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New Data Presented at ASCO Continue to Support Clinical Development of Novacea's Investigational Products

Posted on: Monday, 5 June 2006, 06:00 CDT

Novacea, Inc. (NASDAQ: NOVC) announced today that two of its product candidates, DN-101 and AQ4N, were featured in several oral and poster presentations at the 2006 American Society of Clinical Oncology (ASCO) Annual Meeting held June 2-6 in Atlanta.

"As a result of our active clinical programs, Novacea has a very strong presence at this year's annual ASCO meeting with key data being presented on two of our product candidates," said Brad Goodwin, Chief Executive Officer of Novacea. "These data clearly strengthen and broaden the scientific evidence that form the basis of our development programs for DN-101 and AQ4N. DN-101 is currently being investigated in Novacea's ASCENT-2 Phase 3 clinical trial in androgen-independent prostate cancer (AIPC) and AQ4N is scheduled to begin a Phase 1/2 study for aggressive brain tumors in the second half of this year."

The following presentations were highlighted on Sunday, June 4, 2006: Oral Presentations:

 1.  "Reduced thromboembolic events with DN-101 treatment of androgen-     independent prostate cancer: Hypothesis for a new class of     anticoagulants" (Abstract #4505) demonstrated that AIPC patients who     were treated with DN-101 in combination with Taxotere(R) (docetaxel)     experienced reduced thromboembolic complications as compared to     chemotherapy patients who received placebo. These findings will be     further explored in the ASCENT-2 Phase 3 trial that is currently     underway. 2.  "Intermittent chemotherapy in metastatic androgen-independent     prostate cancer (AIPC): Initial results from ASCENT" (Abstract #4518)     demonstrated that advanced prostate cancer patients can be treated     successfully when they stop their chemotherapy treatment for several     weeks and resume treatment with the same chemotherapy, an     investigational protocol known as intermittent chemotherapy or     chemotherapy holidays. 

Poster Presentations:

 1.  "Skeletal related events (SREs) in metastatic androgen-independent     prostate cancer (AIPC) treated with docetaxel-based chemotherapy:     results from ASCENT" (Abstract #4614) demonstrated trends that support     the addition of DN-101 to a treatment regimen of Taxotere(R)     (docetaxel) in reducing SREs (e.g., bone fractures, spinal cord     compression, surgery or radiation to the bone), which are significant     causes of morbidity in patients with AIPC. Novacea is seeking to     confirm this observation as a secondary endpoint in its ASCENT-2     Phase 3 clinical trial. 2.  "Banoxantrone (AQ4N), tissue CYP 450 targeted prodrug: The results of a     phase I study using an accelerated dose escalation." (Abstract #2011)     demonstrated that AQ4N was well-tolerated and safe, and supported     further clinical investigation involving AQ4N in combination with     chemotherapy and radiation therapy using the dosage schedule determined     by this study. 

About DN-101

DN-101 is a proprietary, high-dose formulation of calcitriol, the most biologically active form of vitamin D, and is being developed as an oral treatment in combination with Taxotere for AIPC. AIPC is an advanced state of cancer that is invariably fatal. As of 2004, a significant percentage of AIPC patients received Taxotere treatment, which is expected to increase as Taxotere treatment is now the FDA approved standard-of-care for first line AIPC patients.

The data from Novacea's ASCENT Phase 2/3 clinical trial demonstrated that use of weekly DN-101 in combination with weekly Taxotere has the potential to prolong the survival of AIPC patients while mitigating some of the toxicities and complications normally associated with chemotherapy and the morbidity of the underlying disease. To confirm these results, Novacea has initiated a Phase 3 clinical trial, known as ASCENT-2, which will consist of approximately 900 patients and is designed to confirm survival and other benefits observed in the ASCENT Phase 2/3 trial. The ASCENT-2 clinical trial compares weekly DN-101 plus Taxotere against the current Taxotere standard of care used for the treatment of AIPC and will be conducted in over 150 sites in the United States, Canada, and Europe.

About AQ4N

Novacea expects to launch a Phase 1/2 trial of AQ4N in patients with an aggressive type of brain tumor, glioblastoma multiforme, in the second half of 2006. AQ4N is a first-in-class tissue-targeted prodrug of AQ4, a potent topoisomerase II inhibitor that works within oxygen-starved, hypoxic tumor cells. It is widely accepted that hypoxic fractions of tumors are less responsive to radiotherapy and chemotherapy. Data collected to date indicate that AQ4N is selectively converted to AQ4, its cytotoxic form, in hypoxic tumor cells where it remains localized. We believe that when the surrounding oxygenated cells are killed by radiotherapy or chemotherapy, the AQ4-containing cells become reoxygenated. When these previously quiescent cells resume replication, we believe they are killed by AQ4's potent action as an inhibitor of topoisomerase II.

About Novacea, Inc.

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 DN-101, which currently is in a Phase 3 clinical trial for androgen-independent prostate cancer, or AIPC. Novacea's second drug 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.

Note: 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; commercialization of products; 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 Registration Statement on Form S-1, as amended, and 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.

 Media and Advocacy Contact:  Paul Laland 650.201.2688 (mobile during ASCO) 650.228.1811 (office)  Investor Contact: Nina Ferrari 415.264.8796 (mobile during ASCO) 650.228.1804 (office)  

SOURCE: Novacea

Source: MARKET WIRE

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