Open-label, Single Center Study of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY86-9596 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 18 µg Mass Dose) for Evaluation of Biodistribution in Pathological Tissue in Patients With Cancer or Inflammation

The study will be conducted as an open label, single-center, single dose and biodistribution study in patients with cancer or inflammation. 56 patients will be selected among the patients undergoing the screening examination conducted within 3 weeks before drug administration. Single dose of the study drug will be administrated in a dose of 300 MBq to these patients. The follow-up period contains the end-of-study telephone interview 5-8 days following the treatment. Key measurements are the PET/CT image acquisitions within a time frame of about 2 hours after the single injection of BAY86-9596.

Start Date01 May 2011

Sponsor / Collaborator

Life Molecular Imaging Ltd.

NL-OMON57022

/ CompletedNot Applicable

Open-label, multicenter study of the 18F labeled PET/CT (positron emission tomography / computed tomography) tracer BAY 86-9596 following a single intravenous administration of 200 or 300 MBq (corresponding to <= 18 µg mass dose), for evaluation of radiation dosimetry, plasma pharmacokinetics, safety and tolerability in healthy volunteers (200 MBq) as well as investigation of safety, tolerability and diagnostic performance in patients (300 MBq) with non small cell long cancer, breast cancer, hea - D-FMT: PET-POM study (proof of mechanism)

Start Date09 Jun 2010

Sponsor / Collaborator

Bayer AG

NCT01089998

/ CompletedPhase 1

Open-label, Multicenter Study of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY86-9596 Following a Single Intravenous Administration of 200 or 300 MBq (Corresponding to ≤ 18 µg Mass Dose) for Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers (200 MBq) as Well as Investigation of Safety, Tolerability and Diagnostic Performance in Patients (300 MBq) With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and in Patients With Inflammation.

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-9596 in patients with cancer and inflammation

Start Date01 May 2010

Sponsor / Collaborator

Life Molecular Imaging Ltd.

100 Clinical Results associated with BAY-86-9596

100 Translational Medicine associated with BAY-86-9596

100 Patents (Medical) associated with BAY-86-9596

Literatures (Medical) associated with BAY-86-9596

31 Dec 2024·Gut Microbes

The fecal microbiota of patients with primary biliary cholangitis (PBC) causes PBC-like liver lesions in mice and exacerbates liver damage in a mouse model of PBC

Article

Author: Yu, Ying ; Jiang, Huiyong ; Shao, Yini ; Lv, Longxian ; Li, Lanjuan ; Hu, Xiaoxiang ; Wang, Feiyu ; Chen, Lifeng ; Du, Bingbing ; Yan, Ren

The role of the gut microbiota in the occurrence and progression of primary biliary cholangitis (PBC) is not fully understood. First, the fecal microbiota of patients with PBC (n = 4) (PBC-FMT) or healthy individuals (n = 3) (HC-FMT) was transplanted into pseudo germ-free mice or 2OA-BSA-induced PBC models. The functions, histology and transcriptome of the liver, and microbiota and metabolome of the feces were analyzed. Second, the liver transcriptomes of PBC patients (n = 7) and normal individuals (n = 7) were analyzed. Third, the liver transcriptomes of patients with other liver diseases were collected from online databases and compared with our human and mouse data. Our results showed that PBC-FMT increased the serum ALP concentration, total bile acid content, liver injury and number of disease-related pathways enriched with upregulated liver genes in pseudo germ-free mice and increased the serum glycylproline dipeptidyl aminopeptidase level and liver damage in a 2OA-BSA-induced PBC model. The gut microbiota and metabolome differed between PBC-FMT and HC-FMT mice and reflected those of their donors. PBC-FMT tended to upregulate hepatic immune and signal transduction pathways but downregulate metabolic pathways, as in some PBC patients. The hematopoietic cell lineage, Toll-like receptor, and PPAR signaling pathway were not affected in patients with alcoholic hepatitis, HBV, HCV, HCV cirrhosis, or NASH, indicating their potential roles in the gut microbiota affecting PBC. In conclusion, the altered gut microbiota of PBC patients plays an important role in the occurrence and progression of PBC. The improvement of the gut microbiota is worthy of in-depth research and promotion as a critical aspect of PBC prevention and treatment.

01 Dec 2023·Journal of gastroenterology and hepatology

Hepatobiliary and pancreatic: Multi‐donor fecal microbiota transplantation attenuated high‐fat diet‐induced hepatic steatosis in mice by remodeling the gut microbiota

Article

Author: Huang, Hongli ; Luo, Qingling ; Chen, Huiting ; Shou, Diwen ; Tang, Wenjuan ; Zhou, Yongjian ; Cao, Chuangyu

Abstract:

Background and Aims:

Fecal microbiota transplantation (FMT) can improve the symptoms of nonalcoholic fatty liver disease (NAFLD) by restoring the gut microbiota. This study was aimed to evaluate the therapeutic effects of single‐donor (SD) or multi‐donor (MD) FMT in a mouse model of hepatic steatosis and explore the underlying mechanisms.

Methods:

Fecal samples were collected from NAFLD patients and healthy controls with similar baseline characteristics, with gut microbiota analyzed. Mice were fed either a normal‐chow diet (NCD) or a high‐fat diet (HFD) for 3 weeks and then administered fecal microbiota collected from healthy SDs or MDs for 12 weeks.

Results:

Fecal samples from NAFLD patients showed significantly lower microbial diversity than those from healthy controls. MD‐FMT reduced liver fat accumulation and body weight and significantly improved serum and liver biochemical indices in HFD‐fed mice. Compared to untreated HFD‐fed mice, MD‐FMT significantly decreased the relative expression of IL‐1β, IL‐6, TNF‐α, IFN‐γ, and IL‐1β mRNAs in the liver. The relative protein level of intestinal barrier components, including claudin‐1, occludin, and E‐cadherin, as well as serum lipopolysaccharide (LPS) level in mice, were found to be improved following MD‐FMT intervention. Furthermore, FMT reversed HFD‐induced gut dysbiosis and increased the abundance of beneficial bacteria such as Blautia and Akkermansia.

Conclusion:

NAFLD patients and healthy controls showed distinct gut microbiota. Likewise, HFD altered gut microbiota in mice compared to NCD‐fed controls. MD‐FMT restored gut dysbiosis in HFD‐fed mice and attenuated liver steatosis, and should be considered as an effective treatment option for NAFLD.

01 Feb 2018·Applied radiation and isotopes : including data, instrumentation and methods for use in agriculture, industry and medicineQ3 · ENGINEERING & TECHNOLOGY

One-pot radiosynthesis of O -[ 18 F]fluoromethyl- D -tyrosine via intra-molecular nucleophilic 18 F-fluorination with 1,2,3-triazolium triflate salt precursor

Q3 · ENGINEERING & TECHNOLOGY

Article

Author: Jeong, Jae Min ; Lee, Yun-Sang ; Chi, Dae Yoon ; Park, Chansoo ; Kim, Ho Young ; Lee, Ji Youn

A radiolabeled amino acid O-[¹⁸F]fluoromethyl-D-tyrosine (D-[¹⁸F]FMT) has been reported to show high tumor uptake. However, introduction of [¹⁸F]fluoromethyl group was difficult and was an issue to be solved. We solved it by using a precursor containing 1,2,3-triazolium salt. D-[¹⁸F]FMT was synthesized from (R)-1-((4-(2-((tert-butoxycarbonyl)amino)-3-((3,4-dimethylbenzyl)oxy)-3-oxopropyl)phenoxy)methyl)-3-methyl-4-phenyl-1H-1,2,3-triazol-3-ium trifluoromethanesulfonate via intra-molecular ¹⁸F-fluorination and subsequent removal of the protecting groups. The total synthesis time was 65min (including purification) and the overall radiochemical yield was 9% based on the isolated product (not decay-corrected). The resulting D-[¹⁸F]FMT was obtained with high radiochemical purity (> 99%) and specific activity (100-150 GBq/μmol). D-[¹⁸F]FMT also achieved excellent results in pharmacological evaluation such as stability test and protein binding assay. We expect that this simple one-pot labeling method would help using D-[¹⁸F]FMT more widely.

News (Medical) associated with BAY-86-9596

30 Aug 2022

·www.globenewswire.com

Neuronetics Announces 510(k) Clearance of D-Tect™ MT Accessory for NeuroStar® Advanced Therapy for Mental Health

MALVERN, Pa., Aug. 29, 2022 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a commercial stage medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced today that they have received 510(k) clearance for their D-Tect™ MT Accessory, which is the latest innovation in NeuroStar’s commitment to simplify the motor threshold determination for physicians. The FDA-cleared technology aids clinicians by visually reporting the magnitude of finger movements during motor threshold (MT) mapping for treatment of major depressive disorder (MDD). D-Tect also allows the MT determination to be performed by only one person. The D-Tect MT Accessory will initially be available via a limited commercial launch, with a national rollout beginning in mid-September. In addition, practices will be trained on this new product at NeuroStar University, which recently opened in Charlotte, North Carolina. “The FDA clearance for the D-Tect MT Accessory is the next chapter in our plan to simplify and accelerate the MT determination for NeuroStar providers,” stated Cory Anderson, VP of R&D and Clinical. “This product aids physicians as they determine the treatment location and treatment level for new patients, and we’re excited to announce that this patent-pending technology is compatible with all new and existing NeuroStar systems.” The D-Tect MT Accessory is designed to recognize the movement in three areas of the hand, and it does not require cords or sensors to be attached to the patient. This streamlines the process compared to the current visual method and provides the clinician with more data, including a comparison of the response to the current versus previous pulse. The D-Tect MT Accessory complements NeuroStar’s Fast MT™ and the MT Cap innovations, completing the solution for determining the motor threshold, and delivering an average time savings of 40% for physicians during the MT determination. “It’s outstanding to see tangible results from NeuroStar’s ongoing commitment to invest in product innovations that deliver real value to practices like mine by streamlining the entire NeuroStar TMS treatment process,” said David Sikowitz, MD of The TMS Center of New Jersey. “Having the latest technology to assist in determining a patient’s motor threshold will make my team more efficient while also allowing us to deliver the best patient care by personalizing each patient’s treatment while saving time.” The D-Tect MT Accessory is compatible across all NeuroStar systems. For more information on NeuroStar, please visit neurostar.com. About D-Tect™ MT Accessory The D-Tect™ MT Accessory is intended to be used as an accessory of the NeuroStar System to aid in the detection of hand movement and amplitude during motor threshold determination for the treatment of major depressive disorder (MDD). About Neuronetics Neuronetics, Inc. believes that mental health is as important as physical health. As a global leader in neuroscience, Neuronetics is redefining patient and physician expectations with its NeuroStar Advanced Therapy for Mental Health. NeuroStar is a non-drug, noninvasive treatment that can improve the quality of life for people suffering from neurohealth conditions when traditional medication hasn’t helped. NeuroStar is FDA-cleared for adults with major depressive disorder (MDD), as an adjunct for adults with obsessive-compulsive disorder (OCD), and to decrease anxiety symptoms in adult patients with MDD that may exhibit comorbid anxiety symptoms (anxious depression). NeuroStar Advanced Therapy is the leading transcranial magnetic stimulation (TMS) treatment for MDD in adults with over 4.8 million treatments delivered. NeuroStar is backed by the largest clinical data set of any TMS system for depression, including the world’s largest depression Outcomes Registry. Neuronetics is committed to transforming lives by offering an exceptional treatment that produces extraordinary results. For safety and prescribing information, www.neurostar.com.

100 Deals associated with BAY-86-9596

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 1	SG	Life Molecular Imaging Ltd.	01 May 2011
Breast Cancer	Phase 1	NL	Life Molecular Imaging Ltd.	01 May 2010
Breast Cancer	Phase 1	CH	Life Molecular Imaging Ltd.	01 May 2010
Head and Neck Neoplasms	Phase 1	NL	Life Molecular Imaging Ltd.	01 May 2010
Head and Neck Neoplasms	Phase 1	CH	Life Molecular Imaging Ltd.	01 May 2010
Non-Small Cell Lung Cancer	Phase 1	NL	Life Molecular Imaging Ltd.	01 May 2010
Non-Small Cell Lung Cancer	Phase 1	CH	Life Molecular Imaging Ltd.	01 May 2010
Inflammation	Phase 1	NL	Life Molecular Imaging Ltd.	01 May 2010
Inflammation	Phase 1	CH	Life Molecular Imaging Ltd.	01 May 2010
Solid tumor	Phase 1	NL	Bayer HealthCare Pharmaceuticals, Inc.	-

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