TransMolecular, Inc.
TransMolecular Receives Orphan Drug Designation for 131I-TM601 for the Treatment of Melanoma
Published in Medical Letter on the CDC and FDA, January 11th, 2009
TransMolecular, Inc., a biotechnology company focused on targeted therapies for cancer, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its anti-cancer compound 131I-TM601 for the treatment of Stage IIb-IV melanoma. The drug candidate is currently in a Phase 1/2 clinical trial for the treatment of recurrent malignant melanoma. The company had previously received Orphan designation for 131I-TM601 in malignant glioma, as well as for the non-radiolabeled version of TM601 for the treatment of malignant glioma.
“The receipt of our third Orphan Drug Designation is a result of our robust regulatory and clinical development...
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