Tanox has reported 48-week results from its Phase II clinical trial of HIV drug candidate, TNX-355. Following previously reported 24-week data, the new results show that HIV-infected patients who received either study dose of TNX-355, in combination with an optimized background regimen (OBR), maintained a considerably greater reduction in viral load than did patients given placebo
in combination with OBR.
At 48 weeks, treatment with a 10 mg/kg dose of TNX-355 resulted in a mean viral-load reduction of 0.96 log10, compared with a 0.14 log10 reduction in the placebo group, representing a 0.82 log10 greater reduction in viral load. Patients who received a 15 mg/kg dose of TNX-355 had a mean viral-load reduction of 0.71 log10, compared with a 0.14 log10 reduction
in the placebo group, representing a 0.57 log10 greater reduction in viral load.
Simplifying Global Compliance
Recommended Products
EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements
The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.
Editor's Picks
FDA Clears Soft Tissue Visualization Addon for MRIdian SmartVision
The updated system offers improved imaging for more precise targeting of tumors.
Compounder to Pay $775,000 Over Kickback Allegations
The payment will resolve a whistleblower lawsuit over unwanted compounded medications from the pharmacy that were billed to Medicare.
