SRI International to Advance Clinical Development of TAS-108, a Late-Stage Breast Cancer Drug

MENLO PARK, Calif., Aug. 19 /PRNewswire/ -- SRI International, an independent nonprofit research and development organization, announced today that it has assumed responsibility for further clinical development of the TAS-108 breast cancer program, in cooperation with Taiho Pharmaceuticals Co., Ltd., a leading Japanese pharmaceutical company. Further clinical development will focus on the lead compound's registration for the treatment of tamoxifen and aromatase inhibitor-resistant breast cancers.

Commercial partners interested in advancing this late stage drug through Phase III clinical development, regulatory approvals including Orphan Drug indications, and global commercialization outside of Japan are welcome to contact SRI.

SRI and Taiho have had a long-term collaboration on the discovery, development, and evaluation of novel endocrine approaches for the treatment of tamoxifen-resistant breast cancers, an area of significant unmet medical need.  Together, they made significant progress in successfully advancing the lead compound, TAS-108, a novel breast cancer drug, through Phase II clinical development at multiple sites around the world.

TAS-108 is an oral steroidal anti-estrogen drug that was designed to have both efficacy and safety advantages over tamoxifen (TAM) and aromatase inhibitors (AIs) in the treatment of advanced or metastatic breast cancers. To date, TAS-108, administered as an oral, once-a-day tablet, has completed a series of five Phase I studies (n=67) and two Phase II studies (n=242). The key benefits demonstrated in these studies include:

• Significant clinical anti-tumor efficacy in patients who have failed treatment with tamoxifen and/or AI therapy.
• No reduction in bone mineral density, a side effect seen with AIs.
• No endometrial thickening, a side effect seen with TAM.
• An excellent overall safety profile, demonstrated in hundreds of patients.

About SRI's Center for Cancer Research

SRI's Center for Cancer Research, comprised of biologists and medicinal chemists with expertise in fundamental and applied cancer research, focuses on the study of the tumor microenvironment, tumor metabolism, and aberrant signaling pathways that cause cancer.  Through collaborative partnerships, SRI's Center for Cancer Research has been successful in generating an extensive drug pipeline by translating discoveries into beneficial treatments. TAS-108 is one of several SRI-discovered cancer drugs to have emerged from these translational research efforts.

About SRI's Biosciences Division

SRI's Biosciences division carries out basic research, drug discovery, and drug development, and provides contract (CRO) services. SRI has all of the resources necessary to take R&D from "Idea to IND"®—from initial discovery to the start of human clinical trials—and specializes in cancer, immunology and inflammation, infectious disease, and neuroscience. SRI's product pipeline has yielded marketed drugs, therapeutics currently in clinical trials, and additional programs in earlier stages. In its CRO business, SRI has helped government and commercial clients and partners advance many drugs into patient testing. SRI is also working to create the next generation of technologies in areas such as diagnostics, drug delivery, medical devices, and systems biology.

About SRI International

Silicon Valley-based SRI International is one of the world's leading independent research and technology development organizations. SRI, which was founded by Stanford University as Stanford Research Institute in 1946 and became independent in 1970, has been meeting the strategic needs of clients and partners for more than 60 years. Perhaps best known for its invention of the computer mouse and interactive computing, SRI has also been responsible for major advances in networking and communications, robotics, drug discovery and development, advanced materials, atmospheric research, education research, economic development, national security, and more. The nonprofit institute performs sponsored research and development for government agencies, businesses, and foundations. SRI also licenses its technologies, forms strategic alliances, and creates spin-off companies. In 2009, SRI's consolidated revenues, including its wholly owned for-profit subsidiary, , were approximately $470 million.

SOURCE SRI International

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