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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 30, 2005
ALFACELL CORPORATION
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(Exact name of registrant as specified in its charter)
Delaware 0-11088 22-2369085
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(State or other jurisdiction of (Commission (IRS Employer
incorporation) File Number) Identification)
225 Belleville Avenue, Bloomfield, New Jersey 07003
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(Address of principal executive offices) (Zip Code)
(Registrant's telephone number, including area code: (973) 748-8082
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(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
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ITEM 8.01 OTHER EVENTS.
On August 30, 2005, Alfacell Corporation reported an update on the status of its
international, confirmatory Phase IIIb malignant mesothelioma trial for
ONCONASE(R) (ranpirnase), the Company's lead investigational drug candidate:
o Nearly 90% of the patients required per the study design for full patient
accrual are now enrolled.
o Active patient enrollment is ongoing at leading cancer centers in the
United States, Canada, Germany, Italy, Poland, Australia and New Zealand.
o Earlier this year, the Company reported that recent regulatory changes in
several large, non-EU countries had delayed the opening of new sites for
the study. The Company is now pleased to announce that government approvals
have been obtained and sites recently opened in Russia, Romania, Mexico and
Brazil.
The Company will continue to provide updates on the trial as key developments
occur.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.
(c) EXHIBITS.
99.1 Press release dated August 30, 2005.
This Form 8-K includes statements that may constitute "forward-looking"
statements, usually containing the words "believe", "estimate", "project",
"expect" or similar expressions. Any such forward-looking statements are based
on assumptions that the Company believes are reasonable, but are subject to a
wide range of risks and uncertainties and, therefore, there can be no assurance
that actual results may not differ materially from those expressed or implied by
such 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 Form
8-K.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Dated: September 1, 2005
By: /s/ Robert Love
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Robert Love
Chief Financial Officer