�ImClone Systems Incorporated (NASDAQ: IMCL), a global loss leader in the development and commercialization of novel antibodies to treat cancer, today announced that its disease-directed Phase 2 clinical trial in patients with advanced prostate cancer randomized to treatment with either IMC-A12 or IMC-1121B plus mitoxantrone and prednisone has commenced patient registration. IMC-A12 and IMC-1121B ar two therapeutic candidates in ImClone's proprietorship receptor-targeted antibody pipeline. IMC-A12 is ImClone's fully human, IgG1 anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody and IMC-1121B is its fully human, IgG1 anti-vascular growth factor receptor-2 (VEGFR-2) monoclonal antibody.
This multicenter, randomized open-label Phase 2 single-arm study is enrolling patients with metastatic androgen-independent prostate cancer who have developed disease progression during or within 60 days of receiving docetaxel-based chemotherapy or demonstrated intolerance to docetaxel-based therapy. A sum of 132 patients are expected to be enrolled at various centers, including those that participate in the Department of Defense's Prostate Cancer Consortium. This Phase 2 study is designed to evaluate the efficacy and safety of both IMC-A12 and IMC-1121B combined with mitoxantrone and prednisone. IMC-A12 and IMC-1121B are administered weekly, whereas mitoxantrone is administered every three weeks with oral daily prednisone.
"We ar very pleased about beginning another disease-directed, proof-of-concept run which efficiently evaluates two of our pipeline antibodies with discrete mechanisms of action, still each with potential applicability in the treatment of prostate cancer based on preclinical investigations performed by ImClone and academic collaborators," said Eric K. Rowinsky, M.D., Chief Medical Officer and Executive Vice President of ImClone. "The results of whatsoever one of the study arms, or even both, in conjunction with those of other ongoing clinical and preclinical studies, may serve as platforms for subsequent registration directed bodily process in several early- and advanced-stage prostate gland cancer settings."
IMC-A12 is a fully human IgG1 monoclonal antibody designed to specifically target the human IGF-1R, thereby inhibiting certain ligands known as IGFs 1 and 2 from binding to and energizing the receptor. This action blocks a signaling nerve pathway that enhances tumor cell proliferation and survival. In 2007, ImClone completed enrollment into two Phase 1 studies of IMC-A12 which demonstrated friendly safety and pharmacokinetic profiles, as comfortably as prelim evidence of antitumor bodily process as a single federal agent when administered either weekly or every two weeks. In addition to this Phase 2 study proclaimed today, Phase 2 studies of IMC-A12 in adult and adolescent patients with soft tissue sarcoma, untreated advanced prostate gland, pancreatic, colorectal, liver, and head and neck cancers, as well as a series of Phase 1/2 studies in pediatric malignancies and another evaluating the combination of IMC-A12 and temsirolimus, have begun to enroll patients.
IMC-1121B is a fully human IgG1 monoclonal antibody designed to bind to the extracellular domain of VEGFR-2 launch on tumor vasculature, thereby inhibiting certain ligands known as vascular endothelial growth factors from binding to and activating the receptor. This natural action blocks a signaling pathway key to new blood vessel formation in growing tumors, which has been shown to starve tumors of their nutrient issue and solution in significant tumor growth inhibition in pre-clinical models. In addition to this Phase 2 study announced today, disease-directed studies of IMC-1121B in patients with advanced malignant melanoma, liver and renal cancers have begun to inscribe patients, and additional Phase 2 and 3 evaluations are in various stages of development. In April 2008, ImClone announced an agreement with the Food and Drug Administration on a Special Protocol Assessment for a Phase 3 study of IMC-1121B in women with metastatic chest cancer, which recently commenced.
About ImClone Systems
ImClone Systems Incorporated is a fully structured global biopharmaceutical company committed to forward-moving oncology care by development and commercializing a portfolio of targeted biologic treatments designed to address the medical of necessity of patients with a variety of cancers. The Company's research and development programs let in growth broker blockers and angiogenesis inhibitors. ImClone Systems' headquarters and research trading 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 situation at hTTP://www.imclone.com.
Certain matters discussed in this news acquittance may make forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the party believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it prat give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could reason actual results to take issue materially from those projecting. Many of these factors are beyond the company's ability to control or predict. Important factors that may suit actual results to disagree materially and could wallop the company and the statements contained in this news release can be found in the company's filings with the Securities and Exchange Commission, including quarterly reports on Form 10-Q, flow reports on Form 8-K and annual reports on Form 10-K. For modern statements in this intelligence release, the company claims the protection of the safe harbor for innovative statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplementation any modern statements whether as a result of new information, future events or other than.
ImClone Systems
More info
