Randomized, Controlled, Multicenter Trial Will Test Ability of Adecatumumab to Prolong Disease Free Survival in High Risk Patients with Liver Metastases
BETHESDA, Md., March 23 /PRNewswire-FirstCall/ -- Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, today announced the commencement of a randomized, controlled phase 2 trial of its human anti-EpCAM IgG1 antibody adecatumumab (MT201) for the treatment of patients with colorectal cancer (CRC) after complete resection of liver metastases. The trial has three arms comparing single agent adecatumumab to combination chemotherapy (FOLFOX: 5-FU/Leucovorin plus Oxaliplatin), and to FOLFOX followed by adecatumumab. The primary endpoint will be the disease-free survival rate at one year.
"The relapse of colorectal cancer patients with liver metastases still represents an area with very high medical need" said the trial's principle investigator, Professor Peter Neuhaus, from the Charite University Hospital in Berlin, Germany. "Recent intensification of chemotherapeutic regimens has shown only modest benefit and there is significant room for improvement in these patients. EpCAM is a cancer target which is highly expressed in colorectal cancer, and targeted therapies such as adecatumumab could become a major breakthrough in this setting if proven successful."
Apart from being the most highly and frequently expressed target antigen on colorectal cancer cells, EpCAM has recently been shown to drive tumor growth and to be expressed on colorectal cancer stem cells (1). The ability of adecatumumab to potentially control and eliminate newly developing metastases has been suggested in a recently reported Phase 2 trial of adecatumumab as monotherapy in metastatic breast cancer. In this trial, patients with high levels of EpCAM expression, in a dose-dependent fashion, developed significantly less new lesions as compared to patients with low levels of EpCAM (2).
"Numerous published clinical and preclinical data suggest that therapies targeting EpCAM such as adecatumumab could prove to be highly effective anti-cancer therapeutics," commented Carsten Reinhardt, MD, Chief Medical Officer of Micromet. "We look forward to exploring the promise of adecatumumab to eliminate minimal residual disease in colorectal cancer patients and thereby to potentially improve cure rates in these patients at high risk of relapse."
Colorectal cancer is the third most common cancer in western countries with more than 145,000 new cases diagnosed in the US each year. About 25 percent of patients present with liver metastases at first diagnosis, and an additional 35 to 45 percent of patients will develop metastases during the course of their disease. The only chance of long-term survival comes with curative resection of hepatic metastasis by liver surgery with reported five and 10 year survival rates of 41 percent and 22 percent, respectively. Previous trials of combination chemotherapy regimens in these patients have demonstrated only very modest improvements in survival. Even intensified treatment regimens, such as the one recently published EORTC Intergroup trial 40983, which compared peri-operative FOLFOX plus surgery to surgery alone, demonstrated only 7% improvement in progression free survival at three years (3).
1) Maetzel D. et al., Nature Cell Biology 2009; 11: 162-171
2) Dittrich C. et al., AACR-NCI-EORTC meeting 2007
3) Nordlinger et al., Lancet 2008; 371: 1007
Micromet, Inc. (www.micromet-inc.com) is a biopharmaceutical company with offices in Bethesda, MD and Munich, Germany. The Company is focused on developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases. The Company's novel antibody technology is based on its proprietary BiTE(R) antibody platform, representing 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's second BiTE antibody in clinical development is MT110, which targets the epithelial cell adhesion molecule (EpCAM). The Company owns all rights to MT110, 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 traditional 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 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 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. Micromet has granted an exclusive option to Bayer Schering Pharma AG to license a BiTE antibody against an undisclosed solid tumor target. Additional BiTE antibodies, targeting CEA, CD33, Her2, EGFR and MCSP, respectively, are in different stages of preclinical development.
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, safety and intended utilization of adecatumumab, . You are urged to consider statements that include the words "ongoing," "may," "will," "believes," "potential," "expects," "plans," "anticipates," "intends," 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, 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, the risk that we or our collaborators will not obtain approval to market our product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborators, including MedImmune, Merck Serono, TRACON and Nycomed, for the funding or conduct of further development and commercialization activities relating to our product candidates. These factors and others are more fully discussed in Micromet's Annual Report on Form 10-K for the fiscal year ended December 31, 2008, filed with the SEC on March 16, 2009, 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.
|SOURCE Micromet, Inc.|
Copyright©2009 PR Newswire.
All rights reserved