Articles and Resources
Alfacell Provides Update on the ONCONASE Phase IIIb Registration Trial
BLOOMFIELD, N.J., June 22 /PRNewswire-FirstCall/ -- Alfacell
Corporation (Nasdaq: ACEL) today provided an update on the status of the
ongoing confirmatory Phase IIIb registration trial evaluating ONCONASE(R)
(ranpirnase), the Company's lead investigational drug candidate, as a
treatment for unresectable malignant mesothelioma (UMM):
Rolling New Drug Application (NDA) for the ONCONASE UMM indication: 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 program, 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
tumor 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.
About Alfacell Corporation
Alfacell Corporation is a biopharmaceutical company focused on the
discovery, development and commercialization of novel therapeutics for
cancer, using its proprietary RNase technology platform. For more
information, please visit http://www.alfacell.com.
This press release includes statements that may constitute
"forward-looking" statements, usually containing the words "believe,"
"estimate," "project," "expect" or similar expressions. Forward-looking
statements involve risks and uncertainties that could cause actual results
to differ materially from the forward-looking statements. Factors that
would cause or contribute to such differences include, but are not limited
to, uncertainties involved in transitioning from concept to product,
uncertainties involving the ability of the Company to finance research and
development activities, potential challenges to or violations of patents,
uncertainties regarding the outcome of clinical trials, the Company's
ability to secure necessary approvals from regulatory agencies, dependence
upon third-party vendors, and other risks discussed in the Company's
periodic filings with the Securities and Exchange Commission. By making
these forward-looking statements, the Company undertakes no obligation to
update these statements for revisions or changes after the date of this
Elite Financial Communications