Telik Announces Initiation of Third Phase 2 Clinical Trial With TLK286; Non-Small Cell Lung Cancer Trial Underway at Three Leading Cancer Centers.Business Editors and Health/Medical Writers SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif.--(BW HealthWire)--June 28, 2001 Telik, Inc. (Nasdaq:TELK) today announced that a Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. has begun with its TLK TLK The Lion King TLK Thomas Liard Kennedy (Secondary School, Mississauga, Ontario, Canada) TLK Total Left Knee (replacement surgery) 286 product candidate for the treatment of advanced 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. . This trial follows the initiation of Phase 2 trials in colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. in March 2001 and ovarian cancer in May 2001. The Phase 2 non-small cell lung cancer trial is initially being conducted at the University of Arizona (body, education) University of Arizona - The University was founded in 1885 as a Land Grant institution with a three-fold mission of teaching, research and public service. Cancer Center under the direction of Linda Garland, M.D., the University of Texas M.D. Anderson Cancer Center under the direction of Vassiliki A. Papadamitrakopoulou, M.D., and the University of California, Los Angeles UCLA comprises the College of Letters and Science (the primary undergraduate college), seven professional schools, and five professional Health Science schools. Since 2001, UCLA has enrolled over 33,000 total students, and that number is steadily rising. under the direction of Robert A. Figlin, M.D. The trial is a multicenter, single arm, open label study in patients who have tumor progression following treatment with platinum-containing chemotherapy regimens. In this trial, the primary objective is to determine the percentage of patients surviving at twelve months and further evaluate safety, objective response rate, time to tumor progression, and overall survival. The patients will receive TLK286 once every three weeks until disease progression. "The highest priority at Telik is the advancement of the TLK286 Phase 2 program," said Michael M. Wick, M.D., Ph.D., Chairman 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. . "We have initiated three multicenter Phase 2 trials at leading cancer centers which include M.D. Anderson, Memorial Sloan- Kettering, Arizona Cancer Center, and UCLA UCLA University of California at Los Angeles UCLA University Center for Learning Assistance (Illinois State University) UCLA University of Carrollton, TX and Lower Addison, TX Jonsson Comprehensive Cancer Center. We are on track to initiate trials at other major institutions in the coming months. We believe our success in initiating these studies is due in part to the tolerability and clinical benefits seen to date with TLK286 and to the critical need for new approaches for the treatment of refractory cancers." "The clinical trial program at the University of Arizona Cancer Center also complements our ongoing research collaboration with Dr. Daniel Von Hoff and colleagues," said Dr. Wick. "Through this previously announced collaboration, the Arizona Cancer Center is conducting biologic assays to screen TRAP-generated compounds for pharmaceutical activity against cancer-related drug targets. Telik will have exclusive worldwide rights to develop and commercialize selected compounds arising from the collaboration." In May 2001, Telik presented results from the Phase 1 trial of TLK286 at the annual meeting of the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. . The results included more than 50 patients who had been treated on two dosing schedules. According to the American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, , lung cancer is the second most common cancer in the United States, and the most frequent cause of cancer mortality with approximately 169,500 new cases diagnosed in the U.S. in 2001. Approximately 321,400 people in the U.S. are living with a diagnosis of lung cancer, according to National Cancer Institute prevalence statistics. TLK286 is a small molecule drug candidate that was developed through the application of Telik's proprietary TRAP chemogenomics technology. TLK286 has a novel mechanism of activation that targets tumors that over-express GST GST abbr. Greenwich sidereal time GST (in Australia, New Zealand, and Canada) Goods and Services Tax P1-1, a protein that plays an important role in the development of resistance to commonly used chemotherapeutic drugs. Its mechanism of activation in tumor cells suggests a potentially safer, more effective, and directed cancer drug against resistant cancers. Telik, Inc. of South San Francisco, California South San Francisco is a city in San Mateo County, California, United States, located on the San Francisco Peninsula in the San Francisco Bay Area. The population was 60,552 at the 2000 census. , is a biopharmaceutical company working to discover, develop, and commercialize small molecule drugs to treat serious diseases for which there is significant demand for new therapies. The company's most advanced drug development programs include: TLK286, a tumor-activated drug candidate for the treatment of major cancers that are resistant to standard treatments, currently in Phase 2 studies in colorectal and ovarian cancer; TLK199, a candidate for the treatment of low white blood cell levels that occur as a toxic side effect of cancer therapy as well as in other blood diseases such as myelodysplastic syndrome, a pre-leukemic condition; and a family of orally active insulin receptor activators for Type 2 diabetes type 2 diabetes n. See diabetes mellitus. . Telik's product candidates were discovered using its proprietary technology, TRAP, which enables the rapid and efficient discovery of small molecule drug candidates. Additional information is available at www.telik.com. You should not rely on forward-looking statements contained in this press release including, but not limited to, statements regarding the safety and biologic activity of TLK286, its potential in the treatment of one or more forms of cancer, Telik's anticipated timing for the initiation of additional Phase 2 trials, anticipated additional locations for these trials or Telik's future product pipeline. Telik can give no assurance with regard to these statements. The results of Phase 1 trials in a limited number of patients at a single treatment center may not be indicative of results that may be observed in larger clinical trials, including randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , controlled multicenter trials. TLK286 may prove safe and effective in only certain tumor types, if any. Telik may be unable to obtain the necessary institutional approvals to proceed with additional Phase 2 trials in a timely manner, if at all, and Telik is solely dependent upon a single manufacturer of clinical grade material at this point. All of our product candidates are in the early stages of development, and the potential benefits of each product must still be proven. More detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found under the caption "Certain Business Risks" in Telik's report on Form 10-K for the year ended December 31, 2000 and report Form 10-Q for the quarter ended March 31, 2001 filed with the Securities and Exchange Commission. Telik assumes no obligation to update any information in this press release. |
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