�ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to handle cancer, today announced that its disease-directed Phase 2 clinical trial in patients with advanced prostate malignant neoplastic disease 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 proprietary 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 cistron 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 the Crab who take developed disease progression during or inside 60 days of receiving docetaxel-based chemotherapy or demonstrated intolerance to docetaxel-based therapy. A come 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 orasone.
"We are very proud of about offset another disease-directed, proof-of-concept visitation which efficiently evaluates deuce of our pipeline antibodies with distinct mechanisms of action, yet each with potential pertinency 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 activity in respective early- and advanced-stage prostate gland cancer settings."
IMC-A12 is a amply human IgG1 monoclonal antibody designed to specifically prey the human IGF-1R, thereby inhibiting sure ligands known as IGFs 1 and 2 from binding to and activating the sense organ. This action blocks a signaling nerve tract that enhances tumor cellphone proliferation and survival. In 2007, ImClone completed enrollment into two Phase 1 studies of IMC-A12 which demonstrated favourable safety and pharmacokinetic profiles, as advantageously as prelude evidence of antitumor activity as a single agent when administered either weekly or every two weeks. In summation to this Phase 2 study proclaimed today, Phase 2 studies of IMC-A12 in grownup and adolescent patients with soft tissue sarcoma, untreated advanced prostate, pancreatic, colorectal, liver, and head and neck cancers, as well as a series of Phase 1/2 studies in pediatric malignancies and some other evaluating the combination of IMC-A12 and temsirolimus, have begun to enroll patients.
IMC-1121B is a amply human IgG1 monoclonal antibody designed to bind to the extracellular domain of VEGFR-2 constitute on tumour vasculature, thereby inhibiting certain ligands known as vascular endothelial outgrowth factors from binding to and activation the receptor. This action blocks a signaling nerve tract key to new blood vessel formation in growing tumors, which has been shown to starve tumors of their nutrient add and resolution in pregnant tumor growth inhibition in pre-clinical models. In gain to this Phase 2 study announced today, disease-directed studies of IMC-1121B in patients with advanced 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 breast cancer, which recently commenced.
About ImClone Systems
ImClone Systems Incorporated is a fully integrated global biopharmaceutical company attached to forward-moving oncology care by development and commercializing a portfolio of targeted biologic treatments designed to address the medical necessarily of patients with a variety of cancers. The Company's research and development programs let in growth factor 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 than information around ImClone Systems, please visit the Company's web situation at hTTP://www.imclone.com.
Certain matters discussed in this news release may nominate forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the company believes that the expectations reflected in such modern statements ar based upon reasonable assumptions, it can buoy give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could lawsuit actual results to disagree materially from those jutting. Many of these factors are beyond the company's ability to control or predict. Important factors that may cause actual results to disagree materially and could impact the ship's 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, stream reports on Form 8-K and annual reports on Form 10-K. For forward-looking statements in this tidings 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 forward-looking statements whether as a result of new information, future events or differently.
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