THE ARMY, UNITED STATES DEPARTMENT OF

Nyrada's NYR-BI03 Shows Promise in Traumatic Brain Injury and Begins Phase 1 Clinical Trial

2 months ago

• Nyrada's lead drug candidate NYR-BI03 demonstrated statistically significant neuroprotection in a preclinical model of penetrating traumatic brain injury, according to a collaborative study with the Walter Reed Army Institute of Research. • The company has commenced recruitment for a Phase 1 clinical trial to assess safety, tolerability, and pharmacokinetics of NYR-BI03, with final readouts expected in Q3 2025. • Previous preclinical studies showed NYR-BI03 rescued 42% of brain tissue in stroke models and provided 86% cardioprotection following myocardial ischemic-reperfusion injury, positioning it as a promising first-in-class treatment.

60 Degrees Pharmaceuticals Advances ARAKODA for Chronic Babesiosis Treatment with Phase II Trial Approval

4 months ago

60 Degrees Pharmaceuticals (NASDAQ: SXTP) has received IRB approval for a Phase II clinical trial evaluating ARAKODA® (tafenoquine) as a treatment for chronic babesiosis. The study, targeting a potential market of 400,000 U.S. patients, aims to address an unmet medical need for this expanding tick-borne disease, with patient enrollment scheduled to begin in Q3 2025.

Dengue Vaccine Landscape Evolves: New Candidates Show Promise in Clinical Trials

5 months ago

• Several dengue vaccine candidates are progressing through clinical trials, offering potential solutions for this widespread disease. • Butantan-DV showed 67-79% efficacy in preventing dengue in a Phase 3 trial in Brazil and is awaiting regulatory approval. • Panacea Biotech, in collaboration with ICMR, initiated a Phase 3 trial for their DengiAll vaccine in India after promising early-stage results. • Codagenix Inc. received $5.88 million from the U.S. Department of Defense to advance its CodaVax-DENV tetravalent vaccine candidate.

60 Degrees Pharma's Tafenoquine Receives IRB Approval for Phase II Chronic Babesiosis Study

5 months ago

• 60 Degrees Pharmaceuticals has received IRB approval for a Phase II study evaluating Tafenoquine for chronic babesiosis. • The open-label study will assess the efficacy and safety of Tafenoquine over 90 days in patients with chronic babesiosis. • Patient enrollment is expected to commence in Q3 2025, targeting those with significant functional impairment for at least six months. • The company estimates a substantial addressable market for Tafenoquine in babesiosis, potentially exceeding 400,000 patients by 2035.

RPLND Strategies Evolving for Metastatic Testicular Seminoma: Modified Templates and Surgical Outcomes

6 months ago

• Retroperitoneal lymph node dissection (RPLND) is gaining recognition as an effective treatment option for stage IIA/B seminoma, potentially avoiding long-term toxicities of chemotherapy or radiotherapy. • Mapping studies in non-seminomatous germ cell tumors have refined RPLND techniques, emphasizing ipsilateral gonadal vessel resection and minimizing suprahilar dissection. • Recent trials (SEMS, PRIMETEST, COTRIMS) demonstrate favorable survival outcomes with primary RPLND, though recurrence patterns vary, suggesting the need for tailored surgical approaches. • Emerging data suggest that bilateral template dissections may improve survival outcomes compared to unilateral templates in specific patient subgroups with metastatic seminoma.

60 Degrees Pharma's Tafenoquine Study for Babesiosis in Immunocompromised Patients Gains IRB Approval

10 months ago

• 60 Degrees Pharma received IRB approval for an expanded access study of tafenoquine to treat persistent babesiosis in immunocompromised patients. • The study aims to validate an 80% cure rate observed in a previous Yale School of Public Health case series using tafenoquine. • Tafenoquine, approved for malaria prophylaxis as ARAKODA, is being investigated for a new indication to treat babesiosis. • The company plans to file an NDA with the FDA in Q2 2026 for tafenoquine as a treatment for babesiosis, targeting acute and chronic cases.