Dialectic Therapeutics, Inc., o se kamupani biotechnology tulaga tau falemaʻi i Texas e taulaʻi i le fausiaina o tekonolosi fou fou e togafitia ai le kanesa, ua faʻasalalau i aso nei ua tuʻuina atu e le US Food and Drug Administration (FDA) le igoa o vailaʻau matuaoti i le DT2216 mo le togafitiga o le T-cell. lymphoma. O le DT2216 o le Dialectic's first generation compound na fausia i le fa'aogaina o lona fa'avae ma le tala fou Antiapoptotic Protein Targeted Degradation (APTaD™) fa'atekonolosi fa'avae.
"O se mea taua tele lea i le atinaʻeina o le DT2216, o la matou taʻitaʻia APTaD™ faʻalapotopotoga. O le fa'ai'uga a le FDA e fa'aigoaina vaila'au matuaoti ua fa'amamafaina ai lo matou talitonuga e mafai ona avea le DT2216 ma togafitiga lelei mo gasegase T-cell lymphoma” o le tala lea a Dr. David Genecov, le Peresetene ma le Ofisa Sili o le Dialectic. "O loʻo i ai se manaʻoga e leʻi faʻataunuʻuina mo tagata e maua i lenei kanesa seasea, lea o togafitiga faʻamaonia o loʻo iai nei e maualalo le tali atu".
O sela T masani e manaʻomia le faʻaaliga BCL-XL e ola ai lau filifiliga i le taimi o latou atinaʻe. A mae'a lau filifiliga BCL-XL masani T-selau le toe fa'aalia BCL-XL. Ae ui i lea, o le tele o T-cell lymphomas e toe faʻaalia le BCL-XL o se faiga o latou suiga neoplastic ma faʻatagaina lo latou ola faʻaauau o se maʻi. O suʻesuʻega ua faʻaalia ai le taua ole BCL-XL ile T-cell lymphoma ola. Ua fa'aalia e le Dialectic o le DT2216 o se togafitiga lelei mo le T-cell lymphoma i su'esu'ega muamua.
O le FDA's Office of Orphan Products Development e tuʻuina atu le tulaga o tamaiti matuaoti i vailaʻau ma meaola faʻapitoa e faʻamoemoe mo le saogalemu ma le aoga togafitiga, suʻesuʻega poʻo le puipuia o faʻamaʻi e le masani ai, poʻo tulaga e aafia ai le itiiti ifo i le 200,000 tagata i le US Orphan drug designation e maua ai ni faʻamanuiaga, e aofia ai fa'aosofiaga tau tupe e lagolago ai le atina'eina o falema'i ma le ono mafai ona o'o atu i le fitu tausaga o fa'atauva'a fa'atauva'a i totonu o le US pe a fa'atulafonoina.
OA MEA E AVEA MAI LENEI TUSI:
- 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”.
