Novel anti-CD23 antibody granted Fast Track and Orphan Drug designations
CAMBRIDGE, MA, USA | Feb 07, 2007 | Biogen Idec (Nasdaq: BIIB) today announced that it has initiated a randomized, controlled, registration trial of an investigational anti-CD23 monoclonal antibody, lumiliximab, for patients with chronic lymphocytic leukemia (CLL). The trial will compare treatment with lumiliximab in combination with fludaribine, cyclophosphamide and rituximab (FCR), an emerging standard of care, to FCR alone in patients with CLL that has relapsed or failed to respond to initial therapy.
Biogen Idec also announced that lumiliximab was granted Fast Track and Orphan Drug designations by the U.S. Food and Drug Administration (FDA) for the above indication. Biogen Idec owns the worldwide rights to lumiliximab.
"We are pleased that the FDA has recognized the unmet medical need of patients with chronic lymphocytic leukemia, and we believe that this fast track designation may be an important step towards bringing lumiliximab more rapidly to the market," said David Parkinson, M.D., senior vice president, Oncology Research and Development, Biogen Idec.
Fast Track programs are designed to facilitate the development and expedite the review of new drugs or biologics that are intended to treat serious or life-threatening conditions and that may fill an unmet medical need. Orphan drug designation is a special status given to products for rare diseases or conditions upon request of a sponsor and approval from the FDA. Orphan drug designation may qualify recipients for exclusive marketing rights in the United States for seven years if the company is first to receive marketing approval.
The newly initiated lumiliximab registration trial enrolled the first randomized U.S. patient January 17, 2007. The patient was treated on January 22, 2007, by Kelly Pendergrass, M.D., at Kansas City Cancer Center in Kansas City, Mo. The first international patient was also treated on January 22, 2007, by Dr. Paul Cannell at Royal Perth Hospital in Perth, Australia. The study will ultimately enroll approximately 276 patients worldwide at more than 90 centers.
Dr. Pendergrass, clinical investigator and medical oncologist, said, "Kansas City Cancer Center is excited to participate in the lumiliximab clinical trial because our patients rely on us for industry-leading new treatments."
"We are encouraged to continue studying this novel CD23 antibody in combination with FCR following positive data that showed the potential for improved outcomes for CLL patients," said Ian Flinn, M.D., Ph.D., director, Hematologic Malignancies Research, Sarah Cannon Research Institute and clinical director, Sarah Cannon Blood and Marrow Transplant Program, Tennessee Oncology. "The development of this antibody is significant because more targeted therapeutic options are needed for CLL patients."
Data from a Phase I/II study on lumiliximab was presented at the 48th Annual Meeting of the American Society of Hematology (ASH) in December 2006. When added to the FCR regimen, lumiliximab demonstrated a 52 percent complete response (CR) rate in patients who have CLL that was progressing after prior therapy. CR rate is a predictor of progression-free survival in CLL patients.
"Building on our history of successful development and commercialization of antibodies, we are excited at the recent initiation of this lumiliximab trial in conjunction with the initiation of a pivotal trial for our anti-CD80 monoclonal antibody, galiximab," added Dr. Parkinson. "With our strong pipeline, we hope to continue to be a leader in developing new and novel approaches to cancer treatment worldwide."
About the Study
The LUCID Trial (evaLuation of lUmiliximab in Combination with FCR in patIents with relapseD CLL) is a randomized, multi-center study (152CL201) of the anti-CD23 monoclonal antibody lumiliximab in combination with FCR, compared with FCR alone. CD23 is highly expressed on B-CLL cells. The primary study objective is to compare the clinical benefit of each treatment arm in subjects with relapsed CLL. Complete response (CR) rate is the primary study endpoint.
About Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia (CLL) is a cancer that starts in lymphocytes (white blood cells) of the bone marrow. It then invades the blood and can spread to the lymph nodes, spleen, liver and other parts of the body. It is estimated that 77,000 Americans are currently living with CLL, and about 10,000 new cases are expected to occur in the United States this year. More than 21,000 patients in the United States are actively receiving treatment for CLL, with the majority being treated in the relapsed setting. A similar number of CLL cases and treated patients occur in the major European markets including, France, Germany, Italy, Spain and the United Kingdom.
About Biogen Idec
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
Biogen Idec Safe Harbor
This press release contains forward-looking statements regarding the development of lumiliximab and its potential as a treatment for various indications. These statements are based on the companies’ current beliefs and expectation. Drug development involves a high degree of risk. Factors which could cause actual results to differ materially from the companies’ current expectations include: the risk that unexpected concerns may arise from additional data or analysis, that regulatory authorities may require additional information, further studies, or may fail to approve the drug, or that the company may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec’s drug development and other activities, see the periodic reports of Biogen Idec filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE: Biogen Idec
Post Views: 188
Novel anti-CD23 antibody granted Fast Track and Orphan Drug designations
CAMBRIDGE, MA, USA | Feb 07, 2007 | Biogen Idec (Nasdaq: BIIB) today announced that it has initiated a randomized, controlled, registration trial of an investigational anti-CD23 monoclonal antibody, lumiliximab, for patients with chronic lymphocytic leukemia (CLL). The trial will compare treatment with lumiliximab in combination with fludaribine, cyclophosphamide and rituximab (FCR), an emerging standard of care, to FCR alone in patients with CLL that has relapsed or failed to respond to initial therapy.
Biogen Idec also announced that lumiliximab was granted Fast Track and Orphan Drug designations by the U.S. Food and Drug Administration (FDA) for the above indication. Biogen Idec owns the worldwide rights to lumiliximab.
"We are pleased that the FDA has recognized the unmet medical need of patients with chronic lymphocytic leukemia, and we believe that this fast track designation may be an important step towards bringing lumiliximab more rapidly to the market," said David Parkinson, M.D., senior vice president, Oncology Research and Development, Biogen Idec.
Fast Track programs are designed to facilitate the development and expedite the review of new drugs or biologics that are intended to treat serious or life-threatening conditions and that may fill an unmet medical need. Orphan drug designation is a special status given to products for rare diseases or conditions upon request of a sponsor and approval from the FDA. Orphan drug designation may qualify recipients for exclusive marketing rights in the United States for seven years if the company is first to receive marketing approval.
The newly initiated lumiliximab registration trial enrolled the first randomized U.S. patient January 17, 2007. The patient was treated on January 22, 2007, by Kelly Pendergrass, M.D., at Kansas City Cancer Center in Kansas City, Mo. The first international patient was also treated on January 22, 2007, by Dr. Paul Cannell at Royal Perth Hospital in Perth, Australia. The study will ultimately enroll approximately 276 patients worldwide at more than 90 centers.
Dr. Pendergrass, clinical investigator and medical oncologist, said, "Kansas City Cancer Center is excited to participate in the lumiliximab clinical trial because our patients rely on us for industry-leading new treatments."
"We are encouraged to continue studying this novel CD23 antibody in combination with FCR following positive data that showed the potential for improved outcomes for CLL patients," said Ian Flinn, M.D., Ph.D., director, Hematologic Malignancies Research, Sarah Cannon Research Institute and clinical director, Sarah Cannon Blood and Marrow Transplant Program, Tennessee Oncology. "The development of this antibody is significant because more targeted therapeutic options are needed for CLL patients."
Data from a Phase I/II study on lumiliximab was presented at the 48th Annual Meeting of the American Society of Hematology (ASH) in December 2006. When added to the FCR regimen, lumiliximab demonstrated a 52 percent complete response (CR) rate in patients who have CLL that was progressing after prior therapy. CR rate is a predictor of progression-free survival in CLL patients.
"Building on our history of successful development and commercialization of antibodies, we are excited at the recent initiation of this lumiliximab trial in conjunction with the initiation of a pivotal trial for our anti-CD80 monoclonal antibody, galiximab," added Dr. Parkinson. "With our strong pipeline, we hope to continue to be a leader in developing new and novel approaches to cancer treatment worldwide."
About the Study
The LUCID Trial (evaLuation of lUmiliximab in Combination with FCR in patIents with relapseD CLL) is a randomized, multi-center study (152CL201) of the anti-CD23 monoclonal antibody lumiliximab in combination with FCR, compared with FCR alone. CD23 is highly expressed on B-CLL cells. The primary study objective is to compare the clinical benefit of each treatment arm in subjects with relapsed CLL. Complete response (CR) rate is the primary study endpoint.
About Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia (CLL) is a cancer that starts in lymphocytes (white blood cells) of the bone marrow. It then invades the blood and can spread to the lymph nodes, spleen, liver and other parts of the body. It is estimated that 77,000 Americans are currently living with CLL, and about 10,000 new cases are expected to occur in the United States this year. More than 21,000 patients in the United States are actively receiving treatment for CLL, with the majority being treated in the relapsed setting. A similar number of CLL cases and treated patients occur in the major European markets including, France, Germany, Italy, Spain and the United Kingdom.
About Biogen Idec
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
Biogen Idec Safe Harbor
This press release contains forward-looking statements regarding the development of lumiliximab and its potential as a treatment for various indications. These statements are based on the companies’ current beliefs and expectation. Drug development involves a high degree of risk. Factors which could cause actual results to differ materially from the companies’ current expectations include: the risk that unexpected concerns may arise from additional data or analysis, that regulatory authorities may require additional information, further studies, or may fail to approve the drug, or that the company may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec’s drug development and other activities, see the periodic reports of Biogen Idec filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE: Biogen Idec
Post Views: 188
