Galapagos initiates Nanocort® Phase II clinical trial for multiple
sclerosis
(Thomson Reuters ONE) - Mechelen, Belgium; 17 November 2009 - Galapagos NV (Euronext: GLPG)announced today that it has started a Phase II clinical study toevaluate Nanocort's effectiveness in treating flares in multiplesclerosis (MS). Nanocort combines less frequent treatment with lowerdosage and potentially more effective delivery than other MS flaretreatments.Nanocort is a novel pharmaceutical for the treatment of inflammatoryconditions such as MS and rheumatoid arthritis. The Phase II trialwill involve 90 MS patients experiencing flares, episodes ofincreased neurological dysfunction. In the study, a singleadministration of Nanocort will be compared to the standard steroidtreatment of three methylprednisolone infusions, with the aim toevaluate the efficacy and safety of Nanocort in treating MS flares.This study will take place in Belgium and Germany over a period ofone to two years, with an interim readout after treatment of thefirst 20 patients.This Phase II trial follows a Phase I/II study concluded in 2008,which demonstrated safety as well as faster and more pronounceddecrease in rheumatoid arthritis flare symptoms as compared tostandard steroid treatments. Since the completion of the Phase I/IIstudy, the production and formulation were optimized in preparationfor the Phase II studies. In the first half of 2010 Galapagos plansto initiate a small Phase II study to measure targeting of Nanocortto the inflamed joints of RA patients."After the positive outcome of the Phase I/II study last year, wehave evaluated Nanocort's product profile and decided to pursue MS asa first indication. Pre-clinical studies indicate Nanocort'sefficacy, and the product shows distinct advantages over conventionalcorticosteroid use," said Onno van de Stolpe, CEO of Galapagos. "Weare proud that the start of this trial marks Galapagos' entry intoPhase II studies, and the third program in clinical trials thisyear."About NanocortNanocort is a novel candidate drug composed of prednisolone, a widelyused corticosteroid, enclosed in a small lipid vesicle (liposome).Although corticosteroids are a common treatment for many otherinflammatory disorders, their use as a free drug is limited due tosystemic side effects. In the Nanocort treatment, the corticosteroidis largely confined to the liposome in the blood stream. Afteradministration, the Nanocort liposomes selectively accumulate atsites of inflammation where they deliver long-lasting highconcentrations of corticosteroid. As a result, Nanocort may be ableto significantly reduce frequency of administration and thetoxicities of the steroid compared to other therapies.About multiple sclerosisMultiple sclerosis (MS) is an autoimmune disease where the body'simmune system mistakenly attacks the nervous system. MS affects theability of nerve cells in the brain and spinal cord to communicatewith each other. The myelin sheath surrounding these nerve cells isusually the first to be injured, causing symptoms such as visionloss, balance issues, fatigue, numbness and tingling. Once themyelin sheath is damaged, flares, or exacerbations of the disease canoccur, which involves either the appearance of new symptoms or thereappearance of previous symptoms. MS flares can last from a fewdays to a few weeks and are currently treated with corticosteroids,which reduce the severity of the symptoms, but can cause severesystemic side effects. The World Health Organization estimates thatover 2.5 million people suffer from multiple sclerosis worldwide andthat women are twice as likely to be affected by the disease.About GalapagosGalapagos (Euronext: GLPG; OTC: GLPYY) is a drug discovery anddevelopment company with small molecule programs in bone and jointdiseases, bone metastasis, cachexia, anti-infectives and metabolicdiseases. It has established risk sharing alliances with GSK,Janssen Pharmaceutica, Lilly and Merck&Co. Through an alliance withMorphoSys, Galapagos also develops new antibody therapies in bone andjoint diseases. Its division BioFocus offers a full suite oftarget-to-drug discovery products and services to pharmaceutical andbiotech companies and to patient foundations, encompassing targetdiscovery and validation, screening and drug discovery through todelivery of pre-clinical candidates. Galapagos currently employs 495people and operates facilities in six countries, with globalheadquarters in Mechelen, Belgium. More info at: www.glpg.com.CONTACTGalapagos NVOnno van de Stolpe, CEOTel: +31 6 2909 8028ir(at)glpg.comThis release may contain forward-looking statements, including,without limitation, statements containing the words "believes,""anticipates," "expects," "intends," "plans," "seeks," "estimates,""may," "will," "could," "stands to," and "continues," as well assimilar expressions. Such forward-looking statements may involveknown and unknown risks, uncertainties and other factors which mightcause the actual results, financial condition, performance orachievements of Galapagos, or industry results, to be materiallydifferent from any historic or future results, financial conditions,performance or achievements expressed or implied by suchforward-looking statements. Given these uncertainties, the reader isadvised not to place any undue reliance on such forward-lookingstatements. These forward-looking statements speak only as of thedate of publication of this document. Galapagos expressly disclaimsany obligation to update any such forward-looking statements in thisdocument to reflect any change in its expectations with regardthereto or any change in events, conditions or circumstances on whichany such statement is based, unless required by law or regulation.This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 17.11.2009 - 07:32 Uhr
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