Ilya Pharma AB (iyo Kambani), kambani yekiriniki padanho reimmunotherapy nhasi yakazivisa kuti FDA yakabvisa IND kune inotungamira mumiriri ILP100-Topical uye kuti Kambani iri kumhanyisa gadziriro dzechidzidzo chikuru cheChikamu chechipiri, chakagadzirwa seyedzo yakakosha. ILP2-Topical ndeyekutanga-mu-kirasi immunotherapy yakagadzirirwa kurapa maronda ekuvhiya muvarwere vane prediabetes, chirwere cheshuga uye kufutisa. Varwere ava vane mavhiki kusvika kumwedzi kunonoka kuporeswa mushure mekuvhiyiwa uye njodzi yakawedzera yekukuvara kwakakomba kweronda.
Robert D. Galiano, MD, FACS Associate Purofesa; Mutungamiriri weKutsvakurudza; Division of Plastic Surgery Northwestern University Feinberg Chikoro cheMishonga, ichava National Coordinating Investigator uye Chidzidzo Chair chekudzidza icho chichasanganisira varwere mazana maviri nemakumi matanhatu. Kutevera basa ririkuenderera mberi neWound Experts/FDA Clinical Endpoints Project (WEF-CEP) uye mafambiro mune dzimwe nzvimbo senge oncology uye rheumatoid arthritis, iyo yekutanga yakasarudzwa yekupedzisira ndiyo inoumbwa magumo ekuomarara kwemahara kuporeswa. Chidzidzo ichi chine dhizaini inogadzirisa uye ine zvikamu zviviri - chekutanga chiri chikamu chekutsvaga dosi uye chechipiri chikamu chekusimbisa. Kutenda kune dhizaini yekutonga kwemukati, apo murwere wega wega ane kudzora kwake aine ronda rimwechete rinorapwa ne placebo uye ronda rimwe rinorapwa neILP260-Topical, chidzidzo chacho chakanyanya kuderedzwa, nhamba yevarwere vakanyoresa yakaderedzwa uye kusarura pakati pemapoka ekurapa. minimized.
Dr Galiano akati: “Munhu haafanire kuve aine chirwere cheshuga kuti atambure nekukanganisa kupora kwemaronda, uye izvi hazvisi izvo chete zvinokosheswa, asi isu zvakare hatina chero mishonga inonangana nekukanganiswa uku mukupora. Mhedzisiro yekufutisa idenda rakanyarara uye rinokanganisa chirango chese chekuvhiya. Mushonga unovandudza kuporeswa kwemaronda ekuvhiya waizoguma nekuvandudzwa mune zvese zvekuvhiya hunyanzvi uye maitirwo, kwete mukuderedza mazamu chete. Naizvozvo ndinofara kutungamira kutongwa uku ndaona mibairo inokatyamadza yakatowanikwa naIlya muChidzidzo chavo chePhase I.
Ilya Pharma CEO uye Co-muvambi Evelina Vågesjö anowedzera kuti: "Kubvumidzwa kwakauya nekukurumidza kupfuura zvanga zvichitarisirwa, tave kutarisira kurapa murwere wekutanga muQ3 gore rino. Ino zvakare inguva yakakosha kuna Ilya Pharma mushure mekuedza kunoshamisa kwechikwata chedu chikuru. Tichishanda pamwe chete naDr Galiano neboka renyanzvi uye maKOL tinotenda kuti takagadzira dhizaini yakakwana yekuyedza icharatidza mabhenefiti echokwadi eILP100-Topical kuvarwere, kutanga nehuwandu hwevanhu vari panjodzi. Pamusoro pezvo, chiitiko ichi chinosimbisa puratifomu yedu yeILP-tekinoroji uye vamwe vanokwikwidza zvinodhaka mukusimudzira izvo zvataona kuti vari kuwedzera kufarira. "
ZVOKUBVA MUNYAYA INO:
- Thanks to the internal control design, where each patient is its own control with one wound treated with placebo and one wound treated with ILP100-Topical, the study is significantly de-risked, the number of enrolled patients reduced and the bias between the treatment groups minimized.
- “One does not have to have diabetes to be afflicted with impediments in wound healing, and not only is this underappreciated, but we also do not have any therapeutics that target this impairment in healing.
- Working closely with Dr Galiano and a group of experts and KOLs we believe we have devised an optimal trial design that will demonstrate the truly transformational benefits of ILP100-Topical to patients, starting with this at-risk population.
