![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » ALFACELL COMPLETES NON-CLINICAL SECTION OF ONCONASE NDA
ALFACELL COMPLETES NON-CLINICAL SECTION OF ONCONASE NDA
October 3, 2006
Alfacell announced it has completed the non-clinical section of the rolling submission of a new drug application (NDA) in preparation for its submission to the FDA for its lead anticancer compound, Onconase (ranpirnase). Onconase, first in class in the ribonuclease family, is currently the subject of a randomized Phase III clinical trial in combination with doxorubicin as a potential treatment for patients with unresectable malignant mesothelioma. The company will submit the chemistry, manufacturing and controls section of the NDA after completion of a review by external regulatory consultants. The company anticipates completing the NDA submission ending the review of final results of the ongoing trial in 2007.
The FDA granted fast-track designation to Onconase as a treatment for patients with unresectable malignant mesothelioma in September 2003. The FDA's fast-track programs are intended to expedite the review of drugs to treat serious or life-threatening conditions and those that demonstrate the potential to address unmet medical needs.
The rolling submission process enables companies with the designation to submit sections of the NDA to the agency as they become available, allowing the review process to begin before the complete dossier has been submitted.
Onconase has been shown to target tumor cells while sparing normal cells. The drug is internalized by endocytosis and released into the cytosol of the cancerous cell, where it selectively degrades tRNA beyond repair. In doing so, Onconase inhibits protein synthesis, stops cell cycle proliferation and induces apoptosis (programmed cell death).
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
21Oct