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- | RT001 / BioJiva
Journal: Double blind trial of a deuterated form of linoleic acid (RT001) in Friedreich ataxia. (Pubmed Central) - Mar 2, 2023
The results of this study provide no evidence for a significant benefit of RT001 at the dosages tested in this Friedreich ataxia patient population.
- | docosahexaenoic acid (RT011) / BioJiva
Journal: Quantitative High-Field NMR- and Mass Spectrometry-Based Fatty Acid Sequencing Reveals Internal Structure in Ru-Catalyzed Deuteration of Docosahexaenoic Acid. (Pubmed Central) - Sep 29, 2022
The mono-allylic positions near the methyl end (C21) show a steep increase of D only after the D10 isotopologue has been deuterated to >90%, while the mono-allylic position near the carboxyl position, C3, deuterates last and least. These data establish detailed methods for the characterization of Ru-catalyzed deuteration of HUFA as well as the phenomenological reaction kinetics as net product is formed.
- || RT001 / BioJiva
Clinical, Journal: An Expanded Access Protocol of RT001 in Amyotrophic Lateral Sclerosis-Initial Experience with a Lipid Peroxidation Inhibitor. (Pubmed Central) - Sep 21, 2022
RT001 was administered safely to a small group of people living with ALS in the context of an EA protocol. Currently, there is an ongoing randomized, double-blind, controlled study of RT001 in ALS.
- ||||| RT001 / BioJiva
Trial completion, Trial completion date: A Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia (clinicaltrials.gov) - May 27, 2022
P3, N=65, Completed, Sponsor: Retrotope, Inc.
Currently, there is an ongoing randomized, double-blind, controlled study of RT001 in ALS. Active, not recruiting --> Completed | Trial completion date: Dec 2021 --> Aug 2021
- ||| RT001 / BioJiva
Trial completion: A Natural History Study of Infantile Neuroaxonal Dystrophy (clinicaltrials.gov) - Apr 8, 2022
P=N/A, N=43, Completed, Sponsor: Retrotope, Inc.
Active, not recruiting --> Completed | Trial completion date: Dec 2021 --> Aug 2021 Active, not recruiting --> Completed
- | RT001 / BioJiva
Trial completion date, Trial primary completion date: RT001 in Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - Apr 8, 2022
P2, N=40, Recruiting, Sponsor: Retrotope, Inc.
Active, not recruiting --> Completed Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Sep 2021 --> Aug 2022
- RT001 / Retrotope
Phase 2/3 Clinical Trial Results: Safety & Efficacy Results of RT001, a site-specific (C11) di-deutero synthetic homologue of linoleic acid, in Infantile Neuroaxonal Dystrophy () - Mar 6, 2022 - Abstract #AAN2022AAN_3647;
There was statistically significant improvement in survival, and trends toward improvement in all functional assessments, in children treated with RT001 compared to the natural history cohort. We posit that these results are clinically meaningful, and suggest that RT001 can slow disease progression in children with INAD.
- | RT001 / BioJiva
Trial completion date: A Study to Assess Efficacy and Safety of RT001 in Subjects With Infantile Neuroaxonal Dystrophy (clinicaltrials.gov) - Sep 16, 2021
P2/3, N=19, Active, not recruiting, Sponsor: Retrotope, Inc.
We posit that these results are clinically meaningful, and suggest that RT001 can slow disease progression in children with INAD. Trial completion date: Jun 2021 --> Jun 2022
- | RT001 / Retrotope
Preclinical, Journal: RT001 in Progressive Supranuclear Palsy-Clinical and In-Vitro Observations. (Pubmed Central) - Jul 4, 2021
These findings are reversed after incubation with RT001. In PSP patients, the progression of disease may be reduced by treatment with RT001.
- || RT001 / BioJiva
New P2 trial: RT001 in Patients With Progressive Supranuclear Palsy (PSP) PROGRESSIVE SUPRANUCLEAR PALSY (clinicaltrials.gov) - Jun 24, 2021
P2, N=40, Recruiting, Sponsor: Retrotope, Inc.
- || RT001 / Retrotope
Clinical, PK/PD data, Journal: Plasma and red blood cell membrane accretion and pharmacokinetics of RT001 (bis-allylic 11,11-D2-linoleic acid ethyl ester) during long term dosing in patients. (Pubmed Central) - Jun 22, 2021
We conclude that chronic dosing of RT001 and associated dietary guidance can be maintained over many months to achieve target plasma and RBC levels, forming a basis for therapeutic dosing across a broad range of conditions. RT001 has been safe and well-tolerated in 59 different participants treated across 10 different neurodegenerative diseases in multiple clinical trials for up to 36 months with no significant drug related adverse events limiting use.
- RT001 / Retrotope
[VIRTUAL] Retrotope, Inc. () - Apr 3, 2021 - Abstract #BIO2021BIO_113;
The company’s lead candidate, RT001, is in clinical development for a range of orphan neurodegenerative diseases including infantile neuroaxonal dystrophy, Friedreich’s ataxia, amyotrophic lateral sclerosis (ALS) and progressive supranuclear palsy. In addition, the company is advancing a second candidate, RT011, toward the clinic for the treatment of dry age-related macular degeneration (AMD).
- ||| RT001 / BioJiva
Trial completion date, Trial primary completion date: A Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia (clinicaltrials.gov) - Mar 9, 2021
P3, N=65, Active, not recruiting, Sponsor: Retrotope, Inc.
In addition, the company is advancing a second candidate, RT011, toward the clinic for the treatment of dry age-related macular degeneration (AMD). Trial completion date: Apr 2021 --> Dec 2021 | Trial primary completion date: Feb 2021 --> Nov 2021
- || RT001 / BioJiva
Enrollment closed, Trial primary completion date: A Natural History Study of Infantile Neuroaxonal Dystrophy (clinicaltrials.gov) - Feb 21, 2021
P=N/A, N=45, Active, not recruiting, Sponsor: Retrotope, Inc.
Trial completion date: Apr 2021 --> Dec 2021 | Trial primary completion date: Feb 2021 --> Nov 2021 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2020 --> Dec 2021
- || RT001 / BioJiva
New P2 trial: RT001 in Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - Feb 20, 2021
P2, N=40, Recruiting, Sponsor: Retrotope, Inc.
- |||| RT001 / BioJiva
Enrollment closed: A Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia (clinicaltrials.gov) - Dec 7, 2020
P3, N=65, Active, not recruiting, Sponsor: Retrotope, Inc.
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2020 --> Dec 2021 Recruiting --> Active, not recruiting
- | RT001 / BioJiva
Trial completion date: A Study to Assess Efficacy and Safety of RT001 in Subjects With Infantile Neuroaxonal Dystrophy (clinicaltrials.gov) - Sep 3, 2020
P2/3, N=19, Active, not recruiting, Sponsor: Retrotope, Inc.
Recruiting --> Active, not recruiting Trial completion date: Jul 2020 --> Jun 2021
- RT001 / Retrotope
RT001 to Treat Progressive Supranuclear Palsy (PSP)—Altered Progression of Disease in 3 Patients () - Jan 21, 2020 - Abstract #AAN2020AAN_2734;
RT001 (D2-LA) is absorbed and elongated into D2-AA.Within 1 month, D2-LA and D2-AA achieve plasma and RBC membrane levels sufficient to block LPO. RT001 was well tolerated with no toxicities reported.
- Case Report: Expanded Access Treatment of a mid stage Huntington’s Disease (HD) Patient with a Novel Stabilized Polyunsaturated Fatty Acid Drug (RT001) () - Jan 21, 2020 - Abstract #AAN2020AAN_2547;
Summarized by the patient, “This medicine has helped me a lot”. A controlled trial of RT001 in HD patients should be considered.
- |||| RT001 / BioJiva
Enrollment open: A Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia (clinicaltrials.gov) - Nov 13, 2019
P3, N=60, Recruiting, Sponsor: Retrotope, Inc.
A controlled trial of RT001 in HD patients should be considered. Not yet recruiting --> Recruiting
- RT001 / Retrotope
A Randomized, Double-Blind, Controlled, Study of RT001 in Subjects with Friedreich’s Ataxia (EXHIBIT HALL - A) - Nov 11, 2019 - Abstract #IARC2019IARC_3;
Not yet recruiting --> Recruiting The prior pilot study (CLN-RT001-002) demonstrating improvement in cardiac workload in FA subjects treated with RT001 was used to design the current randomized, double-blind, placebo-controlled study of 60 subjects over a 9-month exposure period.
- | RT001 / BioJiva
New P3 trial: A Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia (clinicaltrials.gov) - Sep 24, 2019
P3, N=60, Not yet recruiting, Sponsor: Retrotope, Inc.
- | RT001 / BioJiva
New trial: A Natural History Study of Infantile Neuroaxonal Dystrophy (clinicaltrials.gov) - Jul 22, 2019
P, N=45, Recruiting, Sponsor: Retrotope, Inc.
- | RT001 / BioJiva
Enrollment closed: A Study to Assess Efficacy and Safety of RT001 in Subjects With Infantile Neuroaxonal Dystrophy (clinicaltrials.gov) - Jul 11, 2019
P2/3, N=19, Active, not recruiting, Sponsor: Retrotope, Inc.
The prior pilot study (CLN-RT001-002) demonstrating improvement in cardiac workload in FA subjects treated with RT001 was used to design the current randomized, double-blind, placebo-controlled study of 60 subjects over a 9-month exposure period. Enrolling by invitation --> Active, not recruiting
- | RT001 / BioJiva
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: A Study to Assess Efficacy and Safety of RT001 in Subjects With Infantile Neuroaxonal Dystrophy (clinicaltrials.gov) - Nov 8, 2018
P2/3, N=15, Enrolling by invitation, Sponsor: Retrotope, Inc.
Enrolling by invitation --> Active, not recruiting Not yet recruiting --> Enrolling by invitation | Trial completion date: Dec 2019 --> Jul 2020 | Initiation date: Jul 2018 --> Nov 2018 | Trial primary completion date: Sep 2018 --> Jun 2020
- |||| RT001 / BioJiva
New P2/3 trial: A Study to Assess Efficacy and Safety of RT001 in Subjects With Infantile Neuroaxonal Dystrophy (clinicaltrials.gov) - Jun 27, 2018
P2/3, N=15, Not yet recruiting, Sponsor: Retrotope, Inc.
- | RT001 / BioJiva
Trial completion: A First in Human Study of RT001 in Patients With Friedreich's Ataxia (clinicaltrials.gov) - Oct 4, 2016
P1/2, N=19, Completed, Sponsor: Retrotope, Inc.
Not yet recruiting --> Enrolling by invitation | Trial completion date: Dec 2019 --> Jul 2020 | Initiation date: Jul 2018 --> Nov 2018 | Trial primary completion date: Sep 2018 --> Jun 2020 Active, not recruiting --> Completed
- | RT001 / BioJiva
Enrollment closed: A First in Human Study of RT001 in Patients With Friedreich's Ataxia (clinicaltrials.gov) - May 24, 2016
P1/2, N=19, Active, not recruiting, Sponsor: Retrotope, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- RT001 / BioJiva
Trial primary completion date: A First in Human Study of RT001 in Patients With Friedreich's Ataxia (clinicaltrials.gov) - Apr 6, 2016
P1/2, N=18, Recruiting, Sponsor: Retrotope, Inc.
Recruiting --> Active, not recruiting Trial primary completion date: Jan 2016 --> May 2016
- | RT001 / BioJiva
Enrollment open: A First in Human Study of RT001 in Patients With Friedreich's Ataxia (clinicaltrials.gov) - Aug 17, 2015
P1/2, N=18, Recruiting, Sponsor: Retrotope, Inc.
Trial primary completion date: Jan 2016 --> May 2016 Not yet recruiting --> Recruiting
- RT001 / BioJiva
New P1/2 trial: A First in Human Study of RT001 in Patients With Friedreich's Ataxia (clinicaltrials.gov) - May 15, 2015
P1/2, N=18, Not yet recruiting, Sponsor: Retrotope, Inc.