Clinical Trial News
FluoGuide Receives Approval for Phase II Trial in Head and Neck Cancer
FluoGuide A/S has received approval from the Danish Medicines Agency to initiate a phase II trial for FG001 in head and neck cancer, aiming to improve surgical precision by illuminating cancer cells intraoperatively. The trial, set to begin in Q4 2022, will enroll up to 16 patients, with results expected in the first half of 2023.
UK's National Clinical Trial Platforms Drive Advances in COVID-19 Treatment
- The UK's clinical trial platforms, including RECOVERY and PRINCIPLE, have been crucial in identifying effective COVID-19 treatments and ensuring their availability within the NHS.
- Trials like RECOVERY identified dexamethasone as the first effective COVID-19 treatment, while REMAP-CAP and RECOVERY showed positive results for tocilizumab in severe cases.
- These platforms streamline the evaluation of potential treatments through Phase 1, 2, and 3 trials, facilitating rapid progression from initial testing to large-scale efficacy studies.
- Studies such as STIMULATE-ICP and HEAL-COVID are addressing long-term outcomes and rehabilitation for patients recovering from COVID-19, highlighting a comprehensive approach.
FDA and LUNGevity Collaborate to Standardize Lung Cancer Trial Eligibility
- LUNGevity, FDA, and NCI are collaborating to standardize eligibility criteria for advanced non-small cell lung cancer (NSCLC) clinical trials, aiming to simplify trial navigation for patients.
- The initiative addresses challenges like complex eligibility criteria, which limit patient access and hinder trial recruitment, by creating a prioritized library of terms for trial design.
- A forthcoming FDA draft guidance incorporates these recommendations, covering disease stage, biomarkers, performance status, organ function, and comorbidities, to harmonize trial populations.
- Standardized criteria intend to support inter-trial comparisons of treatment effects and facilitate the development of more inclusive and efficient clinical trials for NSCLC.
Brodalumab Improves Health-Related Quality of Life in Psoriasis Patients, Itching Remains a Challenge
A study on Japanese psoriasis patients treated with brodalumab shows significant improvement in health-related quality of life (HRQoL), yet itching persists as a factor affecting complete HRQoL improvement even after achieving clear or almost-clear skin.
Scemblix Receives European Commission Approval for CML Treatment After TKI Failure
- The European Commission has approved Scemblix (asciminib) for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML-CP).
- Scemblix is intended for patients previously treated with two or more tyrosine kinase inhibitors (TKIs) who have experienced resistance or intolerance.
- Phase III ASCEMBL trial results showed Scemblix nearly doubled the major molecular response rate compared to bosutinib (25.5% vs. 13.2%) at 24 weeks.
- Scemblix offers a novel mechanism of action as a STAMP inhibitor, targeting the ABL myristoyl pocket, providing a new therapeutic option.
Highlighted Clinical Trials:
Novartis Pharmaceuticals
Posted 11/22/2018
Novartis Pharmaceuticals
Posted 10/13/2021
Novartis Pharmaceuticals
Posted 5/25/2021
Novartis Pharmaceuticals
Posted 10/6/2021
Novartis Pharmaceuticals
Posted 10/26/2017
Novartis Pharmaceuticals
Posted 4/24/2014
Novartis Pharmaceuticals
Posted 12/27/2021
Novartis Pharmaceuticals
Posted 12/6/2021
Psychedelic Clinical Trials Enter New Era: Key Protocol Design and Safety Considerations Emerge
- The psychedelic therapeutics market is projected to grow from $2 billion in 2020 to $10.75 billion by 2027, driven by promising evidence for PTSD, depression, and cancer-related distress treatments.
- Psychedelic clinical trials require unique protocol designs focusing on single-dose administration combined with preparatory and integration therapy sessions, differing significantly from conventional psychiatric studies.
- Trial sponsors must address complex ethical considerations including patient safety during altered consciousness states, comprehensive informed consent processes, and ensuring post-trial care continuity for vulnerable participants.
Bispecific Antibodies Teclistamab and Talquetamab Show Promise in Multiple Myeloma Treatment
- Teclistamab and talquetamab, bispecific antibodies, demonstrate efficacy in relapsed/refractory multiple myeloma by reducing soluble BCMA levels in responding patients.
- A reduction in sBCMA levels correlates with the depth of treatment response, with complete or stringent complete responses showing nearly 100% sBCMA reduction.
- Baseline sBCMA levels correlate with tumor burden, suggesting sBCMA as a potential marker, and do not significantly affect teclistamab exposure, indicating maintained clinical activity.
- Clinical trials are underway to evaluate bispecific antibodies in earlier lines of therapy and maintenance settings, potentially transforming myeloma treatment.
Highlighted Clinical Trials:
Janssen Research & Development, LLC
Posted 8/29/2016
GlaxoSmithKline
Posted 10/1/2020
Celgene
Posted 4/16/2019
Janssen Research & Development, LLC
Posted 6/29/2018
Pfizer
Posted 10/7/2021
Stichting European Myeloma Network
Posted 12/14/2018
Janssen Research & Development, LLC
Posted 12/15/2020
Stichting European Myeloma Network
Posted 9/8/2022
Pfizer
Posted 3/25/2022
University Hospital, Toulouse
Posted 10/1/2010
Janssen Research & Development, LLC
Posted 1/22/2024
Pfizer
Posted 11/29/2017
Janssen Research & Development, LLC
Posted 6/12/2020
GlaxoSmithKline
Posted 4/2/2020
Pfizer
Posted 2/2/2021
GlaxoSmithKline
Posted 5/7/2020
Pfizer
Posted 3/22/2021
Janssen Research & Development, LLC
Posted 10/14/2021
Janssen Research & Development, LLC
Posted 10/20/2022
Janssen Research & Development, LLC
Posted 2/16/2015
Kite, A Gilead Company
Posted 8/23/2024
Janssen Research & Development, LLC
Posted 9/17/2020
Janssen Research & Development, LLC
Posted 5/16/2017
Janssen Research & Development, LLC
Posted 12/16/2017
Kite, A Gilead Company
Posted 8/9/2022
Janssen Research & Development, LLC
Posted 2/21/2020
Juno Therapeutics, a Subsidiary of Celgene
Posted 2/24/2021
Ichnos Sciences SA
Posted 11/1/2023
Janssen Research & Development, LLC
Posted 10/25/2022
Bayer Seeks Expanded Approval for Darolutamide in Japan and China for Metastatic Hormone-Sensitive Prostate Cancer
- Bayer has submitted applications in Japan and China for darolutamide, seeking approval for metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (ADT).
- The submissions are based on the Phase III ARASENS trial, which demonstrated a statistically significant improvement in overall survival for darolutamide plus ADT and docetaxel in mHSPC patients.
- Darolutamide, marketed as Nubeqa™, is already approved in multiple markets, including the U.S., EU, Japan, and China, for non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis.
- Prostate cancer is a significant health concern in both Japan and China, with a substantial proportion of patients experiencing disease progression, highlighting the need for new treatment options.
Next-Generation RNA Technologies Promise Longer-Lasting Therapeutics Beyond mRNA
- Biotech companies are developing novel RNA technologies, including circular RNA and transfer RNA, to overcome the rapid degradation limitations of current mRNA therapeutics.
- At least nine biotechnology startups have secured hundreds of millions in funding, with companies like Orna Therapeutics and Laronde leading circular RNA development with over $800M combined funding.
- These next-generation RNA platforms aim to enable longer-lasting protein expression, reduced dosing frequency, and expanded therapeutic applications across cancer, rare diseases, and chronic conditions.
Celltrion Pursues Adalimumab Interchangeability as Formycon Reports Positive Ustekinumab Biosimilar Data
- Celltrion Healthcare has filed an investigational new drug application with the FDA for a Phase 3 clinical trial to establish interchangeability of its adalimumab biosimilar, Yuflyma, with Humira.
- The Phase 3 trial will involve switching patients between Humira and Yuflyma to verify pharmacokinetics, efficacy, and safety in 366 patients with plaque psoriasis.
- Formycon announced positive Phase 3 data for its ustekinumab biosimilar (FYB202), demonstrating comparable efficacy and safety to Stelara in patients with moderate to severe plaque psoriasis.
- The Formycon study met its primary endpoint, showing comparable improvement in Psoriasis Area and Severity Index scores after 12 weeks, with no clinically meaningful differences in adverse events.