The toxicology studies, which are currently underway, are designed to support the filing of an investigational new drug application with the FDA for LOR-253 to initiate a Phase I clinical study in cancer indications. Lorus intends to submit an IND for LOR-253 during the fourth quarter of 2008, following successful completion of the toxicology program.
LOR-253 is a proprietary small molecule compound discovered at Lorus and optimized for its anticancer properties. In preclinical studies, LOR-253 has shown selective and potent antitumor activity in a variety of human cancers, including colon cancer and non-small cell lung cancer, and has an excellent therapeutic window due to its low toxicity.
Aiping Young, president and CEO of Lorus, said: “LOR-253 is the first compound from our small molecule program to advance to GLP toxicology studies. Moving LOR-253 forward is consistent with Lorus’s focus on development of novel drugs from a broad range of technologies.”