Antisoma's AS1411 gains US and EU Orphan Drug Status for acute
myeloid leukaemia
(Thomson Reuters ONE) - London, UK, and Cambridge, MA: 13 October 2009 - Antisoma plc (LSE:ASM; USOTC: ATSMY) announces that its aptamer drug AS1411 has beengranted orphan drug status in both the United States and the EuropeanUnion for the treatment of acute myeloid leukaemia (AML). The grantswill provide seven years of market exclusivity in the US and tenyears of exclusivity in the EU if AS1411 is approved for use in AML.Positive phase II data for AS1411 in AML were presented at the 2008ASH and 2009 ASCO meetings. Addition of AS1411 to high-dosecytarabine increased response rates without significantly increasingside-effects in patients with relapsed or refractory AML. Phase IIbtrials are now planned: the first is expected to start in early 2010.Should this yield positive findings, rapid progress into aregistration trial is anticipated.AS1411 already has orphan drug status in both the US and the EU forthe treatment of renal cancer. A phase II trial in renal cancer isongoing, and expected to report initial data before the end of thisyear.Glyn Edwards, Antisoma's CEO, said: "Gaining orphan drug status inAML further strengthens the exclusivity position of AS1411 in asetting where we have positive phase II data. This is an excitingtime for AS1411, with phase II data in renal cancer coming soon andour investigation of the compound in AML progressing to the nextstage."Enquiries:Antisoma plcGlyn Edwards, CEODaniel Elger, VP Marketing & Communications +44 (0) 7909 915 068Buchanan Communications (media enquiries)Mark Court/Lisa Baderoon/Catherine Breen +44 (0)20 7466 5000The Trout Group (US investorenquiries)Seth Lewis +1 617 583 1308Except for the historical information presented, certain mattersdiscussed in this announcement are forward looking statements thatare subject to a number of risks and uncertainties that could causeactual results to differ materially from results, performance orachievements expressed or implied by such statements. These risks anduncertainties may be associated with product discovery anddevelopment, including statements regarding the company's clinicaldevelopment programmes, the expected timing of clinical trials andregulatory filings. Such statements are based on management's currentexpectations, but actual results may differ materially.About AML (acute myeloid leukaemia)AML is a type of cancer in which the bone marrow makes abnormal andimmature blood cells, eventually leading to bone marrow failure. TheAmerican Cancer Society estimates that there will be over 13,000 newcases of AML diagnosed this year in the US alone.About AS1411AS1411 belongs to a new type of drug called aptamers. These drugs areshort pieces of DNA or RNA that fold into three-dimensionalstructures capable of targeting particular proteins. AS1411 is a DNAaptamer that targets nucleolin, a protein found on the surface ofcancer cells.AS1411 was originally developed by Dr Paula Bates, Dr John Trent andProf. Donald Miller at the University of Alabama and then at theUniversity of Louisville. Antisoma added AS1411 to its pipeline whenit acquired the Louisville-based company Aptamera Inc. in 2005.About orphan drug statusThe US Orphan Drug Act and European Orphan legislation are designedto stimulate the development of drugs for conditions affecting fewerthan a defined number of patients by providing additional incentivesto developers of such drugs. One of the most valuable of theseincentives is a period of market exclusivity. In the US, orphan drugstatus confers a seven-year period of exclusivity after approval inthe given indication. In the EU, a ten-year period of exclusivity isprovided. Other incentives include regulatory guidance from thecompetent authority, fee reductions and, in the US, tax credits.About AntisomaAntisoma is a London Stock Exchange-listed biopharmaceutical companythat develops novel products for the treatment of cancer. The Companyhas operations in the UK and the US. Please visit www.antisoma.comfor further information about Antisoma.---END OF MESSAGE---This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 13.10.2009 - 08:01 Uhr
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