Lorus Therapeutics Provides an Update on Progress in Virulizin(R) Development Program
July 09 2008 - 7:00AM
PR Newswire (US)
TORONTO, July 9 /PRNewswire-FirstCall/ -- Lorus Therapeutics Inc.
(TSX: LOR, AMEX: LRP) ("Lorus" or the "Corporation"), a
biopharmaceutical company specializing in the research and
development of pharmaceutical products and technologies for the
management of cancer, today announced progress made in the
Virulizin(R) development program, including the publication of two
research studies on the Virulizin(R) mode of action and the
issuance of a new patent for Virulizin(R) in Mexico. "Publication
of these two studies in international scientific journals adds
significantly to our previous studies on Virulizin(R) anticancer
mechanisms and activities," commented Dr. Aiping Young, Lorus'
President and CEO. "In addition, allowance of a new patent
strengthens the intellectual property position for this product,
and protects the potential for expanding the use to other cancer
indications in this jurisdiction." New Virulizin(R) patent issued
in Mexico The patent, titled "Immunomodulating Compositions from
Bile for the Treatment of Immune System Disorders", protects
methods of treating several cancers using Virulizin(R). This is the
second patent issued in Mexico for Virulizin(R), and extends patent
protection for Virulizin(R) in this country to 2016. Similar
patents for Virulizin(R) have also been issued in a number of other
countries worldwide, including Canada, Australia, and the United
States. Virulizin(R) is currently approved for the treatment of
malignant melanoma in Mexico. The new patent provides protection
for the potential treatment with Virulizin(R) of additional
cancers, including ovarian and lung cancers. Virulizin(R)
composition, manufacturing process, and use in the treatment of
cancers are also protected in Mexico under an earlier patent issued
to Lorus in 2003. Virulizin(R) has demonstrated significant
anticancer activity against a wide range of human cancers in
preclinical studies, and has been tested in several clinical trials
in solid tumor indications, including a Phase III clinical trial in
combination with gemcitabine in locally advanced and metastatic
pancreatic cancer. Lorus has reported that the overall survival
data in this Phase III study did not reach statistical
significance, although exploratory analysis yielded promising
results in specific patient populations including in patients with
ECOG performance status of 0 or 1. In April 2008, Lorus' subsidiary
GeneSense Technologies entered into an exclusive multinational
license agreement for Virulizin(R) with Zor Pharmaceuticals LLC to
further develop and commercialize Virulizin(R) for advanced
pancreatic cancer and other therapy areas in North and South
America, Europe, and Israel. Virulizin(R) study leads to new drug
candidate IL-17E The article entitled "Virulizin(R) induces
production of IL-17E to enhance antitumor activity by recruitment
of eosinophils into tumors" was published online in the journal
Cancer Immunology Immunotherapy and is available through PubMed
(http://www.ncbi.nlm.nih.gov/PubMed/). The study showed that
Virulizin(R) treatment stimulates the immune system to produce the
cytokine IL-17E, which in turn triggers an anticancer effect
through activation and tumor recruitment of eosinophils. This novel
aspect of the anticancer mechanism of action for Virulizin(R) adds
to previous studies showing that Virulizin(R) activates other cells
of the immune system, including macrophages and Natural Killer (NK)
cells. A key finding of this report was that IL-17E itself had
significant anticancer activity when used in mouse models of human
cancers. Preliminary studies have revealed that IL-17E has potent
activity against several human tumor types, including colon cancer,
melanoma, and pancreatic cancer, with low toxicity. Lorus has
patent applications pending in major markets, including Canada,
Europe and the United States, to protect the use of IL-17E in the
treatment of these cancers, both alone and in combination with
other chemotherapies. Virulizin(R) stimulates production of the
antitumor protein TNFalpha The article titled "Virulizin(R), a
novel immunotherapy agent, stimulates TNFalpha expression in
monocytes/macrophages in vitro and in vivo." was published in the
journal International Immunopharmacology (volume 7, issue 10, pages
1350-9). The study revealed that treatment with Virulizin(R)
resulted in a significant induction of the cytokine TNFalpha in
tumors in a mouse model of malignant melanoma. Virulizin(R) also
stimulated production of TNFalpha in human macrophages in vitro.
Importantly, a direct relationship between TNFalpha production by
Virulizin(R) and cytotoxic activity towards cancer cells was
demonstrated. TNFalpha is a protein that is produced by cells of
the immune system, particularly macrophages, which then activate
other immune cells to attack tumor cells. The anticancer properties
of TNFalpha are well known, and have been studied in both
preclinical and clinical settings. These new findings confirm
initial studies indicating that TNFalpha can contribute to the
antitumor mechanism of Virulizin(R). About Virulizin(R)
Virulizin(R) is a novel biological response modifier (or
immunotherapeutic agent) that stimulates a patient's immune system
through several mechanisms, including the activation of macrophages
and the infiltration of natural killer cells into tumors. In
preclinical studies, Virulizin(R) has demonstrated potential high
levels of antitumor activity against a number of cancer indications
including pancreatic cancer. Virulizin(R) has been granted orphan
drug status and fast track status from the United States FDA and
orphan designation from the Marketing Authorization Application
with the European Medical Evaluation Agency (EMEA). A drug that
receives fast track designation must demonstrate that it is
intended for the treatment of a serious or life-threatening
condition and that it has the potential to address unmet medical
needs for the condition. Virulizin(R) is a registered trademark
owned by Lorus Therapeutics Inc. About Lorus Lorus is a
biopharmaceutical company focused on the research and development
of novel therapeutics in cancer. Lorus' goal is to capitalize on
its research, preclinical, clinical and regulatory expertise by
developing new drug candidates that can be used, either alone, or
in combination with other drugs, 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. Lorus Therapeutics Inc. is listed on the Toronto
Stock Exchange under the symbol LOR, and on the American Stock
Exchange under the symbol LRP. Forward-Looking Statements This
press release may contain forward-looking statements within the
meaning of Canadian and U.S. securities laws. Such statements
include, but are not limited to, statements relating to: our
research program plans, our plans to conduct clinical trials, the
successful and timely completion of clinical studies and the
regulatory approval process, our ability to fund future research,
our plans to obtain partners to assist in the further development
of our product candidates, the establishment of corporate
alliances, the Company's plans, objectives, expectations and
intentions and other statements including words such as "continue",
"believe", "plan", "expect", "intend", "will", "should", "may", and
other similar expressions. Such statements reflect our current
views with respect to future events and are subject to risks and
uncertainties and are necessarily based upon a number of estimates
and assumptions that, while considered reasonable by us are
inherently subject to significant business, economic, competitive,
political and social uncertainties and contingencies. Many factors
could cause our actual results, performance or achievements to be
materially different from any future results, performance, or
achievements that may be expressed or implied by such
forward-looking statements, including, among others: our ability to
obtain the capital required for research and operations, the
inherent risks in early stage drug development including
demonstrating efficacy, development time/cost and the regulatory
approval process; the progress of our clinical trials; our ability
to find and enter into agreements with potential partners; our
ability to attract and retain key personnel; changing market
conditions; and other risks detailed from time-to-time in our
ongoing quarterly filings, annual information forms, annual reports
and annual filings with Canadian securities regulators and the
United States Securities and Exchange Commission. Should one or
more of these risks or uncertainties materialize, or should the
assumptions set out in the section entitled "Risk Factors" in our
Annual Information Form underlying those forward-looking statements
prove incorrect, actual results may vary materially from those
described herein. These forward-looking statements are made as of
the date of this press release and we do not intend, and do not
assume any obligation, to update these forward-looking statements,
except as required by law. We cannot assure you that such
statements will prove to be accurate as actual results and future
events could differ materially from those anticipated in such
statements. Investors are cautioned that forward-looking statements
are not guarantees of future performance and accordingly investors
are cautioned not to put undue reliance on forward-looking
statements due to the inherent uncertainty therein. Lorus
Therapeutics Inc.'s recent press releases are available through the
Company's website at http://www.lorusthera.com/. For Lorus'
regulatory filings on SEDAR, please go to http://www.sedar.com/.
For SEDAR filings prior to July 10, 2007 you will find these under
the company profile for Global Summit Real Estate Inc. (Old Lorus).
DATASOURCE: Lorus Therapeutics Inc. CONTACT: Lorus Therapeutics
Inc., Dr. Saeid Babaei, (416) 798-1200 ext. 490,
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