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TRUST Trial Shows Primary Surgery Improves Progression-Free Survival in Advanced Ovarian Cancer Despite Missing Overall Survival Endpoint

  • The TRUST trial, the first phase III randomized study comparing surgical timing in advanced ovarian cancer, demonstrated statistically significant improvement in progression-free survival with primary cytoreductive surgery versus interval surgery (22.1 vs 19.7 months, HR=0.80, P=.018).
  • Despite improved progression-free survival, the study failed to meet its primary endpoint of overall survival, with median overall survival of 54.3 months for upfront surgery versus 48.3 months for interval surgery (HR=0.89, P=.24).
  • The trial enrolled 796 patients with FIGO stage IIIB/C or IVA/B ovarian cancer at high-volume centers performing at least 36 primary cytoreductive surgeries annually with complete resection rates of at least 50%.
  • Complete gross tumor resection was achieved in 70% of primary surgery patients versus 85% of interval surgery patients, with low morbidity rates of 18% and 12% respectively and 30-day mortality rates under 1%.

Digital Inhaler Technology Shows Promise for Early COPD Exacerbation Detection

  • Digital inhalers can detect significant physiologic changes up to two weeks before COPD exacerbations occur, potentially enabling earlier clinical intervention.
  • The ProAir Digihaler captured three key metrics that changed significantly before acute exacerbations: inhalation volume, inhalation duration, and time to peak inhalation.
  • These physiologic changes preceded the typical increase in rescue inhaler use, suggesting patients may perceive symptoms after lung function deterioration begins.
  • The pilot study involved 40 current smokers with COPD and recorded 23 acute exacerbation events, demonstrating the technology's potential for remote patient monitoring.

Blood Test Detects Early Liver Transplant Rejection Using Cell-Free DNA Analysis

  • Georgetown University and MedStar Health researchers developed a blood test that uses circulating cell-free DNA fragments to detect early signs of liver transplant rejection and complications.
  • The technology analyzes DNA methylation patterns to identify the specific cellular origin of organ damage, enabling more targeted treatment approaches.
  • This liquid biopsy approach could replace invasive liver biopsies and provide continuous monitoring of transplant recipients with greater accuracy.
  • The research, funded by a $2.5 million NIH grant, represents a major advancement in post-transplant care and has potential applications in other organ transplants and cancer treatment.

Mabion and NovalGen Partner to Advance Novel T-Cell Engager NVG-222 for Cancer Treatment

  • Mabion and NovalGen have formed a strategic partnership to bring NVG-222, a bispecific T-cell engager targeting ROR1 and CD3, to phase one clinical trials scheduled for the second half of 2025.
  • NVG-222 is the first therapeutic to utilize NovalGen's proprietary AutoRegulation technology, designed to mitigate toxicity and improve efficacy in T-cell engager therapies for both blood cancers and solid tumors.
  • The partnership marks a significant milestone with the successful release of the first clinical batch, demonstrating Mabion's transformation into a world-class CDMO and providing a platform for future collaboration on NovalGen's pipeline.
  • This collaboration represents a potential paradigm shift in immuno-oncology therapies, offering safer and more effective treatment options for cancer patients with high unmet medical needs.

Enzene Expands New Jersey Biomanufacturing Facility by 26,000 Square Feet Ahead of Opening

Monoclonal Antibody
  • Enzene has expanded its Hopewell, New Jersey biologics manufacturing facility by an additional 26,000 square feet before its official opening later this year.
  • The expansion includes drug substance manufacturing suites, laboratories, storage, dispensing and warehousing facilities to meet strong demand from U.S.-based small and medium-sized innovators.
  • The facility will utilize Enzene's EnzeneX 2.0 platform featuring fully-connected continuous manufacturing technology that enables clinical phase GMP supply from 30-liter scale with improved efficiency.
  • The company is already producing non-GMP batches at the site and aims to reduce monoclonal antibody production costs to below $40 per gram by 2025.

EDX Medical Partners with Spire Healthcare to Advance Diagnostic Innovation for Cancer and Cardiovascular Disease

  • EDX Medical Group has entered into a memorandum of understanding with Spire Healthcare Group to advance diagnostic innovations for major diseases including cancer, cardiovascular and infectious conditions.
  • The partnership will explore applications of EDX Medical's "super tests" for prostate, bowel and testicular cancer, along with molecular profiling cancer tests and tumor response assessment platforms.
  • The collaboration aims to enhance patient referral pathways and develop joint healthcare propositions based on improved understanding of patient biology and disease risk across Spire's network.
  • EDX Medical shares rose 4.2% to 12.50 pence on the Aquis Exchange following the announcement, while Spire Healthcare shares increased 1.0% to 210.50 pence in London.

HELP Therapeutics Partners with China Resources Sanjiu to Advance iPSC-Derived Heart Failure Therapy HiCM-188

  • HELP Therapeutics and China Resources Sanjiu have formed a strategic partnership to co-develop and commercialize HiCM-188, the world's first iPSC-derived regenerative therapy for advanced heart failure with IND clearance in both China and the United States.
  • HiCM-188 is currently in Phase II clinical trials in China and Phase I/II trials in the U.S., Singapore, and Thailand, demonstrating robust safety and efficacy across more than five years of long-term follow-up.
  • The partnership addresses a critical unmet medical need as heart failure prevalence increases at double-digit rates with aging populations, while heart transplantation remains limited by donor deficiency.
  • Professor Junbo Ge noted that this collaboration represents a milestone in China's Cell and Gene Therapy landscape and has the potential to reshape treatment paradigms for patients worldwide.

Cresilon Expands VETIGEL Distribution to Canadian Veterinary Market Through McCarthy Vet Partnership

  • Cresilon Inc. has entered into a distribution agreement with McCarthy Vet to make VETIGEL, a revolutionary plant-based hemostatic gel, available to veterinary surgeons across Canada.
  • VETIGEL has been used in more than 60,000 surgical procedures worldwide since its 2021 debut, providing instant bleeding control during veterinary surgeries including dental extractions, tumor removals, and complex procedures.
  • The partnership with McCarthy Vet, a family-owned company serving Canadian veterinarians for over 60 years, represents Cresilon's first veterinary distribution agreement in Canada.
  • The biocompatible, non-animal derived gel forms an instant mechanical barrier to stop bleeding on contact and can be easily removed or left to resorb naturally in the body.

Lantern Pharma Reports Complete Response in Advanced NSCLC Patient After Failed Standard Therapies

  • A 70-year-old never-smoker with advanced non-small cell lung cancer achieved complete response with LP-300 plus chemotherapy after failing three prior treatment lines including Keytruda, radiation, and Tagrisso.
  • The patient experienced 57% initial tumor reduction followed by complete resolution of lung and adrenal lesions, remaining progression-free for nearly two years across 21 treatment cycles.
  • The sustained response demonstrates LP-300's potential to address critical unmet needs in never-smoker NSCLC patients who have exhausted targeted kinase therapy options.
  • Never-smoker NSCLC represents 15-20% of U.S. lung cancer cases with significantly higher rates in Asian populations, yet no therapies are specifically approved for this patient subset.

A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma

NCT05456256RecruitingPhase 2
Lantern Pharma Inc.
Posted 3/1/2023

Shasqi Achieves First-in-Human Success with Click Chemistry Cancer Therapy, Delivering 12-Fold Higher Doxorubicin Doses

Targeted Therapy
  • Shasqi has published landmark results from the first-in-human clinical trial of SQ3370, marking the inaugural use of click chemistry-based cancer therapeutics in patients with advanced solid tumors.
  • The company's CAPAC® platform enabled delivery of 12-fold higher doses of doxorubicin per cycle compared to conventional approaches while reducing systemic toxicity and myelosuppression.
  • The breakthrough demonstrates that click chemistry can be safely harnessed inside the human body to concentrate cancer drugs at tumor sites while sparing healthy tissues.
  • Nobel Prize winner Carolyn Bertozzi emphasized that this study unlocks a new frontier for oncology innovation by proving biorthogonal chemical groups are tolerated in humans.

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