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Clinical Trial News

Ascentage Pharma Strengthens Leadership Team with New CFO and Senior VP Appointments

  • Ascentage Pharma appointed Dr. Veet Misra as Chief Financial Officer and Eric Huang as Senior Vice President of Global Corporate Development and Finance to support the company's global expansion strategy.
  • Dr. Misra brings over 20 years of investment banking experience in the biopharmaceutical sector, having previously served as Managing Director at Cantor Fitzgerald covering biotechnology companies.
  • The appointments come as Ascentage Pharma advances its pipeline of apoptosis-targeted therapies, including olverembatinib for chronic myeloid leukemia and lisaftoclax for hematologic malignancies.
  • The company is currently conducting multiple global Phase III trials and has established partnerships with major pharmaceutical companies including Takeda, AstraZeneca, Merck, and Pfizer.

FDA Approves First Xolair Biosimilar Omlyclo for Allergic Diseases, Marking Milestone in Allergy Treatment Access

Monoclonal AntibodyDrug Approval
  • The FDA has approved Omlyclo (omalizumab-igec) as the first biosimilar interchangeable with Xolair for treating allergic asthma, chronic rhinosinusitis with nasal polyps, chronic urticaria, and food allergies.
  • Omlyclo demonstrated comparable efficacy and safety to Xolair in a Phase 3 clinical trial involving 619 adults with chronic spontaneous urticaria, with similar itch severity improvements and adverse event rates.
  • The biosimilar will not be available until September 2026 due to Xolair's patent exclusivity, but is expected to cost 15-35% less than the reference drug.
  • Pharmacists can substitute Omlyclo for Xolair without physician consultation due to its interchangeable designation, potentially broadening access to this important allergy medication.

To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria

NCT04426890CompletedPhase 3
Celltrion
Posted 12/9/2020

YIV-906 Shows Promising Results in Phase 2b Trial for Advanced Hepatocellular Carcinoma with Hepatitis B

  • Yiviva's Phase 2b study demonstrated that YIV-906 plus sorafenib significantly improved median overall survival to 14.3 months versus 7.5 months with sorafenib alone in HBV-positive advanced hepatocellular carcinoma patients.
  • The combination therapy also extended median progression-free survival to 4.1 months compared to 3.5 months and median time to tumor progression to 5.59 months versus 2.33 months with sorafenib monotherapy.
  • Patients receiving YIV-906 showed improved tolerability with greater treatment duration and continuation, supporting the drug's potential as a pan-adjuvant that enhances both efficacy and safety.
  • The multi-targeted botanical drug acts as an immunomodulator in the tumor microenvironment and has received two FDA Orphan Drug Designations for hepatocellular carcinoma and pancreatic cancers.

YIV-906 (Formerly PHY906/KD018) With Sorafenib in HBV(+) Hepatocellular Carcinoma (HCC)

NCT04000737CompletedPhase 2
Yiviva Inc.
Posted 1/10/2020

Artelo's ART12.11 Cocrystal Shows Superior Antidepressant Effects Over Leading SSRI in Preclinical Study

  • Artelo Biosciences' ART12.11, a novel CBD-tetramethylpyrazine cocrystal, demonstrated antidepressant efficacy comparable to sertraline in a 28-day preclinical study using chronic stress-induced depression models in male rats.
  • The experimental drug showed superior cognitive restoration capabilities compared to sertraline, reversing stress-induced deficits in both spatial and short-term memory without negatively impacting social memory.
  • ART12.11 successfully restored hedonic and social behaviors to near-baseline levels, positioning it as a potential next-generation treatment for depression with cognitive benefits that existing SSRIs lack.
  • The findings were presented at the 35th Annual International Cannabinoid Research Society Symposium, marking the first preclinical study to directly compare ART12.11 against a leading SSRI antidepressant.

Nanobiotix Secures EU Regulatory Harmonization and New Patent for Cancer Radioenhancer JNJ-1900

  • European health authorities have reclassified JNJ-1900 (NBTXR3) from a medical device to a medicinal product, harmonizing its regulatory status with the US and other major markets.
  • Nanobiotix filed a new composition of matter patent for JNJ-1900 to strengthen the intellectual property foundation of the potential first-in-class radioenhancer.
  • The developments support the global positioning of JNJ-1900, which is currently undergoing comprehensive clinical development including a pivotal Phase 3 trial in head and neck cancer.
  • JNJ-1900 is composed of functionalized hafnium oxide nanoparticles administered via intratumoral injection and activated by radiotherapy to induce tumor cell death and immune response.

Intranasal COVID-19 Vaccines Show Superior Mucosal Immunity and Long-Term Protection in Preclinical Studies

  • Two independent studies demonstrate that intranasal COVID-19 vaccination induces robust mucosal immunity, including durable IgA responses and tissue-resident memory T cells in the respiratory tract, which intramuscular vaccination fails to achieve.
  • Novel albumin-fusion vaccine technology shows promise for needle-free delivery, with engineered human serum albumin variants enhancing mucosal transport and generating protective antibody responses against multiple SARS-CoV-2 variants.
  • Intranasal ChAdOx1 nCoV-19 booster vaccination provides superior and more durable protection in the upper respiratory tract compared to intramuscular mRNA vaccination, maintaining efficacy up to 84 days post-vaccination.
  • Both studies highlight the critical importance of mucosal immunity at the site of viral entry for preventing respiratory infections and potentially reducing transmission.

Insurance Disparities Widen Cancer Survival Gaps Despite Immune Checkpoint Inhibitor Advances

  • A new American Cancer Society study reveals that immune checkpoint inhibitors, while improving survival across all insurance groups, have widened survival disparities between uninsured patients and those with private insurance for advanced melanoma, lung, and kidney cancers.
  • Two-year survival rates for stage IV melanoma patients increased from 16.2% to 28.3% among uninsured individuals compared to 28.7% to 46.0% among privately insured patients, creating a 6.1 percentage point disparity gap.
  • The study analyzed 183,440 patients diagnosed between 2002-2019 and found that Medicaid patients showed similar survival improvements to privately insured patients, suggesting Medicaid expansion could help bridge access gaps.
  • Researchers emphasize the urgent need for health policies expanding insurance coverage and making costly immunotherapies more affordable as these treatments become standard care for early and late-stage cancers.

PD-L1 Expression Correlates with HRD Status and Predicts Survival in High-Grade Serous Ovarian Cancer

  • An ancillary analysis of the phase 3 PAOLA-1 trial revealed that PD-L1 expression is significantly associated with homologous recombination deficiency (HRD) status in newly diagnosed advanced high-grade serous ovarian cancer patients.
  • PD-L1 positivity was more frequently observed in HRD-positive tumors, with 70.4% of HRD-positive patients showing PD-L1 CPS ≥1 compared to 53% of HRD-negative patients.
  • PD-L1 positivity independently predicted improved overall survival, with hazard ratios of 0.70 for CPS scoring and 0.68 for immune cell scoring in multivariate analysis.
  • The findings suggest PD-L1 may serve as a complementary biomarker to HRD for identifying distinct tumor biology and prognostic profiles in ovarian cancer.

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

NCT03522246Active, Not RecruitingPhase 3
pharmaand GmbH
Posted 5/14/2018

Platine, Avastin and OLAparib in 1st Line

NCT02477644CompletedPhase 3
Arcagy Research
Posted 5/6/2015

ASPIVIX Launches MHRA-Approved Carevix Cervical Stabilizer in UK, Demonstrating 73% Pain Reduction in IUD Procedures

  • ASPIVIX has partnered with AGHealth to launch Carevix, an MHRA-approved non-traumatic suction cervical stabilizer in the UK, offering a modern alternative to traditional tenaculum forceps.
  • Clinical trials demonstrated that Carevix achieved a 73% reduction in pain and 78% reduction in bleeding during IUD placement compared to standard tenaculum procedures.
  • The device addresses a significant barrier to contraceptive adoption, as fear of pain during IUD insertion affects 30% to 45% of women globally, representing approximately 120 million women annually.
  • Real-world evaluation through the Carevix Ambassador Program across 21 centers in 9 countries showed 96% clinician satisfaction and 94% overall patient satisfaction rates.

Blue Lake and CyanVac Report Promising Phase 1 Results for Intranasal COVID-19 Vaccine CVXGA

  • Blue Lake Biotechnology and CyanVac published full Phase 1 data in Science Advances showing their intranasal COVID-19 vaccine candidate CVXGA demonstrated safety and immunogenicity in 72 healthy subjects aged 12-51 years.
  • The single-dose PIV5-vectored vaccine achieved 92% CD8+ T cell response rates in low-dose groups and 89% in high-dose groups, with 31-41% of high-dose participants developing three-fold increases in mucosal antibodies.
  • High-dose CVXGA1 showed 67.8% relative vaccine effectiveness against symptomatic COVID-19 infection at 7.3 months post-vaccination compared to low-dose recipients (p=0.048).
  • The vaccine stimulated all three pillars of immunity—humoral, cellular, and mucosal—with minimal reactogenicity and no serious adverse events related to vaccination.

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