Mesothelioma lawyers at Pintas & Mullins Law Firm report that Verastem, during its most recent Research and Development Day, announced that its new drug to treat mesothelioma will be ready to begin clinical trials by the third quarter of 2013.
Members of Verastem’s leadership team gave an overview of the new development program in New York City in early July, including guest speakers such as members of the Verastem Mesothelioma Steering Committee.
Dr. Jose Baselga outlined Verastem’s commitment to pioneering a comprehensive approach to cancer, combining inhibitors of cancer stem cells and chemotherapy to improve response rates in patients. Verastem’s mail compound, which we have written extensively about, is known as VS-6063. It is an oral treatment targeting cancer stem cells through the inhibition of Focal Adhesion Kinase (FAK).
The FAK pathway is critical to cancer development, survival and proliferation. Verastem recently completed Phase I of a study on VS-6063 in combination with chemotherapy drug paclitaxel in patients with ovarian cancer. One of the presenting physicians noted that the combination treatment was tolerated well in patients and a significant decrease in an ovarian cancer biomarker was observed. One patient even showed complete response to the treatment as her biomarkers returned to normal levels.
The mesothelioma trials will be international and focus on malignant pleural mesothelioma, which is the most common type and affects the tissue surrounding the lungs. Mesothelioma has a high percentage of cancer stem cells, making it a prime candidate for VS-6063 trials.
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The clinical trials are designed as adaptive, double-blind, placebo-controlled trials, targeting the biomarker called merlin. This biomarker is present in about half of all mesothelioma patients. Low levels of merlin enhance the effects of inhibiting FAK, so Verastem designed the trail to determine the effect of VS-6063 in both the general patient base and the subgroup with low merlin levels.
The main objectives of the trials are to determine the exact rates of progression-free survival and overall survival with VS-6063 in hopes of obtaining accelerated FDA approval. The study is expected to enroll about 350-400 patients in 11 different countries, including the U.S., Australia, Canada, South Africa, and the U.K. As stated, Verastem expects to begin a Phase I trial in the third quarter of 2013, which began on July 1 and ends on September 30, 2013.
The company hopes to extend its findings on mesothelioma and ovarian cancer patients to those with other cancers as well. One such effort, another clinical trial in those with non-small cell lung cancer (which can also be caused by exposure to asbestos), will soon begin its second Phase.
Exposure to chemicals such as radon, chromium, nickel, arsenic, soot or tar are also risk factors for non-small cell lung cancer. The VS-6063 clinical trial involves patients with a mutated KRAS gene, which is about 50% of patients. KRAS-mutated lung cancer, in conjunction with a second mutation in one of two other genes, has shown to be particularly sensitive to FAK inhibition. The clinical trial will have four separate arms to evaluate the effect of VS-6063 in different combinations of these genetic mutations.
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The current treatment for mesothelioma, Almita, along with various common chemotherapy drugs, all lack the ability to kill cancer stem cells, and therefore do little to actually stop or slow disease progression. This has contributed to the extraordinarily fatal nature of the disease – mesothelioma patients typically do not live longer than one year after their initial diagnosis.
This is why clinical trials such as Verastem’s are so critical in patient treatment and hope of recovery. It takes an astronomical amount of time and money to get new cancer drugs to market, so studies and clinical trials are often the only modes to improve treatment.
Mesothelioma attorneys at Pintas & Mullins Law Firm will continue to report on all developments related to VS-6063 and its studies. If you or a loved one was exposed to asbestos or any other carcinogen and developed mesothelioma or lung cancer, you have important legal rights, and may be entitled to significant compensation for any medical bills, lost wages, or wrongful death.