- |||||||||| tosedostat (CHR-2797) / CTI BioPharma
Clinical, Journal: Discovery of anticancer clinical candidate, tosedostat, as an analgesic agent. (Pubmed Central) - Sep 1, 2020
Additionally, when given in combination with morphine, tosedostat exerts a synergistic analgesic effect resulting in a reduction of effective dosages required to achieve the same analgesic effect. With broad implications in addressing the opioid addiction crisis, these revelations attest to tosedostat being a highly valuable drug candidate with diverse pharmacological functions.
- |||||||||| naltrexone (JKB-122) / Immune Therap
Phase classification, Enrollment change, Trial initiation date, Trial primary completion date: Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH) (clinicaltrials.gov) - Aug 31, 2020
P2, N=120, Not yet recruiting,
With broad implications in addressing the opioid addiction crisis, these revelations attest to tosedostat being a highly valuable drug candidate with diverse pharmacological functions. Phase classification: P2/3 --> P2 | N=210 --> 120 | Initiation date: Jul 2020 --> Nov 2020 | Trial primary completion date: Jul 2023 --> Nov 2023
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Cytocom
Journal: Low-dose naltrexone as a treatment for chronic fatigue syndrome. (Pubmed Central) - Aug 15, 2020
Treatment doses ranged from 4 to 12 mg. Clinical trials may be warranted to explore the potential use of naltrexone in people with these debilitating illnesses which currently have no licensed treatments available.
- |||||||||| methionine enkephalin (IRT-101) / Immune Therap, Cytocom
Journal: The role of peptidase neurolysin in neuroprotection and neural repair after stroke. (Pubmed Central) - Aug 14, 2020
Upregulation of Nln following stroke is viewed as a compensatory cerebroprotective mechanism in the acute phase of stroke, because the main neuropeptides inactivated by Nln are neuro/cerebrotoxic (bradykinin, substance P, neurotensin, angiotensin II, hemopressin), whereas the peptides generated by Nln are neuro/cerebroprotective (angiotensin-(1-7), Leu-/Met-enkephalins)...This is because, the substrates of Nln are less uniform in modulating neurorestorative mechanisms in one direction, some appearing to have neural repair enhancing/stimulating potential, whereas others doing the opposite. Future studies focusing on the role of Nln in pathophysiology of stroke should determine its potential as a cerebroprotective target for stroke therapy, because its unique ability to modulate multiple neuropeptide systems critically involved in brain injury mechanisms is likely advantageous over modulation of one pathogenic pathway for stroke pharmacotherapy.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
New P2/3 trial: LDN and tDCS in Fibromyalgia (clinicaltrials.gov) - Aug 6, 2020
P2/3, N=92, Completed,
- |||||||||| naltrexone (JKB-122) / Immune Therap
Trial completion date, Trial initiation date, Trial primary completion date: A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule (clinicaltrials.gov) - Jul 14, 2020
P1, N=8, Not yet recruiting,
However, as information regarding the pathophysiology of NDPH is extremely scarce, it may be instructive important to share preliminary data with a plan to complete the work in 150 patients, supported by the generosity of the Migraine Research Foundation. Trial completion date: Aug 2020 --> Dec 2020 | Initiation date: Apr 2020 --> Aug 2020 | Trial primary completion date: Jul 2020 --> Dec 2020
- |||||||||| methionine enkephalin (IRT-101) / Immune Therap, Statera BioPharma
Journal: Defining the caudal hypothalamic arcuate nucleus with a focus on anorexic excitatory neurons. (Pubmed Central) - Jul 10, 2020
Microdrop excitation of ARC glutamate cells in brain slices rapidly increased excitatory synaptic activity in anorexigenic proopiomelanocortin neurons. Together these data support the perspective that vGluT2 cells may be more prevalent in the ARC than previously appreciated, and play predominantly an anorectic role in energy metabolism.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Trial completion date, Trial primary completion date: LoDoNaVasc: Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis (clinicaltrials.gov) - Jul 8, 2020
P2, N=36, Recruiting,
Together these data support the perspective that vGluT2 cells may be more prevalent in the ARC than previously appreciated, and play predominantly an anorectic role in energy metabolism. Trial completion date: Dec 2020 --> Apr 2023 | Trial primary completion date: Dec 2020 --> Apr 2023
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap
Journal: Low-dose Naltrexone Therapy for Psoriasis. (Pubmed Central) - Jun 28, 2020
Low-dose naltrexone regulates lymphocyte responses, reduces cytokine production, and likely reduces mast cell activity. Low-dose naltrexone is safe, inexpensive, and appears be effective in this open-label study.
- |||||||||| methionine enkephalin (IRT-101) / Immune Therap
Journal: Characterization of a Multiple-Scan-Rate Voltammetric Waveform for Real-Time Detection of Met-Enkephalin. (Pubmed Central) - Apr 27, 2020
The data reveal co-fluctuations of catecholamine and M-ENK in both locations, and provide measurements of M-ENK dynamics in the brain with sub-second temporal resolution. Importantly, this work also demonstrates how voltammetric waveforms can be customized to enhance detection of specific target analytes, broadly speaking.
- |||||||||| methionine enkephalin (IRT-101) / Immune Therap
Preclinical, Journal: Elevated Prolactin during Pregnancy Drives a Phenotypic Switch in Mouse Hypothalamic Dopaminergic Neurons. (Pubmed Central) - Apr 24, 2020
In late pregnancy and lactation, a sub-population of the mouse hypothalamic tuberoinfundibular dopaminergic (TIDA) neurons alters their behavior to synthesize and release met-enkephalin rather than dopamine...Thus, prolactin effectively facilitates its own secretion, which is essential for lactation and maternal behavior. These studies provide evidence of a physiologically important, reversible alteration in the behavior of a specific population of hypothalamic neurons in the adult brain.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Enrollment closed, Enrollment change, Combination therapy: Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis (clinicaltrials.gov) - Apr 9, 2020
P3, N=2, Active, not recruiting,
These studies provide evidence of a physiologically important, reversible alteration in the behavior of a specific population of hypothalamic neurons in the adult brain. Recruiting --> Active, not recruiting | N=160 --> 2
- |||||||||| methionine enkephalin (IRT-101) / Immune Therap
Journal: Enkephalins and ACTH in the mammalian nervous system. (Pubmed Central) - Mar 29, 2020
The pentapeptides methionine-enkephalin and leucine-enkephalin belong to the opioid family of peptides, and the non-opiate peptide adrenocorticotropin hormone (ACTH) to the melanocortin peptide family...ACTH plays a role in Addison's disease, alcoholism, cancer, Cushing's disease, dermatitis, encephalitis, epilepsy, Graves' disease, Guillain-Barré syndrome, multiple sclerosis, podocytopathies, and stress. In this review, we provide an updated description of the enkephalinergic and ACTH systems.
- |||||||||| methionine enkephalin (IRT-101) / Immune Therap
Journal: Prenatal ethanol exposure and enkephalinergic neurotransmission. (Pubmed Central) - Mar 29, 2020
Prenatal ethanol exposure (PEE) selectively modifies Methionine-enkephalin (Met-enk) content in several brain regions of infant and adolescent rats, particularly those of the reward circuits...PEE also increases Met-enk levels in the prefrontal cortex and other brain regions of 30-day-old adolescent rats. These findings suggest that mesocorticolimbic enkephalins are essential in ethanol reinforcement in offspring, as previously reported in adult rats.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Enrollment closed, Enrollment change: LoDoNaVasc: Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis (clinicaltrials.gov) - Mar 24, 2020
P2, N=36, Active, not recruiting,
These findings suggest that mesocorticolimbic enkephalins are essential in ethanol reinforcement in offspring, as previously reported in adult rats. Recruiting --> Active, not recruiting | N=60 --> 36
- |||||||||| Lodonal (naltrexone low dose oral) / Biostax Corp, Statera BioPharma
Trial completion date, Trial primary completion date: LDN-CRPS: Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome (clinicaltrials.gov) - Mar 18, 2020
P=N/A, N=40, Recruiting,
Recruiting --> Active, not recruiting | N=60 --> 36 Trial completion date: Jun 2019 --> Jun 2021 | Trial primary completion date: Jun 2019 --> Jun 2021
- |||||||||| methionine enkephalin (IRT-101) / Immune Therap
Journal: Site-Selective Dissociation upon Sulfur L-Edge X-ray Absorption in a Gas-Phase Protonated Peptide. (Pubmed Central) - Mar 13, 2020
Near-edge X-ray absorption mass spectrometry has revealed that the resonant S 2p→σ* excitation of the sulfur contained in the methionine side chain leads to site-selective dissociation, which is not the case after core ionization above the sulfur L-edge. The prospects of such results for the study of charge dynamics in biomolecular systems are discussed.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap
Journal: Low-dose naltrexone: a novel adjunctive treatment in symptomatic alopecias? (Pubmed Central) - Feb 25, 2020
For these cases, LDN would be a possible alternative to be added to the therapeutic arsenal owing to its anti-inflammatory properties, analgesic potential, low cost, and few adverse effects described. Further studies are needed to standardize dosing, better understand its mechanism of action, and evaluate its potential therapeutic indications.
- |||||||||| methionine enkephalin (IRT-101) / Immune Therap
Journal: Lysophosphatidic Acid Receptor Signaling Underlying Chronic Pain and Neuroprotective Mechanisms through Prothymosin α (Pubmed Central) - Feb 24, 2020
research topic, I isolated endogenous morphine-like analgesic dipeptide, kyotorphin, which mediates Met-enkephalin release, and discovered kyotorphin synthetase, a putative receptor and antagonist...Heterozygotic mice showed a defect in memory-learning and neurogenesis as well as anxiogenic behaviors. Small peptide, P6Q derived from prothymosin α retains neuroprotective actions, which include blockade of cerebral hemorrhage caused by late treatment with tissue plasminogen activator in the stroke model in mice.
- |||||||||| naltrexone (JKB-122) / Immune Therap
Phase classification: A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis (clinicaltrials.gov) - Feb 23, 2020
P2, N=300, Not yet recruiting,
Small peptide, P6Q derived from prothymosin α retains neuroprotective actions, which include blockade of cerebral hemorrhage caused by late treatment with tissue plasminogen activator in the stroke model in mice. Phase classification: P3 --> P2
- |||||||||| topiramate / Generic mfg., lithium / Generic mfg., Lodonal (naltrexone low dose oral) / Immune Therap
[VIRTUAL] Hailey-Hailey disease - a rare disease, even in psychiatry! (Station 02) - Feb 20, 2020 - Abstract #EPA2020EPA_3431;
Studies indicate that there is a genetic association between HHD and affective disorder, envolving mutations in the ATP2C1 gene encoding a secretory pathway calcium ATPase1. Multiple therapies are available with inconsistent outcomes and potentially severe adverse effects.
- |||||||||| methionine enkephalin (IRT-101) / Immune Therap
Review, Journal: Interaction of opioid growth factor (OGF) and opioid antagonist and their significance in cancer therapy. (Pubmed Central) - Feb 15, 2020
One endogenous opioid, methionine enkephalin (MENK), was reported to modulate cell growth, MENK was identified as an opioid growth factor (OGF) that interacts with the OGF receptor (OGFr) and regulates cell proliferation...During the last decades, insights have been made concerning the interaction between OGF and OGFr, confirming that both opioids and opioid antagonists have an important role in balancing host homeostasis, host immunity and mediating cancer therapy. This review provides insight into the interactions between OGF and OGFr in the treatment of cancers.
- |||||||||| Cerebrolysin (porcine brain-derived proteolytic peptide fraction) / Novartis, EVER Pharma
Journal: An analysis of the peptide composition of a 'light' peptide fraction of cerebrolysin (Pubmed Central) - Feb 14, 2020
This article will therefore propose the potential off-label use of LDN in management of nonmalignant pain in the palliative medicine setting. The results of a proteomic study of the peptide composition of cerebrolysin indicate the widest range of molecular mechanisms responsible for the clinical efficacy of this drug.
- |||||||||| methionine enkephalin (IRT-101) / Immune Therap
Comparison of machine learning methods for representing and deploying high-dimensional free-energy surfaces and designing collective variables (103B, Pennsylvania Convention Center) - Feb 13, 2020 - Abstract #ACSSp2020ACS_Sp_10242;
In this talk, I will explore several machine learning models, including neural networks, Gaussian kernel ridge regression, support vector machines, random forests, and K-nearest neighbors and compare their ability to represent global free energy surfaces as functions of collective variables, to compute observables from them, and to design collective variables for driving the enhanced sampling calculations used to obtain the free energy surfaces. NMR J-couplings for the residues in the pentapeptide Met-enkephalin computed using the free energy surface represented using a trained neural network as a function of the number of training points used.
- |||||||||| Comprehensive pain management program and low dose naltrexone for patients with complex regional pain syndrome (CRPS) () - Feb 11, 2020 - Abstract #ISPRM2020ISPRM_680;
Difficulty in brushing hair and opening jars.Medications: Cymbalta, Gabapentin, Lyrica, and Medical Marijuana Intervention: 21-day CPMP and LDNFollow up: Pain 2/10...edema, allodynia, distorted nails, and decreased grip strength.Medications: Amitriptyline, Cymbalta, Gabapentin...These patients reduced utilization of pain medications, and achieved almost complete remission of CRPS symptoms. A multi-modal interventional approach should be considered as a treatment option for CRPS.
- |||||||||| Cerebrolysin (porcine brain-derived proteolytic peptide fraction) / Novartis, EVER Pharma
Journal: Cerebrolysin peptides as mood stabilizers (Pubmed Central) - Feb 3, 2020
Not yet recruiting --> Recruiting The normothymic effect of Cerebrolysin is due to the stabilization of endorphinergic and dopaminergic neurotransmission.
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