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

申办/合作机构

NYU Langone Health

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项与 JDS Therapeutics LLC 相关的文献（医药）

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

The Effect of a Combination of an Arginine Silicate Complex and Magnesium Biotinate on Hair and Nail Growth in Rats (P06-026-19)

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

Aging, as well as inadequate intake of vitamins and minerals, can neg. affect the growth, strength, and appearance of hair and nails.For instance, biotin deficiency leads to brittle nails and hair loss.Moreover, certain nutrients, such as arginine and silicon, promote the biol. conditions needed for optimal hair and nail growth.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.The purpose of this study was to observe the effects of JDS-ASB on hair and nail growth in rats.Twenty-one female Sprague-Dawley rats (8-wk old) were randomized into one of the following groups; 1: Control (no treatment), 2: ASI + Low Dose MgB (140 mg human equivalent dose (HED) of ASI and 1.5 mg HED of MgB), 3: ASI + High Dose MgB (140 mg HED of ASI and 10 mg HED of MgB).Study product was dosed daily by oral gavage for six weeks.Rat diets included egg whites to standardize absorbable biotin levels.At baseline, hair was shaved from the dorsal area of the rats and hair growth was assessed on days 7, 14, 21, 28, 35, and 42.Hair growth measurements included hair d. (per square cm), and percentage of hair follicles in the anagen (growing phase) and telogen (resting phase) phases of the hair cycle.Mean nail growth was measured on days 14, 28, and 42.Blood samples were collected on day 42.Visual observations revealed greater hair growth in both treatment groups compared to control, however the effect was more pronounced in group 3.Compared to control, the percentage of hair follicles in the anagen phase was significantly greater in group 3 from day 14 onward (Figure 1).Compared to control, hair d. was significantly greater in group 3 from day 21 onward.These parameters improved in group 2 compared to control on day 42.Blood levels of vascular endothelial growth factor, a protein associated with hair growth, were higher in both treatment groups compared to control, with levels greatest in group 3 (p < 0.05).Mean nail growth data showed faster daily growth in group 3 compared to other groups (p < 0.05).The results of this study demonstrate that the combination of an arginine silicate complex and magnesium biotinate promotes hair and nail growth.

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 ; Orhan, Cemal ; Sylla, Sarah ; 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.

项与 JDS Therapeutics LLC 相关的新闻（医药）

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.”

临床研究

2023-04-21

·PRNewswire

Hapbee Launches Dedicated Wellness Store on Amazon

Early Data from Soft Launch Period Shows Improved Sales and Favorable Customer Ratings VANCOUVER, BC, April 20, 2023 /PRNewswire/ - Hapbee Technologies, Inc. (TSXV: HAPB) (OTCQB: HAPBF) (FSE: HA1) ("Hapbee" or the "Company") the wearable, wellness technology company and creator of the Hapbee Smart Sleep Pad, has released results from its recent launch of a dedicated brand store on leading online marketplace Amazon.com. Hapbee leverages patented, magnetic-field technology that helps people optimize their sleep, performance, and moods. Ultra-low frequency electromagnetic signals are derived from compounds like caffeine, nicotine and melatonin and are re-played digitally through Hapbee-powered devices, such as the Smart Sleep Pad and Neckband without the side-effects or dependencies that might otherwise result from the substances. The Company had previously experimented with selling its Neckband device as a discrete product on Amazon. In February 2023, Hapbee soft-launched a completely redesigned dedicated wellness store on the leading e-commerce marketplace – featuring both the Neckband and the new Smart Sleep Pad. The purpose of the soft-launch period was to gauge customer reaction within Amazon, to fine-tune content and messaging, and to optimize promotional strategy while limiting exposure to a portion of Amazon's consumer audience. Since re-launching in mid-February – Hapbee has seen an 8X increase in monthly sales on Amazon when compared to Amazon monthly sales in Q4 2022 - despite limited exposure during the soft-launch period. Customer reaction has been positive, with an average rating of 4.1 (out of 5) for Hapbee from buyers submitting reviews on the platform. "Amazon represents the opportunity to add an important distribution channel for Hapbee as a complement to our own website as many online customers prefer the ease, convenience and confidence of shopping on Amazon," said Yona Shtern, CEO of Hapbee. "Amazon is also a pre-eminent platform for product search and discovery, which makes our positive customer ratings so encouraging as we plan for our expansion moving forward." Hapbee's re-launched Amazon presence is being managed through a partnership by The JDS Group (JDS) - a brand management & marketing company that specializes in helping consumer-facing brands accelerate their growth through implementation of Amazon and online marketplace strategies. "We greatly appreciate our affiliation with Hapbee and are excited about contributing to their growth," said Anthony Fallon, President of JDS. "This partnership will really help to maximize the sleep quality of many customers all across Amazon's platform." About Hapbee Hapbee is a digital wellness technology company that aims to help people take control of how they sleep, perform and feel. Hapbee's digital wellness library of Wellness Routines utilizes patented ultra-low radio frequency energy (ulRFE®), designed to help optimize users' sleep, productivity and focus, recovery, and downtime. Hapbee devices and subscriptions are available for purchase at Hapbee.com and through a growing network of select distributors. You can learn more about how Hapbee works at Forward-Looking Statements Certain statements included in this news release constitute forward-looking information or statements (collectively, "forward-looking statements"), including those identified by the expressions "anticipate", "believe", "plan", "estimate", "expect", "intend", "may", "should" and similar expressions to the extent they relate to the Company or its management. The forward-looking statements are not historical facts but reflect current expectations regarding future results or events. This news release contains forward-looking statements. These forward-looking statements are based on current expectations and various estimates, factors and assumptions and involve known and unknown risks, uncertainties and other factors. Forward-looking statements are not guarantees of future performance and involve risks, uncertainties and assumptions which are difficult to predict. Such statements and information are based on numerous assumptions regarding the Company's ability and intended timing to complete its Filings. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement, and are subject to various risks, uncertainties and assumptions which include, but are not limited to, those described in Hapbee's annual information form dated May 2, 2022, as well as those described in Hapbee's other disclosure documents, copies of which are available on SEDAR at , and could cause actual events or results to differ materially from those projected in any forward-looking statements. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. The Company assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances unless required by law. Readers should not place undue reliance on the Company's forward-looking statements. Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release. SOURCE Hapbee Technologies Inc.

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