Published on January 7, 2010
FOR IMMEDIATE
RELEASE
NOVELOS
THERAPEUTICS REACHES 725th
EVENT
IN
PIVOTAL PHASE 3 LUNG CANCER TRIAL
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- - -
Trial
Conclusion on Track for 1Q 2010
NEWTON, Mass., January 7, 2010 –
Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company
focused on the development of therapeutics to treat cancer and hepatitis, today
announced that the 725th event
(patient death) has been reached in its pivotal Phase 3 trial in advanced
non-small cell lung cancer (NSCLC) studying its lead
product, NOV-002, in combination with first-line
chemotherapy. The 725th event
triggers the steps towards the pre-specified analysis according to the trial’s
Statistical Analysis Plan (SAP). Top-line trial results are expected
to be available later in the first quarter.
This
randomized, controlled, open-label Phase 3 trial, being conducted under a
Special Protocol Assessment (SPA) and Fast Track designation, has enrolled 903
patients with Stage IIIb/IV NSCLC, which includes all histological
subtypes. The trial, conducted across approximately 100 clinical
sites in 12 countries, is evaluating NOV-002 in combination with first-line
paclitaxel and carboplatin chemotherapy versus paclitaxel and carboplatin
alone. The primary efficacy endpoint of the trial is improvement in
overall survival. Enrollment commenced in November 2006 and the
target enrollment was achieved in March 2008. According to the SAP,
a total of 725
events are required to detect a 25% improvement in overall survival
(hazard ratio of 0.8) with 85% power and a
two-sided significance level of 0.05. No interim analysis was
performed.
“We are
on track for our pivotal Phase 3 trial to conclude this quarter,” said Harry
Palmin, President and CEO of Novelos. “Should this registrational
trial be positive, we will proceed with filing a New Drug Application (NDA) in
3Q 2010. Thereafter, based on our Fast Track designation, we would
project FDA approval for first-line treatment of advanced NSCLC in combination
with chemotherapy in 1Q 2011.”
About
NSCLC
NSCLC
accounts for about 87% of lung cancer, which is the leading cause of cancer
death in the U.S. According to the American Cancer Society,
approximately 215,000 people were expected to be diagnosed with lung cancer in
2008 in the U.S., with approximately 162,000 deaths. Approximately
1,500,000 new cases of lung cancer were expected worldwide in 2007 and
approximately 1,350,000 deaths were projected from lung cancer in
2007. Only about 16% of NSCLC patients are diagnosed early enough to
be eligible for surgery. Platinum-based chemotherapy regimens are
standard first-line treatment for advanced NSCLC patients. Paclitaxel
and carboplatin is the most common first-line treatment in the U.S., while
gemcitabine / pemetrexed and cisplatin are more common in
Europe. During treatment, patients are subject to serious
chemotherapy-induced adverse effects. According to results of 12
Phase 3 clinical trials published from 2001-2008, the one-year survival rate for
patients receiving paclitaxel and carboplatin first-line therapy was on average
only about 40%, the weighted average for median survival was 9.7 months and the
objective tumor response (defined as greater than 30% tumor shrinkage) rate was
about 27%. Overall, fewer than 5% of advanced non-small cell lung
cancer patients survive five years.
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About
NOV-002 for NSCLC
NOV-002
is a small molecule compound based on a proprietary formulation of oxidized
glutathione that acts together with chemotherapy as a chemopotentiator and a
chemoprotectant by regulating redox-sensitive cell signaling
pathways. Three separate Phase 2 trials demonstrated clinical
activity and safety of NOV-002 in combination with first-line chemotherapy in
NSCLC. In a controlled, randomized U.S. Phase 1/2 clinical trial,
advanced NSCLC patients treated with NOV-002 in combination with first-line
paclitaxel and carboplatin demonstrated improved objective tumor response
(p<0.05) and higher tolerance of chemotherapy (p<0.01) compared to the
active control group. In a controlled, randomized Russian Phase 2
trial, when used in combination with cisplatin-based first-line chemotherapy,
NOV-002 increased the one-year survival of advanced NSCLC patients from 17% to
63% (p<0.01); median survival (i.e. 50% of patients dead) was not reached in the
NOV-002 arm at 14 months compared to a median survival of 7 months in the active
control. In a single arm Russian Phase 2 trial, advanced NSCLC
patients treated with NOV-002 in combination with first-line cisplatin-based
chemotherapy exhibited greater than 50% one-year survival. NOV-002
has an extensive safety database, and has also demonstrated improved recovery
from chemotherapy toxicity in cancer patients. Importantly, NOV-002
does not appear to be chemotherapy specific or tumor specific.
About
Novelos Therapeutics, Inc.
Novelos
Therapeutics, Inc. is a biopharmaceutical company commercializing oxidized
glutathione-based compounds for the treatment of cancer and
hepatitis. NOV-002, the lead compound currently in Phase 3
development for lung cancer under an SPA and Fast Track, acts together with
chemotherapy as a chemopotentiator and a chemoprotectant. NOV-002 is
also in Phase 2 development for early-stage breast cancer and
chemotherapy-resistant ovarian cancer. Novelos has a partnership with
Mundipharma, an independent associated company of Purdue Pharma, to develop and
commercialize NOV-002 in Europe and Asia (excluding China). Novelos’
second compound, NOV-205, acts as a hepatoprotective agent with immunomodulating
and anti-inflammatory properties. NOV-205 is in Phase 1b development
for chronic hepatitis C non-responders. Both compounds have been
partnered with Lee’s Pharm in China. For additional information about
Novelos please visit www.novelos.com
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COMPANY
|
INVESTOR
RELATIONS
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Harry
S. Palmin, President and CEO
|
Stephen
Lichaw
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Ph:
617-244-1616 x11
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Ph:
201-240-3200
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Email:
hpalmin@novelos.com
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Email:
slichaw@novelos.com
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Novelos Therapeutics, Inc.
One
Gateway Center, Suite 504
Newton,
MA 02458
This
news release contains forward-looking statements. Such statements are
valid only as of today, and we disclaim any obligation to update this
information. These statements are subject to known and unknown risks
and uncertainties that may cause actual future experience and results to differ
materially from the statements made. These statements are based on
our current beliefs and expectations as to such future outcomes. Drug
discovery and development involve a high degree of risk. Factors that
might cause such a material difference include, among others, uncertainties
related to the ability to attract and retain partners for our technologies, the
identification of lead compounds, the successful preclinical development
thereof, the completion of clinical trials, the FDA review process and other
government regulation, our pharmaceutical collaborators’ ability to
successfully develop and commercialize drug candidates, competition from other
pharmaceutical companies, product pricing and third-party
reimbursement.
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