Posted on: 01/07/2008
CAMBRIDGE, Mass.--(BUSINESS WIRE)--TransMolecular, Inc., a biotechnology company focused on targeted therapies for cancer, today announced that the FDA has granted Orphan Drug Designation for the non-radiolabeled version of its anti-cancer compound TM601, which is currently entering clinical trials for the treatment of malignant glioma. The company had previously received Orphan designation for the radiolabeled version, 131I-TM601, which recently completed patient enrollment in a Phase 2 clinical trial in glioma and a Phase 1 trial in multiple tumor types.
“We are pleased to receive orphan drug status for TM601 in malignant glioma,” stated Michael Egan, President and Chief Executive Officer of TransMolecular. “The TM601 platform has performed very well in recent Phase 1 and 2 clinical trials, showing specific tumor targeting in both primary and metastatic disease of multiple tumor types. This adds to a strong clinical rationale supporting its therapeutic promise, and we look forward to initiating Phase 1 clinical trials with the non-radiolabeled form of this drug candidate in malignant glioma. This designation is part of TransMolecular’s strategy to advance this program so that patients with this poor-prognosis disease may eventually have a new treatment option available to them.”
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