CELLDEX THERAPEUTICS INITIATES PHASE 2/3 TRIAL OF CDX110.Celldex Therapeutics, Phillipsburg, N.J, has announced that the company has initiated the ACT III study, a randomized ran·dom·ize
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. , multi-institution Phase 2/3 clinical trial. The study will investigate the clinical efficacy and safety of Celldex's epidermal growth factor receptor This article is about a cell suface receptor. For estimated measure of kidney function (eGFR), see Glomerular filtration rate.
The epidermal growth factor receptor variant III (EGFRvIII) peptide vaccine CDX-110 added to standard-of-care in patients with newly diagnosed glioblastoma multiforme glioblastoma mul·ti·for·me
A virulent brain cancer that is usually fatal. (GBM GBM 1 Glioblastoma multiforme, see there 2. Glomerular basement membrane ) that express the variant III mutation of the EGFR EGFR Epidermal Growth Factor Receptor (a kinase enzyme)
EGFR Estimated Glomerular Filtration Rate receptor.
The CDX-110 investigational immunotherapy activates a patient's immune system against EGFRvIII, a unique protein on cancer cells, recruiting the immune system to attack existing tumor. Prior clinical research led by Dr. John Sampson of Duke University showed promising results of the EGFRvIII vaccine in a Phase 2 study treating brain tumors. The results will be updated by Dr. Sampson at the ASCO ASCO American Society of Clinical Oncology
ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland)
ASCO Australian Standard Classification of Occupations
ASCO Automatic Switch Company Annual Meeting in June.
"We are extremely encouraged by the clinical results we have seen in our CDX-110 patients to date," said Dr. Sampson of Duke. "We are pleased that Celldex is advancing our early work into a Phase 2/3 randomized, multi-center clinical trial to clearly demonstrate this efficacy in a larger treatment group."
The ACT III trial will evaluate CDX-110 in 90 patients, randomized to receive the investigational vaccine treatment or standard therapy in a 2:1 ratio (vaccine to control). Over 20 tertiary brain tumor centers across the United States and Canada will participate in the Phase 2 portion of the study. Specific accruing sites can be identified through the company's web site (www.celldextherapeutics.com) or the NCI See Liberate. clinical trials site (http://clinicaltrials.gov/ct/show/NCT00458601). If improved outcome in disease control is apparent at 6 months, the trial will accrue additional patients to characterize clinical benefit at a Phase 3 level.
CDX-110 is an investigational immunotherapy that targets the tumor specific molecule EGFRvIII, a functional variant of the epidermal growth factor receptor (EGFR), which is a protein that has been well validated as a target for cancer therapy. This particular variant, EGFRvIII, was discovered in a collaborative effort between Dr. Bert Vogelstein and Dr Albert Wong at Johns Hopkins University Johns Hopkins University, mainly at Baltimore, Md. Johns Hopkins in 1867 had a group of his associates incorporated as the trustees of a university and a hospital, endowing each with $3.5 million. Daniel C. and Dr. Darell Bigner at Duke University. Unlike EGFR, EGFRvIII is not present in normal tissues, suggesting this target will enable the development of a tumor-specific therapy for cancer patients. Furthermore, EGFRvIII is a transforming oncogene oncogene
Gene that can cause cancer. It is a sequence of DNA that has been altered or mutated from its original form, the proto-oncogene (see mutation). Proto-oncogenes promote the specialization and division of normal cells. that can directly contribute to cancer cell growth. While originally discovered in Glioblastoma Multiforme (GBM), the most common and aggressive form of brain cancer, the expression of EGFRvIII has also been observed in various other cancers such as breast, ovarian, metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.
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pertaining to or of the nature of a metastasis. prostate, colorectal, and head & neck cancers. Celldex has exclusive worldwide rights to EGFRvIII vaccines and is pursuing the development of CDX-110 for GBM therapy, as well as in other cancers through additional clinical studies.
About Celldex Therapeutics, Inc.
Celldex Therapeutics, Inc. is a biotechnology company focused on developing therapeutic vaccines that target and stimulate the body's immune system for the treatment of cancer, infectious and autoimmune diseases. Celldex has three product candidates already in or about to enter clinical development targeting multiple cancers and Hepatitis B. Four additional product candidates are in preclinical development for cancer and autoimmune disease. Celldex's proprietary technology platform uses fully human monoclonal antibodies administered directly to patients to target and stimulate dendritic cells -- key cells within the immune system. Celldex was formed in 2004 as a spin-out from Medarex, Inc. The company is headquartered in Phillipsburg, New Jersey Phillipsburg, known locally as P'burg, is a town in Warren County, New Jersey, in the United States. As of the United States 2000 Census, the town population was 15,166. .
For more information, call 908/454-7120 or visit http://www.celldextherapeutics.com or http://clinicaltrials.gov/ct/show/NCT00458601