OBI Pharma re­ceives FDA ODD for OBI-3424

BioSpectrum (Asia) - - Regulatory News -

OBI Pharma, Inc., a Tai­wan bio­pharma com­pany, re­cently an­nounced that the US Food and Drug Ad­min­is­tra­tion (FDA) has granted Or­phan Drug Des­ig­na­tion (ODD) for OBI-3424 for the treat­ment of Acute Lym­phoblas­tic Leukemia (ALL). OBI-3424 is a first in class DNA alky­lat­ing can­cer ther­a­peu­tic agent tar­get­ing aldo-keto re­duc­tase 1C3 (AKR1C3) over­ex­press­ing can­cers. This is the sec­ond FDA or­phan drug des­ig­na­tion for OBI-3424. On July 9, 2018 OBI-3424 was granted or­phan drug sta­tus for the treat­ment of Hepa­to­cel­lu­lar Car­ci­noma (HCC). A Phase 1/2 study of OBI-3424 in pa­tients with solid tu­mors, in­clud­ing HCC and cas­trate-re­sis­tant prostate can­cer (CRPC), has com­menced en­roll­ment at the Univer­sity of Texas M.D. An­der­son Can­cer Cen­tre. Ac­cord­ing to Amy

Huang, Gen­eral Man­ager of OBI Pharma, this ad­di­tional or­phan drug des­ig­na­tion for OBI-3424 by the FDA is a sig­nif­i­cant step in the de­vel­op­ment of this drug can­di­date in ALL, in­clud­ing T-ALL, an un­met med­i­cal need dis­ease with lim­ited treat­ment op­tions.

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