By Karen Young
Lorus Therapeutics Inc. initiated a Phase III trial to evaluate its lead product, Virulizin for advanced pancreatic cancer, as it prepares to file an NDA with the FDA.
Toronto-based Lorus CEO Jim Wright said that the trial is scheduled for completion in two-and-a-half to three years.
¿We have orphan drug status, so that gives us some advantages,¿ Wright said, noting that while the FDA would probably move quickly at the administrative level, the process of approval always takes a number of months.
The double-blind, randomized clinical trial is expected to include 350 patients at about 40 centers, primarily in the United States, and will have two parts. First, patients with advanced pancreatic cancer will be randomized to receive either treatment with Virulizin in combination with the current front-line treatment of gemcitabine, or gemcitabine alone. Those patients who do not respond to gemcitabine will be given 5-Fluorouracil (5-FU) or 5-FU in combination with Virulizin.
¿We¿re looking to extend the life of patients,¿ Wright said, noting that survival is the primary endpoint and clinical benefit is the secondary endpoint.
One reason Lorus is looking at pancreatic cancer with Virulizin is there are no other drugs available, he said, noting gemcitabine generally gives patients an extra six weeks of life. Patients eventually become resistant or intolerant to gemcitabine, Wright said.
¿Any drug that is able to extend the patient beyond six weeks of life would be very welcome by the FDA,¿ Wright said.
Wright said Virulizin withstood Phase II trials and ¿looked as good or better in some cases than the gold standard¿ of gemcitabine, although Lorus did not do a direct comparison of the two drugs.
Virulizin is an immunotherapeutic drug that leads to stimulation of macrophages, monocytes and natural killer cells to attack tumor cells, giving the patient the ability to resist or fight the disease.
The drug already is approved in Mexico to treat malignant melanoma. Last month, Lorus entered into an exclusive seven-year distribution agreement in Latin America with Faulding (Canada) Inc., of Montreal. Lorus will receive royalties on sales and will be responsible for manufacturing. Faulding will share in any additional clinical costs the companies deem appropriate in Mexico and the rest of Latin America. The deal also gives Faulding the option to enter into agreements to sell Virulizin in Brazil and Argentina, and Faulding would be responsible for regulatory approval in those countries.
Faulding will begin the marketing and selling of Virulizin in Mexico in the first quarter of 2002, which will generate the first revenues for Lorus from one of its drugs.
¿Lorus might expect 50 percent of the profits of sales,¿ Wright said.
Lorus is in discussions with various companies for partnering agreements regarding Viruzilin in the United States, he said. The company is not considering Virulizin for clinical trials in any other indications at this time, although it has shown promise in preclinical studies for breast, prostate, ovarian and lung cancers. If Lorus does consider moving it into clinical trials for other indications, it would do so with a partner.
Wright said Lorus is financially stable with enough cash to sustain the company for three years or longer, including financial support for the Phase III trial just launched.
Lorus also has other drugs in the clinic, including GTI2040 in Phase II for renal cell carcinoma. GTI2040 is an antisense drug, and Wright said it is showing some ¿very interesting¿ positive results.
Another compound, GTI2501, is in a Phase I trial for solid tumors and lymphoma.
A third, small-molecule platform technology at Lorus was in-licensed from Harvard Medical School. These are drugs developed at the medical school, and Lorus is identifying lead compounds from among them. They have proven very safe in animal models, are given orally and have anticancer effects, Wright said. Lorus is engaged in a cooperative agreement with the National Cancer Institute, which is helping Lorus with toxicology studies and will help it bring one of these small-molecule compounds into the clinic.
Lorus¿ stock (TSE:LOR) fell 2 cents Tuesday to close at $1.35.