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Clinical Trial News

Bharat Biotech and Hilleman Laboratories Launch Oral Cholera Vaccine, Hillchol, in India

  • Bharat Biotech has launched Hillchol, an oral cholera vaccine developed in partnership with Hilleman Laboratories, after successful Phase III trials.
  • Hillchol utilizes a single, genetically engineered inactivated Hikojima bacteria strain and is manufactured in Hyderabad, India.
  • The vaccine aims to address the growing global shortage of cholera vaccines, with Bharat Biotech having capacity to produce 200 million doses.
  • Hilleman Laboratories, a joint venture between MSD and Wellcome Trust, facilitated the vaccine's development from Phase II through technology transfer.

THINK Surgical's TMINI Robot Cleared for Zimmer Biomet's Persona Knee System

  • THINK Surgical received FDA 510(k) clearance for its TMINI robotic system to be used with Zimmer Biomet's Persona Knee System, expanding surgical options.
  • The TMINI system features a wireless, handheld design intended to enhance precision in total knee replacement procedures, particularly in outpatient settings.
  • This clearance positions THINK Surgical as the only company offering both an implant-exclusive option and an open implant platform for total knee arthroplasty.
  • Zimmer Biomet plans a limited launch of the customized TMINI system in select U.S. markets in the second half of 2024, offering advanced robotic assistance.

Moderna's mRNA-1769 Vaccine Shows Superior Protection Against Mpox in Preclinical Study

  • Moderna's mRNA-1769 vaccine demonstrated superior efficacy in preventing severe mpox disease compared to the Jynneos vaccine in a monkey model.
  • The mRNA vaccine led to reduced viral replication in blood and throat, along with decreased lesion formation, suggesting potential for reduced transmission.
  • mRNA-1769 targets four mpox virus antigens, leveraging mRNA technology for rapid development and adaptability to emerging viral strains.
  • A Phase I/II clinical trial (NCT05995275) is underway in the UK, with data expected in mid-2025 to inform Phase III trial design.

A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines

NCT05988203Active, Not RecruitingPhase 1
BioNTech SE
Posted 9/21/2023

A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of Age to <50 Years of Age

NCT05995275CompletedPhase 1
ModernaTX, Inc.
Posted 8/15/2023

Phage Therapy Shows Promise in Largest UTI Clinical Trial

• A recent clinical trial, the largest of its kind, suggests phage therapy is a promising treatment for urinary tract infections (UTIs). • The study demonstrated the potential of phages to target and eliminate bacterial pathogens responsible for UTIs, offering an alternative to traditional antibiotics. • Researchers are optimistic about the role of phage therapy in combating antibiotic resistance, a growing concern in treating bacterial infections. • Further research is needed to optimize phage cocktails and delivery methods for broader clinical application in UTI treatment.

Lupin Gains US FDA Approval for Generic Mirabegron to Treat Overactive Bladder

  • Lupin has received US FDA approval for its generic version of Mirabegron extended-release tablets (50 mg) used to treat overactive bladder.
  • The generic drug is an equivalent to Astellas Pharma's Myrbetriq, with estimated annual sales of $1.6 billion in the US.
  • Lupin and Zydus are the only companies with approval for both 25 mg and 50 mg strengths, potentially securing a six-month exclusivity period.
  • Lupin's stock price reached a 52-week high following the announcement, reflecting positive market sentiment.

Light-Activated Therapy Shows Promise in Improving Oral Health for Adolescents with Braces

  • A clinical trial is underway to assess light-activated antibacterial therapy's effectiveness in improving plaque control for adolescents with braces.
  • The Lumoral device, combining antibacterial blue and red light with a photosensitive mouth rinse, aims to reduce harmful bacteria and plaque buildup.
  • Orthodontic treatments with fixed appliances pose oral hygiene challenges, increasing the risk of caries and gingivitis in adolescent patients.
  • Preliminary findings suggest that light-activated therapy could be a valuable tool in minimizing the oral health risks associated with orthodontic treatments.

Tisagenlecleucel Shifts to Earlier Use in Pediatric B-ALL Treatment

  • Tisagenlecleucel is increasingly used in earlier lines of therapy for pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL).
  • A study showed a decrease in patients receiving tisagenlecleucel in later relapses and a reduction in hematopoietic stem cell transplants (HSCT) prior to CAR T-cell therapy.
  • Morphologic complete remission rates have increased, particularly in patients without morphologic disease, following tisagenlecleucel treatment.
  • Long-term safety profiles of tisagenlecleucel remain favorable across age groups, with expected low incidence of high-grade cytokine release syndrome.

A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL

NCT04984356CompletedPhase 1
Wugen, Inc.
Posted 1/14/2022

Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients

NCT02435849CompletedPhase 2
Novartis Pharmaceuticals
Posted 4/8/2015

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

NCT04245839RecruitingPhase 2
Celgene
Posted 7/14/2020

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

NCT02631044CompletedPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 1/6/2016

A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)

NCT02614066CompletedPhase 1
Kite, A Gilead Company
Posted 3/7/2016

NImmune and BioTherapeutics Form Strategic Alliance to Accelerate Precision Medicine Development for Autoimmune Diseases

  • NImmune Biopharma partners with BioTherapeutics to enhance precision immunology capabilities through advanced preclinical services and regulatory expertise.
  • The collaboration will utilize BioTherapeutics' sophisticated animal models, including pig models for inflammatory bowel disease, and computational platforms for drug development.
  • This partnership expands NImmune's R&D ecosystem, building on their successful track record with NIMML Institute that led to the development and AbbVie acquisition of NX-13.

NOX Inhibitors Show Promise in Fibrotic Diseases and Cancer Treatment

  • NADPH oxidase (NOX) inhibitors are emerging as potential treatments for fibrotic diseases and cancers by reducing reactive oxygen species (ROS) production.
  • Calliditas Therapeutics' setanaxib, a NOX1 and NOX4 inhibitor, has shown promise in reverting cancer-associated fibroblasts to a normal state, enhancing CD8+ T-cell penetration into tumors.
  • Phase II trial data indicates that setanaxib, combined with pembrolizumab, significantly improved overall survival in patients with squamous cell carcinoma of the head and neck (SCCHN).
  • Setanaxib is also being investigated for primary biliary cholangitis and Alport Syndrome, with data readouts expected in Q3 2024 and Q1 2025, respectively.

Alzamend Neuro Partners with Mass General for Phase 2 Trial of AL001 in Alzheimer's

  • Alzamend Neuro is collaborating with Massachusetts General Hospital to advance AL001, a novel lithium-delivery system, into a Phase 2 clinical trial for Alzheimer's disease.
  • The trial aims to compare brain levels of AL001 with those of marketed lithium, seeking to determine the minimum effective dose and evaluate the therapy’s safety profile.
  • AL001 is designed to deliver lithium specifically to the brain, potentially reducing exposure to other organs and minimizing side effects compared to current lithium treatments.
  • Previous Phase 1/2 trial data suggest AL001 was generally well-tolerated and achieved similar lithium blood levels at lower doses than marketed lithium.

Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects

NCT05363293CompletedPhase 1
Alzamend Neuro, Inc.
Posted 5/4/2022

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