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Lorus Advances Its Antisense Clinical Program For Renal Cell Carcinoma.


Business Editors

TORONTO--(BUSINESS WIRE)--Oct. 30, 2001

Company Begins Its Combination Phase II Clinical Trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II
 Involving

GTI-2040 and Capecitabine

Lorus Therapeutics Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:LORFF)(TSE See Tokyo Stock Exchange.

TSE

1. See Tokyo Stock Exchange (TSE).

2. See Toronto Stock Exchange (TSE).
:LOR LOR Letter Of Reprimand (military)
LoR Lord of the Rings (J.R.R. Tolkien)
LOR Learning Object Repository
LOR Linux.Org.
.)("Lorus") today announced it has expanded the Phase II clinical trial of its antisense antisense, DNA or RNA manipulated in a laboratory so that its components (nucleotides) form a complementary copy of normal, or "sense," messenger RNA (mRNA; see nucleic acid).  drug GTI-2040 in patients with advanced or metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.

Mentioned in: Coagulation Disorders


metastatic

pertaining to or of the nature of a metastasis.
 renal cell carcinoma renal cell carcinoma
 or hypernephroma

Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced.
.

The study, to be conducted at Wake Forest University in North Carolina by Dr. Frank Torti, will investigate the effectiveness of the combined use of GTI-2040 and capecitabine, an oral treatment that has shown promising response rates in patients with metastatic renal cell carcinoma.

The clinical trial is designed as a 21-day continuous infusion of GTI-2040 with twice-daily oral administrations of capecitabine, followed by a one-week rest period. The investigation will examine the safety profile of GTI-2040 in combination therapy, will determine the maximum tolerated dose of GTI-2040 when the two drugs are administered together, and will observe the therapeutic effectiveness of GTI-2040 and capecitabine in combination.

"In the first part of the Phase II clinical trial program, patients with renal cell carcinoma were treated with GTI-2040 as a monotherapy at the recommended Phase II dose to further investigate the toxicology profile of the drug. These results demonstrated that GTI-2040 was well tolerated as a monotherapy in patients with this disease," said Dr. Jim A. Wright, chief executive officer, Lorus. "The findings provide further confidence in the tolerability of GTI-2040 and we are looking forward to determining how it performs when used with capecitabine."

In the dose-escalating Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained
phase I
 of GTI-2040 involving 30 patients with advanced or metastatic solid tumors or lymphoma, the primary clinical endpoints of safety and tolerability were met. In addition, biological activity in the form of disease stabilizations was observed and the recommended dose for Phase II studies was identified.

Renal cell carcinoma is the most common type of kidney cancer and there are more than 34,000 cases diagnosed annually in North America. Advanced metastatic renal cell carcinoma patients have five-year survival rates of 10 per cent. Current treatment regimes include interferon and interleukin-2 (IL-2). Proleukin, a recombinant form of IL-2 and associated with severe side effects, is the only FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approved drug for the treatment of renal cell carcinoma. New drugs like GTI-2040, that are designed to stabilize disease and have a high safety profile, have the potential to extend the lives of patients without the debilitating de·bil·i·tat·ing
adj.
Causing a loss of strength or energy.


Debilitating
Weakening, or reducing the strength of.

Mentioned in: Stress Reduction
 side effects often observed in current therapies.

About Lorus

Lorus Therapeutics Inc. is a biopharmaceutical company specialising in the research, development and commercialisation of pharmaceutical products and technologies for the management of cancer. With products entering all stages of evaluation, from pre-clinical through Phase III trials, Lorus is a leader in the development of therapeutics that complement the new cancer treatment paradigm that seeks to manage the disease with efficacious non-toxic compounds that improve patients' quality of life. Founded in 1986, Lorus Therapeutics Inc. is a public company listed on the Toronto Stock Exchange Toronto Stock Exchange (TSE)

Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options.
 under the symbol LOR, and on the OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
 BB exchange under the symbol LORFF.

Except for historical information, this press release contains forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties, which may cause actual results to differ materially from those statements. Those risks and uncertainties include, but are not limited to, changing market conditions, 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, and other risks detailed from time-to-time in the Company's ongoing quarterly filings, annual information form, annual reports and 40-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. In light of these risks, uncertainties and assumptions, the forward-looking events in this press release might not occur.

Lorus Therapeutics Inc.'s press releases are available through the Company's Internet site: http://www.lorusthera.com.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Oct 30, 2001
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