�ImClone Systems Incorporated (NASDAQ: IMCL), a global 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 crab randomized to treatment with either IMC-A12 or IMC-1121B plus mitoxantrone and deltasone has commenced patient enrollment. 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 constituent receptor-2 (VEGFR-2) monoclonal antibody.
This multicenter, randomized open-label Phase 2 single-arm subject is enrolling patients with metastatic androgen-independent prostate cancer who have developed disease progression during or inside 60 years of receiving docetaxel-based chemotherapy or demonstrated intolerance to docetaxel-based therapy. A total of 132 patients ar expected to be enrolled at assorted 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 are very proud of about beginning another disease-directed, proof-of-concept trial which expeditiously evaluates deuce of our pipeline antibodies with distinct mechanisms of action, til now 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 work arms, or even both, in concurrence with those of former ongoing clinical and preclinical studies, may serve as platforms for subsequent registration directed activity in several early- and advanced-stage prostate cancer settings."
IMC-A12 is a in full human IgG1 monoclonal antibody designed to specifically fair game the human IGF-1R, thereby inhibiting certain ligands known as IGFs 1 and 2 from binding to and activating the receptor. This action blocks a signaling pathway that enhances tumor cell proliferation and survival. In 2007, ImClone completed registration into deuce Phase 1 studies of IMC-A12 which demonstrated favorable safety and pharmacokinetic profiles, as advantageously as preliminary evidence of antitumor activity as a single agent when administered either weekly or every two weeks. In gain to this Phase 2 study announced today, Phase 2 studies of IMC-A12 in adult and adolescent patients with soft tissue paper 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 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 found on tumour vasculature, thereby inhibiting sure ligands known as vascular endothelial growth factors from binding to and activating the sensory receptor. This action mechanism blocks a signaling nerve tract key to new blood vessel geological formation in growing tumors, which has been shown to starve tumors of their nutrient supply and resultant in meaning tumor increase inhibition in pre-clinical models. In increase 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 enter 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 titty cancer, which recently commenced.
About ImClone Systems
ImClone Systems Incorporated is a fully integrated global biopharmaceutical company committed to advancing oncology guardianship 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 inquiry and development programs include growth cistron blockers and angiogenesis inhibitors. ImClone Systems' headquarters and research operations are set in New York City, with extra administration and manufacturing facilities in Branchburg, New Jersey. For more information more or less ImClone Systems, please visit the Company's web site at hTTP://www.imclone.com.
Certain matters discussed in this news release may plant 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 advanced 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 causal agency actual results to differ materially from those projecting. Many of these factors are beyond the company's ability to control or predict. Important factors that may cause actual results to differ materially and could wallop the company and the statements contained in this news waiver can be found in the company's filings with the Securities and Exchange Commission, including quarterly reports on Form 10-Q, current reports on Form 8-K and yearly reports on Form 10-K. For advanced statements in this news program release, the company claims the protection of the safe hold for modern 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 otherwise.
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