Alfacell Corporation, a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer, provided an update on the status of the ongoing confirmatory phase IIIb registration trial evaluating Onconase (ranpirnase), the company's lead investigational drug candidate, as a treatment for unresectable malignant mesothelioma (UMM):
The company has now completed nearly all of the key requirements of the Chemistry, Manufacturing and Controls (CMC) section of the NDA, and expects to file the CMC submission by the end of the third quarter of 2006. Once accepted by FDA, the CMC section can be used for future Onconase filings for major cancer indications.
The company continues to allow access to Onconase in key US sites and international sites in the MM programme, as a result accrual has been optimized and the required 316 events to initiate the final analysis is projected to occur earlier than previously estimated. Overall, the company remains on track to file the NDA no later than mid-2007.
Onconase is a first-in-class therapeutic from Alfacell's proprietary ribonuclease (RNase) technology platform. Onconase has been shown to target tumour cells while sparing normal cells. Onconase 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).
Onconase has previously been granted Orphan Drug designation from EMEA and TGA (Australia), as well as Fast Track status by the FDA. The latter has enabled the Company to complete and submit sections of the New Drug Application (NDA) on an accelerated, rolling basis.
The company is also conducting an Onconase phase I / II trial in Non-Small Cell Lung Cancer (NSCLC). The NSCLC market is expected to exceed $4 billion by 2012.