Alfacell Corporation
(Nasdaq: ACEL) announced it has confirmed that 290 evaluable events
(patient deaths) have occurred in the Phase IIIb clinical trial of its lead
compound, ONCONASE, for the treatment of patients with unresectable
malignant mesothelioma. The number of evaluable events was confirmed after
the company learned that total events in the study had reached 316. In
accordance with the statistical plan for the study, the company must wait
until 316 evaluable events have occurred to conduct the formal statistical
analysis required to complete the ONCONASE New Drug Application (NDA).
Enrollment in the ONCONASE Phase IIIb clinical trial is scheduled to close
on Sept. 30, 2007. To date, a total of 425 patients have been enrolled in
the trial.
To be considered evaluable, patients must meet all of the eligibility
requirements for the study and receive at least one dose of study drug.
Alfacell projects that 316 evaluable events will occur before the end of
2007. Upon reaching this milestone, the company expects to proceed using
the following schedule to provide updates regarding the potential
completion of the final sections of its ONCONASE rolling NDA submission:
-- Report occurrence of 316 evaluable events via news release within 72
hours of confirmation by Alfacell
-- If data are positive, submit final clinical section of rolling NDA
within four months of reporting 316 evaluable events and announce
submission via news release
Alfacell estimates that it has sufficient cash resources available to
continue to fund the completion of the ONCONASE Phase III program and the
rolling NDA submission.
In addition, the company also plans to initiate quarterly conference
calls with investors and analysts to discuss financial performance and to
provide corporate updates, beginning with a call currently anticipated to
be conducted in early October to discuss the company's fiscal 2007
performance.
About ONCONASE(R)
ONCONASE is a first-in-class product candidate based on Alfacell's
proprietary ribonuclease (RNase) technology. A natural protein isolated
from the leopard frog, ONCONASE has been shown in the laboratory and clinic
to target cancer cells while sparing normal cells. ONCONASE triggers
apoptosis, the natural death of cells, via multiple molecular mechanisms of
action.
About Alfacell Corporation
Alfacell Corporation is the first company to advance a
biopharmaceutical product candidate that works in a manner similar to RNA
interference (RNAi) through late-stage clinical trials. The product
candidate, ONCONASE, is an RNase that overcomes the challenges of targeting
RNA for therapeutic purposes while enabling the development of a new class
of targeted therapies for cancer and other life-threatening diseases. In
addition to an ongoing Phase IIIb study in malignant mesothelioma, Alfacell
is conducting a Phase I/II trial of ONCONASE in non-small cell lung cancer
(NSCLC) and other solid tumors. For more information, visit
alfacell.
Safe Harbor
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
release.
Alfacell Corporation
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