The drug candidate is currently in a Phase I/II 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.
If 131I-TM601 receives FDA approval for melanoma, this designation will entitle TransMolecular to exclusive marketing rights for the compound for the treatment of melanoma for seven years following an NDA approval. Orphan drug designation provides financial and regulatory incentives for companies pursuing less common diseases.
In a completed Phase I trial it was confirmed that intravenously delivered 131I-TM601 has the ability to target and bind to tumor tissue in multiple solid tumor types, as well as cross the blood-brain barrier to target tumors in the brain, the company said.
Michael Egan, president and CEO of TransMolecular, said: We are pleased that this designation represents another step toward our goal of delivering a new therapy to patients battling this difficult disease. Further, it demonstrates recognition of the broad applicability and promise of this platform across multiple oncology applications.