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Clinical Trial News

aap Implantate AG's Antibacterial Implant Trial Receives Approval for Early End of Recruitment

  • aap Implantate AG received approval from BfArM and the lead ethics committee to conclude patient recruitment early due to positive ongoing results.
  • A total of 202 patients were enrolled in the clinical trial by August 6, 2024, with a one-year follow-up period concluding in August 2025.
  • The company is now preparing for MDR registration, aiming for initial product authorization between 2026 and 2027, backed by EUR 1-2 million in funding.
  • aap's CEO emphasizes the company's commitment to combating antibiotic resistance, positioning them strongly in the multi-billion dollar antibacterial trauma implant market.

Tepezza Approved in Japan for Active Thyroid Eye Disease

• Amgen's Tepezza (teprotumumab) has been approved in Japan for treating active thyroid eye disease (TED) or TED with a high clinical activity score (CAS). • The approval is based on the OPTIC-J study, a Phase 3 trial demonstrating significant improvement in proptosis (eye bulging) in patients treated with Tepezza. • Tepezza is the first and only medicine approved in Japan for active TED, offering a non-surgical, non-steroidal treatment option. • A separate Phase 3 trial is ongoing in Japan to study the efficacy of Tepezza in patients with chronic TED and low CAS.

Enfortumab Vedotin Plus Pembrolizumab Approved in Japan for Urothelial Carcinoma

  • The Japanese Ministry of Health, Labour and Welfare approved enfortumab vedotin plus pembrolizumab for first-line treatment of radically unresectable urothelial carcinoma.
  • Approval was based on the Phase 3 EV-302 trial, demonstrating statistically significant survival benefits compared to platinum-containing chemotherapy.
  • The combination therapy showed a progression-free survival of 12.5 months versus 6.3 months with chemotherapy, significantly improving patient outcomes.
  • Overall survival was also significantly extended, with 31.5 months for the combination versus 16.1 months for chemotherapy, offering new hope to patients.

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

NCT04223856Active, Not RecruitingPhase 3
Astellas Pharma Global Development, Inc.
Posted 3/30/2020

Dual Immunotherapy Shrinks Pancreatic Tumors in Preclinical Models

• Researchers developed a dual immunotherapy that combines tumor microenvironment remodeling with immune system activation for pancreatic cancer treatment. • In animal models of pancreatic ductal adenocarcinoma, the dual therapy led to tumor shrinkage or elimination in eight of nine cases. • The approach uses nanoparticles to deliver immune agonists while suppressing tumor cell defenses, enhancing T cell infiltration and anti-tumor activity. • This strategy may have implications for treating other cancers, including colon, lung, liver, and cholangiocarcinoma.

Pitt Receives $100M DOD Award to Advance Trauma Care Research

  • The University of Pittsburgh has been awarded $100 million by the Department of Defense to continue and expand its trauma research through the LITES Network.
  • The LITES Network will launch the PREEVEnT trial to assess early plasma administration in burn patients compared to the standard of care for improved outcomes.
  • The LITES Network has completed five studies, with four ongoing clinical trials, aimed at transforming trauma care practices and saving lives.
  • The collaborative effort involves multiple trauma centers and focuses on addressing critical gaps in pre-hospital trauma care research and innovation.

ZetaFuse Demonstrates Bone Fusion in Lung Cancer Patient with Degenerative Disc Disease

  • ZetaFuse (Zeta-ZF-002) showed radiographic fusion at all three cervical levels in a Stage 4 lung cancer patient with multi-level degenerative disc disease (DDD).
  • The patient, who had comorbidities and was undergoing chemotherapy, experienced bone healing exceeding expectations after ZetaFuse administration.
  • ZetaFuse has received FDA Breakthrough Designation for spine fusion and shares a mechanism of action with Zetagen's oncology drug candidate, ZetaMet.
  • The case study suggests potential for ZetaFuse in treating cancer patients with orthopedic fusion needs, where limited approved resources exist.

Give Kids a Chance Act Aims to Accelerate Pediatric Drug Development

  • The Give Kids a Chance Act (H.R. 3433) has unanimously passed the House of Representatives, marking a significant step in addressing childhood cancer and rare diseases.
  • The Act reauthorizes the FDA’s pediatric priority voucher program for five years, incentivizing the development of innovative drugs for children.
  • It mandates pharmaceutical companies to conduct pediatric trials with drug combinations, aligning pediatric research practices with those for adults.
  • The legislation also strengthens the FDA's enforcement capabilities to ensure timely completion of pediatric studies, preventing delays in drug availability.

Nxera Pharma Partners with Shionogi for Quviviq Distribution in Japan Following Approval for Insomnia

  • Nxera Pharma has entered a commercial partnership with Shionogi for the distribution and sales of Quviviq in Japan, succeeding a prior agreement with Mochida Pharmaceutical.
  • Quviviq, a dual orexin receptor antagonist, received approval in Japan for treating adult insomnia, marking a significant advancement in addressing sleep disorders.
  • Under the agreement, Nxera will supply the drug, while Shionogi will manage distribution and sales, aiming to address the substantial public health issue of insomnia in Japan.

Iomab-B Demonstrates Durable Remission in Relapsed/Refractory AML, Faces Regulatory Hurdles

  • The SIERRA trial showed that Iomab-B led to a significantly higher durable complete remission rate (17.1%) compared to conventional care (0%) in older patients with relapsed/refractory AML.
  • Despite positive results, the FDA has requested another randomized study before considering Iomab-B for approval, citing concerns about the initial trial design.
  • The new study should evaluate Iomab-B plus reduced-intensity conditioning versus a standard conditioning regimen, without crossover between treatment arms.
  • Investigators express disappointment over the regulatory setback but remain committed to further research with Iomab-B due to the significant unmet need in this patient population.

Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia

NCT02665065Active, Not RecruitingPhase 3
Actinium Pharmaceuticals
Posted 6/1/2016

OCTOPUS Trial Shows Progress in Evaluating Alpha-Lipoic Acid and Metformin for Progressive MS

  • The OCTOPUS trial, a multi-arm study, is assessing R/S alpha-lipoic acid and metformin for progressive multiple sclerosis, aiming to enroll 375 participants in its first stage.
  • As of March 2024, 189 participants have been randomized, with a majority diagnosed with secondary progressive MS and an average disease duration of 20.6 years.
  • The OCTOPUS trial seeks to address the significant unmet need for effective treatments for progressive MS, where ocrelizumab is currently the only FDA-approved option.

Lipoic Acid for Progressive Multiple Sclerosis (MS)

NCT03161028CompletedPhase 2
VA Office of Research and Development
Posted 8/17/2018

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