Lorus Therapeutics announced this week that their Investigational New Drug (IND) application has been approved by the United States Food and Drug Administration (FDA) to begin Phase I human trials of their cancer drug LOR-253. The human trials will begin with a dose escalation trial in advanced or metastatic solid tumors with LOR-253 to assess safety, profile, tolerability and antitumor activity in cancer patients as well as pharmacokinetic and pharmacodynamics properties of LOR-253. The Phase I trials will be hosted at Memorial Sloan-Kettering Cancer Center in New York City.
LOR-253, formerly LT-253, has selective and potent antitumor activity in a variety of human cancers, including colon and non-small cell lung cancer, and has demonstrated an excellent therapeutic index in experimental models during pre-clinical research. With its novel cancer target resulting in induction of a novel tumor suppressor, LOR-253 represents a new class of anticancer agents which Lorus believes may offer a competitive advantage over traditional therapies on the market today.
Lorus, based out of Toronto, Canada, is focused on the development of novel compounds for the treatment of cancers. They have 7 products in their pipeline under development as cancer therapies. Virulizin®, a novel immunotherapy agent that stimulates the body’s immune system through several mechanisms, is their lead compound and has already completed research in Phase I and Phase II human clinical trials. Phase III clinical research has included a randomized placebo-controlled trial for the first line treatment of pancreatic cancer in combination with gemcitabine. While top-line Phase III results did not demonstrate statistical significance in median overall survival, exploratory analysis showed promising trends in specific patient populations.
Additional clinical studies to confirm the survival benefit associated with Virulizin in a predefined patient subpopulation are in planning stages to support approval of Virulizin in jurisdictions covered under the company’s license agreement with Zor Pharmaceuticals, including the countries of North, Central, and South America, Europe, and Israel. Virulizin has been granted orphan drug status and fast track status from the United States FDA and orphan designation from the Marketing Authorization Application with the European Medical Evaluation Agency (EMEA) for treatment of pancreatic cancer.
Lorus trades on the Toronto Stock Exchange under the ticker LOR.TO and the Nasdaq Bulletin Boards under the ticker LRUSF.OB. It is a thinly traded stock with a small share structure after a 1 for 30 reverse split that was exercised at the beginning of June. Shares of LRUSF closed at $1.81 yesterday with zero shares traded. Shares of LOR.TO closed at $2.03 with 10,900 shares traded.
More information on Lorus Therapeutics, Inc., their pipeline of compounds and the investment opportunity it presents can be found on the Company’s website at www.lorusthera.com.