Celldex Announces Expansion of Phase 2 ReACT Study in Recurrent Glioblastoma
PHILLIPSBURG, N.J., Aug. 12, 2013 (GLOBE NEWSWIRE) -- Celldex Therapeutics,
Inc. (Nasdaq:CLDX) Celldex Therapeutics recently completed enrollment in an
initial cohort (n=25) of Avastin^® (bevacizumab) refractory patients in the
Company's ongoing ReACT study of rindopepimut in EGFRvIII (v3)-positive
glioblastoma (GBM). Based on early evidence of anti-tumor activity, including
stable disease, tumor shrinkage and investigator-reported response, the
Company has decided to add an expansion cohort of approximately 75 patients to
better characterize the potential activity of rindopepimut in this refractory
patient population. Enrollment in the expansion cohort has begun and, like the
initial cohort, will evaluate rindopepimut plus Avastin.
"Patients with GBM who have become refractory to Avastin tend to have very
rapid disease progression," said Thomas Davis, MD, Senior Vice President and
Chief Medical Officer of Celldex Therapeutics. "Based upon preliminary
evidence that rindopepimut may have activity in Avastin refractory GBM, we
have decided to expand the refractory group with the hope of better defining
possible therapeutic effect. We expect to share a formal review of the results
from the initial 25 patients at the Society for Neuro-Oncology Annual Meeting
ReACT is a Phase 2 study designed to determine if adding rindopepimut to the
standard of care for recurrent glioblastoma, Avastin, improves the outcomes
for patients with recurrent EGFRvIII-positive glioblastoma. As amended, the
ReACT study will now enroll approximately 170 patients across three groups:
*Group 1 - Avastin naïve, n= apx. 70, enrollment ongoing—patients
randomized to receive either rindopepimut or KLH (administered as a
control), each along with Avastin
*Group 2 - Avastin refractory, n= apx. 25, enrollment completed—patients
receive rindopepimut plus Avastin in a single treatment arm
*Group 2C (C = Confirmatory) - Avastin refractory expansion, n = apx. 75,
enrollment initiated—patients receive rindopepimut plus Avastin in a
single treatment arm
Study endpoints include 6 month progression free survival rate, objective
response rate, overall survival and safety and tolerability.
Avastin is a registered trademark of Genentech, a member of the Roche Group.
Rindopepimut is an investigational immunotherapy that targets the tumor
specific oncogene EGFRvIII (v3), a functional and permanently activated
mutation of the epidermal growth factor receptor (EGFR), a protein that has
been well validated as a target for cancer therapy. Expression of EGFRvIII
correlates with increased tumorigenicity in mouse models and poor long term
survival in clinical studies of patients with glioblastoma (GBM). In addition,
EGFRvIII-positive cells are believed to stimulate proliferation of
non-EGFRvIII cells through IL-6 cell-to-cell signaling and to release
microvesicles containing EGFRvIII, which can merge with neighboring cells,
transferring tumor-promoting activity. EGFRvIII expression may also be
associated with tumor stem cells that have been identified in GBM. These stem
cells contribute to resistance to cytotoxic therapy and tumor recurrence.
EGFRvIII is expressed in tumors in about 30% of patients with GBM. It has not
been detected at a significant level in normal tissues; therefore, targeting
of this tumor-specific molecule is not likely to impact healthy tissues.
Three Phase 2 trials of rindopepimut—ACTIVATE, ACT II, and ACT III—have been
completed in newly diagnosed EGFRvIII-positive GBM and have shown consistent
improvements in both overall survival and median progression-free survival.
The most common adverse events for rindopepimut include injection site
reactions, fatigue, rash, nausea and pruritus. Rindopepimut is currently being
studied in two clinical trials in EGFRvIII-positive GBM—an international Phase
3 study called ACT IV in newly diagnosed GBM and a Phase 2 study called ReACT
in recurrent GBM.
About Celldex Therapeutics, Inc.:
Celldex is developing targeted therapeutics to address devastating diseases
for which available treatments are inadequate. Our pipeline is built from a
proprietary portfolio of antibodies and immunomodulators used alone and in
strategic combinations to create novel, disease-specific therapies that
induce, enhance or suppress the body's immune response. Visit
Safe Harbor Statement Under the Private Securities Litigation Reform Act of
This release contains "forward-looking statements" made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act of 1995,
including those related to the Company's strategic focus and the future
development and commercialization (by Celldex and others) of rindopepimut
(CDX-110), CDX-011, CDX-1135, CDX-1401, CDX-1127, CDX-301, Belinostat and
other products. Forward-looking statements reflect management's current
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and further development and commercialization of rindopepimut, CDX-011 and
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additional capital which will be necessary to complete the clinical trials
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Targeting Technology^TM to develop new, safe and effective vaccines against
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CONTACT: Company Contact:
Vice President of IR & Corp Comm
Celldex Therapeutics, Inc.
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