INVESTIGATIONAL NEW DRUG APPLICATIONS
The CRI has experience with and can assist in generating investigational new drug applications (INDA) for review by the FDA. We can also assist with pre-INDA meetings.
RELEVANT INDA SUBMISSIONS
INDA: 11314: Therapy Targeting the Interleukin-3 Receptor (IL3R) for Patients with Relapsed or Refractory and Elderly or Poor-Risk Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome with DT388IL3 (IND# 11314): a Phase I/II Clinical Trial
INDA: 100712: A Phase I/II Study of A-dmDT390-bisFv (UCHT1) Fusion Protein in Patients with surface CD3+ malignant T cell disease
INDA: 100780: A Phase I Study of DT2219ARL (IND# 100780), A Bispecific Single Chain Immunotoxin for the Treatment of CD19(+), CD22(+) B-Lineage Acute Lymphoblastic Leukemia
INDA: 12866 : A Phase 1 Trial of PSAActivated PSA-PAH1 Therapy for Locally Recurrent Prostate Cancer Without Metastases After Primary Radiation Therapy