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Nereus Pharmaceuticals Initiates Clinical Trial of NPI-2358


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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, March 20 /PRNewswire/ -- 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're 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 Company's discovery

portfolio includes potential drug candidates for cancer, infectious

diseases and inflammation. For more information, visit

http://www.nereuspharm.com.

Nereus Pharmaceuticals is a registered trademark of Nereus

Pharmaceuticals, Inc.

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