TESARO Announces Clearance Of Investigational New Drug Application For TSR-011

WALTHAM, Mass., Oct. 2, 2012 (GLOBE NEWSWIRE) -- TESARO, Inc. (Nasdaq:TSRO) announced today that the Investigational New Drug (IND) application for TSR-011, an orally available ALK inhibitor (targeted anti-cancer agent) has become effective. The Company plans to dose the first patient in a Phase 1/2 clinical study within the next few months. 

Following identification of the maximum tolerated dose of TSR-011 in the dose escalation phase of the Phase 1/2 study, TESARO plans to evaluate TSR-011 in three parallel cohorts of patients: those with ALK+ non-small cell lung cancer (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 pleased with the progress of the TSR-011 development program and we look forward to dosing the first patient within the next few months," said Mary Lynne Hedley, Ph.D., President and Chief Scientific Officer.  "ALK is a key driver of subsets of NSCLC, and may also contribute to the growth of neuroblastoma and lymphoma. 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. 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.

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