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Clinical Trial News

Merck KGaA Partners with Iktos to Accelerate Drug Discovery Through AI-Powered Molecular Design

• Merck KGaA has established a new collaboration with AI technology firm Iktos, leveraging deep generative models to expedite the discovery and design of novel drug compounds.
• The partnership aims to address a critical challenge in drug development by rapidly identifying molecules that meet multiple drug-like criteria for clinical testing, potentially accelerating patient access to new treatments.
• This marks Merck's second major AI initiative following their recent agreement with Cyclica, demonstrating the company's strategic commitment to incorporating artificial intelligence in their R&D process.

BrainStorm Announces First Patient in Phase 2 Clinical Trial for Progressive MS

BrainStorm Cell Therapeutics Inc. has enrolled the first patient in its Phase 2 clinical trial for progressive Multiple Sclerosis (MS), utilizing its NurOwn® technology platform. This trial represents a significant step towards addressing the unmet medical needs in progressive MS, with top-line data expected by mid-2020.

Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients

NCT03280056CompletedPhase 3
Brainstorm-Cell Therapeutics
Posted 8/28/2017

Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS

NCT03799718CompletedPhase 2
Brainstorm-Cell Therapeutics
Posted 3/13/2019

Innovations and Trials in Medical Technology

Recent advancements in medical technology include the launch of the CrossWise RF transseptal access system by Circa Scientific, completion of enrollment in a pivotal trial for Inquis Medical's Aventus thrombectomy system, a distribution agreement between Medtronic and Contego Medical, a $12 million Series A round for Relief Cardiovascular, CE mark approval for Johnson & Johnson MedTech's dual-energy catheter, a temporary pause on Varipulse PFA system cases by Johnson & Johnson MedTech, and the completion of a first-in-human study by AerWave for its lung denervation therapy.

Expanding Cancer Clinical Trial Eligibility to Include More Patients

The National Cancer Institute (NCI) and other organizations are working to broaden eligibility criteria for cancer clinical trials, aiming to include more patients and make trial results more applicable to the general population. This effort includes relaxing restrictions on age, HIV status, and other factors, while ensuring patient safety and the integrity of trial outcomes.

FDA Approves Resmetirom (Rezdiffra) for Treating MASH and Associated Fibrosis

The FDA has approved resmetirom, marketed as Rezdiffra, for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis. This marks a significant advancement in addressing a condition that affects millions globally, particularly those with type 2 diabetes and obesity.

OHSU Researchers Develop Promising Long-Lasting Malaria Vaccine Using Novel Viral Platform

• Scientists at Oregon Health & Science University have developed a novel malaria vaccine that eliminated 75-80% of parasites in vaccinated rhesus macaques, offering a potential breakthrough in the fight against a disease that kills nearly 500,000 people annually.
• The innovative approach uses cytomegalovirus (CMV) as a delivery vehicle to train immune T-cells to target the malaria parasite in the liver before it enters the bloodstream, potentially providing lifelong protection unlike current vaccines.
• While still in early research stages, the vaccine maintained its effectiveness in monkeys a year after administration, suggesting it could overcome the limited durability that has hampered previous malaria vaccine efforts.

FDA Approves Ontruzant, Samsung Bioepis and Merck's Biosimilar to Herceptin for Cancer Treatment

• The FDA has granted approval for Ontruzant, a biosimilar version of Roche's Herceptin, developed by Samsung Bioepis and to be marketed by Merck & Co in the United States.
• The biosimilar is approved for multiple indications including HER2-positive breast cancer and metastatic gastric cancer, offering a potentially more affordable treatment option.
• This marks Samsung Bioepis' first FDA-approved oncology biosimilar, joining other competitors like Celltrion/Teva and Mylan in the Herceptin biosimilar market.

Novel Liquid Biopsy System Shows Promise in Preventing Cancer Metastasis

  • University of Basel researchers demonstrate Angle's Parsortix system can capture over 99% of circulating tumor cell clusters from blood samples, enabling breakthrough metastasis prevention research.
  • FDA-approved drugs identified through the system successfully disrupted cancer cell clusters in mouse models, reducing metastasis by 80-fold without typical chemotherapy side effects.
  • Clinical trials planned for 2019 will use Parsortix as a companion diagnostic in breast cancer patients to identify those who may benefit from cluster-disrupting therapy.

New Study Explores Treatment for Hot Flashes in Women with HR-Positive Breast Cancer

A clinical trial is investigating the effectiveness of elinzanetant, a new treatment for vasomotor symptoms (VMS) or hot flashes in women with or at high risk for hormone-receptor positive breast cancer. The study aims to compare the efficacy and safety of elinzanetant against a placebo, with participants recording their symptoms and undergoing various health checks over a 62-week period.

FDA Rejects Mallinckrodt's Abuse-Deterrent Roxicodone Reformulation

  • The FDA issued a Complete Response Letter for SpecGx LLC's abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride) tablets.
  • The agency provided guidance on areas needing further evaluation before the NDA can be resubmitted for potential approval.
  • Mallinckrodt plans to meet with the FDA to discuss the letter and explore pathways for approval, emphasizing the drug's potential to mitigate opioid abuse.

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