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New Jersey Mesothelioma Lawyers Report on U.S. Orphan Drug Designation for the Treatment of Mesothelioma in the United States

September 10, 2013– The Philadelphia mesothelioma attorneys at Shein Law are pleased and encouraged by the recent news that orphan drug designation has been granted to Verastem, Inc. by the U.S. Food and Drug Administration for the use of VS-6063 in the treatment of mesothelioma, a rare cancer caused by an exposure to asbestos.  This promising news should provide some hope to mesothelioma patients and their families, as Verastem’s innovative approach to treating this aggressive and fatal disease is different from the more traditional treatment methods.  With the poor prognosis for mesothelioma patients, it is critical that new drugs and treatments be investigated and developed in order to prolong and save the lives of the mesothelioma patients.

Additional Benefits for Companies Receiving Orphan Drug Designation

Verastem, Inc. is a Massachusetts based biopharmaceutical company that is dedicated to finding and developing drugs to treat cancer.  Their unique approach is to target and kill cancer stem cells.  Cancer stem cells are the fundamental source of tumor relapse and metastasis.  The company is dedicated to discovering drugs that have the ability to interfere with the signaling pathways that allow cancer stem cells to develop, mature and survive.  The company recently received orphan drug status for the investigational drug VS-6063 in Europe and now has been granted this designation in the United States by the U.S. Food and Drug Administration (FDA).

The FDA awards orphan drug designation to encourage companies to develop drugs that would clinically benefit patients suffering from less common diseases or illnesses, specifically rare conditions that affect less than 200,000 people in the United States.  When a company obtains an orphan drug designation from the FDA, they also gain some additional benefits.  This includes a seven-year marketing exclusivity period, assistance from the agency during the creation of the clinical trials, a waiver of application fees, and exemption from or reduction of other fees associated with pharmaceutical marketing.

VS-6063 Targets Cancer Stem Cells by Inhibiting a Critical Signaling Pathway

Many types of cancer tumors, including mesothelioma cells, depend on specific pathways that allow the cancer cells to thrive.  Verastem has been developing drugs that have the ability to interfere with these important signaling pathways.  Specifically, VS-6063, also known as defactinib, is an oral drug that is an inhibitor of the focal adhesion kinase (FAK) pathway thereby interrupting the critical component that allows the mesothelioma cancer to grow and metastasize.

Phase 1 clinical trials are currently underway using VS-6063 as a treatment for malignant pleural mesothelioma with the plans of initiating Phase 2 trials.  Verastem has also conducted trials using defactinib as a treatment for patients diagnosed with ovarian cancer and plans are ongoing for studies using the drug to treat non-small cell lung cancer.

New Jersey Mesothelioma Attorneys at the Shein Law:  Dedicated Legal Team Fighting for Mesothelioma Victims

If you or someone you love has been exposed to asbestos and developed mesothelioma, lung cancer or any other asbestos-related illness, we encourage you to call Shein Law with offices in Philadelphia, Pennsylvania and Pennsauken, New Jersey.  You can count on our experienced mesothelioma lawyers to provide you with superior legal representation and protect your rights. We will aggressively advocate on your behalf so that you receive the maximum compensation for your medical bills, lost wages, pain and suffering, or the wrongful death of your loved one.  We have been successfully representing victims of mesothelioma in the Philadelphia region for almost 40 years.  We will come to you at a location that is most convenient for you and your family.  Call Shein Law today at 1-877-SHEINLAW (743-4652) to schedule a free consultation or fill out our online contact form.

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