Lorus announces initiation of IND-enabling toxicology studies for its lead small molecule drug, LOR-253
Toxicology studies in preparation for an investigational new drug application to the US FDA
Lorus Therapeutics Inc. announced the start of GLP toxicology studies for its lead anticancer small molecule drug LOR-253. The toxicology studies, which are currently underway, are designed to support the filing of an Investigational New Drug (IND) application with the U.S. 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 (formerly known as LT-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. The mode of action of LOR-253 involves the downregulation of cyclin D1, an important regulator of cell cycle progression and cell proliferation. Alterations in the cyclin D1 regulatory pathway have been linked to the development of cancer.
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