I-Dialectic Therapeutics, Inc., inkampani yase-Texas egxile ekwakhiweni kobuchwepheshe obusha bokwelapha umdlavuza, namuhla imemezele ukuthi i-US Food and Drug Administration (FDA) inikeze igama lesidakamizwa sezintandane ku-DT2216 ukuze zelashwe i-T-cell. i-lymphoma. I-DT2216 iyinhlanganisela yesizukulwane sokuqala se-Dialectic eyakhiwe kusetshenziswa inkundla yobuchwepheshe yayo kanye nenoveli i-Antiapoptotic Protein Targeted Degradation (APTaD™).
“Lesi yingqopha-mlando ekuthuthukisweni kwe-DT2216, inhlanganisela yethu ehamba phambili ye-APTaD™. Isinqumo se-FDA sokunikeza igama lomuthi wezintandane sigcizelela inkolelo yethu yokuthi i-DT2216 ingaba yindlela yokwelapha ethembisayo ezigulini ze-T-cell lymphoma” kusho uDkt. David Genecov, uMongameli we-Dialectic kanye neSikhulu Esiphezulu. "Kunesidingo esibalulekile esingafinyeleleki sabantu abatholakala benomdlavuza ongandile, lapho izindlela zokwelapha ezigunyaziwe zinezilinganiso zokuphendula eziphansi kakhulu".
Ama-T-cell ajwayelekile adinga isisho se-BCL-XL ukuze asinde ekukhethweni kwe-thymic phakathi nokukhula kwawo. Ngemva kokukhetha i-thymic BCL-XL ama-T-cell avamile awasavezi i-BCL-XL. Kodwa-ke, ama-T-cell lymphomas amaningi aphinde aveze i-BCL-XL njengendlela yokuguqulwa kwe-neoplastic futhi avumele ukuqhubeka kwawo ephila njengesifo esiyingozi. Ucwaningo luye lwabonisa ukubaluleka kwe-BCL-XL ekusindeni kwe-T-cell lymphoma. I-Dialectic ibonise ukuthi i-DT2216 iwukwelapha okusebenzayo kwe-T-cell lymphoma ezifundweni zangaphambi komtholampilo.
Ihhovisi le-FDA's Office of Orphan Products Development linikeza isimo sokuqokwa kwentandane kuzidakamizwa nesayensi yezinto eziphilayo ezihloselwe ukwelashwa okuphephile nokusebenzayo, ukuxilonga noma ukuvimbela izifo ezingandile, noma izimo ezithinta abantu abangaphansi kuka-200,000 ekuqokweni kwezidakamizwa ze-US Orphan kunikeza izinzuzo ezithile, okuhlanganisa nokugqugquzela ngokwezimali ukusekela ukuthuthukiswa komtholampilo kanye namandla afinyelela eminyakeni eyisikhombisa yokukhethekile emakethe e-US ngemva kokugunyazwa ngokomthetho.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.
- Orphan drug designation provides certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity in the U.
- The FDA’s decision to grant orphan drug designation underscores our belief that DT2216 could be a promising therapeutic for T-cell lymphoma patients”.
