Phase 2 Study of VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis in Adults With Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, or Allogeneic Hematopoietic Cell Transplant Recipients
Phase of Trial: Phase II
Latest Information Update: 15 Mar 2018
At a glance
- Drugs VL 2397 (Primary) ; Amphotericin B liposomal; Isavuconazole; Voriconazole
- Indications Aspergillosis
- Focus Therapeutic Use
- Sponsors Vical
- 15 Mar 2018 According to a Vical media release,the FDA has advised that VL-2397 would be eligible for a Limited Use Indication (LUI) approval for the treatment of invasive aspergillosis, assuming a successful outcome of this phase 2 trial carried out in accordance with a protocol and statistical analysis plan consistent with the Agencys advice.The final determination whether the drug is approvable will be made by FDA after review of all relevant data.
- 20 Feb 2018 Status changed from not yet recruiting to recruiting, according a Vical media release.
- 01 Feb 2018 According a Vical media release, the Mycoses Study Group Education and Research Consortium (MSGERC) will be serving as advisor to this trial.