BRANFORD, Conn., June 25 CT-CuraGen-breast-can
BRANFORD, Conn., June 25 /PRNewswire-FirstCall/ -- CuraGen Corporation
(Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on
oncology, announced today the treatment of the first patient in its
CR011-vcMMAE Phase II breast cancer study.
The Phase II trial is an open-label, multi-center study of CR011-vcMMAE
administered intravenously once every three weeks to patients with
locally-advanced or metastatic breast cancer who have received prior therapy.
This study will enroll up to approximately 40 patients to confirm the maximum
tolerated dose (MTD) in this population and to assess efficacy using a Simon
2-Stage design with an endpoint of progression-free rate at 12 weeks. The
principal investigator is Dr. Linda Vahdat, Medical Director of the Breast
Cancer Research Program and Associate Professor of Clinical Medicine,
NewYork-Presbyterian Hospital/Weill Cornell.
"We believe that GPNMB is a promising target in breast cancer, and we look
forward to better understanding how CR011-vcMMAE could be used in the
treatment of this disease," commented Dr. Timothy Shannon, President and Chief
Executive Officer of CuraGen Corporation. "We are confident in our ability to
continue the rapid development of this program and look forward to providing
updated CR011-vcMMAE results for the treatment of melanoma by the end of 2008
and the presentation of preliminary results from this newly initiated study in
breast cancer during the first half of 2009."
CR011-vcMMAE targets a protein known as glycoprotein NMB (GPNMB), which is
overexpressed in a variety of cancers including breast cancer, melanoma, and
brain tumors. CR011-vcMMAE is an antibody-drug conjugate comprised of a
fully-human monoclonal antibody against GPNMB linked to a potent tubulin
stabilizing agent, monomethyl auristatin E (MMAE). The enzyme-sensitive
linker, which was licensed from Seattle Genetics, is designed to be stable in
the bloodstream and to release MMAE inside tumor cells, resulting in cancer
cell death.
Dr. Ronit Simantov, Vice President and Chief Medical Officer commented,
"Preclinical studies have shown that GPNMB is expressed in aggressive breast
cancers and is believed to play a role in promoting invasion and metastasis of
breast cancer cells. Furthermore, conjugating an antibody against this
biologically relevant target with MMAE, a cytotoxic drug that belongs to a
class of therapeutics known to be active against breast cancer, represents a
novel approach to treating this disease."
Objective responses have been observed in patients with advanced melanoma
treated with CR011-vcMMAE. A Phase II study of CR011-vcMMAE in patients with
melanoma is currently enrolling patients, and preclinical studies with
CR011-vcMMAE for the treatment of gliomas are ongoing.
About Breast Cancer
Breast cancer is the most common cancer in women and a leading cause of
death in the United States. According to the American Cancer Society, more
than 180,000 women will be diagnosed with invasive breast cancer in 2008 with
more than 40,000 deaths attributed to this disease. Despite recent advances
in therapy, the median survival of patients with metastatic breast cancer is 2
to 3 years, while patients with "triple-negative" or "basal-like" breast
cancer have limited treatment options and poorer outcomes. Therefore, a
significant unmet need remains for novel therapeutic approaches for patients
with locally advanced and metastatic breast cancer who have failed other
therapies.
About CuraGen
CuraGen Corporation (Nasdaq: CRGN) is a dedicated clinical-stage
biopharmaceutical company developing diverse approaches for the treatment of
cancer. CuraGen Corporation is headquartered in Branford, Connecticut. For
additional information please visit http://www.curagen.com.
Safe Harbor
Statements in this press release regarding management's future
expectations, beliefs, intentions, goals, strategies, plans or prospects,
including statements relating to the effectiveness of antibody-drug conjugates
and CuraGen's CR011-vcMMAE program, including the use of CR011-vcMMAE for
breast cancer, melanoma and gliomas, and the timeframe of initiating clinical
trials and presenting results on CR011-vcMMAE may constitute forward-looking
statements within the meaning of the Private Securities Litigation Reform Act
of 1995. Forward-looking statements can be identified by terminology such as
"anticipate," "believe," "could," "could increase the likelihood," "estimate,"
"expect," "intend," "is planned," "may," "should," "will," "will enable,"
"would be expected," "look forward," "may provide," "would" or similar terms,
variations of such terms or the negative of those terms. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors
including the risk that any one or more of CuraGen's drug development programs
will not proceed as planned for technical, scientific or commercial reasons or
due to patient enrollment issues or based on new information from nonclinical
or clinical studies or from other sources, the success of competing products
and technologies, CuraGen's stage of development as a biopharmaceutical
company, government regulation and healthcare reform, technological
uncertainty and product development risks, product liability exposure,
uncertainty of additional funding, CuraGen's history of incurring losses and
the uncertainty of achieving profitability, reliance on research
collaborations and strategic alliances, competition, patent infringement
claims against CuraGen's products, processes and technologies, CuraGen's
ability to protect its patents and proprietary rights and uncertainties
relating to commercialization rights, as well as those risks, uncertainties
and factors referred to in CuraGen's Quarterly Report on Form 10-Q for the
quarter ended March 31, 2008, filed with the Securities and Exchange
Commission under the section "Risk Factors," as well as other documents that
may be filed by CuraGen from time to time with the Securities and Exchange
Commission. As a result of such risks, uncertainties and factors, CuraGen's
actual results may differ materially from any future results, performance or
achievements discussed in or implied by the forward-looking statements
contained herein. CuraGen is providing the information in this press release
as of this date and assumes no obligations to update the information included
in this press release or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
CRGN-P
Contact:
Glenn Schulman, PharmD
Director of Medical Communications
gschulman@curagen.com
(888) 436-6642
SOURCE CuraGen Corporation
