Micromet Initiates Phase 2 Trial of Blinatumomab in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia
BETHESDA, Md., Sep 20, 2010 (BUSINESS WIRE) --
Micromet, Inc. (NASDAQ: MITI) today announced the initiation of a phase 2 trial of the Company's lead product candidate blinatumomab (MT103) in adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is the first of a new class of agents called BiTE(R) antibodies, designed to harness the body's T cells to kill cancer cells.
This phase 2, single-arm study is intended to evaluate the efficacy, safety and tolerability of blinatumomab in 20 adult patients with B-precursor ALL who are resistant or intolerant to standard chemotherapy. Patients will receive blinatumomab daily for 28 days followed by two weeks off therapy over a six week treatment cycle, for up to five treatment cycles. Patients will receive starting doses of blinatumomab of 15 micrograms per meter squared, with dose escalation in subsequent cohorts based on tolerability. The primary endpoint of the study is objective response rate. Secondary endpoints include duration of response and overall survival.
"Existing treatment options for relapsed/refractory ALL fail to produce durable remissions in the majority of patients," said Christian Itin, Ph.D., Micromet's President and Chief Executive Officer. "This trial will enable us to validate blinatumomab's potential utility in patients with ALL with more advanced disease, and, if successful, would be the basis for potential pivotal studies in relapsed/refractory ALL."
Blinatumomab Clinical Experience in ALL
Results from a phase 2 trial reported at the 2010 Congress of the European Hematology Association demonstrated that blinatumomab induced a prolonged hematologic relapse-free survival in patients with MRD-positive ALL and was well tolerated. Of 20 evaluable patients treated, 80% (16 out of 20) achieved a complete MRD response. As of June 2010, seven out of 11 evaluable non-transplanted patients were in hematologic remission with a median of nearly 18 months and ranging up to 23 months. Eight of the patients in the study received an allogeneic stem cell transplant after blinatumomab treatment, all of whom were alive and in remission, ranging up to 21 months. Overall, blinatumomab was well-tolerated. The most common adverse events (any grade) were fever, chills, decreases in immunoglobulins and headache.
Additional information regarding this Phase 2 study is available at www.micromet.com or the U.S. government's clinical trials database at http://www.clinicaltrials.gov.
Blinatumomab (MT103) is a next-generation monoclonal antibody designed to direct the body's cell destroying T-cells against 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 Acute Lymphoblastic Leukemia
Acute Lymphocytic Leukemia (ALL) is an aggressive cancer of the blood and bone marrow that afflicts 5,760 patients in the U.S. annually1. Patients with ALL have abnormal white blood cells (lymphocytes) that crowd out healthy white and red blood cells and platelets, leading to infection, anemia (fatigue), easy bleeding and other serious effects. The average five-year survival rate for adult ALL patients after first relapse is 7%.
About Micromet, Inc.
Micromet, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. Its product development pipeline includes novel antibodies generated with its proprietary BiTE(R) technology, as well as conventional monoclonal antibodies. 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 Bayer Schering Pharma, Boehringer Ingelheim, MedImmune, Merck Serono, Nycomed and sanofi-aventis. Additional information can be found at www.micromet.com.
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 development and commercialization of blinatumomab, including the initiated phase 2 clinical trial of blinatumomab, the plans for future clinical trials and potential safety, efficacy and utility of blinatumomab, and the potential impact on the long-term survival of ALL patients treated with 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 for the fiscal year ended December 31, 2009, filed with the SEC on March 5, 2010, Micromet's Quarterly Report on Form 10-Q for the quarter ended June 30, 2010, filed with the SEC on August 6, 2010, as well as other filings by the Company 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.
1. American Cancer Society. Cancer Facts and Figures 2009.
SOURCE: Micromet, Inc.
Micromet, Inc.Jennifer Neiman, 240-235-0246Director, Corporate [email protected]