The purpose of this study is to determine if elevations in oxidative stress, as measured by oxidation-reduction potential (ORP), can distinguish between semen samples from men with abnormal semen parameters from those with normal semen parameters. Static ORP (sORP) results, measured by the MiOXSYS System- a novel technology, will be compared to the current World Health Organization (WHO) semen analysis parameters (5th Edition WHO Laboratory Manual for the Examination and Processing of Human Semen [2010]).

开始日期2025-09-01

申办/合作机构

Aytu Biopharma, Inc.

NCT05463679 / Suspended临床3期

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Enzastaurin for the Prevention of Arterial Events in Patients With Vascular Ehlers-Danlos Syndrome (vEDS) Confirmed With COL3A1 Mutations, Followed by an Open Label Extension (OLE)

The purpose of this study is to investigate the efficacy of enzastaurin compared to placebo in preventing arterial events (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) leading to intervention or mortality attributable to an arterial event in patients with vEDS confirmed with pathogenic heterozygous COL3A1 gene mutations predicted to derive a mutant protein.

开始日期2025-01-01

申办/合作机构

Aytu Biopharma, Inc.

[+1]

NCT05166915 / WithdrawnN/A

Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Randomized, Sham-Controlled Study

A study of intubated critically ill patients infected with SARS-COV-2 to evaluate the safety and treatment effects of ultraviolet-A (UVA) light administered by a novel device via endotracheal tube in a first-in-human study. Study hypothesis was that respiratory SARS-CoV-2 viral burden would significantly decrease following five (5) days of UVA therapy.

开始日期2022-10-01

申办/合作机构

Aytu Biopharma, Inc.

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项与 Aytu Biopharma, Inc. 相关的文献（医药）

2023-10-01·Applied microbiology and biotechnology

Environmental modulation of exopolysaccharide production in the cyanobacterium Synechocystis 6803

Article

作者: Bavington, Charles D ; Madsen, Mary Ann ; Semerdzhiev, Stefan ; Amtmann, Anna ; Moss, Claire ; Twigg, Jordan D

Abstract:

Microorganisms produce extracellular polymeric substances (EPS, also known as exopolysaccharides) of diverse composition and structure. The biochemical and biophysical properties of these biopolymers enable a wide range of industrial applications. EPS from cyanobacteria are particularly versatile as they incorporate a larger number and variety of building blocks and adopt more complex structures than EPS from other organisms. However, the genetic makeup and regulation of EPS biosynthetic pathways in cyanobacteria are poorly understood. Here, we measured the effect of changing culture media on titre and composition of EPS released by Synechocystis sp. PCC 6803, and we integrated this information with transcriptomic data. Across all conditions, daily EPS productivity of individual cells was highest in the early growth phase, but the total amount of EPS obtained from the cultures was highest in the later growth phases due to accumulation. Lowering the magnesium concentration in the media enhanced per-cell productivity but the produced EPS had a lower total sugar content. Levels of individual monosaccharides correlated with specific culture media components, e.g. xylose with sulfur, glucose and N-acetyl-galactosamine with NaCl. Comparison with RNA sequencing data suggests a Wzy-dependent biosynthetic pathway and a protective role for xylose-rich EPS. This multi-level analysis offers a handle to link individual genes to the dynamic modulation of a complex biopolymer.

Key points:

• Synechocystis exopolysaccharide amount and composition depends on culture condition• Production rate and sugar content can be modulated by Mg and S respectively• Wzy-dependent biosynthetic pathway and protective role proposed for xylose-rich EPS

Graphical Abstract:

2021-06-01·Journal of child and adolescent psychopharmacology3区 · 医学

Open-Label Dose Optimization of Methylphenidate Extended-Release Orally Disintegrating Tablet in a Laboratory Classroom Study of Children with Attention-Deficit/Hyperactivity Disorder

3区 · 医学

Article

作者: Marraffino, Andrea ; Childress, Ann C. ; Cutler, Andrew J. ; Kollins, Scott H. ; Sikes, Carolyn R.

Objective: To examine the efficacy, safety, and tolerability of methylphenidate extended-release orally disintegrating tablets (MPH XR-ODT) for the treatment of attention-deficit/hyperactivity disorder (ADHD) during the open-label dose-optimization/stabilization period of a phase 3 laboratory classroom study. Methods: Children (6-12 years) diagnosed with ADHD were enrolled. Treatment was initiated with MPH XR-ODT 20 mg daily. Doses were adjusted weekly by 10-20 mg during the 4-week dose-optimization period (visits 2-5) until an optimal dose was reached. The optimal dose was sustained during a 1-week stabilization period (visits 6-7). Efficacy was assessed using the ADHD Rating Scale-IV (ADHD-RS-IV) score and the Clinical Global Impression-Improvement (CGI-I) score. Adverse events (AEs) were recorded throughout the study. A secondary subgroup analysis by baseline ADHD-RS-IV score, sex, age, and weight was also performed. Results: The mean (standard deviation [SD]) final optimized MPH XR-ODT daily dose was 41.8 (14.6) mg and ranged from 20 to 60 mg. Final optimized dose was higher for children with more severe baseline ADHD-RS-IV total scores. ADHD-RS-IV total scores decreased progressively during dose optimization, with a mean (SD) change from baseline at visit 7 of -21.4 (8.9). CGI-I scores shifted from "minimally improved" (mean [SD]: 3.1 [1.1]) at visit 3 to "much improved" (1.6 [0.6]) at visit 7. Baseline ADHD-RS-IV total score was highest for participants optimized to 40 mg (mean [standard error]: 40.0 [1.4]) and lowest for those optimized to 20 mg (34.8 [2.1]). By visit 6, mean ADHD-RS-IV score was comparable for all optimized dose groups. Common treatment-emergent AEs (≥5% of participants) included decreased appetite, upper abdominal pain, headaches, and insomnia. Conclusions: Dose optimization of MPH XR-ODT led to a reduction in ADHD symptoms, indicated by a decrease in ADHD-RS-IV and CGI-I scores. AEs were consistent with those of other MPH products. Clinical Trial Registry: NCT01835548 (ClinicalTrials.gov).

2020-02-01·Journal of child and adolescent psychopharmacology

An Open-Label, Multicenter, Single-Dose Pharmacokinetic Study of a Novel Amphetamine Extended-Release Orally Disintegrating Tablet in Preschool-Aged Children

Article

作者: Marraffino, Andrea ; Laage, Thomas ; Sikes, Carolyn R. ; Volosov, Andrew ; Hart, Alison ; Engelking, Dorothy

Objective: In the U.S. ∼33% of children with attention-deficit/hyperactivity disorder (ADHD) are diagnosed during their preschool years (<6 years of age). The majority of these children are treated with a psychopharmacological treatment, despite limited data on pharmacokinetics (PKs), efficacy, or safety of these medications in this population. A phase 4, single-dose open-label study was conducted to assess the PK profile of amphetamine extended-release orally disintegrating tablets (AMP XR-ODT) under fasted conditions in preschool-aged children with ADHD. Methods: Preschool-aged children (aged 4 to <6 years) with a confirmed ADHD diagnosis were enrolled and administered AMP XR-ODT 3.1 mg under fasted conditions. Plasma samples were analyzed for d- and l-amphetamine (AMP) via liquid chromatography-tandem mass spectrometry. Area under the concentration-time curve from time 0 extrapolated to infinity (AUC_0-inf), area under the concentration-time curve from time 0 to the last measurable plasma concentration (AUC_0-T), maximum plasma concentration (C_max), time to maximum plasma concentration (T_max), terminal half-life (t_1/2), apparent volume of distribution (Vz/F), and apparent clearance (CL/F) for d- and l-AMP and safety were assessed. Results: The PK and safety analyses included 15 preschool-aged children (4 years old, n = 6; 5 years old, n = 9); 14 completed the study. Quantifiable plasma concentrations for d- and l-AMP were observed 1.5 hours postdose and throughout the 24-hour sampling period. For d- and l-AMP, mean AUC_0-inf was 315.2 and 104.4 h·ng/mL, AUC_0-T was 296.0 and 96.8 h·ng/mL, t_1/2 was 8.0 and 9.2 hours, C_max was 23.0 and 7.0 ng/mL, T_max was 3.9 and 4.0 hours, CL/F was 6996.3 and 6837.1 mL/h, and Vz/F was 75,874.5 and 84,140.0 mL, respectively. Adverse events included tachycardia (n = 2), neutropenia (n = 1), increased alanine aminotransferase (n = 1), and aspartate aminotransferase (n = 1). Conclusions: AMP XR-ODT 3.1 mg was well tolerated in preschool-aged children, with detectable plasma AMP concentrations over 24 hours, and a PK profile consistent with once-daily dosing.

项与 Aytu Biopharma, Inc. 相关的新闻（医药）

2024-09-19

·BioSpace

Aytu BioPharma to Report Fiscal 2024 Full Year and Fourth Quarter Operational and Financial Results on September 26, 2024

DENVER, CO / ACCESSWIRE / September 19, 2024 / Aytu BioPharma, Inc. (the “Company” or “Aytu”) (NASDAQ:AYTU), a pharmaceutical company focused on commercializing novel therapeutics, will report its operational and financial results for its fiscal 2024 full year and fourth quarter, after the market close on Thursday, September 26, 2024. The Company has scheduled a conference call and webcast that same day, Thursday, September 26, 2024, at 4:30 p.m. Eastern time, to review the results followed by a question and answer session. Conference Call Details Date and Time: Thursday, September 26, 2024, at 4:30 p.m. Eastern time. Call-in Information: Interested parties can access the conference call by dialing (888) 506-0062 for United States callers or +1 (973) 528-0011 for international callers and using the participant access code 216512. Webcast Information: The webcast will be accessible live and archived at , and accessible on the Investors section of the Company’s website at under Events & Presentations. Replay: A teleconference replay of the call will be available until October 10, 2024, at (877) 481-4010 for United States callers or +1 (919) 882-2331 for international callers and using replay access code 51231. About Aytu BioPharma, Inc. Aytu is a pharmaceutical company focused on commercializing novel therapeutics. The Company’s prescription products include Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) and Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of attention deficit hyperactivity disorder (ADHD), Karbinal® ER (carbinoxamine maleate), an extended-release antihistamine suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary fluoride-based prescription vitamin product lines available in various formulations for infants and children with fluoride deficiency. To learn more, please visit aytubio.com. Contacts for Investors Mark Oki, Chief Financial Officer Aytu BioPharma, Inc. moki@aytubio.com Robert Blum or Roger Weiss Lytham Partners aytu@lythampartners.com SOURCE: Aytu BioPharma, Inc. View the original press release on accesswire.com

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2024-05-23

·BioSpace

Aytu BioPharma to Participate in the Lytham Partners Spring 2024 Investor Conference on May 30, 2024

DENVER, CO / ACCESSWIRE / May 23, 2024 / Aytu BioPharma, Inc. (the Company or "Aytu") (NASDAQ:AYTU), a pharmaceutical company focused on commercializing novel therapeutics, today announced that Josh Disbrow, CEO, will participate in a webcasted fireside chat and host one-on-one meetings with investors at the Lytham Partners Spring 2024 Investor Conference, taking place virtually on Thursday, May 30, 2024. Webcast The webcasted fireside chat will take place at 1:15pm ET on Thursday, May 30, 2024. The webcast can be accessed by visiting the conference home page at or directly at . The webcast will also be available for replay following the event. 1x1 Meetings Management will be participating in virtual one-on-one meetings throughout the event. To arrange a meeting with management, please contact Lytham Partners at 1×1@lythampartners.com or register for the event at . About Aytu BioPharma, Inc. Aytu is a pharmaceutical company focused on commercializing novel therapeutics. The Company's prescription products include Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) and Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of attention deficit hyperactivity disorder (ADHD), Karbinal® ER (carbinoxamine maleate), an extended-release antihistamine suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary fluoride-based prescription vitamin product lines available in various formulations for infants and children with fluoride deficiency. To learn more, please visit aytubio.com. Contacts for Investors: Mark Oki, Chief Financial Officer Aytu BioPharma, Inc. moki@aytubio.com Robert Blum or Roger Weiss Lytham Partners AYTU@lythampartners.com SOURCE: Aytu BioPharma, Inc. View the original press release on accesswire.com

2024-05-08

·BioSpace

Aytu BioPharma to Report Third Quarter Fiscal 2024 Financial and Operational Results on May 15, 2024

DENVER, CO / ACCESSWIRE / May 8, 2024 / Aytu BioPharma Inc. (the "Company" or "Aytu") (NASDAQ:AYTU), a pharmaceutical company focused on commercializing novel therapeutics, will report its financial and operational results for its third quarter of fiscal 2024 for the period ended March 31, 2024, after the market close on Wednesday, May 15, 2024. The Company has scheduled a conference call and webcast that same day, Wednesday, May 15, 2024, at 4:30 p.m. Eastern time, to review the results followed by a question and answer session. Conference Call Details Date and Time: Wednesday, May 15, 2024, at 4:30 p.m. Eastern Time Call-in Information: Interested parties can access the conference call by dialing (888) 506-0062 for U.S. callers or +1 (973) 528-0011 for international callers and using the participant access code 300411. Webcast Information: The webcast will be accessible live and archived at , and accessible on the Investors section of the Company's website at under Events & Presentations. Replay: A teleconference replay of the call will be available until May 29, 2024 at (877) 481-4010 for U.S. callers or +1 (919) 882-2331 for international callers and using replay access code 50379. About Aytu BioPharma, Inc. Aytu is a pharmaceutical company focused on commercializing novel therapeutics. The Company's prescription products include Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) and Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of attention deficit hyperactivity disorder (ADHD), Karbinal® ER (carbinoxamine maleate), an extended-release antihistamine suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary fluoride-based prescription vitamin product lines available in various formulations for infants and children with fluoride deficiency. To learn more, please visit aytubio.com. Contacts for Investors: Mark Oki, Chief Financial Officer Aytu BioPharma, Inc. moki@aytubio.com Robert Blum or Roger Weiss Lytham Partners aytu@lythampartners.com SOURCE: Aytu BioPharma, Inc. View the original press release on accesswire.com

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