MannKind's Trials Cleared

The company plans human studies of an experimental cancer treatment.
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MannKind

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received regulatory clearance in the U.S. to proceed with human trials of an experimental cancer treatment.

The Food and Drug Administration's approval is associated with an investigational new drug application for an immunotherapy dubbed MKC1106-PP. Studies of immune response, safety and tolerability of the treatment are set to enroll patients before the end of the year.

The clinical study is designed to target two tumor-specific antigens, preferential antigen of melanoma and prostate-specific membrane antigen, on the basis of their level of expression in commonly occurring adult malignancies, such as ovarian, prostate, renal, pancreatic, breast, colon carcinoma and melanoma.

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