Verastem Inc., recently entered into an agreement with Laboratory Corporation of America (LabCorp) to aid in the development of a new mesothelioma drug and a companion diagnostic. Mesothelioma lawyers are hopeful that the new drug, which is set to begin clinical trials in 2013, will curb the number of patients succumbing to this disease.
Verastem is a Massachusetts-based company that focuses on the discovery and development of drugs specifically targeting cancer stem cells. Verastem is partnering with LabCorp to validate biomarkers for the new drug, which is temporarily being referred to as VS-6063. The relationship is indicative of the importance and prominence of multi-modal, companion, personalized cancer treatments.
VS-6063 is a compound that inhibits cells growth. Specifically, the drug inhibits focal adhesion kinases (FAK), which are the cells responsible for cancer metastasis, or the spreading of cancer to other organs. The CEO of Verastem is adamant that FAK cells are technically cancer stem cells, not the politically controversial embryonic stem cells, which have been hotly debated in the U.S. in recent years. Cancer stem cells are rare, but have an indefinite potential for self-renewal and transformation.
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According to the Wall Street Journal, Doctor Robert Weinberg, a Verastem cofounder, is pioneering the VS-6063 research. Cancer stem cells initiate and spread tumors by signaling FAK, making it a critical pathway for the cancer cells. VS-6063 inhibits the FAK cells and targets and kills the cancer stem cells.
Recent research has shown that mesothelioma tumors lacking the tumor suppressing protein named Merlin appear to be particularly sensitive to FAK inhibitors like VS-6063. This is where the partnership with LabCorp comes in. Researchers estimate that nearly half of mesothelioma patients lack Merlin, and may be significantly more responsive to VS-6063 treatments. LabCorp was recruited to develop a test that will determine if Merlin is present in tumors. This Merlin research and development is intended to be a companion diagnostic for VS-6063.
In Phase 1 studies of VS-6063, the drug was well-tolerated and showed signs of clinical activity in advanced solid tumors. There will be numerous follow-up clinical trials in 2013, including tests specifically for mesothelioma patients. Details about these trials will be released in late spring. They are expected to take place at between 30 to 50 centers in metropolitan areas such as New York, Boston, San Francisco, and Chicago.
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Verastem is also in talks with several European regulatory agencies to gain clinical trial participation in international hospitals. The company is looking to recruit between 300 and 500 mesothelioma patients for the first trial. Ideal patients will have already completed a first-line therapy, such as chemotherapy or surgery, and had a partial or complete response. The recruited patients will then be divided into Merlin-positive and Merlin-negative groups, made possible by LabCorp’s testing development efforts.
A Phase I clinical study by GlaxoSmithKline used a drug similar to VS-6063 to treat mesothelioma patients. The study, which involved nearly 30 patients, found that those with Merlin-negative tumors had much longer median survival rates. In these Merlin-negative patients, the rate was 24 weeks; for Merlin-positive patients, the average progression-free survival rate was 11 weeks. This study offers Verastem substantial proof that FAK inhibitors and Merlin testing procedures are well-worth the investment.
Fortunately, Verastem’s work has attracted the attention of many mesothelioma advocates from around the world. There is currently only one FDA-approved mesothelioma drug on the U.S. markets, and the science surrounding this new drug provides much hope for more desperately-needed treatments. The drug may also benefit from orphan drug status designation, which speeds up the development and approval process for drugs intended for rare and fatal diseases. Verastem is hoping to fill the void of FDA-approved drug therapies for mesothelioma.
Mesothelioma is a cancer of which exposure to asbestos is the only known cause. If you or someone you love was exposed to asbestos and developed mesothelioma or any other asbestos-related illness, such as asbestosis or other lung cancers, you may be entitled to compensation. Contact an asbestos exposure attorney immediately for a free legal consultation.