Healthcare Industry News: AQ4N
News Release - November 1, 2006
Novacea Initiates Phase 1/2 Trial of AQ4N in Glioblastoma MultiformeSOUTH SAN FRANCISCO, CA--(Healthcare Sales & Marketing Network)--Nov 1, 2006 -- Novacea, Inc. (NASDAQ:NOVC ) today announced that it has initiated a multicenter, Phase1b/2a open-label clinical trial of AQ4N (banoxantrone), in combination with radiotherapy and temozolomide, for safety, tolerability and activity in patients with newly diagnosed glioblastoma multiforme (GBM). The trial consists of two parts. The primary objective of the first part will be to evaluate safety and tolerability of three dose levels (200 mg/m2, 450 mg/m2and 750 mg/m2). The second part will further evaluate safety and tolerability as well as efficacy and the highest safe and tolerated dose of the AQ4N treatment determined in part one. Novacea expects to enroll approximately 60 patients in the trial. For more information on the AQ4N trial, you may visit www.ClinicalTrials.gov.
About AQ4N and GBM
Novacea acquired North American rights toAQ4N from KuDOS Pharmaceuticals and is an investigational new drug designed to address the unmet medical needs of certain cancers such as GBM. While many tumors are refractory to radiation and/or chemotherapy, AQ4N is a prodrug that is designed to be activated in regions of tumor hypoxia. Upon activation, AQ4N binds to DNA and functions as a potent topoisomerase II poison thereby blocking the replication of rapidly dividing cancer cells leading to targeted tumor cell killing. Early clinical studies in patients with brain tumors have demonstrated that AQ4N is converted into its toxic form selectively in the hypoxic region of GBM tumors and not in the adjacent normal tissues.
Nearly 1.2 million patients are diagnosed with malignant tumors each year in the United States. The large majority of solid tumors have hypoxic components. According to the American Cancer Society, there were approximately 18,500 new cases and 12,800 deaths from brain and other nervous system tumors in the United States in 2005. GBM is one of the most aggressive and rapidly progressing tumors for which few treatments are available.
Novacea, Inc. is a biopharmaceutical company focused on in-licensing, developing and commercializing novel cancer therapies. Novacea has two product candidates in clinical trials, including Asentar™, which currently is in a Phase 3 clinical trial for androgen-independent prostate cancer, or AIPC. Novacea’s second product candidate, AQ4N, is a hypoxia-activated prodrug and is being investigated in combination with radiation and chemotherapy in a Phase 1/2 clinical trial in brain tumors such as glioblastoma multiforme.
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