Novacea Provides Corporate and Development Update
SOUTH SAN FRANCISCO, CA - Novacea today announced that, as part of its effort to preserve its capital resources and to fully evaluate strategic alternatives, it has decided to scale back on its clinical development activities for AQ4N (banoxantrone), an investigational anti-cancer prodrug, including discontinuing the recently initiated clinical trial in acute lymphoblastic leukemia (ALL) and delaying the planned clinical trial in B-cell lymphoma. The company will continue enrollment in an ongoing Phase 1b/2a clinical trial of AQ4N in patients with glioblastoma multiforme (GBM), which continues to be a clinical development priority.
"Since we terminated the ASCENT-2 trial in advanced prostate cancer, managing our capital resources, which totaled approximately $110 million in cash and receivables at the end of the third quarter of 2007, is a top priority as we seek to maximize the strategic options available to the company," said John P. Walker, Novacea's chairman and chief executive officer. "We now project a cash burn rate totaling $17-19 million in 2008, which should be sufficient to support AQ4N development in GBM and our continued efforts with Schering-Plough surrounding Asentarâ„¢. In regards to the ALL study with AQ4N, we have informed clinical trial sites about our decision to halt the study due purely to business considerations. We appreciate all of the hard work the sites have put into this program and hope at some point in the future that we can re-initiate this study that was intended to expand the development of AQ4N into hematological malignancies."
AQ4N in Glioblastoma Multiforme Development Progress
The company has completed the first two cohorts of the Phase 1b/2a GBM study without any dose limiting toxicities (DLTs), dosing patients at 200 mg/m2 and 450mg/m2 of AQ4N once-weekly for six weeks in combination with a standard regimen of radiation therapy and temozolomide. Three subjects have been treated in the protocol-defined final dose cohort of 750mg/m2 without any DLTs to date. In accordance with the protocol, up to three additional subjects will be enrolled in this cohort during the first quarter of 2008. Assuming no DLTs are found in these additional subjects, 750 mg/m2 will be the dose taken forward in the Phase 2a portion of the study. The company currently anticipates that this phase 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 5 months of follow-up. At the 450 mg/m2 dose level, four of seven patients have not experienced disease progression after approximately three months of follow-up. The company plans to have safety and tolerability data for all cohorts and six-month progression-free survival data from the cohorts dosed at the 200mg/m2 and 450 mg/m2 levels during the first quarter of 2008.
In early November 2007, the company ended its ASCENT-2 Phase 3 clinical trial of Asentar for the treatment of patients with androgen-independent prostate cancer, due to an imbalance of deaths between the two treatment arms observed by the Data Safety Monitoring Board. Novacea and Schering-Plough continue to analyze the ASCENT-2 data and are currently auditing all clinical sites to ensure the accuracy of the data. The company plans to provide an update on the ASCENT-2 analyses later this year.
Novacea, Inc. is a biopharmaceutical company focused on in-licensing, developing and commercializing novel cancer therapies. Novacea has two product candidates, including Asentarâ„¢, 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.
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