ImClone Systems Incorporated today announced that the initial stage of a series of Phase I/II clinical trials of IMC-A12 in patients with advanced pancreatic cancer has opened for patient enrollment
NEW YORK, NY, USA | May 20, 2008 | ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that the initial stage of a series of Phase I/II clinical trials of IMC-A12 in patients with advanced pancreatic cancer has opened for patient enrollment. The Southwest Oncology Group (SWOG), a cancer network sponsored by the National Cancer Institute (NCI), is evaluating IMC-A12, ImClone’s fully human, IgG1 anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in a small Phase I study immediately followed by a much larger randomized Phase II trial.
This study is one of at least 10 Phase I and II clinical trials of IMC-A12 sponsored by the Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment and Diagnosis (DCTD), NCI, to commence patient enrollment. ImClone announced the selection of these proposals by NCI in September 2007.
The insulin-like growth factor (IGF) system plays a critical role in the development and progression of many types of cancer, including pancreatic cancer. The initial 6-12 patient Phase I study will evaluate the side effects and recommend a dose of IMC-A12 administered in combination with gemcitabine and erlotinib, an approved regimen used to treat patients with advanced-stage pancreatic cancer. Immediately upon determination of a recommended Phase II dose for IMC-A12 combined with gemcitabine and erlotinib, a Phase II multicenter study will begin. In the much larger Phase II study, previously untreated patients with advanced pancreatic cancer will be randomized to treatment with either IMC-A12 in combination with gemcitabine and erlotinib or the gemcitabine-erlotinib regimen without IMC-A12. Based on supportive preclinical data indicating favorable anticancer activity when IMC-A12 and inhibitors of the epidermal growth factor receptor (EGFR), such as cetuximab and erlotinib, are combined, the principal objective of this Phase II study is to evaluate the efficacy of IMC-A12 plus gemcitabine and erlotinib.
"The Southwest Oncology Group has designed a rigorous randomized evaluation of IMC-A12 in pancreatic cancer patients based on a firm preclinical rationale indicating the importance of the insulin-like growth factor receptor in pancreatic cancer growth, the anticancer activity of IMC-A12 in animal models of pancreatic cancer, and the favorable anticancer interactions when IMC-A12 is combined with cancer agents targeting EGFR," said Eric K. Rowinsky, M.D., Chief Medical Officer and Executive Vice President of ImClone. "ImClone is truly committed to developing more effective therapies to treat patients with this highly refractory type of cancer who have limited therapeutic options."
"These studies are another important step in achieving our goal of accelerating our pipeline of proprietary antibodies to fulfill the unmet needs of cancer patients around the world and becoming a fully integrated global biotechnology company," said John H. Johnson, Chief Executive Officer of ImClone.
IMC-A12 is a fully human IgG1 monoclonal antibody. It is designed to specifically target the human IGF-1R, thereby inhibiting certain ligands known as IGFs I and II from binding to and activating the receptor. This action blocks a signaling pathway that enhances tumor cell proliferation and survival. In 2007, ImClone completed enrollment into two Phase I studies of IMC-A12, which demonstrated favorable safety and pharmacokinetic profiles, as well as preliminary evidence of antitumor activity as a single agent when administered either weekly or every two weeks. In addition to this Phase II study of IMC-A12 in pancreatic cancer patients, Phase II studies of IMC-A12 in patients with advanced prostate, colorectal and liver cancers have begun to enroll patients, and a series of Phase I/II studies evaluating IMC-A12 in pediatric patients with advanced malignancies has opened for patient enrollment.
About ImClone’s NCI-Sponsored IMC-A12 Trials
In September 2007, the CTEP of the DCTD, NCI selected 10 proposals for Phase I and II clinical trials of ImClone’s IMC-A12, and several other proposals have been selected since that time. The selection of the proposed trials followed NCI’s solicitation for specific disease-directed studies among NCI investigators at academic institutions, clinical trial consortia and NCI-sponsored oncology cooperative clinical trial groups in the U.S. The selected trials represent the first stage of clinical evaluations of IMC-A12 sponsored by CTEP, NCI under a Clinical Trials Agreement between ImClone Systems and DCTD, NCI to facilitate the clinical development of IMC-A12. Both randomized and nonrandomized Phase II trials sponsored by CTEP will explore the clinical activity, pharmacology and biological effects of IMC-A12 as a single agent or combined with other relevant anticancer agents in a wide range of malignancies including breast, lung, pancreas and liver cancers, as well as both adult and pediatric sarcomas. In addition, Phase I/II studies will evaluate the safety, pharmacology, anticancer activity and biological effects of IMC-A12 in children and adolescents with cancer, as well as in combination with other novel targeting agents in which there is a specific rationale for combined use.
About ImClone Systems
ImClone Systems Incorporated is a fully integrated biopharmaceutical company committed to advancing oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers. The Company’s research and development programs include growth factor blockers and angiogenesis inhibitors. ImClone Systems’ headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey. For more information about ImClone Systems, please visit the Company’s web site at http://www.imclone.com.
SOURCE: ImClone Systems Incorporated
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ImClone Systems Incorporated today announced that the initial stage of a series of Phase I/II clinical trials of IMC-A12 in patients with advanced pancreatic cancer has opened for patient enrollment
NEW YORK, NY, USA | May 20, 2008 | ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that the initial stage of a series of Phase I/II clinical trials of IMC-A12 in patients with advanced pancreatic cancer has opened for patient enrollment. The Southwest Oncology Group (SWOG), a cancer network sponsored by the National Cancer Institute (NCI), is evaluating IMC-A12, ImClone’s fully human, IgG1 anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in a small Phase I study immediately followed by a much larger randomized Phase II trial.
This study is one of at least 10 Phase I and II clinical trials of IMC-A12 sponsored by the Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment and Diagnosis (DCTD), NCI, to commence patient enrollment. ImClone announced the selection of these proposals by NCI in September 2007.
The insulin-like growth factor (IGF) system plays a critical role in the development and progression of many types of cancer, including pancreatic cancer. The initial 6-12 patient Phase I study will evaluate the side effects and recommend a dose of IMC-A12 administered in combination with gemcitabine and erlotinib, an approved regimen used to treat patients with advanced-stage pancreatic cancer. Immediately upon determination of a recommended Phase II dose for IMC-A12 combined with gemcitabine and erlotinib, a Phase II multicenter study will begin. In the much larger Phase II study, previously untreated patients with advanced pancreatic cancer will be randomized to treatment with either IMC-A12 in combination with gemcitabine and erlotinib or the gemcitabine-erlotinib regimen without IMC-A12. Based on supportive preclinical data indicating favorable anticancer activity when IMC-A12 and inhibitors of the epidermal growth factor receptor (EGFR), such as cetuximab and erlotinib, are combined, the principal objective of this Phase II study is to evaluate the efficacy of IMC-A12 plus gemcitabine and erlotinib.
"The Southwest Oncology Group has designed a rigorous randomized evaluation of IMC-A12 in pancreatic cancer patients based on a firm preclinical rationale indicating the importance of the insulin-like growth factor receptor in pancreatic cancer growth, the anticancer activity of IMC-A12 in animal models of pancreatic cancer, and the favorable anticancer interactions when IMC-A12 is combined with cancer agents targeting EGFR," said Eric K. Rowinsky, M.D., Chief Medical Officer and Executive Vice President of ImClone. "ImClone is truly committed to developing more effective therapies to treat patients with this highly refractory type of cancer who have limited therapeutic options."
"These studies are another important step in achieving our goal of accelerating our pipeline of proprietary antibodies to fulfill the unmet needs of cancer patients around the world and becoming a fully integrated global biotechnology company," said John H. Johnson, Chief Executive Officer of ImClone.
IMC-A12 is a fully human IgG1 monoclonal antibody. It is designed to specifically target the human IGF-1R, thereby inhibiting certain ligands known as IGFs I and II from binding to and activating the receptor. This action blocks a signaling pathway that enhances tumor cell proliferation and survival. In 2007, ImClone completed enrollment into two Phase I studies of IMC-A12, which demonstrated favorable safety and pharmacokinetic profiles, as well as preliminary evidence of antitumor activity as a single agent when administered either weekly or every two weeks. In addition to this Phase II study of IMC-A12 in pancreatic cancer patients, Phase II studies of IMC-A12 in patients with advanced prostate, colorectal and liver cancers have begun to enroll patients, and a series of Phase I/II studies evaluating IMC-A12 in pediatric patients with advanced malignancies has opened for patient enrollment.
About ImClone’s NCI-Sponsored IMC-A12 Trials
In September 2007, the CTEP of the DCTD, NCI selected 10 proposals for Phase I and II clinical trials of ImClone’s IMC-A12, and several other proposals have been selected since that time. The selection of the proposed trials followed NCI’s solicitation for specific disease-directed studies among NCI investigators at academic institutions, clinical trial consortia and NCI-sponsored oncology cooperative clinical trial groups in the U.S. The selected trials represent the first stage of clinical evaluations of IMC-A12 sponsored by CTEP, NCI under a Clinical Trials Agreement between ImClone Systems and DCTD, NCI to facilitate the clinical development of IMC-A12. Both randomized and nonrandomized Phase II trials sponsored by CTEP will explore the clinical activity, pharmacology and biological effects of IMC-A12 as a single agent or combined with other relevant anticancer agents in a wide range of malignancies including breast, lung, pancreas and liver cancers, as well as both adult and pediatric sarcomas. In addition, Phase I/II studies will evaluate the safety, pharmacology, anticancer activity and biological effects of IMC-A12 in children and adolescents with cancer, as well as in combination with other novel targeting agents in which there is a specific rationale for combined use.
About ImClone Systems
ImClone Systems Incorporated is a fully integrated biopharmaceutical company committed to advancing oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers. The Company’s research and development programs include growth factor blockers and angiogenesis inhibitors. ImClone Systems’ headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey. For more information about ImClone Systems, please visit the Company’s web site at http://www.imclone.com.
SOURCE: ImClone Systems Incorporated
Post Views: 60
