Sports activity represents part of day living people, a knee pain originated by high demand joint activity could represent a limitation to continue sports. The aim of this clinical trial is demonstrate the effects of hyaluronic acid in sportsmen with knee pain.

Start Date01 Jul 2022

Sponsor / Collaborator

Hospital Regional Tlalnepantla

NCT04762758 / Active, not recruitingPhase 3IIT

A Multi-center, Randomized, Double-blind, Placebo Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth Type 1A (CMT1A)

The study will consist of 2 periods: Double-blind Treatment and Open-Label Extension(OLE) Period.
-Double-blind Treatment Period - This will be randomized, double-blind, placebo-controlled part of the study which will be conducted in parallel groups, ie,1 group receiving the active treatment (PXT3003) and the other group receiving placebo.
Primary endpoint of the study will be assessed at Month 15.
-Open-label Extension (OLE) Period - All subjects completing Double-blind Treatment Period will be given an opportunity to enter the OLE Period of the study and receive the active treatment (PXT3003). The duration of the OLE Period will be based on Sponsor discretion, ie, Sponsor intends to keep the study open until the study drug PXT3003 is commercially available.
During this period, the long-term safety and efficacy of PXT3003 will be assessed as an exploratory objective.
Double-blind Treatment Period Objectives:
Primary:
To evaluate the efficacy of treatment with PXT3003 (a fixed-dose combination of [RS]-baclofen, naltrexone hydrochloride [HCl], and D-sorbitol) compared to placebo in subjects with Charcot-Marie-Tooth disease type 1A (CMT1A).
Secondary:
To evaluate the safety and tolerability of PXT3003 treatment in subjects with CMT1A.
Exploratory:
To characterize the relationship between plasma biomarkers and response to PXT3003 treatment.
OLE Period Objective:
Exploratory:
To evaluate the long-term safety and efficacy of PXT3003.

Start Date30 Mar 2021

Sponsor / Collaborator

Worldwide Clinical Trials LLC

100 Clinical Results associated with Sorbitol

100 Translational Medicine associated with Sorbitol

100 Patents (Medical) associated with Sorbitol

3,004

Literatures (Medical) associated with Sorbitol

31 Dec 2024·Animal Cells and Systems

Establishment of a stress granule reporter system for evaluating in vitro colon toxicity

Article

Author: Kim, Kee K ; Kim, Eun-Mi ; Jung, Da-Min ; Cho, Namjoon

Exposure to toxic molecules from food or oral medications induces toxicity in colon cells that cause various human diseases; however, in vitro monitoring systems for colon cell toxicity are not well established. Stress granules are nonmembranous foci that form in cells exposed to cellular stress. When cells sense toxic environments, they acutely and systemically promote stress granule formation, with Ras GTPase-activating protein-binding protein 1 (G3BP1) acting as a core component to protect their mRNA from abnormal degradation. Here, we knocked in green fluorescent protein (GFP)-coding sequences into the C-terminal region of the G3BP1 gene in a human colon cell line through CRISPR-Cas9-mediated homologous recombination and confirmed the formation of stress granules with the G3BP1-GFP protein in these cells under cellular stress exposure. We demonstrated the formation and dissociation of stress granules in G3BP1-GFP expressing colon cells through real-time monitoring using a fluorescence microscope. Furthermore, we validated the toxicity monitoring system in the established colon cell line by observing stress granule formation following exposure to dihydrocapsaicin, bisphenol A, and sorbitol. Taken together, we established a stress granule reporter system in a colon cell line, providing a novel assessment for the real-time monitoring of colon toxicity in response to various chemicals.

01 Dec 2024·BIORESOURCE TECHNOLOGY

Effect of light conditions on phycoerythrin accumulation by thermophilic cyanobacterium Leptothermofonsia sichuanensis and characterization of pigment stability

Article

Author: Daroch, Maurycy ; Yao, Dan ; Jiang, Ying ; Tang, Jie

Phycoerythrin (C-PE) is a cyanobacterial phycobiliprotein with extensive applications. This work sought to investigate the effects of various light conditions on C-PE accumulation by thermophilic Leptothermofonsia sichuanensis and characterize its C-PE stability and purity. Accumulation of C-PE as the predominant phycobiliprotein was significantly affected by light regime and light colours, reaching the highest C-PE accumulation (21.92 mg/g_DCW) under blue light. Importantly, the results suggested the superior C-PE thermostability of Leptothermofonsia than the mesophilic counterparts and good pH stability at a range of 4 to 7. Additionally, C-PE indicated advantageous potential for preservation as revealed by photostability experiments. Moreover, sorbitol, sucrose, and NaCl can further stabilise C-PE at 60 °C, of which 10 % sorbitol is the most effective. The extraction process herein resulted in a C-PE purity of 2.68, much higher than the food grade. Collectively, this work demonstrates the Leptothermofonsia strain as a promising bioresource for thermostable C-PE production.

01 Dec 2024·Antonie van Leeuwenhoek

Clostridium lamae sp. nov., a novel bacterium isolated from the fresh feces of alpaca

Article

Author: Li, Xue ; Li, Ming ; Su, Lei ; Shi, Weixiong ; Li, Xia ; Xiang, Zhiguang

A novel Gram-positive, anaerobic, nonspore-forming, rod-shaped bacterium, designated strain NGMCC 1.200840^T, was isolated from the alpacas fresh feces. The taxonomic position of the novel strain was determined using a polyphasic approach. Phylogenetic analysis based on 16S rRNA gene sequences revealed strain NGMCC 1.200840^T was a member of the genus Clostridium and closely related to Clostridium tertium DSM 2485^T (98.16% sequence similarity). Between strains NGMCC 1.200840^T and C. tertium DSM 2485^T, the average nucleotide identity (ANI) and digital DNA-DNA hybridization (dDDH) were 79.91% and 23.50%, respectively. Genomic DNA G + C content is 28.44 mol%. The strain can utilise D-glucose, D-mannitol, D-lactose, D-saccharose, D-maltose, D-xylose, L-arabinose, D-cellobiose, D-mannose, D-melezitose, D-raffinose, D-sorbitol, L-rhamnose, D-trehalose, D-galactose and Arbutin to produce acid. The optimal growth pH was 7, the temperature was 37 °C, and the salt concentration was 0-0.5% (w/v). The major cellular fatty acids (> 10%) included iso-C_15:0, anteiso-C_15:0 and iso-C_17:0 3-OH. The polar lipids consisted of diphosphatidylglycerol, phosphatidylglycerol, phosphatidylethanolamine, three unidentified phospholipids and two unidentified aminolipids. Based on phenotypic, phylogenetic and chemotaxonomic characteristics, NGMCC 1.200840^T represents a novel species within the genus Clostridium, for which the named Clostridium lamae sp. nov. is proposed. The type strain is NGMCC 1.200840^T (= CGMCC 1.18014^T = JCM 35704^T).

News (Medical) associated with Sorbitol

11 Dec 2023

·www.fiercebiotech.com

Pharnext blames ‘unexpected’ placebo results for lead neurological drug’s phase 3 failure

Pharnext hopes incoming data from a phase 3 trial run by its Chinese partner Tasly will offer some better news. Less than a year after Pharnext dropped its Alzheimer’s program over cost concerns, the French biotech has seen its lead program fail a phase 3 trial in a rare neurological disease. The company is developing PXT3003 in Charcot-Marie-Tooth disease type 1A, an inherited genetic disorder that affects the peripheral nerves, resulting in muscle weakness and potentially sensory loss. The 387-patient trial did not show that the drug was able to improve functional motor disability as measured by the Overall Neuropathy Limitation Scale (ONLS), the company revealed in a Dec. 11 release. Pharnext blamed an “unexpected” improvement in the disease among the placebo cohort, which it said “complicates the interpretation of the results.” “It also confirms what the medical literature as a whole has been saying for many years, namely that ONLS is undoubtedly a relevant endpoint over the long term, but not over such a short period of time as a clinical study,” the company claimed in the release. Trying to see the bright side, the biotech said there had been “no deterioration” of the condition among the patients who received the drug. “This suggests that PXT3003 might stabilize the condition of patients, which is an important consideration for a disease where progression is generally inevitable,” it concluded. PXT3003 is a combination of the approved meds baclofen, naltrexone and sorbitol. The oral drug is designed to downregulate the overexpression of the PMP22 protein in order to improve neuronal signaling in dysfunctional peripheral nerves. Pharnext hopes incoming data from a phase 3 trial run by its Chinese partner Tasly will offer some better news. In the meantime, the company “plans to continue analyzing the data, particularly in collaboration with potential partners for licensing or acquisition of PXT3003.” “Although the results we are sharing today are not exactly what we had hoped for, they are nonetheless very promising,” Pharnext’s Manager Hugo Brugière said in the release. “We are now going to make the most of all the data we have accumulated over the last 10 years, including our two phase 3 studies and our 6-year extension study, which tend to demonstrate a beneficial effect on patients.” “I remind that, today, PXT3003 is the only ray of hope for all CMT1A patients, and that no other drug candidate is currently in an advanced stage,” Brugière added. “It seems to me, therefore, that efficacy results for a risk-free drug could support an application for regulatory approval and market authorization. This is for us the final stage, which we will move forward with the patient community." Investors didn’t appear to see much cause for optimism, sending the company’s share price plunging 68% on Monday morning. However, with the company’s stock already sitting at below one euro cent, the difference was negligible in practicable terms. Pharnext’s stock crashed back in February, when the biotech walked away from its potential Alzheimer’s asset, dubbed PXT864, arguing that the encouraging data produced to date weren't enough to lead to commercialization in the “short or medium term.” Instead, Brugière said at the time that the company would search for a partner to take the clinical baton. It left Pharnext even more reliant on PXT3003. The company said in October that it had received potential international licensing offers worth over 250 million euros for the drug, although it remains to be seen whether these as-yet-undisclosed deals will be impacted by today’s results.

Phase 3Phase 2

25 Apr 2023

·www.biospace.com

Bausch + Lomb Announces U.S. Launch of StableVisc™ Cohesive Ophthalmic Viscosurgical Device and TotalVisc™ Viscoelastic System

Two New OVDs Offer Surgeons Dual-Action Protection during Cataract Surgery VAUGHAN, Ontario--(BUSINESS WIRE)--Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, today announced the U.S. launch of StableVisc™ cohesive ophthalmic viscosurgical device (OVD) as well as TotalVisc™ Viscoelastic System. StableVisc and TotalVisc provide eye surgeons with new options for dual-action protection during cataract surgery. "OVDs are critical to surgeons’ success when performing cataract surgery, which is one of the most common surgical procedures performed in the United States. StableVisc and TotalVisc provide surgeons with new OVD options that offer unique benefits designed to help ensure the best possible surgical outcomes for patients,” said Joe Gordon, president, Global Consumer, Surgical and Vision Care, Bausch + Lomb. StableVisc, a cohesive OVD, helps maintain space in the anterior chamber of the eye to allow surgeons to extract and replace the clouded natural lens. TotalVisc Viscoelastic System includes both StableVisc and ClearVisc™, a dispersive OVD, and protects ocular tissue during the surgical procedure. ClearVisc was approved by the U.S. Food and Drug Administration in 2021. StableVisc and ClearVisc both contain sodium hyaluronate and sorbitol, a unique chemical agent that has been shown to create a strong physical barrier and deliver increased free radical scavenging capabilities compared to other OVDs tested in a laboratory study.2,3* TotalVisc OVD provides dual-action mechanical and chemical protection. TotalVisc is the only dual pack in the United States that includes a dispersive and cohesive OVD formulated with sorbitol. Free radicals form as a result of chemical reactions caused during various steps of cataract surgery, including phacoemulsification, irrigation/aspiration and as part of the insertion and removal of instruments and implants. Free radicals can contribute to corneal damage and possible decompensation, which can lead to post-surgical complications such as a cloudy cornea. “The possibility of complications caused by free radical damage is a real concern both during and after cataract surgery,” said Mitch Shultz, M.D., cornea, cataract and refractive surgeon and medical director, Shultz Chang Vision, Los Angeles. “The dual protection provided by ClearVisc dispersive OVD and StableVisc cohesive OVD gives me added confidence that I am doing everything I can to make my surgeries as safe and efficient as possible and give my patients excellent outcomes. I look forward to having access to both a cohesive and a dispersive OVD that offer these important benefits.” In addition to providing increased free radical protection, StableVisc leads the cohesive OVD segment in fill volume at one milliliter, which reduces the need to open a second pack mid-procedure, thus contributing to surgical efficiency. TotalVisc also leads the dual pack OVD segment in fill volume of device with one milliliter of both ClearVisc and StableVisc. Indications and Important Safety information for ClearVisc, StableVisc and TotalVisc OVDs INDICATIONS FOR USE ClearVisc, StableVisc and TotalVisc OVDs are indicated for use as surgical aids in ophthalmic anterior segment procedures including: Extraction of a cataract; Implantation of an intraocular lens (IOL) CONTRAINDICATIONS There are no contraindications to the use of ClearVisc, StableVisc and TotalVisc when used as a surgical aid in ophthalmic anterior segment procedures. PRECAUTIONS Precautions normally considered during anterior segment procedures are recommended. Pre-existing glaucoma may place patients at risk for increases in intraocular pressure from the OVD during the early postoperative period. WARNINGS Do not use if the sterile barrier has been breached. Sterility cannot be guaranteed, and the patient will be at increased risk for infection. Do not use the OVD in subjects with known allergies to any of its components. An excess quantity of OVD should not be used. Excess OVD can cause increased intraocular pressure. The OVD should be removed from the anterior chamber at the end of surgery to prevent or minimize postoperative intraocular pressure increases (spikes). OVD remaining in the eye can cause increased intraocular pressure. If the postoperative intraocular pressure increases above expected values, corrective therapy should be administered. Increased intraocular pressure may lead to inflammation or vision loss. Do not re-use the cannula. Even after cleaning and rinsing, resterilized cannula could release particulate matter as the OVD is injected. It is recommended that a single-use disposable cannula be used when administering the OVD. Reuse may cause eye inflammation. If any particulate matter is observed, it should be removed by irrigation and/or aspiration. Particulate matter left in the eye may cause increased IOP or Light scattering /obstruction. Store at 2° to 8°C (36° to 46°F). Protect from freezing. The shelf life of ClearVisc, StableVisc and TotalVisc is not guaranteed if it is not properly stored. ADVERSE REACTIONS Sodium hyaluronate is a natural component of tissues within the body and is generally well tolerated in human eyes. Transient postoperative inflammatory reactions and increases in intraocular pressure have been reported. Inflammation may result from increased intraocular pressure caused by use of the OVD. Intraocular inflammation, i.e., toxic anterior segment syndrome (TASS), has been attributed to OVDs. Furthermore, vision loss may be possible as a result of increased intraocular pressure and inflammation. ATTENTION Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc. CAUTION Federal (USA) law restricts this device to the sale by or on the order of a physician. About Cataracts and Cataract Surgery A clouding of the normally clear lens of the eye most commonly caused by aging,4 cataracts are a leading cause of vision loss in the United States and the leading cause of blindness worldwide.5 In the U.S., more than 20 million people aged 40 years and older have a cataract, and more than 6 million of these Americans undergo surgery to have the lens removed.5 An ophthalmic surgeon removes the cloudy lens and replaces it with a clear, artificial implant called an intraocular lens (IOL).6 According to the U.S. National Eye Institute, cataract surgery is one of the safest, most common and effective surgical procedures performed in the United States.7 In most cases, people experience improved vision after the procedure.7 About Bausch + Lomb Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visit and connect with us on Twitter, LinkedIn, Facebook and Instagram. Forward-looking Statements This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb’s filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch + Lomb, including but not limited to its project development timelines, launches and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law. *Compared to ProVisc, Viscoat, Healon Pro, Healon Endocoat, AmVisc, and AmVisc Plus. References Rossi T, Romano MR, Iannetta D, Romano V, Gualdi L, D'Agostino I, Ripandelli G. Cataract surgery practice patterns worldwide: a survey. BMJ Open Ophthalmol. 2021 Jan 13;6(1):e000464. doi: 10.1136/bmjophth-2020-000464. PMID: 33501377; PMCID: PMC7812090. Data on File. Bausch & Lomb Incorporated, 2023. Francesco Maugeri, Adriana Maltese, Keith W. Ward & Claudio Bucolo (2007). Hydroxyl Radical Scavenging Activity of a New Ophthalmic Viscosurgical Device, Current Eye Research, 32:2, 105-111, DOI:10.1080/02713680601147716. American Academy of Ophthalmology. Retrieved from . Accessed March 2, 2023. U.S. Centers for Disease Control and Prevention Web site, Vision Health Initiative (VHI). Retrieved from . Accessed March 2, 2023. American Academy of Ophthalmology. Retrieved from . Accessed March 2, 2023. National Eye Institute Website. Retrieved from . Accessed March 2, 2023. StableVisc, TotalVisc and ClearVisc are trademarks of Bausch & Lomb Incorporated or its affiliates. All other product/brand names and/or logos are trademarks of the respective owners. © 2023 Bausch & Lomb Incorporated or its affiliates. MTB.0103.USA.23

Drug Approval

25 Apr 2023

·www.nsmedicaldevices.com

Bausch + Lomb unveils StableVisc Cohesive OVD and TotalVisc Viscoelastic System in US

The StableVisc OVD and TotalVisc are specified for use as surgical aids in ophthalmic anterior segment procedures like extraction of a cataract, and implantation of an intraocular lens The StableVisc OVD and TotalVisc are designed to offer dual-action protection during cataract surgery. (Credit: Marc Schulte on Unsplash) Eye health company Bausch + Lomb has unveiled its StableVisc cohesive ophthalmic viscosurgical device (OVD) and TotalVisc Viscoelastic System in the US. The StableVisc OVD and TotalVisc are specified for use as surgical aids in ophthalmic anterior segment procedures like extraction of a cataract, and implantation of an intraocular lens (IOL). The OVDs also offer eye surgeons new options for dual-action protection during cataract surgery. StableVisc is said to aid in maintaining room in the anterior chamber of the eye so that doctors can remove and swap out the clouded natural lens. Bausch + Lomb said that the TotalVisc Viscoelastic System consists of StableVisc and ClearVisc, which is a dispersive OVD that protects ocular tissue in the surgical procedure. The US Food and Drug Administration (FDA) approved ClearVisc in 2021. Bausch + Lomb Global Consumer, Surgical and Vision Care president Joe Gordon said: “OVDs are critical to surgeons’ success when performing cataract surgery, which is one of the most common surgical procedures performed in the United States. “StableVisc and TotalVisc provide surgeons with new OVD options that offer unique benefits designed to help ensure the best possible surgical outcomes for patients.” Both StableVisc and ClearVisc are composed of sodium hyaluronate and sorbitol, which is a chemical compound that produces a robust physical barrier and offers improved free radical scavenging abilities in comparison to other OVDs examined in a study. According to the eye health company, TotalVisc OVD delivers dual-action mechanical and chemical protection. TotalVisc is claimed to be the only dual pack in the US that has a dispersive and cohesive OVD formulated with sorbitol. StableVisc serves the cohesive OVD sector in fill volume at one millilitre. This lowers the need to open a second pack mid-procedure and improves surgical efficiency. Additionally, StableVisc provides enhanced free radical protection. TotalVisc is also said to have the highest fill volume in the dual-pack OVD market with one millilitre each of ClearVisc and StableVisc in the device.

Drug Approval

100 Deals associated with Sorbitol

External Link

KEGG	Wiki	ATC	Drug Bank
D00096	Sorbitol	A06AD18 B05CX02 A06AG07	DB01638

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Indication	Country/Location	Organization	Date
Edema	CN	Tianjin KingYork Group Hubei Tianyao Pharmaceutical Co., Ltd.	01 Jan 1981
Constipation	US	B. Braun Medical, Inc.	16 Feb 1978

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02634073 (CTgov)	Phase 4	HIV Infections	16	Lamivudine (A: Lamivudine 300 mg)	opevljqtza(nmulimrmde) = opwqkhdrcp vzqopszdqn (jbenraxhcy, xwjemkrfzh - iwhnogpyzb) View more	-	15 May 2017
				Sorbitol+Lamivudine (B: Lamivudine 300 mg + Sorbitol 3.2 g)	opevljqtza(nmulimrmde) = inwjvrqzph vzqopszdqn (jbenraxhcy, dwnabkndkv - lrlodbeisu) View more

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