The Addario Lung Cancer Medical Institute and Biocept Announce Collaboration and Initiation of Landmark ALCMI-009 Liquid Biopsy Clinical Trial in Lung Cancer
Lung cancer is the leading cause of cancer-related deaths worldwide. New therapies are available and others are in development to provide improved treatment options by targeting specific lung cancer biomarkers. Identifying these biomarkers using tissue biopsy can be challenging for many reasons, including the difficulty in performing a biopsy due to tumor location, limited tumor material due to small biopsy sizes, tumor heterogeneity both within the tumor material and between multiple metastatic sites, and risk of complications. All of these reasons, in addition to the relatively high cost of tumor biopsy, have increased the interest in obtaining molecular information from a simple blood sample.
"We are pleased to join forces with major research institutions and cutting-edge molecular diagnostics companies such as
The large prospective clinical trial, entitled "ALCMI-009: Evaluation of Liquid Biopsies in Localized and Advanced Lung Cancer Patients," will enroll 400 patients with advanced non-small cell lung cancer (NSCLC). Patients will have 4-6 blood samples drawn over the 12-month study duration period, for a cumulative total of 1,600 to 2,400 liquid biopsy data points. Blood samples will be shipped directly to
- illustrate drug response
- predict treatment failure prior to progression observed using radiographic imaging; and
- identify resistance mechanisms (e.g. EGFR T790M)
Due to different goals for the different histologies and stages of lung cancer, the trial plans to distinguish between advanced NSCLC patients with squamous cell and non-squamous cell carcinoma, and plans to evaluate the clinical utility of liquid biopsy in additional patients with early-stage NSCLC (stages I-III) as well as small cell lung cancer (SCLC). Collected data from this study will be centralized in a first-of-its-kind, large-scale database that will include uniform and complete patient demographic, pathology and clinical information. Principal investigators for the study are
"We have targeted several highly important objectives for this trial that could have a profound impact on the treatment of patients with lung cancer," said
About ALCMI
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Forward-Looking Statements Disclaimer Statement
This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as to our ability to improve the outcomes of cancer patients, the success of the ALCMI-009:
Evaluation of Liquid Biopsies in Localized and Advanced Lung Cancer Patients clinical trial and its ability to meet its objectives, our ability to further validate our liquid biopsy technology and our ability to increase the clinical adoption of our testing services, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our
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