Earnings release
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Pioneering Personalized ORYZON Medicine in Epigenetics PRESS RELEASE 2021 ORYZON reports results and corporate update for quarter ended March 31 , 2021 MADRID , SPAIN and CAMBRIDGE , MA , UNITED STATES , May 7th , 2021 - Oryzon Genomics , S.A. ( ISIN Code : ES0167733015 , ORY ) , a clinical - stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need , today reported financial results for the first quarter of 2021 and provided an update on recent developments . Dr Carlos Buesa , Oryzon's Chief Executive Officer , said : " Oryzon continued to make strong progress in our pioneering work in personalized medicine in epigenetics during the first quarter . The enrollment of our first patient in the Phase llb study with vafidemstat in borderline personality disorder and the ongoing collaborations in precision medicine with Columbia University , Seaver Autism Center at Mount Sinai and INGEMM are significant steps forward in our epigenetic approach to CNS . The Phase II trial ALICE , investigating iadademstat in combination with azacitidine in acute myeloid leukemia , continues recruitment and is progressing as planned . We finished the first quarter with a reinforced cash position of $ 45.2 million , which provides funding for the further development of our exciting pipeline until 1Q 2023. " First Quarter and Recent Highlights ladademstat in oncology : The ongoing Phase II trial ALICE , investigating iadademstat in combination with azacitidine in acute myeloid leukemia ( AML ) , continues recruitment . Preliminary results for this trial , last presented at the ASH - 2020 conference , show robust signals of clinical efficacy , with 85.7 % of reported objective responses , of which 58.3 % are complete remissions ( CR / CRi ) . Long responses are maturing , with 4 patients in response already for > 1 year , and the longest remission > 2 years ( still ongoing ) . Of patients with > 120 days on treatment , 40 % have overcome their dependency on blood transfusions . ladademstat and azacitidine combination appears to be safe and well tolerated . The company plans to provide a new clinical update on ALICE at the European Hematology Association ( EHA ) -2021 conference . FDA Orphan Drug Designation granted to iadademstat for the treatment of AML . The drug now has orphan designation in both U.S. and EU . New trials in combination in AML and solid tumors are under preparation . The company believes that there is potential for fast market regulatory paths in both areas . Oryzon expects to announce further details in 2H 2021 . Vafidemstat in neurological and inflammatory disease : Started patient enrollment in the Phase IIb clinical trial with vafidemstat in patients with Borderline Personality Disorder ( BPD ) . The study , named PORTICO , is a multicenter , double - blind , randomized , placebo - controlled Phase IIb to evaluate the efficacy and safety of vafidemstat in BPD patients . The