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Nereus Pharmaceuticals Completes Enrollment of Phase 2 ADVANCE Clinical Trial of Plinabulin in Non-Small Cell Lung Cancer

Tuesday, June 22, 2010 Cancer News J E 4
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SAN DIEGO, June 22 /PRNewswire/ -- Nereus Pharmaceuticals, Inc., a pioneer in drug discovery and development from marine microbial sources, announced completion of enrollment in the randomized Phase 2 ADVANCE study evaluating its tumor selective vascular disrupting agent (VDA), plinabulin (NPI-2358), in patients with non-small cell lung cancer (NSCLC) who have failed treatment with chemotherapy.  Approximately 170 patients were enrolled in this international clinical trial.  The study is comparing treatment with the standard of care drug docetaxel alone versus docetaxel plus plinabulin.  Interim data from the ADVANCE study were presented at the 2010 American Society of Clinical Oncology Annual Meeting in Chicago in early June.  

In connection with the progress of its clinical programs, Nereus' existing investors have provided additional funding and commitments of up to an aggregate of $20 million.  This additional financing was led by HBM BioVentures and included Alta Partners, Forward Ventures, Gimv, Advent International, Pacific Venture Group, Roche Venture Fund, and Astellas Venture Management.  

"Our dedicated investors are committed to see our programs through to important milestones," said President and CEO, Kobi M. Sethna.

In the ADVANCE trial, preliminary data on the primary efficacy endpoint of survival are encouraging and continue to mature.  Safety data are also notable in terms of suggesting plinabulin's excellent safety profile, inclusive of areas of concern with many oncology drugs such as cardiac, neurologic and hematologic safety.  Of significant interest, addition of plinabulin appears to markedly improve the serious adverse effect of docetaxel on patients' infection fighting white blood cells.  This is particularly important as chemotherapy induced neutropenia in cancer patients is a significant source of morbidity and health care expenditures.  Development of a drug that treats tumors while improving this common problem could be a major advance in cancer chemotherapy.  

Nereus' second drug candidate, marizomib (NPI-0052), is a second-generation inhibitor of the 20S proteasome.  Marizomib also continues to progress in a number of clinical trials in patients with multiple myeloma, lymphomas and leukemias.  Data from these studies were presented at the 2009 American Society of Hematology Annual Meeting and 2009 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.

"Nereus has made significant clinical progress with its anti-cancer agents, plinabulin and marizomib, two highly differentiated product candidates that are progressing nicely through mid-stage clinical trials towards pivotal studies," said Matthew A. Spear, M.D., Chief Medical Officer of Nereus Pharmaceuticals, Inc.  "There is significant momentum behind our programs, fueled by enthusiasm from some of the top cancer experts from around the world."

About Plinabulin (NPI-2358)

Plinabulin is a potent, selective tumor vascular disrupting agent (VDA) and one of over 200 synthetic analogues in the series that were prepared following the discovery of the parent compound isolated from a marine fungus.  Plinabulin has a dual effect on tumors: it selectively attacks existing tumor blood vessels leading to tumor necrosis without affecting normal vasculature, and it has a direct apoptotic effect on tumor cells.  Preclinical data demonstrate favorable pharmacokinetic and pharmacodynamic profiles and improvements in efficacy and tolerability when added to standard cancer therapies.  Results from Phase 1 and Phase 2 clinical trials are clearly validating the translation of these findings into patients.

About Marizomib (NPI-0052)

Nereus' novel, small molecule marizomib was discovered from a new marine-obligate actinomycete (Salinispora tropica).  Preclinical studies indicate this potent proteasome inhibitor may be superior to other proteasome inhibitors with broader target inhibition, faster onset and longer duration of action, higher potency, and oral availability that translate into decreasing toxicities and overcoming resistance.  Marizomib has shown preclinical activity against many common cancers, such as leukemias, lymphomas and myeloma, including cells from patients who are resistant to newer cancer therapies and steroid therapy.

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 clinical trials.  Plinabulin (NPI-2358), a novel selective vascular disrupting agent, is being evaluated in patients with solid tumors. The second-generation proteasome inhibitor marizomib (NPI-0052) is being evaluated in patients with lymphomas, leukemias and multiple myeloma.  The company's discovery portfolio includes potential drug candidates for cancer, infectious diseases and inflammation. For more information, visit www.nereuspharm.com.

Nereus Pharmaceuticals is a registered trademark of Nereus Pharmaceuticals, Inc.

SOURCE Nereus Pharmaceuticals, Inc.

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