Study Demonstrates Micromet's Blinatumomab Produces High Single-Agent Activity in Patients with Relapsed Acute Lymphoblastic Leu

LONDON, Jun 10, 2011 (BUSINESS WIRE) --

Data to be presented tomorrow at the 16th Annual Meeting of the European Hematology Association (EHA) in London, UK, show that Micromet's blinatumomab produced a high complete remission rate in adult patients with acute lymphoblastic leukemia (ALL) who had relapsed following treatment with standard therapy.1 Blinatumomab is the most advanced of a new class of agents called BiTE(R) antibodies, designed to harness the body's T cells to kill cancer cells.

Interim results from this phase 2 single-arm trial showed that 75% of patients (9 of 12) achieved a complete remission (CR) or CR with partial recovery of blood counts (CRh*) following treatment with blinatumomab. All nine responding patients achieved a complete molecular response, or had no evidence of leukemic cells in their bone marrow, a key prognostic factor for patient survival. Notably, four patients with genetic abnormalities typically associated with poorer outcomes all achieved a CR or CRh*.

"Relapsed/refractory acute lymphoblastic leukemia is a difficult to treat disease that has seen no meaningful improvement in decades," said Professor Max Topp, Department of Internal Medicine II, University of Wuerzburg and the chair of the study. "To date blinatumomab has shown an impressive and unprecedented level of efficacy in a patient population with limited therapeutic options."

The most common clinical adverse events were fever, peripheral edema and fatigue. Treatment of two of the twelve patients was interrupted due to fully reversible and manageable CNS events. In one patient, cytokine release syndrome was observed, which was mitigated in subsequent patients through dose modification and pre-treatment with concomitant medication. No additional cytokine release syndrome was observed.

"These results are particularly striking relative to the fact that the majority of enrolled patients had characteristics typically associated with a dismal outlook," said Professor Topp.

Current treatment for Philadelphia negative relapsed/refractory ALL consists of combinations of toxic chemotherapy drugs that in the majority of cases fail to drive the disease into remission. In more than 30 years, no new drug has been approved for use in this setting, leaving physicians with few options to improve long-term patient outcomes other than variations in the dose and schedule of old drugs with limited efficacy. With current approaches, complete remission rates range from 17-45%.2-6 Standard chemotherapy is associated with a mortality rate of up to 23%.7 The average five-year survival rate for adult ALL patients after first relapse is 7%.5

Study design

This study is designed to evaluate the efficacy, safety and tolerability of blinatumomab in up to 25 adult patients with B-precursor ALL who relapsed after at least induction and consolidation treatment or who have refractory disease. Patients receive blinatumomab as a continuous infusion for 28 days followed by a treatment free interval of two weeks. Patients who achieve a CR/CRh* within the first two treatment cycles can receive consolidation with either three additional cycles of blinatumomab or allogeneic HSCT. The primary endpoint of the study is the rate of CR/CRh*. Secondary endpoints include molecular response rate, duration of response and overall survival. Enrollment in this study is currently on-going.

Conference Call and Webcast

Micromet management will host a conference call on Monday, June 13 at 8:00 AM EST to review the data presented at EHA. To participate in the conference call, please dial (877) 861-4516 (domestic) or (706) 902 - 4249 (international) and reference the conference ID 74624665.The presentation will be available via webcast at: www.micromet.com.

A replay of the call will be available from 9 AM ET on June 13, 2011 until midnight on July 4, 2011. To access the replay, please dial (800) 642-1687 (domestic) or (706) 645-9291 (international) and reference the access code 74624665. The archived webcast will be available for 30 days in the Investor Relations section of the Micromet website at www.micromet.com.

About Blinatumomab

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. annually. 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.

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 HealthCare Pharmaceuticals, 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, the 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, 2010, filed with the SEC on March 9, 2011, Micromet's Quarterly Report on Form 10-Q for the quarter ended March 31, 2011, filed with the SEC on May 10, 2011 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.

 

 

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