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Clinical Trial News

BlueGenes and Levrx Partner to Integrate Real-Time Pharmacogenetic Testing into Pharmacy Benefit Systems

Precision Medicine
  • BlueGenes and Levrx Technology have formed a strategic partnership to integrate real-time genetic testing insights into pharmacy benefit systems, aiming to accelerate personalized prescribing adoption.
  • The collaboration addresses the critical issue of adverse drug reactions, which cause more than 100,000 deaths annually in the U.S., with BlueGenes targeting a 50% reduction in these fatalities.
  • The integrated solution identifies genetic risks and safer medication alternatives during claims processing, delivering actionable insights through Levrx's digital platform without requiring additional platforms or behavior changes from providers.
  • This partnership represents a shift from passive data collection to proactive decision-making in medication safety, potentially establishing a new standard for personalized healthcare delivery.

Onco-Innovations Partners with University of Alberta to Advance PNKP Inhibitor Research for Glioblastoma Treatment

Oncology
  • Onco-Innovations has entered into a research agreement with the University of Alberta and Cross Cancer Institute to expand preclinical studies of its PNKP inhibitor technology for hard-to-treat cancers, beginning with glioblastoma multiforme.
  • The study will focus on evaluating the therapeutic potential of the company's second-generation nanoparticle formulation of PNKP inhibitors against GBM, which accounts for approximately 50% of all primary malignant brain tumors and affects over 200,000 individuals worldwide annually.
  • Research will be led by Dr. Michael Weinfeld, the original discoverer of the PNKP inhibitor technology, with the preclinical program scheduled to begin in the third quarter of 2025.
  • Key investigation areas will include pharmacological characteristics, DNA damage enhancement in tumor models, effects on normal brain tissue, and potential combination strategies with standard-of-care therapies.

Varenicline-Bupropion Combination Shows Promise for Alcohol Use Disorder Treatment

  • A 13-week randomized trial of 384 patients with moderate to severe alcohol use disorder found that combining varenicline and bupropion produced approximately twice the effect of currently available medications.
  • The combination therapy significantly reduced alcohol consumption and cravings by targeting dopamine deficiency, which researchers hypothesize drives alcohol craving behavior.
  • Patients receiving the combination treatment experienced less nausea and shorter symptom duration compared to varenicline alone, potentially improving treatment completion rates.
  • The study provides pharmacological support for the dopamine deficiency hypothesis of alcohol use disorder and represents a significant advancement in addressing this condition that can reduce life expectancy by 25 years or more.

S.BIOMEDICS Reports Promising 12-Month Data for Parkinson's Cell Therapy A9-DPC in Phase 1/2a Trial

  • S.BIOMEDICS announced positive 12-month results from its Phase 1/2a trial of A9-DPC cell therapy for Parkinson's disease, showing favorable safety profile with no tumorigenesis or immune reactions observed.
  • The study demonstrated significant motor function improvements, with MDS-UPDRS Part III scores decreasing by 12.7 points in low-dose and 15.5 points in high-dose groups compared to baseline.
  • Brain imaging revealed increased dopamine transporter signals that correlated with clinical improvements, providing mechanistic evidence for the therapy's effectiveness in restoring neural connectivity.
  • The therapy consists of high-purity dopaminergic progenitor cells derived from human embryonic stem cells, transplanted bilaterally into the putamen of 12 Parkinson's patients.

Study to Evaluate the Safety and Efficacy of ESC-derived Dopamine Progenitor Cell Therapy in PD Patients

NCT05887466Active, Not RecruitingPhase 1
S.Biomedics Co., Ltd.
Posted 5/9/2023

TG01 Cancer Vaccine Shows Promising Clinical Activity in RAS-Mutant Multiple Myeloma

  • TG01 cancer vaccine demonstrated excellent safety profile and induced mutant RAS-specific T-cell responses in 50% of multiple myeloma patients in a phase 1/2 trial.
  • Six of twelve patients showed vaccine-induced immune responses, with five maintaining stable disease, suggesting clinical benefit in this difficult-to-treat population.
  • The study targets RAS-mutant multiple myeloma, which affects 15-20% of patients and has poor prognosis with no available targeted treatments.
  • Biomarker findings provide mechanistic validation and suggest specific patient selection criteria for future clinical development of the vaccine.

Pulmovant Publishes Phase 1 Data Supporting Once-Daily Inhaled Mosliciguat for Pulmonary Hypertension

  • Pulmovant published Phase 1 pharmacokinetics data in Clinical Pharmacokinetics showing inhaled mosliciguat has a longer half-life than oral and IV administration, supporting once-daily dosing.
  • Three Phase 1 studies in healthy male volunteers demonstrated mosliciguat was well tolerated with no evidence of serious systemic side effects or major effects on heart rate or blood pressure.
  • The data suggest long lung residence time and slow, continuous systemic release, informing the ongoing Phase 2 PHocus study for pulmonary hypertension associated with interstitial lung disease.
  • Mosliciguat represents the first sGC activator designed for dry powder inhalation, targeting up to 200,000 patients across the U.S. and Europe living with PH-ILD who have limited treatment options.

A Study of Mosliciguat in PH-ILD

NCT06635850RecruitingPhase 2
Pulmovant, Inc.
Posted 10/29/2024

Klotho Neurosciences Raises $11 Million Through Warrant Exercises, Achieves Debt-Free Status

  • Klotho Neurosciences raised over $11 million through the exercise of existing warrants by investors over a ten-day period, with Chardan Capital Markets serving as exclusive financial advisor.
  • The company utilized $3.1 million of the proceeds to extinguish all outstanding debt, achieving a debt-free balance sheet.
  • Klotho believes it now exceeds NASDAQ's stockholders' equity requirements outlined in its compliance plan, strengthening its listing position.
  • The biogenetics company focuses on developing cell and gene therapies using its patented Klotho gene technology for neurodegenerative diseases including ALS, Alzheimer's, and Parkinson's disease.

PolTREG Establishes U.S. Subsidiary Immuthera and Receives Positive EMA Opinion for Type 1 Diabetes Cell Therapy

CAR-T
  • PolTREG established Immuthera as a U.S. subsidiary in Delaware and submitted a Pre-IND application to the FDA to advance its T-regulatory cell therapies in the American market.
  • The European Medicines Agency's Paediatric Committee issued a positive opinion on PolTREG's Pediatric Investigation Plan for PTG-007, an autologous Treg therapy for preventing symptomatic type 1 diabetes in children.
  • The EMA committee recommended expanding the eligible patient population from ages 6-16 years to 3-18 years, suggesting the therapy demonstrates exceptional safety profile.
  • PolTREG operates one of Europe's largest GMP-certified manufacturing facilities with over 2,100 sqm of laboratory space and is the first company worldwide to administer Treg therapies to patients.

Olverembatinib Shows Promising Results in Multiple Philadelphia Chromosome-Positive ALL Studies

  • A prospective clinical trial demonstrated that olverembatinib combined with venetoclax and reduced-intensity chemotherapy achieved a 62.0% complete molecular response rate at 3 months in newly diagnosed Ph+ ALL patients.
  • The combination therapy showed excellent survival outcomes with 1-year overall survival and event-free survival rates of 93.1% and 89.1% respectively, without requiring intensive chemotherapy or immunotherapy.
  • Additional Phase II studies revealed olverembatinib's efficacy in various Ph+ ALL treatment settings, including first-line therapy with VP regimen achieving 100% overall response rate and relapsed/refractory disease treatment.
  • Transcriptomic analysis provided mechanistic evidence for the complementary action between tyrosine kinase inhibitors and venetoclax, supporting the rational combination approach.

Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for de Novo Ph+ ALL

NCT05594784CompletedPhase 2
Institute of Hematology & Blood Diseases Hospital, China
Posted 10/8/2022

UK Flair Trial Demonstrates Superior Outcomes with Chemotherapy-Free Combination Therapy for Chronic Lymphocytic Leukaemia

Targeted Therapy
  • The UK-wide Flair trial involving 786 patients showed that 94% of chronic lymphocytic leukaemia patients receiving ibrutinib plus venetoclax were alive with no disease progression after five years, compared to 79% on ibrutinib alone and 58% on standard chemotherapy.
  • The chemotherapy-free combination therapy achieved superior bone marrow clearance rates, with 66% of patients showing no detectable cancer after two years versus 48% on chemotherapy and none on ibrutinib monotherapy.
  • Researchers from Leeds Teaching Hospitals described the results as a "milestone" that could reshape treatment approaches for the most common adult leukaemia, offering more effective and tolerable personalized medicine options.

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