Lorus initiates development program exploring novel route of administration for LOR-2040
22 Abril 2008 - 7:30AM
PR Newswire (US)
TORONTO, April 22 /PRNewswire-FirstCall/ -- Lorus Therapeutics Inc.
('Lorus'), a biopharmaceutical company specializing in the research
and development of pharmaceutical products and technologies for the
management of cancer, today announced the start of a development
program aimed at expanding the therapeutic application of its lead
clinical-stage drug LOR-2040 for the treatment of superficial
bladder cancer. The new development program will examine direct
(intravesical) administration of LOR-2040 into the bladder as a
treatment for superficial or non-invasive bladder cancer. Formal
toxicology evaluation, which is currently in progress, will be used
to determine the appropriate human dose and dose schedule for
LOR-2040 with this route of administration. Results of these
studies will be used in support of an Investigational New Drug
(IND) application for the use of LOR-2040 in the treatment of
bladder cancer. Lorus intends to submit the IND during Q3, 2008,
following successful completion of the toxicology program.
LOR-2040, formerly known as GTI-2040, has shown potent
antiproliferative activity and target downregulation in bladder
cancer in preclinical studies. LOR-2040 is currently being
investigated in several phase I and phase II clinical trials in a
broad range of cancer indications, both alone and in combination
with a number of standard cancer therapies. In clinical trials,
LOR-2040 has demonstrated a high safety profile when administered
intravenously, which is the current route of administration for
this drug. In the U.S. more than 60,000 new cases of bladder cancer
are diagnosed each year, which accounts for approximately 13,000
deaths annually. At initial diagnosis, up to 90% of subjects with
bladder cancers have superficial disease that is confined to the
inner layers of tissue in the urinary bladder. Systemic
chemotherapy is considered less effective than the intravesical
(instilled in the bladder) agents in treating locally confined,
superficial bladder tumors. In fact intravesical administration
exposes the bladder tumor to higher levels of drugs that may
prevent tumor cells from becoming invasive and spreading
(metastasizing) to other organs. This treatment method is a
standard regimen used for many approved chemotherapy drugs to treat
superficial bladder cancer. "I am pleased that we have initiated
the studies that explore a novel way of administering LOR-2040
directly to bladder tumors and that we are on schedule to advance
LOR-2040 in this indication", said Dr. Aiping Young, President and
CEO of Lorus. "Bladder cancer is seventh most common cancer
worldwide and is a significant target indication for new
therapeutics. Coupled with the high risk of recurrence, even in
patients with early stage disease, adding a non-systemic treatment
to the currently available treatment options has significant
potential." About LOR-2040 LOR-2040 (formerly GTI-2040) is an
RNA-targeted drug candidate specific for the R2 subunit of
ribonucleotide reductase, which is required for DNA synthesis and
cell proliferation. LOR-2040 has demonstrated strong antitumor and
antimetastatic activity in a variety of tumor types in both in vivo
and in vitro models. LOR-2040 is under study in a multiple Phase
I/II clinical program, including an advanced Phase II clinical
trial with LOR-2040 and high dose Ara-C (HiDAC) in refractory and
relapsed Acute Myeloid Leukemia (AML). The R2 target has been
described as a malignant determinant that is elevated in a wide
range of tumors, which can cooperate with a variety of cellular
cancer causing genes known as oncogenes to enhance tumor growth and
metastatic potential. About Lorus Lorus is a biopharmaceutical
company focused on the research and development of novel
therapeutics for the treatment of cancer that are at various stages
of development spanning discovery to clinical trials. Lorus' goal
is to capitalize on its research, preclinical, clinical and
regulatory expertise by developing new drugs that can be used,
either alone, or in combination with other agents, 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 contains forward-looking statements
within the meaning of Canadian and U.S. securities laws. Such
statements include, but are not limited to, statements relating to:
financings and corporate reorganizations, the establishment of
corporate alliances, the Company's plans, objectives, expectations
and intentions and other statements including words such as
"continue", "expect", "intend", "will", "should", "would", "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, achievements or the
transactions described in this press release to be materially
different from any future results, performance, achievements or
transactions described in this press release, if at all, that may
be expressed or implied by such forward-looking statements,
including, among others: the progress of negotiations; our ability
to obtain regulatory, security holder and other approvals; 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
filings with Canadian securities regulators and the United States
Securities and Exchange Commission 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' recent press releases are available through its
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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