SOURCE: Novacea

October 30, 2006 09:00 ET

Novacea's Phase 1 Data of Asentar Published in the Journal of Cancer Chemotherapy and Pharmacology

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- October 30, 2006 -- Novacea, Inc. (NASDAQ: NOVC) today announced that the on-line version of the Journal of Cancer Chemotherapy and Pharmacology (http://dx.doi.org/10.1007/s00280-006-0299-1) has published data from a Phase 1 study of the company's lead investigational cancer therapy, Asentar™ (DN-101). The study was conducted at Oregon Health and Science University and Roswell Park Cancer Institute under the leadership of Dr. Tomasz Beer and Dr. Donald Trump. The publication, entitled "Phase 1 study of weekly DN-101, a new formulation of calcitriol, in patients with cancer," reports that Asentar was safe and well tolerated during weekly administration. Asentar is a new, high-dose oral formulation of calcitriol, the most potent natural metabolite of vitamin D, presently being investigated in Novacea's ASCENT-2 Phase 3 clinical study as a potential treatment for men with advanced prostate cancer.

"The use of calcitriol as a treatment for cancer has been considered by many for over 20 years, however, previous clinical studies evaluating daily administration of low doses were essentially all limited by the development of life-threatening hypercalcemia, an excessive amount of calcium in the blood," said John G. Curd, M.D., president and chief medical officer at Novacea. "With Asentar, we believe that dose intense administration of calcitriol can be safely achieved in cancer patients."

"Novacea is presently investigating Asentar in combination with Taxotere® (docetaxel) in men with advanced prostate cancer to determine if this combination can improve patient survival as well as the safety profile of docetaxel," added Dr. Curd.

Thirty-seven patients who completed a previously reported single dose escalation study of Asentar were eligible for the Phase 1 study, which was a continuation weekly dosing study. Patients were treated at doses ranging from 15 to 75 µg oral calcitriol weekly with a maximum tolerated dose established at 45 µg. Dose limiting toxicity (DLT) was defined as grade 2 or greater hypercalcemia or grade 3 or greater persistent treatment-related toxicities. Two of six patients treated with 60 µg of Asentar experienced rapidly reversible grade 2 hypercalcemia. Patients who received Asentar weekly at 45 µg did not experience DLT during exposure for more than 12 months of treatment. The most frequent adverse events were fatigue (27%), grade 1 or grade 2 hypercalcemia (19%) and grade 1 nausea (16%).

An exploratory comparison of pharmacokinetics after repeat dosing was comparable to those for the initial dose in four patients, and there was no indication of accumulation or drug-induced metabolism. The study concludes that repeat doses of Asentar at 45 µg weekly are well tolerated and is suitable for studies of weekly Asentar in cancer patients.

About Novacea

Novacea, Inc. is a biopharmaceutical company focused on in-licensing, developing and commercializing novel cancer therapies. Novacea has three 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, oral vinorelbine, is expected to enter a registration trial for metastatic breast cancer in the second half of 2006. Novacea's third product candidate, AQ4N, is expected to advance into a Phase 1/2 clinical trial in the second half of 2006 for glioblastoma multiforme in combination with radiation and chemotherapy.

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