Lorus analysis shows survival benefit from Virulizin in phase 3 trial for pancreatic cancer

By Lisa Kerner

Erie, Pa., Feb. 1 - Lorus Therapeutics Inc. said further exploratory analysis of data from its phase 3 clinical trial of Virulizin for the treatment of pancreatic cancer showed significant survival benefit for patients continuing to receive the drug.

The analysis showed significant survival benefit for a subgroup of patients who continued to receive Virulizin after entering optional stage 3(x) second-line therapy, according to a company news release. The optional stage 3 second-line therapy included continuation of Virulizin or placebo alone or in combination with 5-flurouracil.

The randomized, double-blind, multi-center phase 3 clinical trial compared Virulizin plus gemcitabine to placebo plus gemcitabine for the treatment of chemonaive patients with locally advanced or metastatic pancreatic cancer as first-line therapy.

In top-line results, made public in October, Virulizin did not demonstrate statistical significance in overall median survival in first-line treatment analysis. Virulizin treatment was well tolerated with no major differences observed between the Virulizin plus gemcitabine arm and the control group.

"Virulizin significantly improved survival in pancreatic cancer patients who remained on the treatment arm even when treatment with the standard-of-care chemotherapy gemcitabine was no longer effective," Jim Wright, chief executive officer of Lorus, said in the release.

"Although this finding is from exploratory analysis and in our view, will not be sufficient for regulatory approval without additional clinical investigation, it provides important new information for further clinical development strategies."

Results of the phase 3 clinical trial and data from further exploratory analysis were presented at the 17th International Congress on Anti-Cancer Treatment in Paris.

Toronto-based Lorus is a biopharmaceutical company that develops and commercializes pharmaceutical products for the management of cancer.

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