Media Contact:
Pam Lord
Porter Novelli Life Sciences
619-849-6003
plord@pnlifesciences.com
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NEREUS PHARMACEUTICALS INITIATES PHASE I CLINICAL TRIAL FOR
ANTI-CANCER COMPOUND NPI-2358
SAN DIEGO, Calif.,
June 7, 2006 - Nereus Pharmaceuticals, Inc., a
pioneer in drug discovery and development from marine microbial
sources, has initiated a Phase I clinical trial to evaluate the
safety and tolerability of NPI-2358, a novel, small molecule tumor
vascular disrupting agent (VDA) for the treatment of patients with
solid tumors.
The open label, single-agent study opened to enrollment for patients
with advanced solid tumor malignancies at two centers with well
known expertise in developing new oncology drugs: the Barbara Ann
Karmanos Cancer Institute in Detroit, Michigan, and the CTRC
Institute for Drug Development in San Antonio, Texas. Trial
participants receive once-weekly, intravenous doses of NPI-2358,
which will be escalated to determine maximum tolerated dose. Other
objectives include tumor response, pharmacokinetic and
pharmacodynamic analyses. The trial is expected to enroll
approximately 35 patients.
- We are excited to have treated the first patient, and look forward
to applying our experience with Phase I clinical trials and VDAs to
a thorough investigation of Nereus' promising new compound, said
Dr. Patricia M. LoRusso, principal investigator and Director of the
Phase I Clinical Trials Program at the Barbara Ann Karmanos Cancer
Institute and Professor of Hematology and Oncology at Wayne State
University.
In preclinical models of cancer, including breast, sarcoma, colon
and prostate, NPI-2358 demonstrated it is a potent and selective
tumor vascular disrupting agent (VDA). NPI-2358 exhibits its effects
by interacting at the colchicine-binding site on microtubules. This
provokes a rapid collapse and occlusion of established vasculature
in the tumor, which induces tumor cell death, leading to necrosis.
In in vitro studies, this selective vascular collapse commences
within minutes of exposure to the VDA and appears to be caused by
the effects of the compound on the shape, cohesiveness and growth of
proliferating immature endothelial cells present in the tumor
vasculature, but not the dormant and mature endothelial cells in
non-tumor vasculature. NPI-2358 also synergizes with
chemotherapeutics in human tumor xenograft models. Nereus
synthesized NPI-2358 and several other analogues from the parent
molecule called Halimide, which originated from a marine fungus.
- Preclinical studies involving various solid tumors demonstrate
NPI-2358 selectively destroys vasculature in the central portion of
tumors, shrinking the malignant mass, explained Dr. Anthony Tolcher,
principal investigator and Director of Clinical Research at the CTRC
Institute for Drug Development. I look forward to continuing to
investigate this new generation of VDAs in this clinical trial.
- This is our second novel compound derived from our discovery effort
to enter clinical trials, and we're pleased to collaborate with
several prestigious research institutions to advance our oncology
drug candidates, said Kobi M. Sethna, President and CEO of Nereus
Pharmaceuticals, Inc.
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's two oncology drug candidates are in Phase I clinical
trials. NPI-2358, a tumor vascular disrupting agent, is being
evaluated for solid tumors, and proteasome inhibitor NPI-0052 is
being developed for solid tumors, lymphomas and multiple myeloma.
Nereus' discovery portfolio also includes additional drug candidates
for oncology, as well as infectious diseases and inflammation. The
Company 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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