Ixico Regulatory News (IXI)

20 Jan 2005 07:01

Phytopharm PLC20 January 2005 Phytopharm announces results of interim data review for phase II proof of principle study in Alzheimer's disease Preliminary results of completed study expected fourth quarter 2005 GODMANCHESTER, Cambridgeshire, U.K. (January 20th, 2005) - Phytopharm plc (LSE:PYM; NASDAQBB: PHYOF; PHYOY) ("Phytopharm") announces today the outcome of ascheduled interim data review for the ongoing phase II proof of principleclinical study of PYM50028 (CoganeTM). The compound is an orally active,synthetic, neuroprotective and neuroregenerative product that is underdevelopment as a treatment for Alzheimer's disease. The study is beingconducted in the UK under the terms of a clinical trial authorisation (CTA),which has been granted by the Medicines and Healthcare products RegulatoryAgency (MHRA). This randomised, double-blind, placebo-controlled study is designed to evaluatethe safety, efficacy and pharmacokinetic profile of PYM50028 after once dailyoral administration for 12 weeks to patients with Alzheimer's disease. Inaccordance with the protocol, an interim review was conducted after the first 60subjects completed the study. The objectives of this review were to evaluatethe emergent safety profile of the study and to re-estimate the total number ofsubjects required to measure the efficacy of PYM50028 on cognitive performance. The safety review was conducted by an independent consultant physician, who wasprovided with blinded data for each of the two treatment groups. He concludedthat "the data obtained to date indicate that the study medication is notassociated with any safety concerns." Therefore, the study will continue withno changes to the safety monitoring. The sample size re-assessment was conducted by an independent statistician, whoreported that the sample size for the study should be increased from 200 to 238subjects. Phytopharm is seeking regulatory and ethics approval for thisamendment. Subject recruitment for the study is expected to be completed during the secondquarter of 2005, with preliminary results still anticipated to be available inthe fourth quarter of 2005. On 1 May 2003, Phytopharm entered a licensing agreement with YamanouchiPharmaceutical Co., Ltd., a leading Japanese pharmaceutical company, for thedevelopment and commercialisation of PYM50028 in Japan and other Asianterritories. Dr Richard Dixey, Chief Executive of Phytopharm, said: "We are encouraged by theemerging safety profile of CoganeTM and look forward to completing the study bythe end of the year. With more than 4.5 million people thought to be sufferingfrom Alzheimer's disease in the US, and similar prevalence in other majormarkets, CoganeTM addresses a major opportunity where there is a clear need forimproved medication." -ENDS- Company Contact: U.S. Investor Relations Contact U.K. Investor Relations ContactPhytopharm, plc Lippert/Heilshorn & Associates, Inc Financial DynamicsRichard Dixey Kim Sutton Golodetz (Kgolodetz@lhai.com) David Yates/Ben Atwell+44 7867 782000 +1 212 838 3777 +44 207 831 3113Wang Chong Bruce Voss (bvoss@lhai.com)+44 1480 437 697 +1 310 691 7100www.phytopharm.com 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 Americans, and itis believed that this number will continue to grow to approximately 16 millionby 2050 (Source: Alzheimer's Association). Several factors have been proposed toplay a role in the underlying neurodegeneration, including the excessiveformation of beta-amyloid, glutamate and a decrease in neurotrophic factors inthe 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