Celldex Announces Upcoming Data Presentations at the Society for Neuro-Oncology 17thAnnual Scientific Meeting and Education Day
NEEDHAM, Mass.--(BUSINESS WIRE)-- Celldex Therapeutics, Inc. (NAS: CLDX) today announced upcoming data presentations at the Society of Neuro-Oncology's 17th Annual Scientific Meeting and Education Day to be held in Washington, DC from November 15 through November 19, 2012. Duane A. Mitchell, MD, PhD, Assistant Professor of Surgery (Neurosurgery), Duke University Medical Center will present updated overall survival data from the rindopepimut Phase 2 ACT III, ACT II and ACTIVATE studies in an educational session entitled "Immunotherapy of Malignant Brain Tumors" to be held from 11:10-11:30 am ET on Thursday, November 15, 2012. Michael Weller, MD, Professor, Department of Neurology, University Hospital Zurich will present data from a cohort of patients with EGFRvIII-positive glioblastoma that were included in the Phase 3 Radiation Therapy Oncology Group's (RTOG) 0525 study (closed to accrual in 2008) in an educational session called "Biomarkers and Clinical Care: are we there yet?" to be held from 5:05 to 5:25 pm ET on Thursday, November 15, 2012. This analysis will provide a more contemporary historical control dataset on expected outcomes for patients with EGFRvIII-positive disease.
Rindopepimut is an investigational immunotherapeutic vaccine that targets the tumor-specific molecule epidermal growth factor receptor variant III (EGFRvIII). EGFRvIII is a mutated form of the epidermal growth factor receptor (EGFR) that is only expressed in cancer cells and not in normal tissue and is a transforming oncogene that can directly contribute to cancer cell growth. Expression of EGFRvIII is linked to poor long term survival regardless of other factors such as extent of resection and age. EGFRvIII is expressed in approximately 30% of glioblastoma tumors. Celldex is actively enrolling two clinical studies of rindopepimut—a Phase 3 international study called ACT IV in patients with newly diagnosed EGFRvIII-positive glioblastoma and a Phase 2 study called ReACT in patients with recurrent EGFRvIII-positive glioblastoma. Dr. Mitchell has a patent that has been licensed by Celldex and may receive royalties related to sales of this immunotherapeutic vaccine.
About Celldex Therapeutics, Inc.
Celldex Therapeutics is the first antibody-based combination immunotherapy company. Celldex has a pipeline of drug candidates in development for the treatment of cancer and other difficult-to-treat diseases based on its antibody focused Precision Targeted Immunotherapy (PTI) Platform. The PTI Platform is a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines and immunomodulators used in optimal combinations to create novel disease-specific drug candidates. For more information, please visit www.celldextherapeutics.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: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 knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our limited cash reserves and our ability to obtain additional capital on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; our ability to adapt APC Targeting TechnologyTMto develop new, safe and effective vaccines against oncology and infectious disease indications; our ability to successfully complete product research and further development of our programs; the uncertainties inherent in clinical testing; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage research and development efforts for multiple products at varying stages of development; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and other factors listed under "Risk Factors" in our annual report on Form 10-K.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
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