WAYNE STATE UNIVERSITY

Partner Treatment Halves Bacterial Vaginosis Recurrence Rate in Landmark Trial

3 months ago

• A groundbreaking randomized controlled trial demonstrates that treating both women and their male partners for bacterial vaginosis reduces recurrence rates by nearly 50% compared to treating women alone. • The study, conducted at Monash University, provides substantial evidence that bacterial vaginosis is sexually transmitted, challenging current treatment approaches for this condition affecting 21 million U.S. women. • Male partners treated with oral metronidazole and topical clindamycin resulted in a significant reduction in BV recurrence rate from 4.2 to 1.6 per person-year in female partners.

Alterity Therapeutics' ATH434 Shows Promise in Multiple System Atrophy Trials

4 months ago

• Alterity Therapeutics anticipates topline data from the ATH434-201 Phase 2 trial in early-stage Multiple System Atrophy (MSA) by early February 2025. • Interim data from the ATH434-202 Phase 2 trial in advanced MSA suggests potential disease-modifying effects, with 30% of participants showing stable or improved clinical outcomes. • Non-clinical data highlights ATH434's neuroprotective qualities and mechanism of action, emphasizing the importance of iron-targeting agents in treating neurodegenerative diseases. • The bioMUSE natural history study demonstrates the utility of advanced neuroimaging to track MSA progression, correlating brain volume reductions with clinical worsening.

Nurix Therapeutics' BTK Degrader NX-5948 Shows Promise in B-Cell Malignancies and Autoimmune Diseases

4 months ago

• Nurix Therapeutics' NX-5948 demonstrates a 75.5% objective response rate in relapsed/refractory CLL/SLL patients in Phase 1 study. • NX-5948 receives PRIME designation from EMA for CLL and Fast Track designation from FDA for Waldenstrom's Macroglobulinemia. • Nurix plans to initiate pivotal trials for NX-5948 in CLL and expand development into autoimmune diseases in 2025. • The company's strong financial position, with $609.6 million in cash, supports aggressive development of its pipeline.

C-Reactive Protein Levels Predict Adalimumab Response in Hidradenitis Suppurativa

4 months ago

• A post-hoc analysis of PIONEER trials reveals that elevated C-reactive protein (CRP) levels in hidradenitis suppurativa (HS) patients are associated with higher BMI and more severe disease. • Patients with elevated CRP showed a diminished clinical response to adalimumab, suggesting that the drug's efficacy may be reduced in those with higher inflammatory loads. • Adalimumab treatment was linked to greater odds of clinical response in both patients with elevated and normal CRP levels, but the effect was less pronounced in the former group. • The study suggests clinicians should consider weight-based dosing, drug level monitoring, or alternative biologics for HS patients with high CRP levels who do not respond to adalimumab.

Stem Cell-Derived Therapy Trial Enrolls First Michigan Patient for Drug-Resistant Epilepsy

5 months ago

• Wayne State University enrolled the first Michigan patient in a Phase I/II trial testing stem cell-derived interneuron implantation to reduce seizure frequency. • The trial, "A First-In-Human Study of Inhibitory Interneurons (NRTX-1001)," targets drug-resistant unilateral mesial temporal lobe epilepsy (MTLE). • The six-hour procedure involves robotic and stereotactic techniques to deliver GABA-secreting cells into the hippocampus, aiming for a 75% seizure reduction. • The study will assess safety, tolerability, cell viability, inflammation, and effects on epilepsy symptoms over two years, with a 13-year follow-up.

Karmanos Cancer Institute First to Prescribe FDA-Approved TheraBionic P1 for Advanced Liver Cancer

5 months ago

• Karmanos Cancer Institute is the first worldwide to prescribe the TheraBionic P1, an FDA-approved at-home device, for advanced hepatocellular carcinoma. • The TheraBionic P1 device delivers low-level radiofrequency electromagnetic fields to block tumor cell growth without harming healthy tissue. • Approved for patients who have failed first- and second-line therapies, the device offers a new systemic treatment option with minimal side effects. • Clinical studies have demonstrated that the TheraBionic P1 device can lead to tumor shrinkage and increased overall survival rates in HCC patients.

Biomarker-Guided Therapies Transform Treatment Landscape Across Multiple Cancers

5 months ago

• Recent advances in targeted therapies including KRAS, BRAF, and CLDN18.2 inhibitors are revolutionizing treatment approaches for pancreatic, colorectal, lung and gastric cancers through molecular profiling-guided precision medicine. • Zolbetuximab plus chemotherapy demonstrated significant survival benefits in CLDN18.2-positive gastric cancer, while KRAS inhibitors showed promising response rates of 20-45% in pancreatic cancer patients with specific mutations. • Multiple biomarker-targeted approaches including HER2, PD-L1, and FGFR2 are expanding treatment options across gastrointestinal cancers, though optimal sequencing strategies are still being determined.

FDA Approves Phase 2 Clinical Trial of Smoked Marijuana for PTSD in Veterans

6 months ago

• The FDA has approved a Phase 2 clinical trial to evaluate smoked marijuana for treating PTSD in veterans, funded by Michigan cannabis sales tax revenue. • The trial, involving 320 veterans with moderate to severe PTSD, will study the effects of inhaled high-THC cannabis versus placebo, self-titrated by participants. • This study aims to provide data on the real-world use of cannabis for PTSD, addressing the lack of rigorous research on its efficacy and potential benefits. • The approval follows three years of negotiations with the FDA, overcoming obstacles related to THC dosage, delivery methods, and participant criteria.

ESK981 Plus Nivolumab Fails to Show Antitumor Activity in Metastatic Castration-Resistant Prostate Cancer

6 months ago

• A Phase II trial evaluating ESK981, a multi-tyrosine kinase inhibitor, combined with nivolumab in metastatic castration-resistant prostate cancer (mCRPC) was terminated due to futility. • The combination therapy of ESK981 and nivolumab did not demonstrate significant antitumor activity in patients with AR-positive mCRPC, showing a maximum PSA decline of only 14% in one patient. • The median radiographic progression-free survival (rPFS) was 3.7 months, and the median overall survival (OS) was 9.6 months, indicating limited clinical benefit from the treatment regimen. • Grade 3 treatment-related adverse events, including fatigue, anemia, and lymphopenia, were observed, further questioning the risk-benefit profile of this combination in mCRPC.