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Pam Lord
Porter Novelli Life Sciences
619-849-6003
plord@pnlifesciences.com
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NEREUS
PHARMACEUTICALS INITIATES CLINICAL TRIAL OF
NPI-2358 IN NON-SMALL CELL LUNG CANCER FOLLOWING ENCOURAGING PHASE 1
DATA
SAN DIEGO, Calif., March 20, 2008 Nereus Pharmaceuticals, Inc., a
pioneer in drug discovery from marine microbial sources, today
announced that enrollment has begun in a Phase 1b study evaluating
the vascular disrupting agent (VDA) NPI-2358 in combination with
standard chemotherapy in patients with non-small cell lung cancer (NSCLC).
This study follows on positive outcomes in a Phase 1 single-agent
clinical trial assessing the safety, pharmacokinetics,
pharmacodynamics (PK/PD) and efficacy of NPI-2358 in various tumor
types.
The open-label Phase 1b study will assess escalating doses of
NPI-2358 in combination with docetaxel in patients with NSCLC who
previously failed at least one chemotherapy regimen. The existing
preclinical and clinical data suggests that VDAs may be
complementary or synergistic with chemotherapeutics and
anti-angiogenesis agents due to the different targets and mechanisms
of action. NPI-2358 has a dual effect on tumors: It selectively
attacks existing tumor blood vessels leading to hemorrhagic tumor
necrosis without affecting normal vasculature, and it has a direct
apoptotic effect on tumors cells. NPI-2358 in combination with
chemotherapeutic agents in human xenograft models of NSCLC and other
cancers was markedly more effective than either treatment alone.
We are excited to have a leading role in the clinical development
of Nereus NPI-2358 for the treatment of non-small cell lung cancer.
At The Sir Charles Gairdner Hospital, we felt this combination study
with NPI-2358 was a high priority given the favorable preclinical
and clinical data we have seen, said Michael Millward, M.D., Cancer
Council Professor of Clinical Cancer Research at The University of
Western Australia based at Sir Charles Gairdner Hospital, Perth.
Our clinical program for NPI-2358 holds promise in non-small cell
lung cancer, a large market indication where novel compounds could
make a significant impact on patients. We are pleased to advance our
clinical program for NPI-2358 and involve first-rate cancer research
centers with unique expertise with this class of vascular disrupting
agents, said Kobi M. Sethna, President and CEO, Nereus
Pharmaceuticals, Inc.
Upon successful completion of the Phase 1b trial and determination
of the recommended doses for the combined agents, Nereus expects to
advance NPI-2358 into an international randomized Phase 2 study of
approximately 150 patients at 30 centers late in 2008. Nereus is
also evaluating NPI-2358 in other solid tumor indications.
About NPI-2358 A Novel Vascular Disrupting Agent
NPI-2358 is a vascular disrupting agent currently in clinical
development for the treatment of cancer by Nereus. Initial results
from a single-agent Phase 1 trial in various tumor types indicate
NPI-2358 has a favorable safety profile, including cardiac safety.
It is also being evaluated in a Phase 1b study in combination with
docetaxel for the treatment of non-small cell lung cancer. NPI-2358
is one of over 200 synthetic analogues that were prepared following
the discovery of the compound Halimide isolated from a marine
fungus. In preclinical models of cancer, including lung, breast,
sarcoma, colon and prostate, NPI-2358 demonstrated potent and
selective anti-tumor effects in combination with docetaxel and other
oncology therapies, as well as single-agent efficacy in a number of
orthotopic models. NPI-2358 interacts with soluble beta-tubulin and
prevents the polymerization of tubulin without altering dynamic
microtubule function of formed microtubules. As demonstrated in
preclinical testing, this target profile results in a highly
specific nanomolar cytotoxicity while reducing the side effects seen
in first-generation VDAs due to cardiotoxicity, hemodynamic changes
and neuropathies.
About Nereus Pharmaceuticals, Inc.
Nereus Pharmaceuticals pursues novel sources of chemical diversity
to discover and develop new therapeutics. Using its unmatched
expertise in marine microbiology to identify unique biologically
active compounds, Nereus has two oncology drug candidates in Phase I
clinical trials. NPI-2358, a novel vascular disrupting agent, is
being evaluated in patients with solid tumors and lymphomas, and the
second-generation proteasome inhibitor NPI-0052 is being developed
in patients with solid tumors, lymphomas, leukemias and multiple
myeloma. The Companys discovery portfolio includes potential drug
candidates for cancer, infectious diseases and inflammation. For
more information, visit www.nereuspharm.com
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Nereus Pharmaceuticals is a registered trademark of Nereus
Pharmaceuticals, Inc. All other product and company names may be
registered trademark or trademarks of their respective owners.
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