8-K: Current report filing
Published on February 24, 2010
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)
February
23, 2010
NOVELOS
THERAPEUTICS, INC.
(EXACT
NAME OF REGISTRANT AS SPECIFIED IN CHARTER)
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DELAWARE
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333-119366
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04-3321804
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(STATE
OR OTHER
JURISDICTION
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(COMMISSION
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(IRS
EMPLOYER
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OF
INCORPORATION)
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FILE
NUMBER)
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IDENTIFICATION
NO.)
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One
Gateway Center, Suite 504, Newton, Massachusetts 02458
(ADDRESS
OF PRINCIPAL EXECUTIVE OFFICES) (ZIP CODE)
REGISTRANT’S
TELEPHONE NUMBER, INCLUDING AREA CODE: (617) 244-1616
NOT
APPLICABLE
(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:
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¨
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WRITTEN
COMMUNICATIONS PURSUANT TO RULE 425 UNDER THE SECURITIES ACT (17 CFR
230.425)
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¨
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SOLICITING
MATERIAL PURSUANT TO RULE 14a-12 UNDER THE EXCHANGE ACT (17 CFR
240.14a-12)
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¨
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PRE-COMMENCEMENT
COMMUNICATIONS PURSUANT TO RULE 14d-2(b) UNDER THE EXCHANGE ACT (17 CFR
240.14d-2(b))
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¨
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PRE-COMMENCEMENT
COMMUNICATIONS PURSUANT TO RULE 13e-4(c) UNDER THE EXCHANGE ACT (17 CFR
240.13e-4(c))
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ITEM
7.01 REGULATION
FD DISCLOSURE
A copy of
the press release issued by us on February 24, 2010 announcing the results of
our pivotal phase 3 lung cancer trial is furnished as Exhibit 99.1 and is
incorporated by reference in this Item.
ITEM
8.01 OTHER
MATERIAL EVENTS
On
February 23, 2010, we received a report of the top-line results of our pivotal
Phase 3 clinical trial in advanced non-small cell lung cancer studying our lead
product, NOV-002, in combination with first-line chemotherapy. Upon
evaluation and review of the data contained in the report, we determined that
the primary endpoint of improvement in overall survival was not met in the
trial.
Based on
a preliminary analysis of the clinical trial data, it appears that internal
simulations suggesting positive trial results were inaccurate due to the
deviation of certain trial data from our statistical model, the impact of
censoring patterns and the survival of patients in the control arm exceeding our
expectations, which had been based on historical precedents. We
expect to present detailed Phase 3 lung cancer trial results at an appropriate
scientific venue later this year.
ITEM
9.01 FINANCIAL
STATEMENTS AND EXHIBITS
(c)
Exhibits
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Number
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Title
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99.1
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Press
Release dated February 24, 2010 entitled “Novelos Therapeutics Pivotal
Phase 3 Lung Cancer Trial Does Not Meet the Primary Survival
Endpoint.”
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SIGNATURE
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.
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Dated:
February 24, 2010
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NOVELOS THERAPEUTICS,
INC.
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By:
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/s/
Harry S. Palmin
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Harry
S. Palmin
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President
and Chief Executive Officer
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EXHIBIT
INDEX
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Number
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Title
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99.1
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Press
Release dated February 24, 2010 entitled “Novelos Therapeutics Pivotal
Phase 3 Lung Cancer Trial Does Not Meet the Primary Survival
Endpoint.”
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