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Fed mandates additional mesothelioma treatment tials

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Officials with the FDA have said a promising mesothelioma treatment will have to through another set of clinical trials.

Onconase will be subjected to another clinical trial involving patients with malignant mesothelioma that cannot be treated surgically (unresectable) and who have already failed a course of chemotherapy.

A prior Phase IIB clinical trial showed that, while Onconase treatment did not result in a statistically significant improvement in survival for patients with unresectable mesothelioma overall, Onconase treatment was correlated with a significantly significant improvement in survival for patients with unresectable disease who have already failed a course of chemotherapy.

Mesothelioma is a rare form of lung cancer and is very hard to diagnose. Mesothelioma is one of a whole host of illnesses related to asbestos exposure.

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The problem is the company that manufactures Onconase cannot finance an additional clinical trial unless it is able to secure outside capital. Alfacell  Corp is undergoing a reduction in force and operations. The company anticipates that its current cash reserves will be able to sustain scaled-down operations until December 2009.

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  1. [...] the original post: Fed mandates additional mesothelioma treatment tials   Tags: asbestos, asbestos-exposure, asbestosis, birth-trauma, bladder-cancer, cancer-patient, [...]

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