a key development and we look forward to receiving themin December. With more than 4.5 million people thought to be suffering fromAlzheimer's disease in the US, and similar prevalence in other major markets,CoganeTM addresses a major opportunity where there is a clear need for improvedmedication." NOTES TO EDITORS Alzheimer's disease Alzheimer's disease is a neurodegenerative disorder that mainly affects theelderly and is characterised by a progressive loss of learning ability andmemory. Alzheimer's disease is thought to affect 4.5 million of the USpopulation, and it is believed that this number will continue to grow toapproximately 16 million by 2050 (Source: Alzheimer's Association). Severalfactors have been proposed to play a role in the underlying neurodegeneration,including the excessive formation of beta-amyloid, glutamate and a decrease inneurotrophic factors in the brain. In pre-clinical studies, the synthetic chemical PYM50028 has been shown to beneuroprotective against beta-amyloid and glutamate damage, to reverse thedecrease of neuronal growth factors and to reverse neuronal degenerationobserved in the ageing brain. Importantly, this product restores levels ofproteins that are altered in the ageing brain, returning them to levels observedin the young and causing beneficial neurite outgrowth and branching. Inaddition, PYM50028 restores the learning and memory ability in Alzheimer'sdisease models and thereby offers the potential to reverse the symptoms ofAlzheimer's disease. The global annual market for Alzheimer's disease is estimated to be worth inexcess of $2.5 billion (source: Datamonitor); it is also estimated that in theUS, the total annual cost burden for Alzheimer's disease exceeds $100 billion(source: US Alzheimer's Association). Phytopharm plc Phytopharm is focused on the research and development of novel pharmaceuticaland functional food products based on clinical and pre-clinical data generatedfrom medicinal plant extracts. The Company has seven development programmes infour disease areas: neurodegeneration, obesity and metabolic disease,dermatology and inflammation and has a portfolio of two marketed veterinaryproducts. More information concerning Phytopharm's activities can be found on its web siteat http://www.phytopharm.com This press release may contain forward-looking statements within the meaning ofSection 27A of the U.S. Securities Act of 1933 and Section 21E of the U.S.Securities Exchange Act of 1934 with respect to the financial condition, resultsand business achievements/performance of Phytopharm and certain of the plans andobjectives of its management. These statements are statements that are nothistorical facts. Words such as "should", "expects", "anticipates", "estimates", "believes" or similar expressions, as they relate to Phytopharm, are intendedto identify forward-looking statements. By their nature, forward-lookingstatements involve risk and uncertainty because they reflect Phytopharm'scurrent expectations and assumptions as to future events and circumstances thatmay not prove accurate. There is no guarantee that the expected events, trendsor results will actually occur. Any changes in such assumptions or expectationscould cause actual results to differ materially from current expectations. This information is provided by RNS The company news service from the London Stock Exchange