PVG.L Regulatory News (PVG)

5 Sep 2006 07:03

Ark Therapeutics Group PLC05 September 2006 Ark Therapeutics Announces Initial Results of One Year Voluntary Extension Phase For EG005 In HIV-Related Lipodystrophy Study Improvements in metabolic risk factors observed London, UK, 5 September 2006 - Ark Therapeutics Group plc ("Ark" or the "Company") today announces initial results from the open label one year extension phaseof its exploratory Phase II study of EG005 for the treatment of lipodystrophy inHIV positive patients. The results of the initial three months blinded placebocontrolled stage, which assessed patients on a wide range of disease markers,were reported in April 2005 and showed trends in a number of markers consistentwith EG005 producing an improvement in certain aspects of the condition.Patients in the one year extension all received active drug. The patient group completing the extension phase showed little or nodeterioration from baseline in mean scores for the main morphological diseasemarkers of central and peripheral fat and total body fat measurements nor in thewaist, trunk, hip and thigh measurements. Improvements in mean concentration ofatherogenic lipid markers were observed, indicating that the patients' risk ofdeveloping cardiovascular disease and type II diabetes, already elevated bytheir disease, was reduced by the end of treatment. Lipodystrophy is a serious problem that develops in HIV positive patients ontriple anti-retroviral therapy, one of the most common treatment regimes usedfor such patients. It is characterised by an increased, and potentiallyharmful, accumulation of central body fat and the development of an unsightly "buffalo hump" and "pot belly" appearance. Increases in cholesterol,triglycerides and low density lipoproteins (LDL) caused by the condition areassociated with an increase in the incidence of atherosclerotic cardiovasculardisease and type II diabetes in these patients. HIV-associated lipodystrophy isa progressive disease; its severity is directly proportional to age, duration ofdisease and length of protease inhibitor treatment(1). All patients who completed the initial three month blinded study were free toenter the one year extension in the certainty that they would get activetreatment. The results thus reflect 15 months' treatment for patients whoreceived active in the first stage and 12 months' treatment for controls whoreceived placebo originally. In total, 35 of the 46 who completed the firststudy entered the extension study and, of those, up to 26 patients gave final(12 months) data, depending on the parameter measured. Individual patients showed considerable variation from baseline by the end ofthe treatment period, although mean scores for the main body shape measurements(assessed by DEXA scan and skin thickness) indicated that the group overall hadnot deteriorated significantly whilst on treatment. In addition the overallgroup showed no deterioration in mean lean body mass score during the study. Compared with baseline, patients showed a 12% (mean) reduction in triglycerides(n=15), mean high density lipoproteins (HDL) levels improved 12% (n=14) and meanLDL levels were reduced 17% (n=13) by the end of the treatment period. Thissuggests that treatment with EG005 reduced the cardiovascular and type IIdiabetes risk profiles of these patients, key concerns in this disease.Physician assessment of the completing patients' overall lipodystrophy condition(Chelsea and Westminster score(2)) recorded a 12% improvement (n=6), withpatients' own assessments indicating a 14% improvement (n=6). In terms of sub-group analysis, 7 out of 8 control patients who appeared to begaining central body fat in the first three month study appeared to have lostcentral fat after switching to treatment and in the other patient the rate ofweight gain was markedly slower than before treatment commenced. The overall adverse event profile was in line with expectations and does notgive any cause for concern. Professor John Martin, CSO of Ark commented, "This initial study seems tosupport the hypothesis that EG005 has a beneficial metabolic effect andspecifically on the cardiovascular and diabetic consequences of the disease. Itwould suggest further exploratory work is needed to investigate these effectsbefore determining how to take the product into full development." Dr Nigel Parker, CEO, commented: "We are pleased to see that some trendsidentified after three months' treatment were maintained in the one year resultsfor this early stage experimental study. At present we are focusing on theprogress of our advanced clinical leads and we will let our scientistsinvestigate these data further before we make any decisions about the futuredevelopment of EG005." Notes (1) Ali Hendi, MD; Lipodystrophy, HIV; eMedicine 18 January 2006 (2) Chelsea and Westminster Score is a validated series of 19 differentassessments combined to give an overall measure of the seriousness of thecondition. For further information please contact: Ark Therapeutics +44 (0)20 7388 7722Dr Nigel Parker, Chief Executive OfficerMartyn Williams, Chief Financial Officer Financial Dynamics +44 (0)20 7831 3113David Yates / Anna Keeble Notes to Editors Ark Therapeutics Group plc Ark is a specialist healthcare group (the "Group"), addressing high value areasof clear unmet medical need. With one marketed product, Kerraboot(R), and threefurther lead products in late stage clinical development: VitorTM, CereproTM andTrinam(R), the Group is transitioning from an R&D focused company to acommercial, revenue generating business. Capitalising on over ten years ofresearch in vascular biology and gene-based medicine, Ark has a broad productportfolio targeted at specific unmet clinical needs within vascular disease,wound care and cancer. These are large and growing markets, where opportunitiesexist for effective new products to generate significant revenues. CereproTM ison track to becoming one of the world's first commercially available gene-basedmedicines. Ark's products are sourced from related but largely non-dependent technologieswithin the Group and have been selected to enable them to be taken throughdevelopment within the Company's own means and to benefit from Orphan DrugStatus and/or Fast Track Designation, as appropriate. This strategy has allowedthe Group to retain greater value and greater control of clinical developmenttimelines, and to mitigate the risks of dependency on any one particularprogramme or development partner. Ark has secured patents or has patentapplications pending for all its lead products in principal pharmaceuticalmarkets. Ark has its origins in businesses established in the mid-1990s by Professor JohnMartin and Mr Stephen Barker of University College London and Professor SeppoYla-Herttuala of the AI Virtanen Institute at the University of Kuopio,Finland, all of whom play leading roles in the Company's research anddevelopment programmes. Ark's shares were first listed on the London Stock Exchange in March 2004(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, readers are cautioned not torely on any forward-looking statement. This information is provided by RNS The company news service from the London Stock Exchange