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news.Lorus Therapeutics, a biopharmaceutical company specialising in the discovery, research and development of pharmaceutical products and technologies for the management of cancer, has completed production of the first clinical batch of its new anticancer drug candidate LOR-253.
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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.