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NeuroGenesis plans to initiate randomized double-blind Phase 2b studies in secondary progressive MS & ALS. Clinical sites include University of Rochester Medical Center (URMC), Mass General, Brigham & Women’s Hospital, and Hadassah Medical Center. Each clinical site will be managed by world renowned KOLs.
Following dozens of pre-clinical studies which resulted in over 20 pre-clinical publications, NG-01 was administered in a Phase IIa (NCT00781872) open label trial to 34 progressive MS and ALS patients. The results were quite encouraging as the mean ALSFRS score remained stable whereas the mean EDSS score improved. There were no serious treatment-related adverse events during the duration of the study.
In a Phase 2a (NCT04823000) open-label long-term study in 24 progressive MS patients, the repeated administration of NG-01 for a period of up to four years showed significant clinical benefits (improved disability, EDSS scores and immunomodulatory effects) particularly in patients treated with >2 injections. There were no serious treatment-related adverse events during the whole four-year duration of the study.
The randomized Phase 2 trial (NCT02166021) was a 48-patient double-blind study that
compared clinical effects of intravenous (IV) and intrathecal (IT) injections of NG-01 with
those of sham injections in patients with active or worsening progressive MS. The study
duration was 14 months. No serious treatment-related safety issues were reported in this
study.
Significantly fewer patients experienced treatment failure in the NG-01 IT (intrathecal
administration) and NG-01 IV (intravenous administration) groups compared with those in
the sham-treated group (6.7%, 9.7%, and 41.9%, respectively, p = 0.0003 and p = 0.0008).
During the one-year follow-up, 58.6% and 40.6% of patients treated with NG-01 IT and NG-
01 IV, respectively, exhibited no evidence of disease activity compared with 9.7% in the
sham-treated group (p< 0.0001 and p< 0.0048, respectively). NG-01 IT transplantation
induced additional statistically significant benefits on the relapse rate, on the monthly
changes of the T2 lesion load on MRI, and on the timed 25-foot walking test, 9-hole peg test,
optical coherence tomography, functional MRI, and cognitive tests.
