LOR-253 is a small molecule compound that has shown selective and potent antitumor activity in a variety of human cancers, including colon cancer and non-small cell lung cancer, and has a therapeutic window due to its low toxicity.
Lorus Therapeutics said that the clinical batch of LOR-253 was manufactured in full compliance with current good manufacturing practice (cGMP) and is to be used in a first-in-man study of LOR-253. An investigational new drug (IND) application for LOR-253 is being finalised for filing with the FDA for a Phase I dose escalation trial in selected solid tumors.
Aiping Young, president and CEO of Lorus Therapeutics, said: “Production of our first cGMP-compliant clinical batch of LOR-253 is a significant milestone in the development of this novel compound, and demonstrates our commitment to advance LOR-253 into the clinic.