8-K: Current report filing
Published on March 18, 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)
March 18,
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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o
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WRITTEN
COMMUNICATIONS PURSUANT TO RULE 425 UNDER THE SECURITIES ACT (17 CFR
230.425)
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o
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SOLICITING
MATERIAL PURSUANT TO RULE 14a-12 UNDER THE EXCHANGE ACT (17 CFR
240.14a-12)
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o
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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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o
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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 March 18, 2010 announcing that the secondary
endpoints were not met in Novelos’ pivotal Phase 3 trial in advanced non-small
cell lung cancer (NSCLC) with its lead product, NOV-002, and that the
development of NOV-002 for NSCLC in combination with first-line paclitaxel and
carboplatin chemotherapy, is furnished as Exhibit 99.1 and is incorporated by
reference in this Item.
ITEM
8.01 OTHER
MATERIAL EVENTS
As
previously disclosed, on February 23, 2010, we received a report of the top-line
results of our pivotal Phase 3 clinical trial in advanced NSCLC studying our
lead product, NOV-002, in combination with first-line
chemotherapy. Upon initial 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. After further
analysis of the data in the report, we confirmed that the secondary endpoints
also were not met in the pivotal Phase 3 trial, and that adding NOV-002 to
paclitaxel and carboplatin chemotherapy was not statistically or meaningfully
different in terms of efficacy-related endpoints or recovery from chemotherapy
toxicity versus chemotherapy alone. On the basis of these results, we
have determined to discontinue development of NOV-002 for NSCLC in combination
with first-line paclitaxel and carboplatin chemotherapy.
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 March 18, 2010 entitled “Novelos Therapeutics Discontinues
Current Development Program for NOV-002 in
NSCLC.”
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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:
March 18, 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 March 18, 2010 entitled “Novelos Therapeutics Discontinues
Current Development Program for NOV-002 in
NSCLC.”
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