Lorus moving into pivotal phase three trials
Lorus Therapeutics Inc LOR
Shares issued 120,945,940 Jun 23 close $3.15
Mon 26 Jun 2000 News Release
Ms. Jody Bullen reports
Lorus Therapeutics has completed meta-analysis of three phase one and two
studies of Virulizin. The studies showed that the drug demonstrated
clinical activity (such as increasing survival rate and preserving quality
of life) and was well tolerated by patients. Based on these encouraging
findings, Lorus plans to file an investigational new drug application (IND)
later in the year in preparation for a pivotal phase three clinical trial.
Dr. Benny Zee, senior biostatistician at the National Cancer Institute of
Canada, conducted the meta-analysis of results obtained with patients with
advanced pancreatic cancer and found that the number of adverse effects of
Virulizin were low for all three studies. He also found that the survival
results of Virulizin were superior to those found in a comparable study
using gemcitabine, the standard anticancer treatment for pancreatic cancer,
and as well as other benchmark findings.
"In the most conservative estimate of survival, the results of the
Virulizin study were better than a similar patient population receiving
gemcitabine in a phase two study setting as reported by Rothenberg in
1996," said Mr. Zee. "The survival experience of the Virulizin patients was
also significantly better than that of the 5-FU arm of the Burris phase
three study (1997) with respect to nine-month survival rates."
"By pursuing phase three trials independently for Virulizin, Lorus will
provide shareholders with the greatest value as the product is moved closer
to market. Lorus is well positioned to move forward with Virulizin, we have
the results, resources, knowledge and infrastructure to proceed," said
Philippe G. Lacaille, chairman and chief executive officer of Lorus. "
Virulizin's meta-analysis results combined with the evidence obtained from
previous studies have led to our decision to begin a phase three clinical
trial for Virulizin, confirming our belief that it will be an effective
therapy and important treatment of pancreatic cancer in the future."
Sixty-one patients were included in this analysis, with 49 classified as
evaluable. The majority of these patients (87 per cent) had received some
form of treatment prior to entering these studies: 46 per cent receiving
gemcitabine, 5-FU or other chemotherapeutic agents and 84 per cent had
prior surgery. There was no difference in survival between patients who had
or had no prior chemotherapy, but those who did not receive prior surgery
had worse prognosis as compared to those who had prior surgery.
Among the 61 eligible patients treated with Virulizin, the median survival
rate was 4.6 months. The six-month survival rate was 38 per cent and the
nine-month survival rate was 25 per cent. In terms of evaluable patients
(49 patients) the median survival rate was 5.7 months (95 per cent C.I.
from 4.6 months to 8.0 months) with six-month and nine-month survival rates
of 48 per cent and 31 per cent, respectively.
This result is better when compared with that of 63 patients who received
gemcitabine as second line therapy after they had failed 5-FU as
chemotherapy (Rothenberg et al.). The median survival in the Rothenberg
study was approximately 3.8 months, with a six-month survival rate of 31
per cent and a nine-month survival of 15 per cent.
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