TransMolecular has received orphan drug designation from the FDA for the non-radiolabeled version of its anti-cancer compound TM601, which is currently entering clinical trials for the treatment of malignant glioma.
Subscribe to our email newsletter
If the non-radiolabeled TM601 receives FDA approval for malignant glioma, it will entitle TransMolecular to exclusive marketing rights for the compound for the treatment of malignant glioma for seven years following the NDA approval.
TM601 is a synthetic version of chlorotoxin, a naturally occurring peptide derived from scorpion venom, which is highly specific in targeting both primary tumors and metastases.
Michael Egan, president and CEO of TransMolecular, said: “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.”
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.