Lorus releases phase II GTI-2040 trial results
Lorus Therapeutics Inc LOR
Shares issued 171,517,340 Jan 9 close $1.06
Mon 12 Jan 2004 News Release
Ms. Grace Tse reports
LORUS THERAPEUTICS ANNOUNCES INTERIM CLINICAL RESULTS OF GTI-2040 IN
COMBINATION CHEMOTHERAPY FOR THE TREATMENT OF RENAL CELL CANCER
Lorus Therapeutics has released interim results from a recently conducted
exploratory phase II clinical trial of GTI-2040 in patients with advanced,
end-stage renal cell cancer in the United States. This trial was a
single-arm pilot study examining the safety and efficacy of GTI-2040 used
in combination with the anticancer agent capecitabine. To date, data have
been collected on 21 patients evaluable for tumour assessment. One patient
is still receiving treatment after eight months of therapy with GTI-2040
and capecitabine. Four additional patients will be accrued.
The majority of patients had failed two or more prior therapies before
entering the study, exhibited extensive metastases, and were representative
of a population with very poor prognostic outcome in renal cell cancer. In
the present clinical study, few treatment-related toxicities outside of
those already known to occur with the test drugs were observed. Unaudited
data analysis showed that more than half of the 21 evaluable patients in
this study exhibited disease stabilization, ranging up to eight months.
Tumour shrinkages of index tumours compared with baseline measurements were
observed in some patients. A full assessment of tumour responses will be
completed and a final independent review of results will occur following
conclusion of the study.
Lorus's objective is to further the clinical development of its lead
antisense drug, GTI-2040, in renal cell cancer with the intention of
progressing the drug into a definitive phase II/III registration program.
The drug would be studied in early stage rather than late stage renal cell
cancer in combination with a cytokine, as these are agents commonly used in
the first or second-line clinical setting. This decision also reflects
recent promising preclinical data, showing positive antitumour efficacy in
combination with cytokines like interleukin and interferon. Discussions
with leading clinical experts on the design of the investigation are under
way, but will likely include a pharmacokinetic and disease response
analysis of GTI-2040 in combination with a first-line approved therapy
versus first-line therapy alone, in previously untreated, newly diagnosed
patients.
"We are encouraged by initial clinical evidence in this single-arm trial of
disease stabilizations and tumour shrinkages in a heavily pretreated and
multiple-relapsed population," said Dr. Jim Wright, chief executive officer
of Lorus. "Lorus has decided to move development of GTI-2040 to a first or
second-line indication in renal cell cancer, rather than end-stage disease.
We believe this approach provides the greatest opportunity to demonstrate
the anticancer activity of GTI-2040 in renal cell cancer, and the potential
to enhance the commercial value of the drug."
Renal cell carcinoma is the most common type of kidney cancer with more
than 190,000 cases diagnosed annually across all countries. The majority of
patients are over the age of 40. More than 90,000 patients die annually
from this disease worldwide. The age-adjusted world incidence in renal cell
carcinoma has been increasing steadily at an annual rate of approximately 2
per cent. Advanced renal cell cancer is typically resistant to
chemotherapy, with reported response rates of less than 10 per cent.
Current treatments include the cytokines interferon, and interleukin-2,
however tumour response rates for these agents are low, in the range of 15
per cent.
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