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WEBCAST: Noble 4th Annual Equity Conference, August 18, 2008 (Archived)
08-18-2008...
NOVELOS THERAPEUTICS CLOSES $3 MILLION PRIVATE PLACEMENT...
See News section for details...
06-02-2008...
NOVELOS ANNOUNCES PRESENTATION OF ENCOURAGING RESULTS IN
PHASE 2 OVARIAN CANCER TRIAL AT 2008 ASCO MEETING BY MGH AND
DANA-FARBER/HARVARD CANCER CENTERS...
See News section for details...
05-12-2008...
NOVELOS THERAPEUTICS ANNOUNCES POSITIVE RESULTS IN
ONGOING PHASE 2 NEOADJUVANT BREAST CANCER TRIAL AT MUSC
HOLLINGS CANCER CENTER...
See News section for details...
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About Us
Click Here for Corporate Overview
Novelos Therapeutics, Inc. (OTCBB: NVLT) is a biopharmaceutical company commercializing oxidized
glutathione-based compounds for the treatment of Cancer and Hepatitis. NOV-002, the lead
compound in Phase 3 development for lung cancer under a Special Protocol Assessment (SPA) and Fast Track, acts together
with chemotherapy as a chemoprotectant and chemopotentiator by regulating redox-sensitive cell
signaling pathways. NOV-002 is also in Phase 2 development
for chemotherapy-resistant ovarian cancer and early-stage breast cancer.
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
completed clinical trials in humans and have been approved for use in Russia where
they were originally developed.
Novelos' pipeline of drugs is based on oxidized glutathione, a natural metabolite that is part of the
glutathione pathway. This pathway is the primary determinant of intracellular redox (oxidation/reduction)
potential and, as such, plays a key role in cell protection (e.g. detoxification) and in regulation of
cell signaling pathways (e.g. leading to cytokine production). Novelos’ lead products are believed
to act, in part, via post-translational modification (glutathionylation) of critical regulatory
proteins that mediate processes including immune function, cell proliferation and tumor
progression (in combination with chemotherapy). They may also sensitize tumor cells to certain
chemotherapeutic drugs by modifying drug detoxification processes.
NOV-002, the lead compound, acts as a chemoprotectant and a chemopotentiator.
NOV-002 was approved in Russia where it is marketed by PharmaBAM under the trade name
Glutoxim®.
NOV-002 has already been administered to over 10,000 patients, including clinical
studies of 390 patients across many tumor types, demonstrating clinical efficacy and
excellent safety. In one controlled, randomized Russian Phase 2 trial, NOV-002 in
combination with cisplatin-based chemotherapy increased the one-year survival of advanced
NSCLC patients from 17% to 63% (p < 0.01) and improved tolerance of chemotherapy (p < 0.05)
versus the control. In a controlled, randomized U.S. Phase 2 trial, advanced NSCLC
patients treated with NOV-002 in combination with paclitaxel and carboplatin demonstrated
improved objective tumor response (p < 0.05) and improved tolerance of chemotherapy
(p < 0.01) versus the control. Novelos finalized a SPA with the FDA (May 2006) for a
single pivotal Phase 3 trial in advanced NSCLC in combination with first-line chemotherapy,
obtained Fast Track designation in August 2006 and commenced the trial in November 2006.
Target enrollment of 840 patients was reached in March 2008 and trial conclusion is expected
mid-2009. NOV-002 is also in Phase 2 development to treat chemotherapy-resistant ovarian
cancer and early-stage breast cancer.
NOV-205, a second compound acts as a hepatoprotective agent with immunomodulating and
antiinflammatory properties. Novelos’ IND for NOV-205 as mono-therapy for chronic hepatitis C
has been accepted by the FDA, and a U.S. Phase 1b trial in patients who previously failed
treatment with pegylated interferon plus ribavirin was concluded based on favorable safety
profile. Russian clinical studies in hepatitis B and C patients showed that after relatively
short treatment periods (1 to 2 months) with NOV-205, viral load was undetectable in a high
proportion of patients and serum biochemical markers of liver damage were significantly decreased.
Novelos' intellectual property is very strong. The intellectual property
includes 5 U.S., 2 European and 1 Japanese patents. Overall, Novelos filed more than
30 patent applications worldwide, with coverage including
composition of matter, method of use and manufacturing. The breadth of
the intellectual property will also allow Novelos to expand its pipeline
by claiming and commercializing additional compounds that are based on
oxidized glutathione.
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