ROCKVILLE, Md.--(BUSINESS WIRE)-- Micromet (Nasdaq: MITI) announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to expand development of the Company’s lead product candidate blinatumomab in patients with acute lymphoblastic leukemia (ALL) and various sub-types of lymphoma. Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body's T cells to kill cancer cells.
Under the terms of the agreement, the NCI and Micromet will collaborate on a series of clinical trials to evaluate the safety and efficacy of blinatumomab in patients with B-cell derived hematologic malignancies. The initial NCI-sponsored studies will explore blinatumomab’s utility as a first-line treatment for patients newly diagnosed with ALL, older patients with ALL, and patients with Waldenstrom’s macroglobulinemia. Additional studies will be designed based on the agreement of both parties.
“We are very pleased that the NCI has chosen to support the clinical development of blinatumomab,” said Jan Fagerberg, M.D., Ph.D., Micromet’s Senior Vice President and Chief Medical Officer. “This partnership will enable us to further explore blinatumomab’s clinical potential across a wide range of blood cancers and will expand leading U.S. investigators’ experience with the drug."
Blinatumomab (MT103) is a next-generation monoclonal antibody-based therapeutic designed to direct the body's cell destroying T-cells against target cells expressing CD19, a protein expressed on the surface of B-cell derived acute lymphoblastic leukemias and non-Hodgkin's lymphomas. Micromet has received orphan drug designation from the European Medicines Agency for blinatumomab for the treatment of acute lymphoblastic leukemia, mantle cell lymphoma and chronic lymphatic leukemia and from the U.S. Food and Drug Administration for the treatment of acute lymphoblastic leukemia, chronic lymphocytic leukemia and indolent B cell lymphoma.
About Micromet, Inc.
Micromet is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. The Company is advancing a robust pipeline of novel therapeutics based on its proprietary BiTE® technology. The Company's lead product candidate blinatumomab (MT103) is currently the subject of a European pivotal trial in patients with minimal residual disease positive acute lymphoblastic leukemia. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including Amgen, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, MedImmune, Nycomed and Sanofi.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein that do not describe historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. These forward-looking statements include statements regarding the clinical trials planned to be conducted under the CRADA and the potential efficacy and utility of blinatumomab. You are urged to consider statements that include the words "will," "believes," "potential," "plans," "intends," “may,” “suggests,” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that blinatumomab does not demonstrate safety and/or efficacy in on-going or future clinical trials, delays in development and testing, including the risk that we will not obtain approval to market blinatumomab, and the risks associated with reliance on outside financing to meet capital requirements. These factors and others are more fully discussed in Micromet's Annual Report on Form 10-K, as amended, for the fiscal year ended December 31, 2010, and Micromet's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2011, filed with the SEC on November 8, 2011 as well as other filings by Micromet with the SEC. Micromet cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Micromet also disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Director, Corporate Communications
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