PVG.L Regulatory News (PVG)

14 Apr 2005 07:00

Ark Therapeutics Group PLC14 April 2005 ARK THERAPEUTICS ANNOUNCES FAVOURABLE TRENDS IN INITIAL PHASE II RESULTS FOR EG005 IN LIPODYSTROPHY 14 April 2005, London UK: Ark Therapeutics Group plc ("Ark" or the "Company")today announces initial results from its recently completed exploratory Phase IIstudy of EG005 for the treatment of lipodystrophy in HIV positive patients.Preliminary analysis of the results to date has revealed encouraging trends in anumber of clinically important measures that are consistent with EG005 producingan improvement in the underlying condition. Following completion of the initialthree month study period, a voluntary one year open label extension phase wasavailable. The majority of patients have elected to continue on active treatmentduring this period, with some encouraging initial trends also observed in thosepatients who have so far completed this extension phase. Assuming the fullanalysis of the results to date and the subsequent results from patientscompleting the extension phase are consistent with the beneficial trends seen inthese initial results, Ark anticipates that a Phase III study may be initiatedin 2006. Lipodystrophy is a serious problem that develops in HIV positive patients ontriple anti-retroviral therapy, one of the most common treatments used in suchpatients. It is characterised by an increased, and potentially harmful,deposition of body fat centrally and the development of unsightly "buffalo hump"and "pot belly" appearance. Increased central fat deposition is a risk factorfor cardiovascular disease. In certain cases, lipodystrophy is associated withsudden and unpredictable death through lacticacidosis. Ark's exploratory study is a randomised, double-blinded, placebo-controlledstudy investigating a range of metabolic, morphological and disease assessmentparameters. A total of 50 patients were enrolled into the trial, with a totalof 46 patients successfully completing the initial three month study period. Todate, 12 of these patients have also completed the one year extension phase. Physician assessments of the overall status of the condition were carried outusing the Chelsea and Westminster score of lipodystrophy, a validated series ofnineteen assessments. These assessments showed that the mean improvement inlipodystrophy score after three months in patients treated with EG005 wasapproximately twice that seen in patients receiving placebo, with a meanreduction of 17% from baseline scores for EG005 patients versus 8.6% in thosereceiving placebo. Metabolic profiles, including lipids and insulin, showedchanges consistent with the hypothesis of increased metabolism of fat byincreasing mitochondrial efficiency. In both study arms, similar numbers ofpatients showed increases and decreases in central body fat. However, DEXAscans indicated that where central fat reserves increased by more than 5% frombaseline, the potentially harmful increases were lower in EG005-treatedpatients. Similarly, where central fat reserves decreased by more than 5% frombaseline, EG005-treated patients had greater reductions. In addition, skinthickness in the "buffalo hump" area decreased from baseline by 3% inEG005-treated patients in contrast to a 7% increase in the placebo group. As part of the study, lean body mass (muscle and bone), as well as body fat, wasassessed after three months to determine whether any signs of muscle wasting/loss occurred. As a group, patients treated with EG005 on average maintainedtheir lean body mass, whereas those receiving placebo lost an amount approaching1%. Unintentional reductions in lean body mass of 3-4% are generally consideredto amount to clinical cachexia. The overall adverse event profile in both groups was similar and gave no causefor concern, indicating an acceptable safety profile for EG005. Commenting on these initial results, Professor John Martin, Ark's ChiefScientific Officer, said: "To date, research has not provided effectivetherapies for patients suffering from lipodystrophy and we are stillinvestigating the various parameters that would constitute clinically-relevanttreatment effects. The morphological and clinical chemistry changes we haveobserved at three months, albeit in a small number of patients, are in the areasof concern in lipodystrophy, and beneficial differences have been seen betweenthe control and treatment groups in favour of EG005. We now need to completethe full analysis of the three month data and await the data from the rest ofthe patients in the one year extension phase." Nigel Parker, Chief Executive Officer of Ark, added: "On the results to date,EG005 could offer valuable clinical benefits to patients as a treatment forlipodystrophy. Overall, we expect to gather data from approximately 35patients from the extension phase and will know during the course of this yearhow the trends continue and, as a result, what would be required from any PhaseIII program. Assuming that the potential for a clinical role for EG005 isconfirmed by this further data, a Phase III study may be initiated during 2006." ENDS Enquiries:Ark Therapeutics Tel: 020 7388 7722Nigel Parker, CEO Financial Dynamics Tel: 020 7831 3113Lucy Briggs Ark Therapeutics Group plc Ark is an emerging specialist healthcare group (the "Group") with one marketedproduct and four further lead products in late stage clinical development.Capitalising on over ten years of research in vascular biology and gene-basedmedicine, Ark has a balanced portfolio of proprietary healthcare productstargeted at specific unmet clinical needs predominantly with within vasculardisease and cancer. These are large and growing markets, where opportunitiesexist for effective new products to generate significant revenues. Ark's products are sourced from related but largely non-dependent technologieswithin the Group and have been selected to enable Ark to take each productthrough development and to benefit from Orphan Drug Status and/or Fast TrackDesignation, as appropriate. The Group generally retains ownership of itsproduct candidates throughout clinical development and intends to conduct it'sown sales and marketing in certain territories as well as securing marketingpartners in others. The Group has operations in London, UK and Kuopio, Finland. Ark's shares are traded on the London Stock Exchange (AKT.L). This announcement includes "forward-looking statements" which include allstatements other than statements of historical facts, including, withoutlimitation, those regarding the Group's financial position, business strategy,plans and objectives of management for future operations (including developmentplans and objectives relating to the Group's products and services), and anystatements preceded by, followed by or that include forward-looking terminologysuch as the words "targets", "believes", "estimates", "expects", "aims","intends", "will", "can", "may", "anticipates", "would", "should", "could" orsimilar expressions or the negative thereof. Such forward-looking statementsinvolve known and unknown risks, uncertainties and other important factorsbeyond the Group's control that could cause the actual results, performance orachievements of the Group to be materially different from future results,performance or achievements expressed or implied by such forward-lookingstatements. Such forward-looking statements are based on numerous assumptionsregarding the Group's present and future business strategies and the environmentin which the Group will operate in the future. Among the important factors thatcould cause the Group's actual results, performance or achievements to differmaterially from those in forward-looking statements include those relating toArk's funding requirements, regulatory approvals, clinical trials, reliance onthird parties, intellectual property, key personnel and other factors. Theseforward-looking statements speak only as at the date of this announcement. TheGroup expressly disclaims any obligation or undertaking to disseminate anyupdates or revisions to any forward-looking statements contained in thisannouncement to reflect any change in the Group's expectations with regardthereto or any change in events, conditions or circumstances on which any suchstatements are based. As a result of these factors, prospective investors arecautioned not to rely on any forward-looking statement. This information is provided by RNS The company news service from the London Stock Exchange