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news.Lorus Therapeutics, a biopharmaceutical company, has completed investigational new drug-enabling toxicology studies for its lead small molecule LOR-253 anticancer drug, formerly known as LT-253.
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The good laboratory practice, investigational new drug (IND)-enabling toxicology studies conducted for LOR-253 included maximum tolerated dose studies and repeat-dose toxicity studies in rodents and nonrodents. The data have established the toxicity profile for LOR-253, the company said.
Importantly, the study results indicate that LOR-253 is well tolerated at higher dose levels than efficacious dose levels determined from preclinical pharmacology studies. The toxicology studies were designed to support the dosing regimen and intravenous route of administration for LOR-253 that is planned for a Phase I clinical trial upon filing an IND submission with the FDA.
According to the company, LOR-253 represents a new targeted approach in cancer drug development, by inducing KLF4, a tumor suppressor factor that is reduced in a variety of important cancers.
Aiping Young, president and CEO of Lorus, said: “The successful completion of the toxicology program for LOR-253 is an important milestone in the development of this novel drug candidate which represents a ‘first in class’ development program. We are now one step closer to initiating clinical trials with this exciting compound, which was identified at Lorus using our drug discovery platform.”