CuraGen Updates CR011-vcMMAE Data at ASCO
June 02 2009 - 5:30AM
PR Newswire (US)
- Activity Demonstrated in Advanced Breast Cancer and Melanoma -
BRANFORD, Conn., June 2 /PRNewswire-FirstCall/ -- CuraGen
Corporation (NASDAQ:CRGN) reported three data presentations from
its ongoing clinical trials of CR011-vcMMAE, an antibody-drug
conjugate that targets GPNMB, in patients with advanced breast
cancer and melanoma at the 2009 Annual Meeting of the American
Society of Clinical Oncology (ASCO) in Orlando, Florida. The Phase
I/II study of CR011-vcMMAE administered intravenously once every
three weeks in patients with advanced breast cancer began with a
bridging phase to confirm the maximum tolerated dose and has
expanded into a Phase II open-label, multi-center study. The study
is designed to assess efficacy 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. Preliminary data were presented on 18
evaluable patients treated at doses of 1.0 - 1.88mg/kg from the
Phase I portion and the initial portion of the Phase II study.
Selection for enrollment was not based on expression of GPNMB in
patients' tumors. The median number of prior chemotherapy regimens
for metastatic disease was 4 (range 2-11). Triple negative disease
(ER/PR/Her-2 negative) was present in 44% of patients. Partial
responses were seen in 3 patients (1 confirmed), including a
patient with triple negative disease. Fifty percent (50%) of
patients showed tumor shrinkage. Toxicities were similar to those
observed in previous studies with CR011-vcMMAE; the most common
adverse events were rash, alopecia, and fatigue. Twelve patients
have now been enrolled in the Phase II portion of the study at a
dose of 1.88mg/kg given once every three weeks, with total Phase II
enrollment planned for up to 25 patients. "We are very encouraged
by the early evidence of activity demonstrated in this trial and
look forward to presenting additional data on the Phase II study in
the second half of the year," commented Dr. Ronit Simantov, Chief
Medical Officer of CuraGen. "The emerging role of GPNMB, which is
present in 25-40% of breast cancer patients, combined with our
clinical activity, suggests that GPNMB may be an important new
target in breast cancer." Also at ASCO, data from a Phase II trial
of CR011-vcMMAE in patients with advanced melanoma were presented
at a poster discussion session. Thirty-six patients were enrolled
into this Phase II open-label, multi-center trial that evaluated
the efficacy and safety of CR011-vcMMAE 1.88 mg/kg administered
intravenously once every three weeks. Eligible patients had
progressive disease at trial entry and may have received one prior
cytotoxic regimen and any number of prior immunotherapies. Of the
patients enrolled, 94% had Stage IV disease of which two-thirds
were classified as M1c, the poorest risk group. The study
successfully met its primary activity endpoint, with 5 objective
responses (1 unconfirmed) observed in 34 evaluable patients, and
median duration of response of 5.3 months. The median overall
progression-free survival (PFS) was 4.4 months. Tumor shrinkage was
observed in 58% of patients, and 20 patients had best response of
stable disease. Dermatologic adverse events consisting of rash,
alopecia, and pruritus were the most common toxicities in this
study. Other adverse events included fatigue, diarrhea, anorexia
and nausea. Grade 3 or 4 neutropenia was observed in 5 patients.
The absence of rash in the first cycle of treatment predicted a
worse PFS. Additionally, in a subset of patients with tumor
biopsies, high levels of tumor expression of GPNMB appeared to
correlate with favorable outcome. "These Phase II results show
evidence of activity in patients with advanced melanoma that
compares favorably to activity seen with other currently used
treatments for these patients, who are in need of additional
options," commented Dr. Simantov. In addition, data from the
ongoing assessment of more frequent dosing of CR011-vcMMAE in 28
patients with advanced melanoma were presented at ASCO. Thus far, a
dose of 1.0 mg/kg given once every week has been identified as the
maximum tolerated dose in a weekly schedule, and a dose of 1.5mg/kg
is currently being explored in the two out of three week schedule.
Although median duration of follow-up is only 6 weeks, objective
responses have thus far been observed in 3 of 11 evaluable patients
treated with weekly CR011-vcMMAE (1 confirmed) and 1 confirmed
response in 8 evaluable patients treated with CR011-vcMMAE two out
of every three weeks. "This study has confirmed that CR011 is
active and that more total drug can be safely given with more
frequent dosing," stated Dr. Simantov. "The expansion phase of the
study will be used to generate a better estimate of the response
rate with these schedules to compare to the once every three week
schedule." "The results presented at ASCO are important because
they expand the activity of CR011 into patients with metastatic
breast cancer and open this area up as an important development
opportunity in addition to the opportunity in patients with
metastatic melanoma," commented Dr. Timothy Shannon, President and
Chief Executive Officer of CuraGen. "The remainder of these studies
will be used to better understand the breast cancer opportunity and
to understand how dose, schedule and the use of biomarkers such as
the presence of GPNMB and rash might be used to enhance activity in
further development." Reprints of the presentation are available on
CuraGen's website at http://www.curagen.com/ or can be requested by
emailing . Conference Call Details and Dial-in Information Date:
Wednesday, June 3, 2009 Time: 11:00 a.m. EDT Dial-in:
(877)-856-1956 (U.S. and Canada) (719)-325-4771 (international)
Webcast: Access available at http://www.curagen.com/ A replay of
the conference call will be available starting at 2:00 p.m. Eastern
time on Wednesday, June 3, 2009 through Thursday, September 3, 2009
by dialing 888-203-1112 (domestic) or 719-457-0820 (international).
The passcode for the replay is 3269449. An archive of the webcast
will be available for one year 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. 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. CR011-vcMMAE is currently in two
Phase II trials assessing the safety and efficacy in the treatment
of melanoma and for the treatment of metastatic breast cancer, and
in a Phase I trial to evaluate the safety and activity of alternate
dosing schedules. About Melanoma According to the American Cancer
Society, it is expected that approximately 60,000 new cases of
melanoma will be diagnosed, including nearly 11,000 patients
diagnosed with Stage III or Stage IV disease, and an estimated
8,000 people in the U.S. will die of the disease during 2009. The
prognosis for patients with advanced melanoma is poor, and studies
have shown that the median survival is less than nine months. 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 2009 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 CuraGenCuraGen
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, 2009 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. Contacts: Sean Cassidy Chief Financial
Officer Ronit Simantov Chief Medical Officer (888) 436-664 CRGN-P
DATASOURCE: CuraGen Corporation CONTACT: Sean Cassidy, Chief
Financial Officer, , or Ronit Simantov, Chief Medical Officer, ,
both at +1-888-436-6642, both of CuraGen Web Site:
http://www.curagen.com/
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