As part of its effort to preserve capital resources and fully evaluate strategic alternatives, Novacea Inc. has decided to scale back on its clinical development activities for AQ4N (banoxantrone), an investigational anti-cancer prodrug.
The company is also planning to discontinue the recently initiated clinical trial in acute lymphoblastic leukaemia (ALL) and delaying the planned clinical trial in B-cell lymphoma.
The company will continue enrolment in an ongoing phase Ib/IIa 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, chairman and chief executive officer, Novacea. "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 Asentar.
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 haematological malignancies."
The company has completed the first two cohorts of the phase Ib/IIa 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 IIa 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 Ib 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 III 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 commercialising novel cancer therapies. Novacea has two product candidates, including Asentar and AQ4N