Clinical Trial News

Oleolive, Inc., awarded a $400,000 STTR Phase 1 grant, researches Propentofylline (PPF) for Glioblastoma Multiforme (GBM) treatment. PPF, a repurposed drug, aims to enhance GBM tumor cells' chemosensitivity, potentially improving patient survival beyond the current 1.25-year average. Oleolive, a preclinical biotech company, focuses on treating brain cancer, Alzheimer's, and other conditions.

Continuous i.c.v. A-dopamine treatment for PD significantly reduces L-dopa-related complications, showing high safety and efficacy. It allows oral treatment reduction by 40-70%, decreases dyskinesias by 80%, and nearly eliminates severe "off" periods. Patients prefer long-term use with home refills.

The COVID-19 Antivirals and Therapeutics Taskforce closed on 31 March 2023, aligning with the government's strategy to live with COVID-19. Clinical trials, including phases 1, 2, and 3, are crucial for discovering effective treatments. The UK has established clinical trial platforms like AGILE, RECOVERY, REMAP-CAP, PRINCIPLE, PROTECT-V, HEAL-COVID, STIMULATE-ICP, and PANORAMIC to test and implement COVID-19 treatments. These trials aim to improve patient outcomes, reduce hospital admissions, and enhance recovery, with some treatments already proven effective and integrated into NHS care.

A collaborative effort by LUNGevity, FDA, NCI, and industry sponsors developed standardized eligibility criteria for NSCLC clinical trials, aiming to simplify criteria, enhance trial accessibility, and support inter-trial comparisons. The recommendations, forming the basis for FDA draft guidance, cover disease stage, biomarkers, performance status, and organ function, among others, to streamline trial design and improve patient access to novel therapies.

Scemblix® (asciminib) approved in Europe for Ph+ CML-CP, showing a 25.5% MMR rate vs. 13.2% for Bosulif®, with lower discontinuation rates due to adverse reactions. It targets the ABL myristoyl pocket, offering a new option for patients resistant or intolerant to prior TKIs.

Bayer submitted a regulatory application to China’s NMPA for darolutamide, an oral androgen receptor inhibitor, to treat metastatic hormone-sensitive prostate cancer (mHSPC) with docetaxel. Supported by Phase III ARASENS trial results showing improved overall survival, darolutamide, marketed as Nubeqa™, is already approved in over 60 markets for non-metastatic castration-resistant prostate cancer. Bayer aims to address the rising prostate cancer incidence in China, emphasizing the need for treatments that extend survival and delay disease progression.

Celltrion seeks FDA approval for its adalimumab biosimilar Yuflyma's interchangeability with Humira, aiming for a 2023 launch. Formycon reports positive phase 3 trial results for its ustekinumab biosimilar FYB202, comparable to Stelara in treating psoriasis, highlighting progress in biosimilar development.

A new Lyme disease vaccine, VLA15, is in its final clinical trial phase, aiming to protect people aged five and up. Developed by Pfizer and Valneva, it targets a protein of the Borrelia bacteria, omitting a region linked to past adverse reactions. If successful, it could seek approval by 2025, offering a new defense against the spreading disease.

Metformin, a diabetes drug, shows promise in preventing aging-related diseases. Nir Barzilai's TAME Trial aims to prove this, facing FDA and funding hurdles. Despite interest, securing the $30-50M needed remains challenging, with hopes pinned on new philanthropists and organizations like Hevolution.

Doxycycline post-exposure prophylaxis (doxyPEP) effectively prevents syphilis and chlamydia in gay, bisexual men, and trans women, with less efficacy against gonorrhoea. Concerns about antibiotic resistance persist. Research supports its use in high-risk groups, though evidence for cisgender women is lacking. Guidelines vary, with some advocating for its use while others caution due to resistance risks.