Media Contact:
Pam Lord
Porter Novelli Life Sciences
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plord@pnlifesciences.com
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NEREUS PHARMACEUTICALS INITIATES PHASE I CLINICAL TRIAL FOR
ANTI-CANCER PROTEASOME INHIBITOR
SAN DIEGO, Calif.,
May 15, 2006 - 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 (VelcadeŽ) 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.
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Nereus Pharmaceuticals is a registered trademark of Nereus
Pharmaceuticals, Inc.
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