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Nereus Pharmaceuticals Initiates Clinical Trial of NPI-2358 in Non-Small Cell Lung Cancer Following Encouraging Phase 1 Data
Date:3/20/2008

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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SOURCE Nereus Pharmaceuticals, Inc.
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