Lorus Therapeutics Inc. today announced the start of a development program aimed at expanding the therapeutic application of its lead clinical-stage drug LOR-2040 for the treatment of superficial bladder cancer.
The new development program will examine direct (intravesical) administration of LOR-2040 into the bladder as a treatment for superficial or non-invasive bladder cancer. Formal toxicology evaluation, which is currently in progress, will be used to determine the appropriate human dose and dose schedule for LOR-2040 with this route of administration. Results of these studies will be used in support of an Investigational New Drug (IND) application for the use of LOR-2040 in the treatment of bladder cancer. Lorus intends to submit the IND during Q3, 2008, following successful completion of the toxicology program.
LOR-2040, formerly known as GTI-2040, has shown potent antiproliferative activity and target downregulation in bladder cancer in preclinical studies. LOR-2040 is currently being investigated in several phase I and phase II clinical trials in a broad range of cancer indications, both alone and in combination with a number of standard cancer therapies. In clinical trials, LOR-2040 has demonstrated a high safety profile when administered intravenously, which is the current route of administration for this drug. In the U.S. more than 60,000 new cases of bladder cancer are diagnosed each year, which accounts for approximately 13,000 deaths annually. At initial diagnosis, up to 90% of subjects with bladder cancers have superficial disease that is confined to the inner layers of tissue in the urinary bladder. Systemic chemotherapy is considered less effective than the intravesical (instilled in the bladder) agents in treating locally confined, superficial bladder tumors. In fact intravesical administration exposes the bladder tumor to higher levels of drugs that may prevent tumor cells from becoming invasive and spreading (metastasizing) to other organs. This treatment method is a standard regimen used for many approved chemotherapy drugs to treat superficial bladder cancer.