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Clinical Trial News

Starton Therapeutics Launches Phase 2a Trial for Continuous Low-Dose Lenalidomide in Multiple Myeloma

  • Starton Therapeutics has activated two clinical sites for its Phase 2a trial evaluating STAR-LLD, a continuous low-dose lenalidomide formulation for multiple myeloma treatment.
  • The Phase 1b study demonstrated that all six relapsed/refractory multiple myeloma patients achieved objective responses with no grade >2 drug-related hematologic toxicity.
  • Preclinical studies showed STAR-LLD achieved 100% overall response rate and caused 80% tumor shrinkage, compared to 0% response rate with higher-dose daily lenalidomide.
  • The Phase 2a trial will randomize at least 24 patients to compare continuous subcutaneous STAR-LLD against oral lenalidomide, both combined with dexamethasone and protease inhibitors.

Australian Researchers Launch World-First Clinical Trial of PMR-116 to Target 'Undruggable' MYC-Driven Cancers

Oncology
  • A world-first clinical trial targeting MYC-driven cancers will begin later this year, led by researchers from The Australian National University and funded by the Medical Research Future Fund.
  • The experimental drug PMR-116 targets approximately 70% of all cancers by inhibiting a pathway downstream of the MYC protein, which has long been considered 'undruggable' due to its disordered structure.
  • The basket trial design will include patients with multiple cancer types including prostate, breast, ovarian, and haematological cancers, all unified by MYC protein involvement rather than cancer type.
  • Clinical trials will be conducted across major Australian cancer centers including Canberra Hospital, Peter MacCallum Cancer Centre, and St Vincent's Hospital Sydney.

Elanco's Zenrelia Receives Positive EU Regulatory Opinion for Canine Allergic Dermatitis Treatment

Drug ApprovalDrug Approval
  • Elanco Animal Health's Zenrelia (ilunocitinib) received a positive opinion from the European Medicines Agency's Committee for Veterinary Medicinal Products, paving the way for EU marketing authorization within 60 days.
  • The regulatory committee recommended approval based on demonstrated efficacy in treating pruritus associated with allergic dermatitis and clinical manifestations of atopic dermatitis in dogs.
  • Zenrelia represents Elanco's fastest globalized veterinary product with eight major regulatory approvals expected within 18 months, already available in Brazil, Canada, Japan, and the United States.
  • The company expects to launch the product in the EU market before the end of the third quarter, with additional approvals anticipated in Australia and the United Kingdom in 2025.

Merck Animal Health Receives EU Regulatory Milestone for First-in-Class JAK Inhibitor NUMELVI for Canine Allergic Dermatitis

  • The European Medicines Agency's Committee for Veterinary Medicinal Products issued a positive opinion for NUMELVI (atinvicitinib), positioning it as the first and only second-generation JAK inhibitor for treating canine allergic dermatitis.
  • NUMELVI demonstrates at least 10-fold greater selectivity for JAK1 compared to other JAK family members, enabling safe use in dogs as young as six months with once-daily dosing.
  • The treatment addresses a significant unmet need, as itch affects more than 20 percent of dogs in general veterinary practice and represents one of the most frequent reasons for veterinary visits.
  • European Commission marketing authorization is expected in the third quarter of 2025, following the CVMP's positive recommendation.

Cancer Pain Market Poised for Transformation with Novel Non-Opioid Therapies by 2034

  • The cancer pain therapeutics market is expected to experience significant growth by 2034, driven by increasing cancer incidence and the anticipated launch of breakthrough non-opioid therapies.
  • The United States leads the global market with 2.4 million cancer pain cases in 2023, with nociceptive pain representing the most common pathophysiology type.
  • Six promising pipeline therapies from companies including InhaleRX, Dogwood Therapeutics, and WinSanTor are positioned to address the critical unmet need for effective non-opioid cancer pain treatments.
  • Current opioid-dominated treatment approaches face significant limitations including refractory pain cases and safety concerns, creating substantial opportunities for innovative therapeutic mechanisms.

Tazemetostat-Pinometostat Combination Shows Promise for B-Cell Lymphoma Treatment Resistance

Targeted Therapy
  • Researchers at The Institute of Cancer Research, London, have demonstrated that combining tazemetostat with DOT1L inhibitor pinometostat can overcome treatment resistance in B-cell lymphoma patients.
  • The drug combination significantly shrunk tumors in preclinical models, with treated tumors shrinking while control tumors tripled in size after 15 days.
  • The combination therapy could potentially benefit thousands of patients with diffuse large B-cell lymphoma, the most common type affecting around 5,000 UK patients annually.
  • Clinical trials are anticipated to test this dual-targeting approach that combines EZH2 and DOT1L inhibition to overcome cancer's drug resistance mechanisms.

Silence Therapeutics Reports Promising Phase 1 Data for Divesiran in Polycythemia Vera at EHA 2025

Orphan DrugRare Disease
  • Silence Therapeutics presented updated Phase 1 data for divesiran at EHA 2025, showing the siRNA therapy essentially eliminated the need for phlebotomies in 21 polycythemia vera patients with a combined history of 79 prior phlebotomies.
  • The SANRECO Phase 1 study demonstrated that divesiran maintained hematocrit levels at ≤45% across all dose cohorts while increasing hepcidin and ferritin levels, with no dose-limiting toxicities observed.
  • The company announced that its Phase 2 SANRECO study has exceeded 50% enrollment and remains on track for full enrollment by year-end 2025.
  • Divesiran represents a first-in-class siRNA therapy targeting TMPRSS6 to regulate iron metabolism and reduce excessive red blood cell production in polycythemia vera patients.

Study to Assess SLN124 in Patients With Polycythemia Vera

NCT05499013RecruitingPhase 1
Silence Therapeutics plc
Posted 1/26/2023

FDA Approves Roche-AbbVie's Venclexta Plus Gazyva as First-Line Chemotherapy-Free Treatment for CLL

Drug Approval
  • The FDA has approved Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) for previously untreated chronic lymphocytic leukemia and small lymphocytic lymphoma patients.
  • The approval is based on phase 3 CLL14 trial results showing significant reduction in disease progression risk compared to standard Gazyva plus chemotherapy treatment.
  • This represents the first chemotherapy-free, fixed-duration treatment option for first-line CLL therapy, potentially expanding the patient population by approximately 20,000 in the US.
  • Venclexta generated $344 million in worldwide sales last year, with AbbVie projecting sales to reach $725 million this year following the expanded indication.

Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

NCT03836261Active, Not RecruitingPhase 3
Acerta Pharma BV
Posted 2/25/2019

Tekton Research Adds Fourth Clinical Site in 2025 with Richmond Pediatric Associates Partnership

  • Tekton Research has partnered with Richmond Pediatric Associates as its fourth new clinical research site in 2025, expanding pediatric research capabilities in diabetes, obesity, ADHD, and mood disorders.
  • The Virginia-based multi-physician clinic, led by Dr. David Gosselin, represents Tekton's second location in the Richmond region alongside Virginia Endocrinology, enabling longitudinal studies across adult and pediatric populations.
  • This strategic expansion brings Tekton's nationwide network to more than 25 active research sites, focusing on therapeutic areas with high unmet medical need while bringing research closer to real-world communities.

Courage Therapeutics Appoints Giovanni Ferrara as CEO to Advance Melanocortin-Targeted Obesity Treatments

  • Courage Therapeutics has appointed biopharma veteran Giovanni Ferrara as CEO following a significant investment from Arsenal Bridge Ventures in May.
  • The company is developing novel treatments for obesity and eating disorders by targeting the central melanocortin system, specifically MC3 and MC4 receptors that regulate energy balance.
  • Ferrara brings extensive experience from leading Medeor Therapeutics through Phase 3 cell therapy development and founding NeuroVia as a partner at Novartis Venture Funds.
  • The leadership change positions Courage to accelerate clinical development of its selective MC4R and MC3R compounds while raising additional seed funding.

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