I-Lutris Pharma namhlanje ibhengeze ukuba igqibile ukubhaliswa kwesigaba sesibini sesigaba sayo se-1/2 solingo lwezonyango lwekhompawundi ekhokelayo, LUT014, isetyenziselwe ngokwesihloko, inoveli ye-B-Raf inhibitor, kunyango lwe-radiation-induced dermatitis (RD) kwizigulana ezineempembelelo ze-radiation. umhlaza webele. Idatha ephezulu kakhulu ilindeleke kwikota yesithathu ka-2022.
I-randomized, i-double-blind-blind, i-placebo-controlled part of two of the phase 1/2 study iye yabhalisa inani lezigulane ze-20 kwaye yenzelwe ukuvavanya ukuphumelela kwe-LUT014 elawulwa ngokusemthethweni kwizigulane zomhlaza webele nge-RD. Izigulane ziye zenziwa ngokungenamkhethe kwi-1: umlinganiselo we-1 wokufumana i-LUT014 okanye i-placebo elawulwa ngesihloko kwiintsuku ze-28, ilandelwa yi-2-inyanga yokulandelela ixesha.
Isiphelo esiphambili secandelo lesibini lutshintsho kubunzima be-radiation dermatitis esekelwe kwi-self-reporting Dermatology Life Quality Index (QoL) imibuzo ngeentsuku ze-14. Iziphelo zesibini zibandakanya utshintsho kubunzima be-radiation dermatitis esekelwe kwi-questionnaire ye-Dermatology QoL kunye neziganeko zonyango-ezivela kwiziganeko ezimbi njengoko zihlolwe yi-Common Terminology Criteria for Adverse Events (CTCAE) yokulinganisa isikali ukusuka kwisiseko ukuya kwiiveki ze-12.
"Iziphumo eziqinileyo ezibonwe kwizigulane ezisibhozo kwiSigaba 1 sovavanyo lwe-LUT014 ukunyanga i-RD, yasinika ithemba elongezelelweyo kumandla olu nyango kwaye yasikhuthaza ukuba siqale inxalenye ye-2, ngaphambi kokuba kulindelwe," kusho uBenjamin W. Corn, MD, iGosa eliyiNtloko lezoNyango lweLutris Pharma. "Kusekho isidingo esibalulekileyo esingafezekanga phakathi kwezigulane ezinomdlavuza webele eziphethwe yi-RD, okwangoku akukho zikhetho zonyango ezivunyiweyo. I-LUT014 inendlela ekhethekileyo yokwenza izinto ezijolise ukulungelelanisa ukutshatyalaliswa kweeseli kwi-basal layer yesikhumba ngokuphucula ukwanda kweeseli, ngaloo ndlela kunokuthi kuguqulwe imiphumo ye-RD. "
"Ukubhaliswa kwesigulane sokugqibela kwisigaba esingaboniyo kwisigaba sesibini sesigaba sethu se-1 / 2 sokufunda kusizisa inyathelo elinye phambili ekuphuhlisweni kweklinikhi ye-LUT014 njengonyango lwe-RD," watsho uNowa Shelach, Ph. Lutris Pharma. "Kuqikelelwa ukuba malunga nesiqingatha sezigulana ezinomhlaza zinyangwa ngonyango lwemitha, ngonyaka, kwaye uninzi lwabaguli abanomhlaza wamabele, ngakumbi, bafumana uhlobo oluthile lwe-RD. Ngokusekelwe kwindlela yokusebenza kwe-LUT014, sikholelwa ukuba i-LUT104 ingaba nefuthe elibalulekileyo kwesi sigulane sabantu. Sijonge phambili ekunikezeni ingxelo ngedatha eyomeleleyo kolu vavanyo kwikota yesithathu yalo nyaka. "
