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Clinical Trial News

Advances in the Clinical Development of Oncolytic Viruses

This article reviews the progress in clinical trials of oncolytic viruses (OVs) for cancer treatment, highlighting their safety, effectiveness, and the challenges faced in their development. OVs selectively infect and kill cancer cells without harming normal cells, showing promise in treating various tumors with mild adverse events.

Radiofrequency Ablation Combined With Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma.

NCT03790059Unknown StatusNot Applicable
Southwest Hospital, China
Posted 10/1/2016

Intraperitoneal Injection of Oncolytic Viruses H101 for Patients With Refractory Malignant Ascites

NCT04771676CompletedPhase 2
Fudan University
Posted 3/5/2021

HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B

NCT03780049Unknown StatusPhase 3
Sun Yat-sen University
Posted 10/1/2018

Intra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies

NCT05051696Active, Not RecruitingPhase 2
Liu Zi
Posted 9/26/2021

TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma

NCT01869088Unknown StatusPhase 3
Sun Yat-sen University
Posted 1/1/2013

Systemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients

NCT02579564Unknown StatusPhase 3
Xinqiao Hospital of Chongqing
Posted 10/1/2016

Valbiotis Announces Major Success in Phase II HEART Clinical Study for TOTUM-070

Valbiotis has reported significant success in its Phase II HEART clinical study, demonstrating that TOTUM-070, a patented plant-based active substance, effectively reduces LDL cholesterol and triglycerides, key cardiovascular risk factors, in individuals with mild to moderate hypercholesterolemia. The study, involving 120 volunteers, showed promising results after just three months of supplementation, with plans for commercialization by the first half of 2024.

Sling Therapeutics Launches with $35M Series A Financing to Develop Oral Small Molecule for Thyroid Eye Disease

Sling Therapeutics, Inc. has officially launched with a $35M Series A financing led by TPG's The Rise Fund, aiming to develop linsitinib, an oral small molecule for treating Thyroid Eye Disease (TED). The company has received FDA IND clearance and is preparing to initiate a Phase 2b clinical trial. Linsitinib, designed to inhibit the IGF-1R signaling pathway, offers a potential convenient oral treatment option for TED patients, aiming to reduce the treatment burden significantly.

Lead Pharma and Oxeltis Secure €800K Grant to Develop First-in-Class DLBCL Therapy

OncologyDrug Discovery
  • Lead Pharma and Oxeltis received an €800K EUREKA Eurostars grant to fund their three-year EPIGENEXT project developing a first-in-class small molecule therapy for diffuse large B-cell lymphoma.
  • DLBCL affects approximately 115,000 people worldwide annually, with 30-50% of patients experiencing relapse after standard R-CHOP treatment and poor long-term survival rates.
  • The collaboration aims to address the significant unmet medical need in DLBCL treatment, where current chemotherapy approaches cause debilitating side effects and fail to cure nearly half of patients.

Bayer's BlueRock Therapeutics Expands to Europe with New Berlin Site

Bayer AG announced the establishment of a new site for BlueRock Therapeutics in Berlin, Germany, to strengthen its cell therapy capabilities and accelerate the development of innovative treatments, including the ongoing BRT-DA01 clinical trial for Parkinson's disease.

FDA Draft Guidance Supports Use of ctDNA in Early-Stage Solid Tumor Drug Development

  • The FDA issued draft guidance on using circulating tumor DNA (ctDNA) as a biomarker in early-stage solid tumor clinical trials and in vitro diagnostic assays.
  • ctDNA, derived from tumors, is used in liquid biopsies to detect tumors, monitor progression, and detect minimal residual disease (MRD), aiding in cancer relapse prediction.
  • The guidance outlines four main uses for ctDNA in clinical trials: patient selection, patient enrichment, response measurement, and as an early endpoint.
  • The FDA provides recommendations for ctDNA assay types, sampling, analytical validation, and encourages sponsors to consult with the agency on validation plans.

DBV Technologies Announces Positive Topline Results from Phase 3 EPITOPE Trial of Viaskin Peanut in Peanut-Allergic Toddlers

DBV Technologies has announced positive topline results from its Phase 3 EPITOPE trial, evaluating the safety and efficacy of Viaskin Peanut in treating peanut-allergic toddlers aged 1 to 3 years. The trial met its primary endpoint, showing a significant treatment effect with 67.0% of subjects in the Viaskin Peanut arm meeting response criteria at 12 months, compared to 33.5% in the placebo arm.

Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age

NCT03211247CompletedPhase 3
DBV Technologies
Posted 7/31/2017

Dostarlimab Achieves 100% Complete Response Rate in Rectal Cancer Trial with Mismatch Repair Deficiency

  • A phase 2 clinical trial at Memorial Sloan Kettering Cancer Center found that dostarlimab achieved complete cancer remission in all 14 patients with locally advanced rectal cancer harboring mismatch repair deficiency mutations.
  • Patients received dostarlimab every three weeks for six months, avoiding the need for standard chemotherapy, radiation, and surgery while maintaining normal body functions and quality of life.
  • The immunotherapy drug targets a rare genetic subtype affecting 5-10% of rectal cancer patients, with follow-up ranging from six to 25 months showing no cancer recurrence.
  • Researchers emphasize the need for larger studies to confirm these unprecedented results and determine long-term cure rates in this specific patient population.

FDA Approves Fylnetra, Fifth Biosimilar of Neulasta, for Febrile Neutropenia

  • The FDA has approved Fylnetra (pegfilgrastim-pbbk), a biosimilar referencing Neulasta, developed by Amneal Pharmaceuticals and Kashiv Biosciences.
  • Fylnetra is indicated to treat or prevent febrile neutropenia in cancer patients undergoing chemotherapy, addressing a critical need in supportive cancer care.
  • This approval marks the fifth pegfilgrastim biosimilar in the US, the third biosimilar approval for Amneal, and the second drug approval for Kashiv Biosciences.
  • Amneal Pharmaceuticals anticipates launching Fylnetra, along with Releuko and Alymsys, in the latter half of 2022, expanding access to these vital medications.

Eagle Pharmaceuticals Submits NDA for Landiolol, Ultra-Short-Acting Beta Blocker for Critical Care Tachycardia

Drug Approval
  • Eagle Pharmaceuticals announced that AOP Orphan Pharmaceuticals submitted a new drug application to the FDA for landiolol, seeking approval for short-term reduction of ventricular rate in patients with supraventricular tachycardia.
  • Landiolol is an ultra-short-acting, cardio-selective beta-1 adrenergic blocker with a β1:β2 ratio of 255:1, making it the most cardioselective beta blocker available.
  • The drug is already commercially available in Japan and several European markets, with multiple clinical studies demonstrating its safety and efficacy for rapid short-term control of tachyarrhythmias.
  • If approved, Eagle expects five years of new chemical entity exclusivity and anticipates approval by mid-year 2023 based on FDA feedback from a Type C meeting.

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