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Novacea's Proof-of-Principle Study of AQ4N in Solid Tumors Published in Clinical Cancer Research

Posted on: Friday, 15 February 2008, 09:00 CST

Novacea, Inc. (NASDAQ: NOVC) today announced that Clinical Cancer Research, a peer-reviewed publication by the American Association of Cancer Research, has published a proof-of-principle Phase 1 study evaluating AQ4N (banoxantrone) in patients with advanced solid tumors. A novel investigational anti-cancer prodrug, AQ4N is converted selectively to the drug's active form, AQ4, a potent topoisomerase II inhibitor, within hypoxic, or oxygen-starved, tumor cells. Hypoxia is an important distinguishing characteristic of tumors that limits the effectiveness of radiation and chemotherapy treatments. AQ4N is currently being evaluated in a Phase 1b/2a clinical trial in patients with glioblastoma multiforme (GBM).

"As we continue our clinical development program for AQ4N in GBM, this data clearly demonstrate that the activated form of the prodrug, AQ4, preferentially accumulates in the tumor rather than normal tissue, is present at higher levels in tumors with greater degrees of hypoxia, and appears to be localized within regions comprising hypoxic tumor cells. To our knowledge, this is the first time that the activation of a bioreductive cytotoxic agent in clinical tumor samples has been demonstrated," said Alshad S. Lalani, Ph.D. director of Translational Medicine at Novacea and co-author of the study.

This translational study evaluated 32 patients with various advanced cancers (glioblastoma, n=8; bladder, n=9; head and neck; n=8; breast, n=6; and cervical, n=1) who received a single 200 mg/m2 dose of AQ4N prior to elective surgery. AQ4 and AQ4N levels in 95 tissues (tumor, healthy tissue) were assessed by analytical techniques and tissue sections were also analyzed for AQ4 fluorescence distribution and correlation with a hypoxia marker, Glut-1, by microscopy. Activated AQ4 was detected in all tumor samples with highest levels present in glioblastoma (mean 1.2 ug/g) and head and neck (mean 0.65 ug/g) tumors; 22 of 32 patients had tumor AQ4 concentrations greater than or equal to 0.2ug/g, levels previously shown to be active in preclinical studies. In 24 of 30 tumor samples, AQ4 was detected at higher concentrations than in adjacent normal tissue (tumor to normal ratio range 1.1 - 63.6); distant skin samples contained very low concentrations of AQ4 (mean 0.037 ug/g).

AQ4N in Glioblastoma Multiforme Development Update

The company has completed the three cohorts of the Phase 1b/2a GBM study without any dose limiting toxicities (DLTs), dosing patients at 200 mg/m2, 450mg/m2 and 750mg/m2 of AQ4N once-weekly for six weeks in combination with a standard regimen of radiation therapy and temozolomide. The company currently anticipates that the Phase 2a stage of the trial will commence during the second quarter of 2008.

In the Phase 1b portion of the study, six patients received 200mg/m2 of AQ4N and one patient has not experienced disease progression after approximately 10 months of follow-up. At the 450 mg/m2 dose level, patients have not experienced disease progression as far out as eight months of follow-up. At the 750 mg/m2 dose level, the final cohort (seven patients) has now been fully enrolled.

About Novacea

Novacea, Inc. is a biopharmaceutical company focused on in-licensing, developing and commercializing novel cancer therapies. Novacea has two product candidates, including Asentar(TM), which has been in a Phase 3 clinical trial for androgen-independent prostate cancer, or AIPC, and in a Phase 2 trial for advanced pancreatic cancer. Asentar is part of a development and commercialization agreement with Schering-Plough Corporation. Novacea's second product candidate, AQ4N, is a hypoxia-activated prodrug that is currently in a Phase 1b/2a clinical trial in glioblastoma multiforme. More information on any of Novacea's trials can be found at www.ClinicalTrials.gov.

Except for the historical information contained herein, the matters set forth in this press release, including statements as to development, clinical studies, regulatory review and approval, and commercialization of products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements speak only as of the date the statements are made and are based on information available at the time those statements are made and/or management's good faith belief as of that time with respect to future events. You should not put undue reliance on any forward-looking statements. Important factors that could cause actual performance and results to differ materially from the forward-looking statements we make include: early stage of development; the focus, conduct, enrollment and timing of our clinical trials; regulatory review and approval of product candidates; success or failure of our present and future collaboration agreements; commercialization of products; developments relating to our licensing and collaboration agreements; market acceptance of products; funding requirements; intellectual property protection for our product candidates; competing products and other risks detailed from time to time under the heading "Risk Factors" in our most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K, as may be updated from time to time by our future filings under the Securities Exchange Act. If one or more of these risks or uncertainties materialize, or if any underlying assumptions prove incorrect, our actual performance or results may vary materially from any future performance or results expressed or implied by these forward-looking statements. We assume no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws.

Novacea is a registered trademark of Novacea, Inc., and Asentar is a trademark of Novacea, Inc. All other trademarks are property of their respective owners.

 Novacea Contact:  Paul Laland Vice President, Corporate Communications Tel: 650-228-1811 E-mail: Email Contact

SOURCE: Novacea, Inc.

Source: MARKET WIRE

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