NPI-0052 update

Nereus Pharmaceuticals, Inc., a pioneer in drug discovery and development from marine microbial sources, has initiated a Phase I clinical trial of NPI-0052, a novel, small molecule proteasome inhibitor, to treat patients with solid tumors and lymphomas. The single-agent study is designed to evaluate the safety and tolerability of the anti-cancer compound.

The open label trial is expected to enroll approximately 50 patients with advanced solid tumors or refractory lymphomas at two trial sites, M.D. Anderson Cancer Center and Memorial Sloan-Kettering Cancer Center. Participants will receive once-weekly, intravenous doses of NPI-0052, which will be escalated to determine a maximum tolerated dose. Other objectives include tumor response, pharmacokinetic and pharmacodynamic analyses.

"We are enthused to have given this exciting new compound to the first patient, and look forward to continuing to assess its effects as the trial progresses. The preclinical data for NPI-0052 in various cancers such as colon, pancreas, lung, and multiple myeloma have been very encouraging, and my colleagues and I have been eager to evaluate it in cancer patients," said Razelle Kurzrock, M.D., Director, Division of Cancer Medicine, Phase I Program, and Professor of Medicine, M.D. Anderson Cancer Center, one of the principal investigators.

NPI-0052 was discovered during the fermentation of Salinispora sp., a new class of marine Gram-positive bacteria identified in sediment from the ocean floor. The compound is a potent inhibitor of human proteasomes, a high interest drug target for pharmaceutical companies after bortezomib (Velcade(R)) was approved to treat multiple myeloma in 2003. Nereus and its collaborators' in vitro and in vivo studies showed NPI-0052 inhibited growth and shrank tumors in various animal models. This activity was enhanced when NPI-0052 was combined with biologics and chemotherapeutics. Nereus expects to begin a clinical trial for NPI-0052 in patients with multiple myeloma in upcoming months.

"The activity of NPI-0052 in preclinical models of lymphomas, myeloma and solid tumors has demonstrated it to be a potent and selective second generation proteasome inhibitor with comparatively durable biological effects that may provide significant advances in the treatment of many cancers," said Kobi M. Sethna, President and CEO of Nereus Pharmaceuticals, Inc. "This trial is the first clinical program to open at Nereus and we're excited to begin the important process of determining whether our novel compound can successfully treat solid tumors and lymphomas."

About Nereus Pharmaceuticals, Inc.

Nereus Pharmaceuticals pursues untapped sources of chemical diversity to discover and develop novel therapeutics. With unmatched expertise in marine microbiology and integrated technologies to identify and synthesize novel biologically active compounds, the Company is developing two oncology drug candidates. The proteasome inhibitor NPI-0052 is in a Phase I clinical trial for solid tumors and lymphomas, and will be evaluated in multiple myeloma in the near future. NPI-2358, a vascular disrupting agent, will be evaluated for solid tumors. The Company's discovery portfolio includes additional drug candidates for oncology, as well as infectious diseases and inflammation. Nereus is privately held and based in San Diego, California. For more information, visit www.nereuspharm.com.