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Clinical Trial News

Fresenius Kabi Launches First Generic Iodixanol Contrast Agent in Canada, Addressing Critical Supply Shortages

Drug Approval
  • Fresenius Kabi Canada launched Iodixanol Injection 270 and 320, marking the first generic injectable iodinated contrast media available in the Canadian market.
  • Health Canada granted Notice of Compliance approval on December 17, 2024, based on pharmaceutical equivalence to reference drug Visipaque®.
  • The launch addresses critical supply shortages that previously forced healthcare agencies to ration contrast media and reduce dosages for patients.
  • Iodixanol injection was classified as a tier 3 drug shortage in June 2022, indicating significant potential impact on Canada's healthcare system.

Annamycin Shows 59% Clinical Benefit Rate in Soft Tissue Sarcoma Lung Metastases Phase 2 Trial

Orphan Drug
  • Annamycin demonstrated a 59.4% clinical benefit rate in patients with soft tissue sarcoma lung metastases, comprising 18 patients with stable disease and 1 with partial response in the phase 1b/2 MB-107 trial.
  • Patients in the phase 2 portion achieved a median overall survival of 13.5 months despite having received a median of 6 prior therapies, exceeding typical second-line monotherapy results.
  • The next-generation anthracycline analog showed no cardiotoxicity across all treatment cohorts, addressing a major safety concern with traditional anthracyclines.
  • Responders who achieved stable disease or partial response after 2 cycles demonstrated improved outcomes with median overall survival of 19.7 months and progression-free survival of 122 days.

Study of Liposomal Annamycin for the Treatment of Subjects with Soft-Tissue Sarcomas (STS) with Pulmonary Metastases

NCT04887298CompletedPhase 1
Moleculin Biotech, Inc.
Posted 6/5/2021

Halia Therapeutics Completes Enrollment in Phase 2a Trial of Novel NLRP3 Inflammasome Inhibitor for Myelodysplastic Syndrome

  • Halia Therapeutics has completed enrollment of 33 patients in its Phase 2a clinical trial evaluating HT-6184 (Ofirnoflast) for lower-risk myelodysplastic syndrome patients who are refractory to or ineligible for erythropoiesis-stimulating agents.
  • HT-6184 represents a novel therapeutic approach as an allosteric modulator of NEK7 that disrupts the NEK7-NLRP3 protein interaction, preventing NLRP3 inflammasome formation and targeting inflammatory pathways implicated in bone marrow dysfunction.
  • The two-stage study design includes a 16-week treatment period with response-based continuation, evaluating efficacy through hematological improvement, clonal suppression, and variant allele frequency reduction.
  • Topline results from the complete study are expected later this year, with the potential to validate a new mechanism of action targeting innate immune dysregulation in MDS treatment.

Study to Evaluate HT-4253 in Healthy Subjects

NCT06537817CompletedPhase 1
Halia Therapeutics, Inc.
Posted 9/17/2024

Biodexa Initiates Phase 2 Trial of Tolimidone for Type 1 Diabetes Treatment

  • Biodexa Pharmaceuticals has enrolled the first patient in a Phase 2 study evaluating tolimidone, a selective Lyn kinase activator, for Type 1 diabetes treatment.
  • The investigator-initiated trial will assess C-peptide levels and HbA1c markers in 12 patients across three dose groups over three months at the University of Alberta.
  • Preclinical studies demonstrated tolimidone's ability to promote beta cell survival and proliferation, including inducing proliferation in human cadaver-derived beta cells.
  • Originally developed by Pfizer for gastric ulcers, tolimidone amplifies insulin signaling cascades and represents a potential first-in-class glucose modulating agent.

Commit Biologics Forms Scientific Advisory Board to Advance Complement-Based Cancer and Autoimmune Therapies

  • Commit Biologics has established a Scientific Advisory Board co-chaired by antibody expert Janine Schuurman and CEO Mikkel Wandahl Pedersen to guide development of its BiCE™ complement activation platform.
  • The board includes five industry veterans with expertise in molecular biology, immunology, and antibody research, including former executives from Genmab, Regeneron, and Novo Nordisk.
  • The BiCE™ technology platform aims to harness the largely untapped complement system to selectively kill target cells in autoimmune diseases and cancer through enhanced C1q engagement.
  • This strategic move positions Commit to accelerate development of first-in-class complement engager therapeutics by leveraging decades of combined industry experience from the advisory members.

Tata Memorial Centre Partners with GE HealthCare to Establish Advanced Cancer Research & Innovation Centre

AIOncology
  • Tata Memorial Centre has signed a Memorandum of Understanding with GE HealthCare Technologies Inc. to establish a Cancer Research & Innovation Centre, with TMC serving as the clinical oncology partner and GE HealthCare as the technology partner.
  • The five-year collaboration will focus on accelerating development and validation of AI-based applications for medical imaging, clinical workflows, and advanced visualization tools in oncology care.
  • The partnership addresses the urgent need for enhanced cancer care as India faces a forecasted 12.8% rise in cancer incidence by 2025, with emphasis on early detection and equitable access challenges.
  • A Joint Working Group will chart key project areas including data annotation for application development and enterprise health informatics solutions to support personalized cancer care.

Continuity Biosciences Acquires Focal Medical to Advance Iontophoresis-Based Pancreatic Cancer Therapy

Targeted Therapy
  • Continuity Biosciences has acquired Focal Medical, a North Carolina-based company developing site-specific chemotherapy using iontophoresis technology for pancreatic cancer treatment.
  • Focal Medical's lead product candidate uses an iontophoresis device to deliver gemcitabine directly to pancreatic tumors, which has received FDA IND clearance with Phase 1b trials expected to begin later this year.
  • The acquisition includes Focal Medical's patent estate, technology platform, and a dedicated R&D facility in Cary, NC, positioning Continuity as a leader in device-targeted therapeutics for solid tumors.
  • The iontophoresis approach enhances local drug concentration while minimizing systemic toxicity, addressing key limitations of traditional gemcitabine administration in pancreatic cancer.

Buscar Company Acquires 70% Stake in Armorgenix to Enter Pharmaceutical Market

  • Buscar Company (OTC: CGLD) acquired a 70% stake in Armorgenix Company through a strategic stock swap, marking its expansion into the pharmaceutical sector with focus on antiviral and detoxification solutions.
  • The acquisition includes Armorgenix's clinically evaluated DetoxShield product and positions Buscar to capitalize on the U.S. antiviral market valued at $22.2 billion in 2024.
  • Armorgenix plans to establish a Texas-based manufacturing facility and Wyoming-based IP management entity within 24-36 months to enhance North American market penetration.
  • The deal complements Buscar's diversified portfolio spanning natural resources through Eon Discovery and sustainable bioplastics via Terramer Inc.

Elpis Biopharmaceuticals Partners with Singapore General Hospital to Advance Next-Generation CAR-γδT Therapies for Blood Cancers

CAR-T
  • Elpis Biopharmaceuticals has entered a research collaboration with Singapore General Hospital to develop armored and bi-specific CAR-γδT therapies targeting acute myeloid leukemia and multiple myeloma.
  • The partnership involves technology transfer of Elpis's proprietary bispecific and armored CAR technologies to SGH, which will advance development into investigator-initiated clinical trials.
  • The collaboration aims to overcome key challenges in cancer treatment including immune suppression and antigen heterogeneity through next-generation allogeneic CAR technologies.
  • Both parties have expressed mutual intention to explore forming a joint venture for further development and commercialization if clinical data proves favorable.

M42, AstraZeneca, and SOPHiA GENETICS Launch UAE Liquid Biopsy Initiative to Transform Cancer Diagnosis

  • M42, AstraZeneca, and SOPHiA GENETICS announced a strategic collaboration to bring cutting-edge liquid biopsy testing to the UAE, enabling non-invasive genomic profiling through simple blood draws.
  • The partnership will integrate SOPHiA GENETICS' MSK-ACCESS® technology across select UAE hospitals over 12 months, initially targeting lung, ovarian, breast, colorectal, and pancreatic cancers.
  • Validation studies will commence at Cleveland Clinic Abu Dhabi with full clinical launch planned for the latter part of Q2 2025, providing faster and less invasive biomarker testing compared to traditional tissue biopsies.
  • The initiative aims to democratize precision oncology by making advanced diagnostics accessible to patients unable to undergo solid tumor biopsies, supporting personalized treatment matching and real-time disease monitoring.

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