Company plans to initiate EU pivotal trial in MRD-positive ALL in mid-2010
Bethesda, MD, USA | February 10, 2010 | At its annual investor R&D Day today, Micromet, Inc. (NASDAQ: MITI) outlined the design of a registration study for the Company’s lead product candidate blinatumomab in acute lymphocytic leukemia (ALL), highlighted clinical data demonstrating the breadth of blinatumomab’s activity in B-cell non-Hodgkin’s lymphomas and announced plans to expand clinical development of blinatumomab in the U.S.
"We are very pleased with the strong support received from the medical community for the planned pivotal study in adult ALL," said Christian Itin, Ph.D., Micromet’s President and Chief Executive Officer. "Based on our discussions with the EMEA on the study design, we plan to initiate patient enrollment in the EU in mid-2010."
Blinatumomab Development Program Highlights
Micromet provided additional details today on its plans to expand development of blinatumomab in leukemia:
· EU pivotal study of blinatumomab in MRD-positive adult ALL – The Company plans to initiate a pivotal, single-arm study that will seek to enroll approximately 130 adult patients with MRD-positive ALL. Patients will receive up to four 4-week treatment cycles of blinatumomab at a dose of 15 µg/m2/day. Key endpoints of the study include molecular complete response (MRD negativity) and relapse-free survival rate. The Company currently anticipates enrolling patients in both the EU and US. The Company plans to discuss its registration strategy for blinatumomab in the U.S. with the FDA later this year.
· Development of blinatumomab in pediatric ALL – Based on experience from compassionate use utilization of blinatumomab in pediatric patients with relapsed/refractory ALL, the efficacy results in adult ALL and preliminary discussions with the EMEA, the Company is in the process of designing studies to facilitate expedited development of blinatumomab in this setting. The Company expects to finalize discussions with FDA and EMEA regarding its registration strategy in pediatric ALL during the course of 2010.
"Children resistant to available treatments for ALL are in dire need of new therapeutic options," said Arend von Stackelberg, M.D., Pediatric Oncology/Hemotology, Charité – University Clinic, Berlin, Germany. "The experience to date with blinatumomab in ALL is very encouraging and provides a strong rationale for expanded development in the pediatric setting."
· Phase 2 study in relapsed/refractory adult ALL – The Company plans to initiate an exploratory Phase 2 single-arm study in adult patients with relapsed/refractory ALL. The primary endpoint of the study is hematological complete response rate. The Company currently expects to initiate the study in mid-2010.
"Many adults with ALL who achieve complete remission will eventually relapse, making prevention of recurrence the best strategy for long-term patient survival," said Deborah Thomas, M.D., Associate Professor, Department of Leukemia, MD Anderson Cancer Center, Houston, Texas. "Novel therapeutic approaches for the treatment of this disease are therefore desperately needed."
· Phase 2 study in relapsed/refractory Chronic Lymphocytic Leukemia (CLL) – In collaboration with leading investigators in the EU and US, the Company plans to design and conduct an exploratory Phase 2 single-arm study in adult patients with relapsed/refractory CLL. The Company currently plans to initiate patient enrollment by the end of 2010.
About Blinatumomab
Blinatumomab (MT103) is a novel, next-generation monoclonal antibody designed to direct the body’s cell destroying T-cells against CD19, a protein expressed on the surface of most B-cell derived non Hodgkin’s lymphomas. Blinatumomab has demonstrated potent activity against adult Acute Lymphocytic Leukemia, achieving an 80% molecular response rate in a Phase 2 study. Blinatumomab was generally well-tolerated by patients in the Phase 2 study. The most frequently reported grade 3/4 adverse event was lymphopenia. All other adverse events were infrequent and transient in nature. Micromet received orphan drug designation from the EMEA for blinatumomab for the treatment of ALL in August 2009.
About Acute Lymphocytic Leukemia
Acute Lymphocytic Leukemia (ALL) is a cancer of the blood and bone marrow that afflicts 5,760 patients in the U.S. annually.1 ALL is the most common type of cancer in children. The average five-year survival rate for adult ALL patients after 1st relapse is 7%. The presence of minimal residual disease, or 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® technology, as well as conventional monoclonal antibodies. Two of Micromet’s BiTE antibodies and three of its conventional antibodies are currently in clinical trials. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including sanofi-aventis, Bayer Schering Pharma, Merck Serono, MedImmune and Nycomed. Additional information can be found at www.micromet-inc.com
References:
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.
Post Views: 130
Company plans to initiate EU pivotal trial in MRD-positive ALL in mid-2010
Bethesda, MD, USA | February 10, 2010 | At its annual investor R&D Day today, Micromet, Inc. (NASDAQ: MITI) outlined the design of a registration study for the Company’s lead product candidate blinatumomab in acute lymphocytic leukemia (ALL), highlighted clinical data demonstrating the breadth of blinatumomab’s activity in B-cell non-Hodgkin’s lymphomas and announced plans to expand clinical development of blinatumomab in the U.S.
"We are very pleased with the strong support received from the medical community for the planned pivotal study in adult ALL," said Christian Itin, Ph.D., Micromet’s President and Chief Executive Officer. "Based on our discussions with the EMEA on the study design, we plan to initiate patient enrollment in the EU in mid-2010."
Blinatumomab Development Program Highlights
Micromet provided additional details today on its plans to expand development of blinatumomab in leukemia:
· EU pivotal study of blinatumomab in MRD-positive adult ALL – The Company plans to initiate a pivotal, single-arm study that will seek to enroll approximately 130 adult patients with MRD-positive ALL. Patients will receive up to four 4-week treatment cycles of blinatumomab at a dose of 15 µg/m2/day. Key endpoints of the study include molecular complete response (MRD negativity) and relapse-free survival rate. The Company currently anticipates enrolling patients in both the EU and US. The Company plans to discuss its registration strategy for blinatumomab in the U.S. with the FDA later this year.
· Development of blinatumomab in pediatric ALL – Based on experience from compassionate use utilization of blinatumomab in pediatric patients with relapsed/refractory ALL, the efficacy results in adult ALL and preliminary discussions with the EMEA, the Company is in the process of designing studies to facilitate expedited development of blinatumomab in this setting. The Company expects to finalize discussions with FDA and EMEA regarding its registration strategy in pediatric ALL during the course of 2010.
"Children resistant to available treatments for ALL are in dire need of new therapeutic options," said Arend von Stackelberg, M.D., Pediatric Oncology/Hemotology, Charité – University Clinic, Berlin, Germany. "The experience to date with blinatumomab in ALL is very encouraging and provides a strong rationale for expanded development in the pediatric setting."
· Phase 2 study in relapsed/refractory adult ALL – The Company plans to initiate an exploratory Phase 2 single-arm study in adult patients with relapsed/refractory ALL. The primary endpoint of the study is hematological complete response rate. The Company currently expects to initiate the study in mid-2010.
"Many adults with ALL who achieve complete remission will eventually relapse, making prevention of recurrence the best strategy for long-term patient survival," said Deborah Thomas, M.D., Associate Professor, Department of Leukemia, MD Anderson Cancer Center, Houston, Texas. "Novel therapeutic approaches for the treatment of this disease are therefore desperately needed."
· Phase 2 study in relapsed/refractory Chronic Lymphocytic Leukemia (CLL) – In collaboration with leading investigators in the EU and US, the Company plans to design and conduct an exploratory Phase 2 single-arm study in adult patients with relapsed/refractory CLL. The Company currently plans to initiate patient enrollment by the end of 2010.
About Blinatumomab
Blinatumomab (MT103) is a novel, next-generation monoclonal antibody designed to direct the body’s cell destroying T-cells against CD19, a protein expressed on the surface of most B-cell derived non Hodgkin’s lymphomas. Blinatumomab has demonstrated potent activity against adult Acute Lymphocytic Leukemia, achieving an 80% molecular response rate in a Phase 2 study. Blinatumomab was generally well-tolerated by patients in the Phase 2 study. The most frequently reported grade 3/4 adverse event was lymphopenia. All other adverse events were infrequent and transient in nature. Micromet received orphan drug designation from the EMEA for blinatumomab for the treatment of ALL in August 2009.
About Acute Lymphocytic Leukemia
Acute Lymphocytic Leukemia (ALL) is a cancer of the blood and bone marrow that afflicts 5,760 patients in the U.S. annually.1 ALL is the most common type of cancer in children. The average five-year survival rate for adult ALL patients after 1st relapse is 7%. The presence of minimal residual disease, or 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® technology, as well as conventional monoclonal antibodies. Two of Micromet’s BiTE antibodies and three of its conventional antibodies are currently in clinical trials. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including sanofi-aventis, Bayer Schering Pharma, Merck Serono, MedImmune and Nycomed. Additional information can be found at www.micromet-inc.com
References:
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.
Post Views: 130
