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Orphan drug gives hope the sun'll come out tomorrow for MPM patients

The majority of patients diagnosed with the most common form of mesothelioma, malignant pleural mesothelioma, are not candidates for surgery. Instead, they undergo chemotherapy in the hope that they can stretch their time left from the median 5.7 months to a little more than a year. MPM strikes about 3,000 people every year.

Pharmaceutical company Aduro Biotech Inc. announced recently that its researchers have had positive results with a drug that has already helped to improve outcomes for patients with pancreatic cancer. The results are promising enough that the Food and Drug Administration has granted the drug, CRS-207, "orphan drug" status. For patients, orphan drug status translates into continued research and larger clinical trials.

Aduro's first study, still in progress, has shown a 94 percent rate of disease control for the 16 participants. Cancer researchers use standard criteria to measure results. The Response Evaluation Criteria In Solid Tumors system classifies the effect of the therapy on the targeted cancer. The categories are: complete response; partial response, which indicates at least a 30 percent decrease; stable disease, which means either no change or a less than 30 percent change; and progressive disease, which means at least a 20 percent increase.

None of the participants had surgery or chemotherapy before enrolling in the study, where they were treated with CRS-207 in addition to standard-of-care chemo. At the end of the first trial period, 12 of the 16 patients had partial responses; even better, three patients were rated stable. The new treatment resulted in about 7.5 months without progression -- in one case, the progression-free period has lasted 19 months.

There are benefits for the drug manufacturer, Aduro, too. Pharmaceutical companies request orphan drug status for drugs that treat rare diseases and promise little opportunity for profit. Aduro now can claim tax credits and qualify for federal grants to cover the costs of CRS-207 research. Should Aduro decide to get full FDA approval to market CRS-207, the application process will be streamlined and less time-consuming.

Sources:

Aduro Biotech Inc., "Aduro Receives Orphan Drug Designation for CRS-207 in Mesothelioma," March 26, 2015

European Organisation for Research and Treatment of Cancer, "Response Evaluation Criteria In Solid Tumors - RECIST Version 1.1," accessed April 2, 2015

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