- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
Crofelemer Improves Symptoms of Chronic Idiopathic Diarrhea (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_4568;
Two patients (10.5%) described worsening diarrhea, 6 (31.6%) described a neutral effect, and 11 (57.9%) improved with crofelemer (Figure 1). Using a binary outcome, 58.8% (11/19) improved with crofelemer while 42.1% (8/19) did not improve.
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
Pilot Study of Crofelemer for Functional Diarrhea (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_4546;
Average BSFS decreased from 5.88 +/- 0.35 (mean +/- SD) at baseline to 5.28 +/- 0.66 in the crofelemer group. Average BSFS decreased from 6.09 +/- 0.60 to 5.85 +/- 0.74 in the placebo group.
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
Trial completion, Trial completion date, Trial primary completion date: OnTARGET: Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy (clinicaltrials.gov) - Jul 25, 2024
P3, N=287, Completed,
Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Dec 2024 --> Jun 2025 Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Oct 2023 | Trial primary completion date: Apr 2024 --> Aug 2023
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
Trial completion date, Trial primary completion date: Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients (clinicaltrials.gov) - May 8, 2024
P4, N=100, Recruiting,
Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Oct 2023 | Trial primary completion date: Apr 2024 --> Aug 2023 Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Oct 2024
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
Trial completion date, Trial initiation date, Trial primary completion date: Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for Preventive Treatment of Migraine (clinicaltrials.gov) - Feb 23, 2024
P=N/A, N=57, Not yet recruiting,
Trial primary completion date: Nov 2023 --> Mar 2024 Trial completion date: Aug 2024 --> Dec 2024 | Initiation date: Jan 2024 --> Jul 2024 | Trial primary completion date: Aug 2024 --> Dec 2024
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap, Nerlynx (neratinib) / Puma, Knight Therap, Pierre Fabre
Journal: Effects of orally administered crofelemer on the incidence and severity of neratinib-induced diarrhea in female dogs. (Pubmed Central) - Jan 28, 2024
The average number of weekly loose/watery stools were not different between the crofelemer BID and QID treatment groups (p = 0.84). This study showed that crofelemer prophylaxis reduced the incidence/severity of neratinib-associated diarrhea in female beagle dogs without the need for any loperamide administration.
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
Journal: Toward New AQP4 Inhibitors: ORI-TRN-002. (Pubmed Central) - Jan 27, 2024
This study showed that crofelemer prophylaxis reduced the incidence/severity of neratinib-associated diarrhea in female beagle dogs without the need for any loperamide administration. Evaluating ORI-TRN-002 on AQP4-expressing Xenopus laevis oocytes using a high-resolution volume recording system revealed an IC of 2.9
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
Trial completion date, Trial initiation date, Trial primary completion date: Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for Preventive Treatment of Migraine (clinicaltrials.gov) - Oct 26, 2023
P=N/A, N=57, Not yet recruiting,
Most frequent TTx were CDK 4/6 and EGFR inhibitors. Trial completion date: Dec 2023 --> Aug 2024 | Initiation date: Sep 2023 --> Jan 2024 | Trial primary completion date: Dec 2023 --> Aug 2024
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
Journal: Patient-derived Enteroids provide a Platform for the Development of Therapeutic Approaches in Microvillus Inclusion Disease. (Pubmed Central) - Oct 22, 2023
The chloride channel-blocking antidiarrheal drug crofelemer dose-dependently inhibited agonist-mediated fluid secretion...Transcriptomic analysis revealed potential pathways involved in the rescue of MVID cells including serum- and glucocorticoid-induced protein kinase 2 (SGK2), and NHE regulatory factor 3 (NHERF3). These results demonstrate the utility of patient-derived enteroids for developing therapeutic approaches to MVID.
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
S67: Insufficient sleep and adipose tissue dysfunction: Insights from experimental sleep restriction studies (Room 33) - Aug 28, 2023 - Abstract #WSS2023WSS_1046;
Virend K. Somers and Dr...Unanswered questions and areas that need to be further explored on the proposed subject will be identified and discussed by the panel. Given that obesity trends continue to exhibit rising trajectories worldwide, understanding the impact of such a widespread risk factor as is insufficient sleep on adiposity may be critical for attenuating the prevalence and consequences of obesity and improving population health.Learning objectivesUpon completion of this CME activity, participants will be able to:
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
Trial initiation date: Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for Preventive Treatment of Migraine (clinicaltrials.gov) - Jun 13, 2023
P=N/A, N=57, Not yet recruiting,
Given that obesity trends continue to exhibit rising trajectories worldwide, understanding the impact of such a widespread risk factor as is insufficient sleep on adiposity may be critical for attenuating the prevalence and consequences of obesity and improving population health.Learning objectivesUpon completion of this CME activity, participants will be able to: Initiation date: May 2023 --> Sep 2023
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
Enrollment closed, Trial completion date, Trial primary completion date: OnTARGET: Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy (clinicaltrials.gov) - May 25, 2023
P3, N=256, Active, not recruiting,
Initiation date: May 2023 --> Sep 2023 Recruiting --> Active, not recruiting | Trial completion date: Aug 2023 --> Apr 2024 | Trial primary completion date: Mar 2023 --> Nov 2023
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Crofelemer for Functional Diarrhea (clinicaltrials.gov) - Dec 15, 2022
P4, N=17, Terminated,
Recruiting --> Active, not recruiting | Trial completion date: Aug 2023 --> Apr 2024 | Trial primary completion date: Mar 2023 --> Nov 2023 N=80 --> 17 | Trial completion date: Dec 2021 --> Sep 2022 | Recruiting --> Terminated | Trial primary completion date: Aug 2021 --> Sep 2022; low enrollment
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap, Miostat (carbachol) / Novartis
DEVELOPMENT OF PATIENT-DERIVED ENTEROIDS AS A THERAPEUTIC PLATFORM FOR MICROVILLUS INCLUSION DISEASE (24 - San Diego Convention Center) - Apr 25, 2022 - Abstract #DDW2022DDW_589;
Conclusion : Quantitative studies of transport indicate significant intact chloride secretion with decreased sodium-dependent nutrient transport in MVID cells. Agonist stimulated chloride and fluid secretion in MVID enteroids is significantly inhibited by Crofelemer suggesting that it has clinical potential for symptomatic therapy and fluid management in MVID patients.
- |||||||||| paclitaxel / Generic mfg.
Preclinical, Journal: Specialty molecules from plants and in vitro cultures as new drugs: regulatory considerations from flask to patient. (Pubmed Central) - Mar 30, 2022
Here we discuss broader thinking of such specialty molecules in the form of dietary supplements, nutraceuticals, herbal medicines, botanical drugs, and pure molecules along with potential complex products from a regulatory standpoint and especially within the realm of approved botanical drugs, e.g., Veregen and Fulyzaq, that have new drug applications (NDAs). The United States food and drug administration (US FDA) regulatory categories are used to provide examples of alternative product options that could prove useful for taking specialty molecules to market.
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
S93: Prediction of cardiovascular disease in obstructive sleep apnea: A step towards precision care (Room 24) - Feb 26, 2022 - Abstract #WSS2022WSS_628;
Virend Somers from USA, Dr...The chairs/speakers are also diverse with respect to gender/ethnicity. This is the proposed schedule of speakers (20 mins each):Symptom Clusters and Cardiovascular Disease Prediction (Patel, USA) Doing More with Polysomnograms (PSG): Advanced PSG Metrics in Cardiovascular Prediction (Ayas, Canada) Circulating Proteomics and Cardiovascular Risk in OSA (Mehra, USA) Circulating microRNA Biomarkers and Cardiovascular Risk Prediction in OSA (Sanchez-de-la-Torre, Spain) Summary and questions: 10 mins (Chairs)Learning objectivesUpon completion of this CME activity, participants will be able to:Understand how symptom clusters, advanced polysomnogram metrics, and circulating biomarkers might help to identify patients at high risk of future CV diseaseUnderstand how these disease features may be used to help guide therapy in OSAUnderstand the limitations of these approaches in the management of sleep apnea
- |||||||||| Mytesi (crofelemer) / Jaguar Health
Clinical, Journal: Phylogenetic analysis of HIV-1 archived DNA in blood and gut-associated lymphoid tissue in two patients under antiretroviral therapy. (Pubmed Central) - Mar 25, 2021
We have launched the Provir/Latitude 45 study to identify conserved CTL epitopes in archived HIV-1 DNA according to the HLA class I alleles in aviremic patients under antiretroviral therapy (ART)...The proviral sequences of both compartments intra-patient exhibited a very low genetic divergence while it was possible to differentiate the sequences inter-patients; single genome sequencing analysis of two couples of samples confirmed that there was no compartmentalization of the sequences intra-patient. We conclude that, considering these two cases, the proviral DNA sequences in blood and GALT are similar and that the epitope analysis of HIV-1 provirus in blood should be considered as relevant to that observed in the GALT, a hard-to-reach major compartment, and can therefore be used for therapeutic vaccine approaches.
- |||||||||| Ibodutant (MEN 15596) / Menarini, Mytesi (crofelemer) / Jaguar Health
Review, Journal: Sex-Gender Differences in the Effectiveness of Treatment of Irritable Bowel Syndrome: A Systematic Review. (Pubmed Central) - Mar 25, 2021
Due to the limited number of studies per treatment option, no recommendations can be made on the choice of a specific treatment. It is clear, however, that so as not to miss beneficial treatment options for either sex, the inclusion, analysis and description of data on the basis of sex is of the utmost importance.
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Veregen (sinecatechins) / SynCore Biotechnology, Medigene
Journal: Scientific and Regulatory Approach to Botanical Drug Development: A U.S. FDA Perspective. (Pubmed Central) - Mar 6, 2021
The FDA published a revised Botanical Drug Development Guidance for Industry document in December 2016 to address developmental considerations for late-phase trials and to provide recommendations intended to facilitate botanical drug development. Herein, we present an analysis of botanical INDs showing their variety of botanical raw materials (e.g., coming from different geographic regions, single vs multiple herbs), the varied levels of previous human experience, and therapeutic areas, as well as provide an overview of experience and challenges in reviewing botanical drugs.
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
Enrollment open, Trial completion date, Trial primary completion date: Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients (clinicaltrials.gov) - Nov 4, 2020
P4, N=100, Recruiting,
In conclusion, reactivity to HFVAC was high in this ART-treated population with dominant HLA alleles, despite potential cellular exhaustion associated with the PD-1 marker. Not yet recruiting --> Recruiting | Trial completion date: Apr 2021 --> Apr 2022 | Trial primary completion date: Apr 2021 --> Apr 2022
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Enrollment closed, Trial completion date, Trial primary completion date: HALT-D: Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients (clinicaltrials.gov) - Nov 3, 2020
P2, N=53, Active, not recruiting,
Not yet recruiting --> Recruiting | Trial completion date: Apr 2021 --> Apr 2022 | Trial primary completion date: Apr 2021 --> Apr 2022 Recruiting --> Active, not recruiting | Trial completion date: Jun 2020 --> Jan 2021 | Trial primary completion date: Jun 2020 --> Dec 2020
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
Enrollment open: Crofelemer for Functional Diarrhea (clinicaltrials.gov) - Aug 20, 2020
P4, N=80, Recruiting,
Further studies are warranted to evaluate the potential of crofelemer as a visceral analgesic. Not yet recruiting --> Recruiting
- |||||||||| Mytesi (crofelemer) / Jaguar Health, Knight Therap
New P4 trial: Crofelemer for Functional Diarrhea (clinicaltrials.gov) - Jul 23, 2020
P4, N=80, Not yet recruiting,
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