OHSU and Novacea Announce Patent for Unique Formulation and Use of Vitamin D for Cancer Treatment

03/18/03    Portland, Ore. and South San Francisco, CALIF.

Oregon Health & Science University (OHSU) and Novacea, Inc., a privately held biopharmaceutical company, announced today that OHSU has been issued U.S. Patent No. 6,521,608 for "Vitamin D and its analogs in the treatment of tumors and other hyperproliferative disorders."

Novacea is utilizing the technology supporting this patent to develop DN-101 for the treatment of various types of cancer. DN-101 is a newly formulated pill that contains high amounts of calcitriol, a naturally occurring hormone and the biologically active form of vitamin D. Novacea has the exclusive worldwide rights to OHSU's technology for high-dose pulse administration of calcitriol and its analogs.

Both Tomasz M. Beer, M.D., and W. David Henner, M.D., the inventors listed on the patent, have been involved with the development of calcitriol for methods covered by the patent. Beer, an investigator in the OHSU Cancer Institute, led the development of the Phase 2/3 ASCENT (AIPC Study of Calcitriol Enhancing Taxotere) study currently ongoing at 60 medical centers across the United States and Canada, including the OHSU Cancer Institute. Henner, formerly an OHSU faculty member, recently joined Novacea as vice president, oncology, to play a key role in the development of DN-101.

"We are pleased that the U.S. Patent Office has recognized that the regimen of calcitriol pioneered at OHSU that Novacea is using to develop DN-101 merits such broad patent protection," said Beer. "Our goal now is to move forward in developing DN-101 into a useful new treatment for cancer patients."

To help facilitate development of DN-101 into a commercial product for the treatment of various cancers, Novacea completed a financing round late last year. "Capital can be hard to come by in this economic climate," said Todd Sherer, Ph.D., director of Technology and Research Collaborations at OHSU. "The fact that Novacea's most recent round of funding was oversubscribed when many companies aren't being funded at all really speaks to the credibility of this business opportunity."

About DN-101

DN-101 is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA). It is a newly formulated pill taken orally that contains high amounts of calcitriol, a naturally occurring hormone and the biologically active form of vitamin D. DN-101 results in much higher blood levels of calcitriol than the body can produce from dietary vitamin D or vitamin D supplements. Novacea intends to study DN-101 in multiple cancers as a monotherapy and in combination with several chemotherapeutic agents. Novacea is currently collaborating with Aventis to conduct the Phase 2/3 ASCENT trial. ASCENT is evaluating the use of DN-101 in combination with Taxotere(R) (docetaxel) for the potential treatment of androgen-independent prostate cancer (AIPC), a form of advanced prostate cancer. Novacea is also conducting a Phase 2 trial of DN-101 for the potential treatment of patients with a blood cancer disorder called myelodysplastic syndrome (MDS). Other supportive trials are also ongoing.

About Novacea

Novacea is a privately held biopharmaceutical company committed to creating a world-class drug development and commercialization organization that addresses significant unmet medical needs in oncology and hematology. The company's first product to enter the clinic is DN-101, a novel formulation of calcitriol designed specifically for the treatment of cancer. For more information about the company and its programs, visit its World Wide Web site at www.novacea.com

About Oregon Health & Science University

Oregon Health & Science University is a health and research university focused on improving the well-being of people in Oregon and beyond. OHSU educates health practitioners, bioscientists, high-technology professionals, and environmental scientists and engineers, and it undertakes the indispensable functions of patient care, community service and biomedical research.

The OHSU Office of Technology and Research Collaborations supports OHSU through the management of new discovery. This support includes managing commercial applications as well as the management of corporate, nonclinical research agreements leading to new discovery.

Specifics:
Tomasz Beer, M.D., is an assistant professor of medicine (hematology and medical oncology) in the OHSU School of Medicine and a member of the OHSU Cancer Institute.

William David Henner, M.D., Ph.D., formerly was a professor of medicine and pharmacology in the OHSU School of Medicine and formerly was a member of the OHSU Cancer Institute.

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