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Exhibit 99.4
CONTACTS:
LORUS THERAPEUTICS INC. CANADIAN MEDIA CONTACT: US MEDIA CONTACT
Corporate Communications Eliza Walsh Jennifer Taylor
Grace Tse Mansfield Communications Inc. Mansfield Communications Inc.
Tel: (416) 798-1200 ext. 380 Tel: (416) 599-0024 Tel: (212) 370-5045
Email: ir@lorusthera.com Email: eliza@mcipr.com Email: jennifer@mcipr.com
LORUS THERAPEUTICS ANNOUNCES INTERIM CLINICAL RESULTS OF GTI-2040
IN COMBINATION CHEMOTHERAPY FOR THE TREATMENT OF RENAL CELL CANCER
- Further clinical development plans to proceed -
TSX: LOR
OTC BB: LORFF
TORONTO, CANADA, JANUARY 12, 2004 - Lorus Therapeutics Inc. ("Lorus") announced
today 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 tumor 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. Tumor shrinkages of
index tumors compared to baseline measurements were observed in some patients. A
full assessment of tumor responses will be completed and a final independent
review of results will occur following conclusion of the study.
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Lorus' 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 antitumor efficacy in combination with cytokines like interleukin and
interferon. Discussions with leading clinical experts on the design of the
investigation are underway, 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 tumor 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 two per cent. Advanced
renal cell cancer is typically resistant to chemotherapy, with reported response
rates of less than 10 percent. Current treatments include the cytokines
interferon, and interleukin-2, however tumor response rates for these agents are
low, in the range of 15 per cent.
About GTI-2040
GTI-2040 is an antisense drug that specifically targets the R2 component of
ribonucleotide reductase, which is required for DNA synthesis and cell
proliferation. It has also been described as a malignant determinant that is
elevated in a wide range of tumors, and through deregulation can cooperate with
a variety of cellular cancer causing genes known as oncogenes to enhance tumor
growth and metastatic potential. GTI-2040 showed significant antitumor activity
against many different human tumors in preclinical studies. In addition to the
clinical trial in renal cell cancer described above, GTI-2040 is currently the
subject of a Clinical Trial Agreement with the United States National Cancer
Institute (NCI) under which GTI-2040 will be tested in combination chemotherapy
in six different clinical trials. Three of these trials have been initiated
including treatment of metastatic breast cancer at the University of California,
Davis Cancer Center; acute myeloid leukemia at the Ohio State University Medical
Center and non-small cell lung cancer at Princess Margaret Hospital in Toronto,
Canada. The three remaining clinical trials to be initiated with NCI sponsorship
will investigate GTI-2040 in colon cancer, prostate cancer, and a variety of
solid tumors.
About Lorus
Lorus is a biopharmaceutical company focused on the research and development of
cancer therapies. Lorus' goal is to capitalize on its research, pre-clinical,
clinical and regulatory expertise by developing new drug candidates that can be
used, either alone, or in combination, to successfully manage cancer. Through
its own discovery efforts and an acquisition and in-licensing program, Lorus is
building a portfolio of promising anticancer drugs. Late-stage clinical
developments and marketing may be done in cooperation with strategic
pharmaceutical partners. Founded in 1986, Lorus Therapeutics Inc. is a public
company listed on the Toronto Stock Exchange under the symbol LOR, and on the
OTC BB exchange under the symbol LORFF.
Forward Looking Statements
Except for historical information, this press release contains forward-looking
statements, which reflect the Company's current expectation and assumptions, and
are subject to a number of risks and uncertainties that could cause actual
results to differ materially from those anticipated. These forward-looking
statements involve risks and uncertainties, including, but not limited to,
changing market conditions, the Company's ability to obtain patent protection
and protect its intellectual property rights, commercialization limitations
imposed by intellectual property rights owned or controlled by third parties,
intellectual property liability rights and liability claims asserted against the
Company, the successful and timely completion of clinical studies, the
establishment of corporate alliances, the impact of competitive products and
pricing, new product development, uncertainties related to the regulatory
approval process, product development delays, the Company's ability to attract
and retain business partners and key personnel, future levels of government
funding, the Company's ability to obtain the capital required for research,
operations and marketing and other risks detailed from time-to-time in the
Company's ongoing quarterly filings, annual information form, annual reports and
20-F filings. We undertake no obligation to publicly update or revise any
forward looking statements, whether as a result of new information, future
events or otherwise.
Lorus Therapeutics Inc.'s press releases are available through the Company's
Internet site: http://www.lorusthera.com.
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