Followers | 145 |
Posts | 27554 |
Boards Moderated | 3 |
Alias Born | 02/07/2004 |
Thursday, July 30, 2020 1:35:10 PM
Orion’s phase 3 REFALS trial evaluating the efficacy of oral levosimendan in treatment of ALS patients did not reach its pre-specified endpoints
July 28, 2020 14:45 ET | Source: Orion Oyj
multilang-release
ORION CORPORATION STOCK EXCHANGE RELEASE INSIDE INFORMATION
28 JULY 2020 at 9.45 p.m. EEST
Orion’s phase 3 REFALS trial evaluating the efficacy of oral levosimendan in treatment of ALS patients did not reach its pre-specified endpoints
Orion has completed the clinical phase 3 REFALS trial evaluating the efficacy and safety of oral levosimendan in the treatment of ALS (amyotrophic lateral sclerosis).
The primary endpoint of the trial was to show a statistically significant difference between levosimendan and placebo in slow vital capacity (SVC) in supine position at 12 weeks compared to the baseline. An important secondary endpoint was to show a statistically significant difference between levosimendan and placebo in patient functionality measured by ALSFRS-R Scale (Revised Amyotrophic Lateral Sclerosis Functional Rating Scale) in combination with survival at 48 weeks compared to the baseline.
These pre-specified endpoints were not met in the trial. No new safety concerns were identified for levosimendan in this study. The REFALS phase 3 trial data will be presented at a future scientific meeting.
“We would like to express our warmest thanks to the patients, carers and investigators for participating in the REFALS trial. The results were not what we wished and particularly we are disappointed on behalf of the ALS patients and their caregivers. There are very limited treatment options for ALS at the moment and there is a high unmet need for new innovative therapies. The REFALS trial still provides great resources to aid ongoing ALS research”, says professor Outi Vaarala, Senior Vice President, Head of Research and Development at Orion.
About REFALS and REFALS-ES
REFALS was a Phase 3, double blind, randomized, placebo-controlled, study of oral levosimendan in patients with ALS. A total of 496 participants across 104 sites in the U.S., Canada, EU and Australia were enrolled for the study and 492 patients were being treated with levosimendan 1-2 mg or placebo daily up to 48 weeks. The primary outcome assessment of the study was slow vital capacity (SVC) in the supine position at 12 weeks. In addition, secondary assessments included the ALS functional rating scale and respiratory events through 48 weeks. The purpose of the trial was to demonstrate that levosimendan by enhancing respiratory muscle function, can help maintain breathing capacity and hence preserve overall functionality of patients with ALS.
https://alsnewstoday.com/2020/07/30/phase-3-update-orion-levosimendan-fail-breathing-problems-als
Recent BCLI News
- BrainStorm Cell Therapeutics to Unveil Phase 3b NurOwn® Trial Design at MDA Clinical and Scientific Conference • PR Newswire (US) • 02/27/2024 11:30:00 AM
- BrainStorm Cell Therapeutics Submits Special Protocol Assessment (SPA) Request to FDA for Phase 3b Trial of NurOwn® in ALS • PR Newswire (US) • 02/23/2024 11:00:00 AM
- BrainStorm Cell Therapeutics to Present at European Life Sciences CEO Forum • PR Newswire (US) • 02/13/2024 11:30:00 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/12/2024 03:06:24 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/20/2023 10:04:29 PM
- The Gross Law Firm Notifies Shareholders of Brainstorm Cell Therapeutics Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of January 2, 2024 - (NASDAQ: BCLI) • PR Newswire (US) • 12/18/2023 10:45:00 AM
- The Gross Law Firm Notifies Shareholders of Brainstorm Cell Therapeutics Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of January 2, 2024 - (NASDAQ: BCLI) • PR Newswire (US) • 12/04/2023 10:45:00 AM
- The Gross Law Firm Notifies Shareholders of Brainstorm Cell Therapeutics Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of January 2, 2024 - (NASDAQ: BCLI) • PR Newswire (US) • 11/28/2023 10:45:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 11/22/2023 09:00:54 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/22/2023 11:03:08 AM
- The Gross Law Firm Notifies Shareholders of Brainstorm Cell Therapeutics Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of January 2, 2024 - (NASDAQ: BCLI) • PR Newswire (US) • 11/21/2023 10:45:00 AM
- The Gross Law Firm Notifies Shareholders of Brainstorm Cell Therapeutics Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of January 2, 2024 - (NASDAQ: BCLI) • PR Newswire (US) • 11/14/2023 10:45:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/09/2023 09:01:16 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 11/08/2023 10:28:04 PM
- The Gross Law Firm Notifies Shareholders of Brainstorm Cell Therapeutics Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of January 2, 2024 - (NASDAQ: BCLI) • PR Newswire (US) • 11/07/2023 06:57:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/03/2023 08:07:51 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/24/2023 11:30:11 AM
- Biotech Shares Halted Premarket As FDA Reviews Application • AllPennyStocks.com • 09/27/2023 02:10:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/05/2023 09:16:20 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2023 11:31:22 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2023 11:21:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/07/2023 10:02:05 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/04/2023 08:05:35 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/19/2023 08:05:15 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/19/2023 01:28:58 PM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM
Avant Technologies Launches Advanced AI Supercomputing Network and Expansive Data Solutions • AVAI • Apr 23, 2024 8:00 AM
BestGrowthStocks.com Issues Comprehensive Analysis of Triller Merger with AGBA Group Holding Limited • AGBA • Apr 22, 2024 1:00 PM
Cannabix Technologies to Present Marijuana Breathalyzer Technology at International Association for Chemical Testing (IACT) Conference in California • BLO • Apr 22, 2024 8:49 AM
Kona Gold Beverages, Inc. Prepares for First Production Run Set to Launch May 17, 2024 • KGKG • Apr 22, 2024 8:30 AM