Micromet Initiates European Pivotal Trial of Blinatumomab in Adult Patients with Acute Lymphoblastic Leukemia
BETHESDA, Md., Sep 20, 2010 (BUSINESS WIRE) --
Micromet, Inc. (NASDAQ: MITI) today announced the initiation of a pivotal, multi-center study of the Company's lead product candidate blinatumomab (MT103) in adult patients with minimal residual disease (MRD) positive 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 trial is an important element of a broader clinical development plan aimed at establishing blinatumomab as an essential component of ALL therapy," said Christian Itin, Ph.D., Micromet's President and Chief Executive Officer. "We view the initiation of this study to be a key milestone in the development of blinatumomab and a potentially important future value driver for the company."
This Phase 2 multi-center, single-arm study, also known as BLAST (Blinatumomab Adult ALL MRD Study of T cell engagement), is intended to evaluate the efficacy, safety and tolerability of blinatumomab in up to 130 evaluable adult patients with B-precursor ALL with MRD after treatment with front-line chemotherapy. Patients will receive 15 micrograms per meter squared per day of blinatumomab for 28 days followed by two weeks off therapy over a six week treatment cycle, for up to four treatment cycles. The primary endpoint of the study is MRD response. Secondary endpoints include 18 month relapse-free survival rate (for non-transplanted patients) and mortality rate within 100 days after stem cell transplantation. The Company currently expects that enrollment at up to 70 leading cancer centers in Europe and the U.S. will take approximately two years to complete.
"Historical experience suggests that the majority of ALL patients with MRD following front-line chemotherapy who do not receive a transplant will relapse within one year," said Nicola Goekbuget, M.D., Goethe University Hospital Frankfurt and the international study chair. "Results reported to date suggest that blinatumomab has the potential to fundamentally change the long-term clinical outcome for this difficult to treat disease."
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 the BLAST 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%. The presence of leukemic cells in the bone marrow following treatment with front-line chemotherapy, also known as minimal residual disease (MRD), is a recognized negative prognostic factor for patients with ALL. According to published results2, MRD-negative patients incurred a 6% risk of relapse compared to an 89% risk in patients remaining MRD positive after chemotherapy. There are currently no therapies approved for the treatment of MRD-positive ALL.
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 enrollment timeline for the initiated pivotal clinical trial of blinatumomab, the number of clinical sites expected to participate in this clinical trial, 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 "designed," "aimed," "will," "expects," "potential," "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 future clinical trials, difficulty in enrolling patients in 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.
2. Raff et al. Molecular relapse in adult standard-risk ALL patients detected by prospective MRD monitoring during and after maintenance treatment. Blood. 2007109: 910-915
SOURCE: Micromet, Inc.
Micromet, Inc.Jennifer Neiman, Director, Corporate [email protected]