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Clinical Trial News

RESMAIN Trial of Resminostat for CTCL Maintenance Continues After Positive Safety Review

  • The Data Safety Monitoring Board (DSMB) recommended the RESMAIN study of resminostat continue without modifications after reviewing safety data from the first 150 patients.
  • The RESMAIN trial evaluates resminostat as a maintenance treatment for advanced-stage cutaneous T-cell lymphoma (CTCL) patients who have achieved disease control with prior systemic therapy.
  • Enrollment in the RESMAIN study has been increased to 190 patients to minimize the time to unblinding, with top-line results expected by mid-2021.
  • A Phase II study of resminostat in biliary tract cancer in Japan, conducted by Yakult Honsha, has been discontinued, with no financial impact on 4SC.

US Biosimilar Market Reaches Critical Milestone: Key Learnings from 5 Years of Growth

  • The US biosimilar market has evolved significantly since Sandoz's Zarxio launch five years ago, with six major biosimilar launches occurring in recent months and potential cost savings of $54 billion through 2026.
  • Physician confidence remains a significant barrier to biosimilar adoption, with 74% of surveyed physicians citing it as a major challenge, highlighting the critical need for enhanced educational initiatives.
  • Strategic planning, comprehensive provider education, and continued advocacy efforts have emerged as crucial factors for successful biosimilar market penetration and sustainability.

Psilocybin Therapy Shows Sustained Mental Health Benefits for Cancer Patients Years After Single Dose

  • A single dose of psilocybin, combined with psychotherapy, shows significant, sustained improvements in emotional and existential distress in cancer patients.
  • Benefits from psilocybin therapy, including reduced anxiety, depression, and death anxiety, can last up to 4.5 years after administration.
  • Between 60% and 80% of participants experienced clinically significant reductions in depression or anxiety at the 4.5-year follow-up.
  • Participants reported the psilocybin-assisted therapy as one of the most meaningful and spiritually significant experiences of their lives.

NICE Declines NHS Coverage of Spravato for Treatment-Resistant Depression Citing Cost and Clinical Concerns

• The UK's healthcare cost-effectiveness agency NICE has rejected Johnson & Johnson's nasal spray antidepressant Spravato for NHS funding, citing concerns over its £10,500 per course price tag and clinical evidence gaps.
• NICE highlighted uncertainties about Spravato's long-term efficacy maintenance and lack of comparative data against existing treatments like ECT and psychological therapies for treatment-resistant depression.
• Janssen-Cilag, J&J's pharmaceutical unit, criticized the decision, arguing it could deny access to a needed treatment option for patients with treatment-resistant major depressive disorder, affecting up to 30% of depression cases.

Global Lung Ambition Alliance Takes Aim at Three Major Challenges in Lung Cancer Care

  • The Lung Ambition Alliance, a partnership of major healthcare organizations, aims to double five-year lung cancer survival rates by 2025 through improved screening, innovative medicines, and enhanced quality of care.
  • Current global statistics show only 20% of lung cancer patients survive five years post-diagnosis, with significant disparities between countries like Japan (30% survival) and other regions.
  • The Alliance is addressing key challenges through initiatives including cloud-based screening registry ELIC, the Major Pathologic Response Project for pre-operative therapy, and the ILC2 grant programme for patient organizations.

Clinical Trial Sponsors Still Failing to Report Results Despite Regulations

  • A recent investigation reveals that many clinical trial sponsors continue to neglect the mandatory reporting of their results in the federal database, ClinicalTrials.gov.
  • Despite a 2007 law and a 2017 "final rule" by the NIH and FDA intended to enforce compliance, many trial sponsors still fail to disclose their findings.
  • The lack of enforcement by federal officials allows this non-compliance to persist, hindering doctors and patients from accessing crucial information on treatment safety and efficacy.

Cytokinetics Unveils Vision 2025 and 2020 Corporate Milestones

Cytokinetics, Inc. has announced its Vision 2025, outlining key imperatives for the next five years, including achieving regulatory approvals for at least two drugs, building commercial capabilities, and expanding its development pipeline. The company also detailed its expected 2020 milestones, focusing on advancing cardiac and skeletal muscle programs, with significant clinical trial results anticipated.

MRD Monitoring Predicts Relapse Risk Post-Allo-HSCT in AML Patients

  • Measurable residual disease (MRD) after induction chemotherapy is a strong predictor of relapse and shorter survival in acute myeloid leukemia (AML) patients.
  • A Spanish AML12 trial evaluated risk-adapted treatment based on AML genetics and MRD presence after consolidation chemotherapy.
  • The AML12 trial's results indicated that MRD monitoring can effectively predict relapse risk following allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Blood-Brain Barrier Breakthrough: Novel Delivery System Shows Promise for Brain Disease Treatment

  • A new molecular Trojan horse delivery system successfully transports therapeutic proteins and genes across the blood-brain barrier, potentially revolutionizing treatment for neurological diseases.
  • The HIRMAb-IDUA fusion protein (valanafusp alpha) has shown positive results in human clinical trials for MPSI, demonstrating both safety and efficacy in treating this rare brain disorder.
  • Trojan horse liposomes enable targeted delivery of gene therapies to the brain with lower doses than viral methods, while avoiding safety concerns associated with viral vectors.

Record Attendance at San Antonio Breast Cancer Symposium 2024

The San Antonio Breast Cancer Symposium (SABCS) 2024 concluded with record attendance, featuring groundbreaking clinical trial studies and a strong sense of community among participants. Highlights and updates from the event are available online, with plans already underway for SABCS 2025.

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