ONCOGENEX BEGINS FIRST OF 4 PHASE 2 CLINICAL 0GX-011 TRIALS.OncoGenex Technologies Inc., Vancouver, has initiated a Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. of OGX-011 in newly diagnosed, previously untreated patients with clinically localized, high-risk prostate carcinoma. OGX-011 is a second-generation antisense antisense, DNA or RNA manipulated in a laboratory so that its components (nucleotides) form a complementary copy of normal, or "sense," messenger RNA (mRNA; see nucleic acid). drug designed to specifically inhibit the production of clusterin, a cell-survival protein that is up-regulated in response to standard anti-cancer treatments. This clinical trial, funded in part by a grant from the U.S. Department of Defense and the first of four Phase 2 studies planned for OGX- 011 in 2005, is designed to assess the safety and efficacy of OGX-011 in prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. patients receiving neoadjuvant hormone therapy Hormone therapy Treating cancers by changing the hormone balance of the body, instead of by using cell-killing drugs. Mentioned in: Breast Cancer, Thyroid Cancer hormone therapy . OncoGenex is developing OGX-011 in collaboration with Isis Pharmaceuticals Ltd. This single-center, open label Phase 2 study will enroll up to 45 newly diagnosed, previously untreated patients. Patients will receive 2-hour intravenous infusions of 640 mg OGX-011 weekly plus concomitant hormone ablation therapy ablation therapy See Ablation–cardiology. for 12 weeks prior to radical prostatectomy Radical prostatectomy Surgical removal of the entire prostate, a common method of treating prostate cancer. Mentioned in: Prostate Cancer radical prostatectomy . Increased clusterin expression protects prostate cancer cells from the cytotoxic effects of hormone ablation and chemotherapy and elevated levels of clusterin are associated with hormone resistance and metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases 1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to . "Our recently completed Phase 1 study demonstrated that OGX-011 prevents increases in clusterin expression induced by hormone ablation therapy," said Dr. Martin Gleave, chief scientific officer of OncoGenex and Professor of Surgery at the University of British Columbia Locations Vancouver The Vancouver campus is located at Point Grey, a twenty-minute drive from downtown Vancouver. It is near several beaches and has views of the North Shore mountains. The 7. . "In those studies, a once-weekly 640 mg dose of OGX-011 produced a 90 percent down- regulation of clusterin expression in patient's tumors." The primary objective of this Phase 2 study is to assess the combined effects of OGX-011 and neoadjuvant hormone therapy on pathologic response rates (elimination of all tumor cells) and suppression of clusterin levels in men with high risk localized prostate cancer. "We are pleased to advance the development of OGX-011 with the start of our first Phase 2 trial," stated Scott Cormack, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of OncoGenex. "This study will provide data on the ability of OGX-011 to enhance the activity of hormone ablation therapy in prostate cancer. The rapid movement of OGX-011 from discovery to Phase 2 development in only five years is proof of our ability to achieve our stated goals and our commitment to building value for our shareholders." "This collaboration provides an opportunity to assess the potential ability of OGX-011 to improve outcomes in patients with cancer," said Dr. Kim N. Chi, Medical Oncologist medical oncologist Oncology An oncologist who diagnoses and treats cancer with chemotherapy, hormones, biologicals, or immunologic agents; the MO becomes a cancer Pt's de facto primary care giver, and coordinates treatment provided by other specialists. at the Vancouver Prostate Center and the BC Cancer Agency, and the Principal Investigator for the study. "This study is an excellent example of industry and academia working together to try and make a real difference in the lives of prostate cancer patients." Preliminary results from three Phase 1 clinical trials show that OGX-011 is well tolerated, achieves excellent drug concentrations in prostate tissue, and produces a 91 percent dose-dependent down-regulation of clusterin in prostate cancer cells removed from prostate cancer patients. Additional Phase 2 clinical trials in breast, prostate and lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. will begin later this year. The OncoGenex and Isis partnership combines OncoGenex' proprietary antisense position in inhibitors to the target, clusterin, with Isis' proprietary second-generation antisense chemistry called 2'-O-methoxyethyl. Second-generation antisense drugs offer greater potency, enhanced tolerability, and improved dosing convenience compared to first-generation antisense drugs. About OGX-011 OGX-011 is a targeted therapeutic that sensitizes resistant tumors to conventional cancer therapeutics, such as chemotherapy, hormone ablation therapy and radiation therapy. OGX-011 targets the protein clusterin, which is highly expressed in many cancers including prostate, lung and breast cancer. Clusterin is a cell survival protein that is increased in cancer cells in response to standard anti-cancer treatments. Clusterin prevents cancer cell death and undermines the effectiveness of standard anti-tumor therapies. Additional Phase 2 trials of OGX-011 in combination with standard chemotherapy will begin in 2005 in patients with prostate, breast and non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. . About Prostate Cancer More than one million men in the United States have prostate cancer, with an estimated 232,000 new cases of prostate cancer diagnosed each year. Prostate cancer is the second-leading cause of cancer-related deaths in men as more than 30,000 men die each year of the disease. There is an unmet need for a therapeutic drug that can prevent or delay progression to the aggressive androgen-independent stage of advanced prostate cancer. It is this form of the disease that is resistant to current therapeutic intervention and is responsible for patient death. About OncoGenex Technologies OncoGenex Technologies Inc. (OncoGenex) is a clinical-stage biotechnology company dedicated to improving survival and quality of life of cancer patients by developing targeted therapeutics for treatment-resistant and metastatic cancer Metastatic cancer A cancer that has spread to an organ or tissue from a primary cancer located elsewhere in the body. Mentioned in: Liver Cancer metastatic cancer . The company's lead drug candidate, OGX-011, is commencing Phase 2 studies in prostate, breast and lung cancer this year. OGX-427 is in preclinical development and is expected to enter clinical investigation in 2006. OncoGenex' ability to advance drugs quickly and efficiently results from its ability to unite groups with a common interest in treating cancer: universities, hospitals, clinical networks, companies, granting agencies and investors. This efficient business model has enabled OncoGenex to add six products to its development program since 2001. For more information about OncoGenex is available at http://www.oncogenex.ca. About Isis Pharmaceuticals Isis Pharmaceuticals, Inc. is exploiting its expertise in RNA RNA: see nucleic acid. RNA in full ribonucleic acid One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic to discover and develop novel drugs for its product pipeline and for its partners. The company has successfully commercialized the world's first antisense drug and has 11 antisense drugs in development to treat metabolic, cardiovascular and inflammatory diseases, and cancer. In its Ibis ibis (ī`bĭs), common name for wading birds with long, slender, decurved bills, found in the warmer regions of both hemispheres. The body is usually about 2 ft (61 cm) long. Most ibises nest in colonies. division, Isis is developing and commercializing the TIGER biosensor A device that detects and analyzes body movement, temperature or fluids and turns it into an electronic signal. See lab on a chip and data glove. Biosensor system, a system that has the potential to revolutionize the identification of infectious organisms. As an innovator in RNA-based drug discovery and development, Isis is the owner or exclusive licensee of more than 1,500 issued patents worldwide. Additional information about Isis is available at http://www.isispharm.com. |
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