Follow-Up Data Presented at the American Society of Hematology (ASH) Annual Meeting Indicates that Blinatumomab is Able to Induce Durable Remission in Patients with Relapsed NHL
BETHESDA, Md., Dec. 9 /PRNewswire-FirstCall/ -- Micromet, Inc. , a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, today presented an update from its ongoing phase 1 clinical study of BiTE(R) antibody blinatumomab (MT103/MEDI-538) in patients with relapsed non-Hodgkin’s lymphoma (NHL) at the 50th annual meeting of the American Society of Hematology, held December 6 to 9 in San Francisco, CA. Blinatumomab is a novel therapeutic antibody that activates a patient’s T cells to seek out and destroy cancer cells.
As previously reported, 11 of 27 patients treated at doses of 0.015 mg/m2 per day and higher have responded to treatment with blinatumomab with partial and complete responses. The responses were confirmed by a central laboratory using standard Cheson criteria. Of the seven patients treated at 0.06 mg/m2 per day, all seven have been in durable remission lasting for at least six months and up to 14 months. Five of the seven responders continue to be in remission. The most common adverse events (AEs) included lymphopenia, pyrexia, and leukopenia. The vast majority of AEs occurred early during treatment and improved or resolved during treatment. Permanent treatment discontinuation due to AEs occurred in a total of nine patients resulting from infections, liver enzyme increases and fully reversible central nervous system events.
“The duration of responses seen after monotherapy of NHL patients with blinatumomab is very encouraging and may represent a next breakthrough in targeted therapy after the discovery of rituximab,” said Ronald Levy, M.D., Professor of Medicine, Chief of the Division of Oncology, at Stanford University School of Medicine.
“These follow-up data continue to demonstrate blinatumomab’s potential as a single-agent therapy for non-Hodgkin’s lymphoma patients,” said Micromet’s Senior Vice President and Chief Medical Officer, Carsten Reinhardt, M.D. “The observation of durable objective responses to the drug indicates the potential that blinatumomab and BiTE antibodies in general may have in fighting cancer.”
About BiTE Antibodies
BiTE(R) antibodies are designed to direct the body’s cytotoxic, or cell- destroying, T cells against tumor cells, and represent a new therapeutic approach to cancer therapy. Typically antibodies cannot engage T cells because T cells lack the appropriate receptors for binding antibodies. Previous attempts have shown the potential of T cells to treat cancer, but the therapeutic approaches tested to date have been hampered by cancer cells’ ability to escape recognition by T cells. The use of BiTE antibodies that are specifically designed to engage T cells for attacking cancer cells may provide a more effective anti-tumor approach than conventional monoclonal antibodies.
About Micromet, Inc.
Micromet, Inc. (www.micromet-inc.com) is a biopharmaceutical company with offices in Bethesda, Maryland and Munich, Germany. The Company is developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases. The Company uses its proprietary BiTE(R) antibody platform to create a new class of antibodies that specifically activate T cells from the patient’s own immune system to eliminate cancer cells or other disease-related cells. Four of the Company’s antibodies are currently in clinical trials, with the remainder of its product pipeline in preclinical development. The Company’s lead program is a BiTE antibody known as blinatumomab, or MT103. It is in a phase 2 clinical trial for the treatment of patients with acute lymphoblastic leukemia and a phase 1 clinical trial for the treatment of patients with non-Hodgkin’s lymphoma. Micromet is developing blinatumomab in collaboration with MedImmune, a subsidiary of AstraZeneca plc. Micromet’s second BiTE antibody in clinical development is MT110, which targets the epithelial cell adhesion molecule (EpCAM). The Company owns all rights to MT 110, which is currently in a phase 1 clinical trial for the treatment of patients with solid tumors. The Company’s third clinical stage antibody is adecatumumab, also known as MT201, a conventional human monoclonal antibody that targets EpCAM-expressing solid tumors. Micromet is developing adecatumumab in collaboration with Merck Serono in a phase 1b clinical trial evaluating adecatumumab in combination with docetaxel for the treatment of patients with metastatic breast cancer. Micromet has licensed a fourth clinical stage antibody, MT293, to TRACON Pharmaceuticals, Inc. MT293 is being developed in a phase 1 clinical trial for the treatment of patients with cancer. The Company’s preclinical programs include MT203, which is being developed in collaboration with Nycomed. MT203 is a traditional human antibody neutralizing the activity of granulocyte/macrophage colony stimulating factor (GM-CSF), which has potential applications in the treatment of inflammatory and autoimmune diseases, such as rheumatoid arthritis, psoriasis, or multiple sclerosis. Additional BiTE antibodies, targeting CEA, CD33, Her2, EGFR and MCSP, respectively, are in different stages of preclinical development.
Forward-Looking Statements
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 efficacy and intended utilization of our product candidates and the development of our BiTE antibody technology. You are urged to consider statements that include the words “may,” “potential,” 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 product candidates that appeared promising in early research, preclinical studies or clinical trials do not demonstrate safety and/or efficacy in subsequent clinical trials, the risk that encouraging results from early research, preclinical studies or clinical trials may not be confirmed upon further analysis of the detailed results of such research, preclinical study or clinical trial, and the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data. These factors and others are more fully discussed in Micromet’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2008, filed with the SEC on November 6, 2008, as well as other filings by the company with the SEC.
Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. Micromet, Inc. undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
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