Ixico Regulatory News (IXI)

28 Nov 2005 15:03

Phytopharm PLC28 November 2005 Company Contact: U.K. Investor Relations Contact:Phytopharm, plc Financial DynamicsDr Richard Dixey David Yates / Ben Atwell+44 7867 782000 +44 207 831 3113www.phytopharm.com Preliminary results of Phase II proof of principle study in Alzheimer's disease GODMANCHESTER, Cambridgeshire, U.K. (28 November 2005) - Phytopharm plc (LSE:PYM; NASDAQBB: PHYOF; PHYOY) ("Phytopharm") announces today the preliminaryresults obtained from the Phase II proof of principle clinical study of PYM50028(CoganeTM). The compound is novel, orally active and has neuroprotective andneurotrophic properties. It is under development for Alzheimer's disease as apotential disease modifying agent. The Oxford Project to Investigate Memory andAgeing (OPTIMA) was the lead clinical centre and 15 other sites in the UKparticipated in the study. Two hundred and fifty six subjects with mild to moderate Alzheimer's diseasewere randomly allocated to receive either CoganeTM (n = 127) or a placebo (n =129) orally once daily for 12 weeks. The patients were monitored for a further 6weeks following the completion of dosing, with measurements taken during thestudy to determine the safety, efficacy and pharmacokinetic profile of CoganeTMcompared to placebo. The baseline demography data confirmed that the treatmentgroups were well balanced for factors such as age, gender and severity ofdisease. The overall safety data confirm that CoganeTM administered orally once daily forup to 12 weeks is well tolerated and has a good clinical safety profile. Therewere no substantial differences in the adverse event and laboratory safety datafor each group. Treatment emergent adverse events considered to be possiblyattributable to the study medication were reported by 17 (13%) of the subjectsin the CoganeTM group and 21 (16%) of the subjects in the placebo group. Onlyfour subjects in the CoganeTM group prematurely discontinued the study due to anadverse event compared with six in the placebo group. One hundred and two subjects in the CoganeTM group and 106 subjects in theplacebo group completed the treatment period in accordance with the protocol andwere therefore included in the primary ('per- protocol') analysis. Theprospectively defined primary efficacy measure was the change in word recallscore, assessed using the Hopkins verbal learning test. The average baselineand end of treatment scores (maximum = 36) were 12.1 (33.7%) and 12.6 (35.1%)for the CoganeTM group, compared with 10.9 (30.2%) and 11.6 (32.2%) for theplacebo group. The baseline scores and changes over time were not significantlydifferent between the groups. A variety of other secondary measures ofcognitive function (including a computerised neuropsychological test battery,the clinical dementia rating and the mini mental state examination) did notdetect significant changes over the treatment period or a difference betweenCoganeTM and the placebo treatment groups in the per protocol analysis. Commenting on these results, Professor David Smith (OPTIMA Project Leader andEmeritus Professor of Pharmacology, Oxford University) said: "This studyconfirms that CoganeTM has a good clinical safety profile. Since the placebogroup did not show any evidence of deterioration during the 12 week treatmentperiod, a short term clinical study such as this is unlikely to detect asignificant treatment effect when attempting to evaluate a disease modifyingagent. However these results, together with the striking pre-clinical data,suggest that this novel neurotrophic agent should now be taken forward into alonger term clinical study to determine its efficacy as a treatment forAlzheimer's disease." Dr Richard Dixey, Chief Executive of Phytopharm, said: "Whilst we were surprisedby the lack of deterioration in the placebo group, the CoganeTM data show theproduct has a good safety profile and was well tolerated. Taken together withthe encouraging and extensive pre-clinical and early clinical data pack we havecompiled on CoganeTM, we will immediately discuss these data with potentiallicensing partners and look forward to the future development of this product." -ENDS- There will be a conference call for analysts today at 4pm UK time. Please callClaire Rowell at Financial Dynamics for details on +44 (0)207 269 7285 or emailclaire.rowell@fd.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 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 (CoganeTM) has beenshown to be neuroprotective against beta-amyloid and glutamate damage; toreverse the decrease of neuronal growth factors and to reverse neuronaldegeneration observed in the ageing brain. Importantly, this product restoreslevels of proteins that are altered in the ageing brain, returning them tolevels observed in the young and causing beneficial neurite outgrowth andbranching. In addition, PYM50028 restores the learning and memory ability inAlzheimer's disease models and thereby offers the potential to reverse thesymptoms of Alzheimer'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