- Data presented at the 2008 ASCO Annual Meeting -
- Conference call to be hosted Wednesday, June 4 at 9:00 a.m. EDT to
discuss results -
BRANFORD, Conn., June 1 /PRNewswire-FirstCall/ -- CuraGen Corporation
(Nasdaq: CRGN) today presented encouraging results from the ongoing Phase
I/II study of CR011-vcMMAE for the treatment of unresectable Stage III or
Stage IV melanoma. The results were presented by Dr. Patrick Hwu,
Co-Principal Investigator, and Professor, Chairman, Dept. of Melanoma
Medical Oncology at The University of Texas, M.D. Anderson Cancer Center.
"In this heavily pretreated group of patients with primarily Stage IV
disease, the observation of dose-dependent objective responses, tumor
shrinkage, and encouraging early progression-free rate at 12 weeks at doses
in the anticipated active range, leads us to believe that CR011-vcMMAE
could be a potentially useful treatment for patients with advanced
melanoma," commented Dr. Timothy Shannon, President and Chief Executive
Officer of CuraGen Corporation. "Based on these promising results in
melanoma we have expanded the CR011-vcMMAE development program to include a
Phase II trial in metastatic breast cancer, and are also exploring
additional doses and schedules to further optimize the activity of this
antibody-drug conjugate."
As of April 4, 2008, forty patients were treated in this first-in-man
Phase I/II study including a total of 32 patients in the Phase I
dose-escalation portion of the trial that aimed to identify the safety and
maximum tolerated dose (MTD) of CR011-vcMMAE and 8 patients in the ongoing
Phase II portion of the study. During Phase I, doses of CR011-vcMMAE
between 0.03 mg/kg to 2.63 mg/kg were evaluated and generally well
tolerated, with rash and neutropenia emerging at higher doses. A total of
130 treatment cycles were administered (range 2 - 19+ cycles per patient).
Two dose-limiting toxicities, consisting of rash, were reported at the
highest dose evaluated, and therefore the per-protocol MTD was determined
to be 1.88 mg/kg administered intravenously (IV) once every three weeks.
Over 80% of the patients treated had Stage IV disease and had received
a median of 2 prior therapies (range 0 - 6). A total of 37 patients from
both Phase I and the ongoing Phase II were evaluable for tumor response by
RECIST criteria. The activity of CR011-vcMMAE was dose dependent with 50%
of those patients treated with doses at or above 1.34 mg/kg exhibiting
tumor shrinkage and 64% progression-free at 12 weeks compared to 17% with
tumor shrinkage seen and 28% progression-free at 12 weeks for patients
treated at lower doses. In the Phase I portion of the study, 13 evaluable
patients were treated with doses at or above 1.34 mg/kg of which one
confirmed partial response and six patients with stable disease were
reported. In the Phase II portion of the study evaluating CR011-vcMMAE 1.88
mg/kg, there were six evaluable patients of which one partial response
(confirmatory visit pending at time of presentation) and three patients
with stable disease were reported.
"The overexpression of the GPNMB protein by melanoma makes it an
intriguing and novel therapeutic target. The antibody-drug conjugate
CR011-vcMMAE, which targets GPNMB, has shown some encouraging activity in
this ongoing study, and we look forward to continuing to explore the
potential of this drug in this patient population in need of new
therapies," commented Dr. Hwu.
In addition to M.D. Anderson Cancer Center, other study sites in the
melanoma trial include Yale Cancer Center, New Haven, CT; The Angeles
Clinic and Research Institute, Santa Monica, CA; and New York University
Medical Center, New York, NY. This Phase II trial is evaluating the safety
and efficacy of CR011-vcMMAE for patients with unresectable Stage III or
Stage IV melanoma who have failed no more than one prior line of cytotoxic
therapy.
Reprints of the poster presentation will be made available on CuraGen's
website at http://www.curagen.com or can be requested by emailing
info@curagen.com.
Conference Call Details and Dial-in Information
Date: Wednesday, June 4, 2008
Time: 9:00 a.m. EDT
Dial-in: 877-272-5391 (domestic)
706-758-4315 (international)
Passcode: 50070965
Webcast: Access to the live webcast is available at
http://www.curagen.com
A replay of the conference call will be available starting at 12:00
p.m. Eastern time on Wednesday, June 4, 2008 through Friday, July 4, 2008
by dialing 800-642-1687 (domestic) or 706-645-9291 (international). The
passcode for the replay is 50070965. An archive of the webcast will be
available for 30 days at http://www.curagen.com
About CR011-vcMMAE
CR011-vcMMAE is an antibody-drug conjugate (ADC) being developed by
CuraGen that consists of a fully-human monoclonal antibody, CR011, linked
to a potent cell-killing drug, monomethyl-auristatin E (MMAE). The ADC
technology, comprised of MMAE and a stable linker system for attaching it
to CR011, was licensed from Seattle Genetics, Inc. (Nasdaq: SGEN). The ADC
is designed to be stable in the bloodstream. Following intravenous
administration, CR011-vcMMAE targets and binds to GPNMB, a specific protein
that is predominantly expressed on the surface of cancer cells, including
melanoma, breast cancer and gliomas. Upon internalization into the targeted
cell, CR011-vcMMAE is designed to release MMAE from CR011 to produce a
cell-killing effect. Preclinical studies conducted with this potential
therapeutic demonstrate that CR011-vcMMAE produces strong, reproducible and
durable effects against tumors in animal models of human cancer.
CR011-vcMMAE is currently in a Phase II trial assessing the safety and
efficacy in the treatment of melanoma and will enter Phase II during the
third quarter of 2008 for the treatment of metastatic breast cancer.
About Melanoma
Melanoma is a very serious form of skin cancer that accounts for the
majority of skin-cancer related deaths each year. The number of people
diagnosed with melanoma is rapidly increasing with more than 62,000 new
cases expected to be diagnosed in the U.S. during 2008. While the chance of
developing melanoma increases with age, it remains one of the most common
cancers in young adults. This type of cancer begins in specific cells in
the skin and can metastasize, or spread, throughout the body to many organ
systems. Patients with Stage IV metastatic melanoma typically have a median
survival of less than nine months despite current standard therapies,
underscoring the need for novel therapeutics to address the unmet medical
need in this patient population.
About CuraGen
CuraGen Corporation (Nasdaq: CRGN) is a clinical-stage
biopharmaceutical company developing promising approaches for the treatment
of cancer. CuraGen Corporation is headquartered in Branford, Connecticut.
For additional information please visit http://www.curagen.com
Forward-Looking Statements
Statements in this press release regarding management's future
expectations, beliefs, intentions, goals, strategies, plans or prospects,
including statements relating to CuraGen's development program for
CR011-vcMMAE, including CuraGen's ability to advance CR011-vcMMAE through
Phase II clinical trials for melanoma and metastatic breast cancer, to
explore additional doses and schedules of this antibody-drug conjugate, and
to explore the potential of CR011-vcMMAE in a patient population in need of
new therapies 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 period 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.
Contact:
Glenn Schulman, PharmD
Director of Investor Relations
gschulman@curagen.com
(888) 436-6642
CRGN-P
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Via: Healthcare
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