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The companies' decision to amend the ACT III clinical trial, which follows the recommendation of the Independent Data Monitoring Committee, was based on the observation that the majority of patients randomized to the control (standard of care) arm withdrew from this open-label study after being randomized to the control arm. Patients currently participating on the control arm of the study will be offered the option to receive treatment with CDX-110. Under this amendment, the ACT III study will provide a multi-center non-randomized dataset for CDX-110 in patients with newly diagnosed GBM. These data will provide additional information on the overall clinical profile for the development of CDX-110.
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The companies will be working in collaboration with investigators and regulatory authorities to determine the best development path for this novel vaccine with the hope of providing doctors and patients with a new treatment option for this devastating disease.
CDX-110 is an investigational immunotherapy vaccine that targets the tumor specific EGFR mutant EGFRvIII. It is under development in GBM, the most common form of brain tumor. GBM is an aggressive tumor with very poor prognosis. There are an estimated 10,000 new cases diagnosed annually in the United States, and the disease predominantly affects adults aged 45 to 70. The EGFRvIII mutation may be expressed in up to 50% of GBM. Current GBM treatment options include surgical resection, radiotherapy and chemotherapy.
In April 2008, Pfizer and Celldex entered into an agreement that granted Pfizer an exclusive worldwide license to CDX-110.
About Celldex Therapeutics, Inc.
Celldex Therapeutics is an integrated biopharmaceutical company that applies its comprehensive Precision Targeted Immunotherapy Platform to generate a pipeline of candidates to treat cancer and other difficult-to-treat diseases. Celldex's immunotherapy platform includes a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines and immunomodulators to create novel disease-specific drug candidates. For more information, please visit http://www.celldextherapeutics.com.
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and development of treatments and currently has 22 innovative compounds in clinical development across four platforms. By leveraging the strength of our resources and scientific talent, Pfizer Oncology strives to discover and develop novel treatment options to improve the outlook for oncology patients. Pfizer currently devotes more than 22 percent of its total R&D budget to the field of oncology, investing annually in worldwide research initiatives. We also partner with healthcare providers, governments and local communities around the world to provide better quality healthcare and health system support. For more information on the above information, please visit http://www.Pfizer.com.
PFIZER DISCLOSURE NOTICE: The information contained in this release is as of December 18, 2008. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains information about a product candidate, including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for such product candidate as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2007 and in its reports on Form 10-Q and Form 8-K.
CELLDEX DISCLOSURE NOTICE: The information contained in this release is as of December 18, 2008. Celldex assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains information about a product candidate, including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for such product candidate as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; decisions by Pfizer concerning the timing, scope and progress of research, development and commercialization of the product candidate, which decisions are outside of our control; and competitive developments.
A further description of risks and uncertainties can be found in Celldex's Annual Report on Form 10-K for the fiscal year ended December 31, 2007 and in its reports on Form 10-Q and Form 8-K.
SOURCE Celldex Therapeutics
