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Clinical Trial News

Kenya Slashes Breast Cancer Treatment Costs by 67% Through Roche Partnership

Oncology
  • The Kenyan Ministry of Health has partnered with Roche East Africa to reduce breast cancer treatment costs from Sh120,000 to Sh40,000 per session, representing a 67% cost reduction.
  • The agreement eliminates co-payments for patients at all Social Health Authority-accredited facilities, including public, faith-based, and private hospitals.
  • This initiative addresses a critical need as breast cancer affects 6,799 women annually in Kenya and accounts for 23.3% of all cancer diagnoses among women.
  • The partnership aims to strengthen Kenya's cancer care framework by improving access to essential medicines, enhancing healthcare professional capacity, and expanding screening programs.

Neuronata-R Stem Cell Therapy Shows Promise in ALS Subgroup, Targets FDA Accelerated Approval

Orphan Drug
  • CorestemChemon's Neuronata-R demonstrated statistically significant improvements in slow-progressing ALS patients across multiple efficacy measures including CAFS, ALSFRS-R scores, and respiratory function in Phase 3 subgroup analysis.
  • The autologous mesenchymal stem cell therapy showed consistent reductions in neurofilament light chain (NfL) biomarker levels, mirroring the regulatory pathway used for Tofersen's FDA accelerated approval.
  • The company plans to submit a biologics license application by Q4 2025 and target regulatory approval by mid-2026, following FDA meetings scheduled for Q3 2025.
  • While the overall Phase 3 trial missed its primary endpoint, post hoc analysis revealed meaningful clinical benefits in patients with slower disease progression, supporting a targeted therapeutic approach.

Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients with ALS

NCT04745299Active, Not RecruitingPhase 3
Corestemchemon, Inc.
Posted 3/23/2021

Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis

NCT01363401CompletedPhase 1
Corestemchemon, Inc.
Posted 2/1/2011

Acclaro Medical Secures $23 Million Series B Funding to Advance Revolutionary 2910 nm Fiber Laser Technology for Aesthetic Medicine

  • Acclaro Medical completed a $23 million Series B funding round led by Accelmed Partners to advance its groundbreaking 2910 nm fiber laser technology for aesthetic treatments.
  • The company's flagship UltraClear laser represents the first cold ablative fiber laser of its kind, offering improved safety for all skin types including previously high-risk skin-of-color patients.
  • The funding will accelerate global expansion of UltraClear and AuraLux products while supporting development of new technologies in the company's pipeline.
  • Accelmed's investment reflects confidence in Acclaro's potential to revolutionize laser aesthetics by enabling safe treatment of all skin types with a single device.

Accelus Secures Growth Financing to Advance Expandable Spinal Implant Technology

  • Accelus, a medical technology company specializing in expandable spinal implant technology, closed a new equity financing round led by Concord Health Partners to support commercial expansion and pipeline development.
  • The company has achieved significant clinical adoption with more than 32,000 cages implanted across 25 countries using its FlareHawk and Toro-L interbody fusion systems.
  • Industry veteran Bernie Haffey was appointed Chairman of the Board of Directors to oversee the company's next growth phase and expansion of minimally invasive spine surgery solutions.
  • The funding will enable Accelus to deepen its U.S. market presence and invest in future innovations for transforaminal lumbar interbody fusion, posterior lumbar interbody fusion, and other spine surgery techniques.

Navigator Medicines Initiates Phase 1b Trial of NAV-240 Bispecific Antibody for Autoimmune Diseases

  • Navigator Medicines has dosed the first participants in a Phase 1b trial of NAV-240, a bispecific antibody targeting both OX40L and TNFα for autoimmune diseases.
  • The multiple-ascending dose study will enroll approximately 24 healthy volunteers across three dosing cohorts, with interim data expected before year-end 2025.
  • NAV-240 demonstrated safety and tolerability in Phase 1a studies and supports once-monthly dosing, advancing development for complex autoimmune conditions like hidradenitis suppurativa.
  • The drug was originally developed by Y-Biologics, IMBiologics, and HK inno.N as IMB-101 before being licensed to Navigator Medicines for $944.7 million in June 2024.

LyoWave Secures $300K NSF Grant to Scale Microwave-Enhanced Freeze-Drying Technology for Pharmaceutical Manufacturing

  • LyoWave Inc. received a $304,436 Phase I SBIR grant from the National Science Foundation to advance its high-frequency microwave heating technology for pharmaceutical lyophilization.
  • The company's technology uses tunable microwave frequencies in the tens of gigahertz range to accelerate freeze-drying processes while maintaining product stability and uniformity.
  • LyoWave has partnered with Millrock Technology and secured additional funding from Indiana Economic Development Corp., positioning the company to scale from laboratory innovation to commercial manufacturing.
  • The technology could significantly reduce manufacturing costs and increase availability of injectable pharmaceuticals, vaccines, and diagnostic reagents by shortening drying cycles and improving energy efficiency.

CDMOs Expand End-to-End Services and Facilities to Meet Growing Pharmaceutical Manufacturing Demands

  • Contract Development and Manufacturing Organizations (CDMOs) are adopting comprehensive end-to-end regulatory solutions that encompass the entire pharmaceutical product lifecycle from development through regulatory approval.
  • CDMOs are expanding facilities and implementing automation systems to meet unprecedented demand for fill/finish services driven by increased biologics, vaccines, and personalized medicine production.
  • Industry experts report this trend reflects a shift toward collaborative partnerships between pharmaceutical companies and service providers to streamline operations and reduce development timelines.
  • The expansion includes assistance with formulation development, clinical trial material production, commercial manufacturing, and navigating complex regulatory frameworks to secure approvals.

Keros Therapeutics Discontinues PAH Drug Development Following Safety Concerns in Phase 2 Trial

  • Keros Therapeutics has discontinued development of cibotercept (KER-012) for pulmonary arterial hypertension after observing dose-dependent pericardial effusions in the TROPOS Phase 2 trial.
  • The company halted all dosing in the trial following safety reviews that revealed higher incidence rates of pericardial effusions compared to placebo and existing PAH treatments.
  • No clinically meaningful improvements in pulmonary vascular resistance or 6-minute walk distance were observed, leading to complete program termination.
  • The company is reducing its workforce by 45% to 85 employees, expecting $17 million in annual cost savings while exploring alternative development strategies.

A Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (PAH) (TROPOS Study).

NCT05975905CompletedPhase 2
Keros Therapeutics, Inc.
Posted 10/17/2023

SKYTROFA Receives Australian Approval as First Once-Weekly Growth Hormone Therapy for Children

Rare DiseaseDrug Approval
  • The Therapeutic Goods Administration has approved SKYTROFA (lonapegsomatropin) as a once-weekly injectable treatment for pediatric growth hormone deficiency in children aged 3-18 years.
  • The therapy addresses a rare condition affecting approximately 2,000 Australian children, offering a significant improvement over daily injection regimens previously required.
  • SKYTROFA utilizes Ascendis Pharma's TransCon technology platform to provide sustained release of unmodified growth hormone over one week.
  • The approval was based on three pivotal Phase 3 clinical trials that collectively treated over 300 pediatric patients with growth hormone deficiency.

A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency

NCT04615273CompletedPhase 3
Ascendis Pharma Endocrinology Division A/S
Posted 12/3/2020

Rune Labs and Parkinson's Foundation Launch Groundbreaking Study Combining Genetic Testing with AI-Powered Digital Biomarkers

Precision MedicineAI
  • Rune Labs and Parkinson's Foundation have launched the first clinical program to correlate genetic and digital biomarkers for Parkinson's disease, supported by the Global Parkinson's Genetics Program.
  • The study combines StrivePD AI software with Apple Watch monitoring and PD GENEration genetic testing to map gene variants to real-world symptom data in Parkinson's patients.
  • Researchers aim to identify biological and digital signatures that could enable earlier diagnosis, more precise patient stratification for clinical trials, and development of personalized treatment strategies.
  • Initial genotype-response findings are expected in 2026, with the goal of moving from average-patient dosing to genome-matched therapy recommendations for the 25 million people expected to have Parkinson's by 2050.

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