Non-hormonal alternatives for the treatment of genitourinary syndrome of menopause (GSM) are needed. In this proposed trial, patients who are diagnosed with GSM will be randomized to receive either a hyaluronic acid (HLA) vaginal insert or vaginal estrogen topical cream for 12 weeks. There will be a baseline visit and an 12 week follow up visit, at which points the patient will undergo a detailed history and physical examination including a pelvic exam, vaginal pH sampling, vaginal cell sample for microscopic analysis, and will fill out a vulvovaginal symptom questionnaire (VSQ). These study arms will be analyzed to assess the efficacy of HLA as compared to the gold standard of vaginal estrogen to treat GSM symptoms.

开始日期2021-09-01

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NYU Langone Health

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2021-07-01·Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association2区 · 医学

Toxicologic evaluation of a novel, highly soluble biotin salt, magnesium biotinate

2区 · 医学

Article

作者: Blum, Jason L ; Komorowski, James ; Ellis, Melissa ; Mendes, Odete ; Sylla, Sarah ; Ojalvo, Sara Perez ; Chen, Jayson X

A novel, highly soluble biotin salt, magnesium biotinate (MgB), was assessed for general and genetic toxicity using several toxicologic tests. This battery of tests included in vitro bacterial reverse mutation test, in vitro mammalian micronucleus assay, and oral acute, 14-day, and 90-day repeat-dose toxicity in Sprague-Dawley (SD) rats. The results of the in vitro studies indicate that MgB is not mutagenic, clastogenic, or aneugenic. The acute oral toxicity study established an LD₅₀ ≥ 5000 mg MgB/kg. In the 14-day oral toxicity study, doses of MgB up to 2500 mg MgB/kg/day produced no clinical signs or mortality. In the 90-day oral toxicity study, administration of 600 mg MgB/kg/day resulted in no clinical signs and was determined to be the no-observed-adverse-effect-level (NOAEL), which equates to 39 g biotin/day for a 70 kg human. Since MgB is composed of 93% biotin, the 600 mg NOAEL equates to approximately 1.3 million times the current recommended daily allowance of 30 μg biotin/day and 3900 times supplement levels of 10 mg biotin/day. Based on the toxicologic profile and lack of findings in various in vitro and in vivo studies, MgB may be considered safe for long-term human use.

2019-06-01·Current Developments in Nutrition

Pharmacokinetics of a Novel Form of Biotin, Magnesium Biotinate, in Healthy Subjects (P06-027-19)

作者: Ojalvo, Sara Perez ; Komorowski, James ; Sylla, Sarah

Biotin, also known as vitamin B7, plays an important role in the metabolization of nutrients into energy.Magnesium biotinate (MgB) is a novel biotin compound that has been shown to be 40 times more soluble than D-Biotin.Preclin. evidence has shown that MgB is well absorbed into the bloodstream and tissues, particularly the brain, over time.The following pharmacokinetic study was carried out to further explore the absorption and bioavailability of MgB.In an open-label clin. study, 30 healthy female subjects (18-45 years, BMI 18.0-29.9 kg/m2) were randomized to receive a single oral capsule containing one of the following doses of MgB (n = 10 per group): 1) 10 mg MgB, 2) 40 mg MgB, 3) 100 mg MgB.Serial blood samples were collected in K2-EDTA tubes at pre-dose (within 1 h of dose) and at 0.5, 1.0, 1.5, 3.0 and 6.0 h post-dose.Plasma samples were analyzed for biotin by LC/MS/MS.Pharmacokinetic data were calculated for each dose group.Study results showed that plasma biotin levels increased at 0.5, 1.0, 1.5, 3.0 and 6.0 h post-dose for all groups.However, the largest biotin increase was seen in the 100 mg group (Figure 1).Peak plasma concentrations were observed as follows: 84.8 ng/mL 1 h after a 10 mg dose, 214.6 ng/mL 1.5 h after a 40 mg dose, and 508.5 ng/mL 1.5 h after a 100 mg dose.Area under the curve values increased with increasing biotin dose level (10 mg: 210.0 ng*h/mL; 40 mg: 605.1 ng*h/mL; 100 mg: 1652.4 ng*h/mL).No adverse effects were observedfrom this single-dose pharmacokinetic clin. study demonstrate that magnesium biotinate is a bioavailable form of biotin, with increasing blood levels associated with increasing dose levels.This study was funded by JDS Therapeutics, LLC.

2019-06-01·Current Developments in Nutrition

The Protective Effects of a Combination of an Arginine Silicate Complex and Magnesium Biotinate Against UV-Induced Skin Damage in Rats (P06-028-19)

作者: Cicek, Demet ; Sahin, Kazim ; Sylla, Sarah ; Orhan, Cemal ; Komorowski, James ; Sahin, Nurhan ; Demir, Betul ; Tuzcu, Mehmet ; Ojalvo, Sara Perez

Skin appearance and function begin to decline as humans age due to physiol. changes as well as external factors such as prolonged sun exposure and inadequate nutrient intake.Replenishing the body with nutrients such as silicon and biotin has been shown to improve skin appearance.JDS-ASB is a novel combination of inositol-stabilized arginine silicate complex (ASI), a highly bioavailable form of arginine and silicon, and magnesium biotinate (MgB), a novel, well-absorbed biotin salt.This study was conducted to observe the effects of JDS-ASB on skin appearance and health in rats chronically exposed to UV radiation.Thirty-five female Sprague-Dawley rats (8-wk old) were randomized into one of the following groups; 1: Control (no treatment), 2: UV (exposed to UV radiation with no other treatment), 3: UV + ASI + Low Dose MgB (140 mg human equivalent dose (HED) of ASI and 1.5 mg HED of MgB), 4: UV + ASI + High Dose MgB (140 mg HED of ASI and 10 mg HED of MgB), 5: UV + ASI + High Dose MgB (140 mg HED of ASI and 10 mg HED of MgB) + MgB cream (10 mg HED).Rat diets included egg whites to standardize absorbable biotin levels.Rats had a dorsal area of hair shaved throughout the study and were exposed to UV lamps five times per wk.Each day rats were dosed with study product by oral gavage and/or cream two hours before UV exposure for ten weeks.Rats exposed to UV radiation with no other treatment showed significant signs of skin damage.Skin appearance score improved with all treatments compared to UV exposure alone (p < 0.05).This parameter improved the most in group 5 compared to all treatment groups (p < 0.05), with scores similar to control, while scores did not differ between groups 3 and 4 (Figure 1).Skin elasticity evaluation showed similar results.Inflammatory cell levels in the skin were lower and collagen content was higher in all treatment groups compared to UV exposure alone (p < 0.05).In group 5, inflammatory cells were no different than control levels, and collagen content was the highest compared to all treatment groups (p < 0.05).Treatment with ASI and MgB strongly protects against the skin damage that results from chronic UV exposure.The addition of a 10 mg MgB cream further increases the ability of JDS-ASB to improve skin appearance, elasticity, inflammation, and overall health.This study was funded by JDS Therapeutics, LLC.

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2023-06-01

·Outsourcing Pharma

London start-up Lindus Health announces trials for insomina, tinnitus and short-sightedness

Lindus Health will use their technology platform and machcine learning to manage trials from start to finish aiming to help treatments reach patients quickly in a bid to improve and extend lives. The news comes as the company reveals it has to date raised $6 million from investors, including from Firstminute, Seedcamp and Peter Thiel (PayPal co-founder and the first outside investor in Facebook), to accelerate their use of machine learning and data science to revolutionise clinical trials. Lindus Health is also announcing that it has received an Innovate UK Smart Grant, part of UK Research and Innovation (UKRI), worth almost £500,000, with their work in machine learning and data science described by UKRI assessors as a ‘hugely valuable and game-changing project’. Lindus Health says its technology speeds up the time it takes to approve treatments and get them to market, with their trials to date having been completed three times more quickly than the old-fashioned industry standard. Lindus has delivered more than 80 trials for treatments across the US, UK and Europe and will next be working with healthcare company, Pharmanovia, to evaluate the safety and efficacy of a treatment for patients with severe insomnia in a real-world setting. It will use digital technology to find hard-to-reach insomnia patients. Working with Oto, a provider of digital tinnitus programs, the company will run a trial for 200 people evaluating their digital tinnitus solution against in-person therapy. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Additionally, Lindus is partnering with Berlin-based start-up Dopavision to trial the MyopiaX treatment for children affected by progressive short sightedness. This aims to increase dopamine levels in the retina to slow the progression of the condition. This year, Lindus Health is also launching a trial aimed at treating and reversing type 2 diabetes with George Medicines and a trial aimed at reducing symptoms of menopause, with US-based Bonafide Health, whose parent company is JDS Therapeutics. Launched in 2021 by Michael Young and Meri Beckwith, Lindus Health has already worked with 20,000 patients to find new treatments for chronic conditions. Co-founder of Lindus Health, Michael Young, said: “Clinical trials are the biggest bottleneck to improving human health. We’re working with high-growth companies developing the next wave of breakthrough treatments to accelerate the clinical trials process. “It’s fantastic to be working with the Government and industry pioneers to revolutionise clinical trials to deliver treatments to benefit patients more quickly. “From monitoring trial data in real time to using machine learning to predict trial outcomes and make improvements to trial designs in advance, we want to simplify and accelerate the trials process and put patients first.”

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