WALTHAM, Mass. — Nov. 1, 2012 — TESARO, Inc. (Nasdaq: TSRO) announced today that the first clinical trial of its proprietary Anaplastic Lymphoma Kinase (ALK) inhibitor, TSR-011, has commenced with the dosing of the first patient at the Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, a partnership between Scottsdale Healthcare and the Translational Genomics Research Institute (TGen).
TSR-011 is an orally available ALK inhibitor (targeted anti-cancer agent) that will be studied in patients, including non-small cell lung cancer (NSCLC) patients, with ALK+ tumors. TESARO plans to expand the Phase 1/2 clinical trial of TSR-011 to multiple clinical trial sites in the U.S. and Europe.
"TSR-011 has the profile of a promising targeted anti-cancer agent and we are enthusiastic about the opportunity to investigate its potential in patients," said Dr. Glen Weiss, Director of Thoracic Oncology at the Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare and Clinical Associate Professor at TGen.
Following identification of the maximum tolerated dose of TSR-011 in patients with advanced cancer during the dose escalation phase of the trial, TESARO plans to evaluate TSR-011 in three parallel cohorts of patients in the phase 2 portion: those with ALK+ NSCLC who have not been previously treated with ALK inhibitors, those with NSCLC who have progressed during treatment with other ALK inhibitors, and those with other tumor types expressing ALK.
"We are very pleased to have progressed TSR-011 into a human clinical trial and look forward to identifying a dose that may be utilized in the expansion phase of the study which will assess both the safety and efficacy of the compound," said Mary Lynne Hedley, Ph.D., TESARO's President and Chief Scientific Officer. "ALK is a key driver of subsets of NSCLC, and may also contribute to the growth of neuroblastoma, lymphoma and other cancers. In order to maximize the commercial potential of TSR-011, we plan to study TSR-011 in multiple treatment and tumor settings."
About Anaplastic Lymphoma Kinase and Non-Small Cell Lung Cancer
ALK gene fusions that result in constitutive activation of ALK are associated with sub-sets of certain cancers including non-small cell lung cancer (NSCLC). Abnormal ALK proteins are also associated with sub-populations of other cancers including lymphoma and neuroblastoma. ALK is generally not expressed in normal adult tissue and therefore represents a promising molecular target for the development of a cancer therapeutic.
According to the American Cancer Society, over 1.6 million new lung cancer cases are identified worldwide annually, of which over 200,000 of these new lung cancer cases are in the United States. Lung cancer is the leading cause of cancer death in men and the second leading cause of cancer death in women. Lung cancer is typically divided into two groups based upon the histologic appearance of the tumor cells—small cell and non-small cell lung cancer, each of which is treated with distinct chemotherapeutic approaches. According to the American Cancer Society, NSCLC accounts for approximately 85% of lung cancer cases, with approximately 75% of these patients being diagnosed with metastatic or advanced disease. Despite the introduction of new therapies patients with locally advanced or metastatic NSCLC have five-year survival rates of just 24% and 4%, respectively, according to the Surveillance Epidemiology and End Results program of the National Cancer Institute. ALK is believed to be a key driver of tumor development in approximately 5% of all NSCLC patients.
About the Virginia G. Piper Cancer Center at Scottsdale Healthcare
The Virginia G. Piper Cancer Center at Scottsdale Healthcare opened in 2001 as the first major cancer center in greater Phoenix, offering comprehensive cancer care and research through Phase I clinical trials, diagnosis, treatment, prevention and support services in collaboration with leading researchers and community oncologists. The Scottsdale Healthcare cancer program holds Accreditation with Commendation from the Commission on Cancer of the American College of Surgeons. Scottsdale Healthcare is the nonprofit parent organization of the Virginia G. Piper Cancer Center at Scottsdale Healthcare, Scottsdale Healthcare Research Institute, Scottsdale Healthcare Osborn Medical Center, Scottsdale Healthcare Shea Medical Center and Scottsdale Healthcare Thompson Peak Hospital. For more information, visit www.shc.org.
Public Relations Coordinator
Virginia G. Piper Cancer Center
The Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. Research at TGen is focused on helping patients with diseases such as cancer, neurological disorders and diabetes. TGen is on the cutting edge of translational research where investigators are able to unravel the genetic components of common and complex diseases. Working with collaborators in the scientific and medical communities, TGen believes it can make a substantial contribution to the efficiency and effectiveness of the translational process. For more information, visit: www.tgen.org.
TGen Senior Science Writer
TESARO, Inc. is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward looking statements contained in this press release include, among others, statements regarding our expectations for expanding our Phase 1/2 clinical trial with TSR-011. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the initiation of future clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, development progress of our companion diagnostics, and other matters that could affect the availability or commercial potential of our drug candidates or companion diagnostics. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Prospectus filed with the Securities and Exchange Commission on June 29, 2012.
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