DiscGenics, Inc., yekiriniki nhanho biopharmaceutical kambani yakatarisana nekugadzira regenerative cell-based therapies iyo inoderedza marwadzo uye kudzoreredza basa muvarwere vane zvirwere zvinopera zvemusana, nhasi yakazivisa kuratidzwa kweiyo yakanaka yenguva data kubva kuchirikuenderera Phase 1/2 kiriniki kuyedzwa. yeIDCT (rebonuputemcel), an allogeneic injectable discogenic cell therapy ye degenerative disc chirwere (DDD), paSpine Summit 2022.
Iyo yekutanga efficacy endpoint yekudzidza (n = 60) yakagadziriswa, nehuwandu hunokosha huri nani mumarwadzo ekudzokera shure akaonekwa muchikwata chepamusoro cheIDCT. Kune varwere ava, marwadzo ekudzokera shure akavandudzwa> 30% sezvakayerwa pa100mm Visual Analog Scale (VAS) paMavhiki 12 (-54.53% [-69.46, -39.60], p = 0.0056), 26 (-50.94% [-] 66.10, -35.78], p=0.0140), uye 52 (–62.79% [-77.13, -48.46], p=0.0005).
Panguva idzi dzenguva dzakafanana, yakakwira dose IDCT yakagadzirawo zvine musoro, zviverengero zvakakosha kuvandudzwa kwebasa sekuyerwa neOswestry Disability Index (ODI) uye hupenyu hwehupenyu sekuyerwa neEQ-5D Index Score.
Zvakakosha, hapana zvidzidzo mumapoka ekurapa eIDCT zvakasangana nezviitiko zvakakomba zvekurapa-zvinobuda zvakashata (TEAEs).
“Tinokurudzirwa zvikuru nedata iri renguva pfupi rekiriniki. Kwete chete isu tiri kuona yakasimba yekuchengetedza mbiri uye kuderera kunorwadza kuderedzwa nemhinduro yedosi inoitika nekukurumidza uye inoenderera panguva yegore rimwe chete kune varwere vakagamuchira iyo yakanyanya dose IDCT, tiri kuona nekukurumidza, kwakakosha, uye kwakasimba kuvandudzwa. mukushanda uye hupenyu hwehupenyu, "akadaro Kevin T. Foley, MD, Chief Medical Officer weDiscGenics uye Sachigaro weSemmes-Murphy Neurologic & Spine Institute. "Patakamirira kuverengwa kwedata kwemavhiki makumi manomwe nemasere uye mavhiki zana nemakumi mana, tinotarisira kuona kuvandudzwa kwakasimba mune imwe neimwe yeaya matanho anochinja hupenyu."
Kuvandudzwa kwemarwadzo, kushanda, uye hupenyu hwehupenyu hwegore rimwe mushure mejekiseni zvakapfuura izvo zvinozivikanwa sezvishoma zvakasiyana-siyana zvakakosha zvekliniki (MCIDs), izvo zvinoratidza kuchinja mukupindira kwekliniki kune chinangwa kune murwere.
"Kuvandudzika kwakakosha uye kwakasimba kwatiri kuona mukurwadziwa, kushanda, uye hupenyu hwehupenyu zviratidzo zvakakosha zveiyo IDCT inogona kushandura paradigm yekuchengeta varwere vane DDD," akadaro Flagg Flanagan, Chief Executive Officer uye Sachigaro weDDD. Bhodhi yeDiscGenics. “Sevatariri vetekinoroji iyi, timu yakazvipira uye ine tarenda pano paDiscGenics iri kushanda nesimba kuendesa IDCT kuburikidza nekiriniki nehurongwa hwekuita kutengeserana, nechinangwa chekupedzisira chekuvandudza hupenyu hwemamirioni avanhu vari kutambura nemhedzisiro yekusagadzikana. kurwadza kwemusana.”
DiscGenics iri mushishi yekuongorora dhata kubva kushanya kwekutevera kwemurwere pamasvondo 78 ne104. Kambani inotarisira kuendesa dhatabheti rakazara kuUS Food & Drug Administration's (FDA) Hofisi yeTissues uye Advanced Therapies (OTAT) kuti itariswe Kupera kweChikamu 2 musangano wakanangana nehafu yechipiri ya2022.
Zvichakadaro, DiscGenics iri kuenderera mberi nekukwirisa hunyanzvi hwayo hwekugadzira-mumba kuitira kuti ive nemasero akagadzirira ramangwana rekiriniki uye / kana kushandiswa kwekutengesa, zvichienderana nemhedzisiro yeongororo yeFDA yedata.
ZVOKUBVA MUNYAYA INO:
- Not only are we seeing a strong safety profile and dramatic pain reduction with a dose response that occurs early and continues at the one-year time point in patients who received the high dose IDCT, we’re also seeing rapid, significant, and durable improvements in function and quality of life,”.
- “As stewards of this technology, the dedicated and talented team here at DiscGenics is working tirelessly to usher IDCT through the clinical and regulatory process to commercialization, with the ultimate goal of improving the lives of millions of people suffering from the debilitating effects of chronic low back pain.
- , a clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced the presentation of positive interim data from its ongoing Phase 1/2 clinical trial of IDCT (rebonuputemcel), an allogeneic injectable discogenic cell therapy for degenerative disc disease (DDD), at Spine Summit 2022.
