SOURCE: Novacea

October 11, 2007 09:00 ET

Novacea Initiates Phase 2 Trial of AQ4N in Acute Lymphoblastic Leukemia

SOUTH SAN FRANCISCO, CA--(Marketwire - October 11, 2007) - Novacea, Inc. (NASDAQ: NOVC) today announced the initiation of a Phase 2 trial of AQ4N (banoxantrone), an investigational anti-cancer prodrug, in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

This Phase 2 multicenter, single arm, open-label study will enroll approximately 56 evaluable patients. The primary efficacy objective is the response rate (confirmed complete response or confirmed complete response without platelet recovery) achieved over 3 cycles of AQ4N. The secondary efficacy objectives are duration of response and overall survival. Additionally, the study will evaluate the safety and tolerability of AQ4N as a monotherapy for patients with ALL, whose disease had either relapsed or was refractory to one or more prior chemotherapy regimens.

"As part of our expanded development plans for AQ4N, we believe the product candidate has the potential to help patients with acute lymphoblastic leukemia, a devastating disease with limited treatment options," said John G. Curd, M.D., president and chief medical officer at Novacea. "AQ4N is a proprietary anti-cancer prodrug with a novel mechanism of action. In pre-clinical models, we have observed that the activated AQ4 metabolite demonstrated potent cytotoxicity against tumor cells derived from hematological malignancies, including those from ALL and other forms of leukemia."

About Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia (ALL) is a type of cancer that starts from white blood cells in the bone marrow. According to the American Cancer Society, in 2007 there will be about 44,000 new cases of all types of leukemia in the United States. Of these, about 5,200 will be ALL. Although this disease primarily affects children, about 1,100 cases will be in adults. Approximately 1,400 people will die of ALL in the United States in 2007; about two-thirds of them will be adults.

About AQ4N

Novacea is developing AQ4N as a novel, tumor-selective prodrug with applicability to multiple tumor types, both in combination with a number of chemotherapeutic agents and as a monotherapy for hematological malignancies. AQ4N is an investigational prodrug designed to address the challenges of treating certain cancers with significant hypoxic (oxygen-starved) regions. AQ4N is selectively bioreduced by cytochrome P450 to AQ4, a potent DNA intercalator and topoisomerase II inhibitor. Preclinical studies demonstrate that AQ4N selectively targets lymphoblastoid cell lines as well as the hypoxic portions of solid tumors.

AQ4N was originally discovered by Professor Laurence Patterson, Ph.D., currently director of the Institute of Cancer Research at the University of Bradford in England, working in collaboration with the intellectual property and a life sciences company, BTG International Limited.

About Novacea

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, and a Phase 2 study for advanced pancreatic cancer. Asentar is the subject of the development and commercialization agreement with Schering-Plough. 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 financial guidance, 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; 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 or 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.

Contact Information

  • Novacea Contact:

    Paul Laland
    Vice President, Corporate Communications
    Tel: 650-201-2688
    E-mail: Email Contact