Followers | 18 |
Posts | 634 |
Boards Moderated | 0 |
Alias Born | 05/19/2017 |
Thursday, May 12, 2022 9:43:52 AM
Summary of Safety Results (data cutoff: January 18, 2022)
? All 24 treated patients reported at least one adverse event (“AE”) and at least one ocular AE.
? The majority of AEs reported with OpRegen were mild (Cohorts 1-3, 87%; Cohort 4, 93%), and the immunosuppressive regimen was well tolerated.
? The ocular AEs reported with OpRegen were mainly related to the surgical procedures used for subretinal delivery, with the most common being conjunctival hemorrhage/hyperemia (n=17) and epiretinal membrane (n=16).
? One patient discontinued the study due to an AE that was determined unrelated to treatment.
? No cases of rejection following OpRegen subretinal delivery have been reported.
? No acute or delayed intraocular inflammation, or sustained intraocular pressure increase following OpRegen subretinal delivery has been observed.
-2-
Summary of Activity Results (data cutoff: January 18, 2022)
? Preliminary evidence of improvement in visual function using the Early Treatment Diabetic Retinopathy Study (“ETDRS”) assessment of BCVA:
? Cohort 4 subjects (n=12) had an average 7.6 letter gain in the study (treated) eye and an average 1.7 letter gain in the fellow (untreated) eye at Month 12 compared to baseline. Cohorts 1-3 subjects (n=11) had an average 4.7 letter gain in the study eye and an average 6.0 letter gain in the fellow eye at Month 12 compared to baseline.
? Three subjects in Cohort 4, or 25% of Cohort 4, and one subject in Cohorts 1-3 had a 15 letter or greater gain in the study eye at Month 12 compared to baseline. None of the fellow (untreated) eyes had a 15 letter or greater gain.
? Five Cohort 4 subjects with OpRegen delivered to most or all of the GA area, including the fovea, had greater gains in visual function at Month 12 (average 12.8 letter gain) as compared with subjects who did not receive OpRegen in a similar manner to most or all of the GA area, with evidence for regions of apparent improvement of outer retinal structure as assessed by spectral domain optical coherence tomography (“SD-OCT”).
? SD-OCT imaging analysis of all subjects is ongoing.
These data support the potential for OpRegen to slow, stop, or reverse disease progression in GA. Further assessment of the optimal disease stage for intervention, surgical procedure for subretinal delivery, and target delivery location of OpRegen in a larger, controlled clinical study is needed to confirm these preliminary findings.
Recent LCTX News
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:15:44 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 08:10:17 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 09:05:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 09:05:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 09:05:26 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 03/07/2024 10:17:24 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 09:10:09 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/15/2024 10:27:49 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/13/2024 02:30:12 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/13/2024 02:27:33 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 12:00:09 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/08/2024 11:58:18 PM
- Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend] • Edgar (US Regulatory) • 02/08/2024 11:57:07 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 02/06/2024 02:25:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/06/2024 02:20:38 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 02/06/2024 02:00:23 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/03/2024 12:08:49 AM
- Take Part in the Next Generation of Spinal Cord Injury Treatments with These Companies • AllPennyStocks.com • 11/16/2023 09:21:00 PM
- Take Part in the Next Generation of Spinal Cord Injury Treatments with These Companies • AllPennyStocks.com • 11/16/2023 09:21:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 11/13/2023 09:19:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/09/2023 09:10:32 PM
- Small Company Working on Big Breakthrough in Treating Spinal Cord Injuries • AllPennyStocks.com • 10/11/2023 02:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/07/2023 09:01:43 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/10/2023 08:16:11 PM
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM