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Micrometa?s Blinatumomab Produces High Objective Response Rate in Spectrum of Relapsed Non-Hodgkina?s Lymphoma Patients

^{Published on 2010-12-06 05:36:38 - Market Wire}
 

BETHESDA, Md.--([ BUSINESS WIRE ])--Micromet, Inc. (NASDAQ: MITI) today announced the presentation of updated results from an on-going Phase 1 trial of the Company's lead product candidate blinatumomab (MT103) in patients with relapsed non-Hodgkin's lymphoma (NHL). Results of the expanded experience suggest that blinatumomab continues to produce a high response rate and duration of response in a number of different NHL subtypes. Among patients who received the target dose of 60 micrograms per meter squared, 82% (18 of 22) achieved an objective response, including 4 out of 5 mantle cell lymphoma (MCL) patients. 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.

"Blinatumomab continues to demonstrate a high objective response rate in heavily pre-treated non-Hodgkin's lymphoma patients"

The data were reported in a poster presentation (abstract # 2880) yesterday at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, FL.

aBlinatumomab continues to demonstrate a high objective response rate in heavily pre-treated non-Hodgkin's lymphoma patients," said Andreas Viardot, M.D., University Hospital, Ulm, Germany. "Results of the expanded Phase 1 experience suggest that blinatumomab has the potential to alter the clinical course of disease in patients with a variety of NHL sub-types."

Phase 1 Study Design and Results

This multi-center Phase 1 study evaluates the safety and tolerability of blinatumomab in adult patients with relapsed non-Hodgkin's lymphoma (NHL). The key objectives of the study are to assess safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-lymphoma activity. Patient response is assessed using the Cheson criteria by independent radiologic review.

The data presented at ASH included 62 patients, mainly with diagnoses of mantle cell lymphoma (37%) and follicular lymphoma (FL) (39%). Most patients had received three or more prior lines of chemotherapy.

Investigators reported for the first time on the experience of patients with diffuse large B cell lymphoma. Notably, complete responses were observed in 3 of 6 patients treated.

"Blinatumomab demonstrates an attractive benefit risk profile in patients with mantle cell lymphoma that supports expanded development," said Christian Itin, Ph.D., Micrometa™s President and Chief Executive Officer. aWe will continue to explore blinatumomaba™s potential utility in other NHL subtypes with a focus on DLBCL.a

The most common adverse events were early, transient, fully reversible and did not require discontinuation of treatment. The clinically most relevant adverse events were fully reversible and manageable CNS events.

Conference Call and Webcast

Micromet management will host a conference call on Tuesday, December 7 at 8:00 AM EST to review the data presented at ASH. To participate in the conference call, please dial 866-362-4666 (domestic) or 617-597-5313 (international) and reference the access code 19082934. The presentation will be available via webcast in the aInvestors & Mediaa section of the Micromet website at [ www.micromet.com ].

A replay of the call will be available from 11:30 AM ET on December 7, 2010 until midnight on December 29, 2010. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international) and reference the access code 33687960. The archived webcast will be available for 30 days on the Companya™s website.

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 Mantle Cell Lymphoma

Mantle cell lymphoma (MCL) is an aggressive form of non-Hodgkina™s lymphoma that comprises approximately 6% of all NHL cases¹. It is one of the more difficult-to-treat types of lymphoma and often does not respond to chemotherapy. It is found in lymph nodes, the spleen, bone marrow, and gastrointestinal system. Mantle cell lymphoma usually develops in men over age 60.

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® technology, as well as conventional monoclonal antibodies. The Companya™s lead product candidate blinatumomab (MT103) is currently the subject of a 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 certain 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 and other BiTE antibodies by us and our collaborators, including the development of BiTE antibodies for the treatment of hematological cancers and the conduct and timing of ongoing and future clinical trials involving these product candidates, as well as plans regarding our regulatory strategy and announcements and publication of clinical data. You are urged to consider statements that include the words "continues," "will," "believes," "potential," "plans," "intends," "expects" 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 or our other product candidates do not demonstrate safety and/or efficacy in future clinical trials, delays in development and testing, the risk that we will not obtain approval to market blinatumomab or our other BiTE antibodies, 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, and Micromet's Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, filed with the SEC on November 9, 2010, as well as other filings by the Company with the SEC.

Reference:

1. Armitage et al. Non-Hodgkina™s Lymphoma Classification Project. JCO 1998