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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.

MRD Negativity as a Surrogate Endpoint for PFS in Multiple Myeloma

  • Achieving minimal residual disease (MRD) negativity is increasingly recognized as a crucial endpoint in multiple myeloma treatment, indicating deeper remission and improved outcomes.
  • Meta-analysis of six randomized clinical trials suggests that MRD status could serve as a surrogate endpoint for progression-free survival (PFS) in newly diagnosed multiple myeloma (NDMM).
  • The FDA is considering MRD negativity as a potential surrogate endpoint for accelerated drug approval, which could expedite the development of more effective therapies.
  • Studies show that patients achieving MRD-negative complete response (CR) experience superior survival outcomes compared to those with MRD-positive CR, highlighting the importance of MRD monitoring.

PARP Inhibitors in Frontline Ovarian Cancer Treatment: A Review of Clinical Trials

  • Frontline PARP inhibitor maintenance shows greatest benefit in patients with BRCA-associated ovarian cancers, followed by those with homologous recombination deficient (HRD) tumors.
  • Key factors in deciding on frontline PARP inhibitor therapy include FDA indication, dosing preference, toxicity profiles, patient-specific risk-benefit assessment, and cost considerations.
  • Ongoing trials are exploring PARP inhibitor combinations with anti-angiogenics, immunotherapies, and agents targeting PARP inhibitor resistance to further improve outcomes.
  • The optimal timing of PARP inhibitor use should also be considered, balancing potential benefits in the frontline setting against the possibility of PARP-inhibitor resistance when used later.

A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer.

NCT03106987CompletedPhase 3
AstraZeneca
Posted 6/8/2017

Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)

NCT03740165Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 12/18/2018

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

NCT03522246Active, Not RecruitingPhase 3
pharmaand GmbH
Posted 5/14/2018

Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients

NCT03737643Active, Not RecruitingPhase 3
AstraZeneca
Posted 1/4/2019

A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

NCT03602859Active, Not RecruitingPhase 3
Tesaro, Inc.
Posted 10/11/2018

A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

NCT03326193Active, Not RecruitingPhase 2
Tesaro, Inc.
Posted 12/12/2017

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