LORUS
THERAPEUTICS INC.
Material
Change Report
Section
75(2) of the Securities Act (Ontario)
Section
85(1)(b) of the Securities Act (British Columbia)
Section
146(1)(b) of the Securities Act (Alberta)
Section
84(1)(b) of The Securities Act, 1988 (Saskatchewan)
Section
81(2) of the Securities Act (Nova Scotia)
Section
76(2) of the Securities Act (Newfoundland)
1.
Reporting Issuer
Lorus
Therapeutics Inc.
2
Meridian Road
Toronto,
Ontario
M9W
4Z7
2.
Date of Material Change
October
18, 2005
3.
Press Release
The
press release prescribed by section 75(1) of the Securities Act
(Ontario) (and attached hereto)
was issued at Toronto on October 18, 2005.
4.
Summary of Material Change
Lorus
Therapeutics Inc. (“Lorus”) announced the results of the Phase III clinical
trials of its lead product Virulizin®.
5.
Full Description of Material Change
Please
see attached press release.
6.
Reliance on Confidentiality Provisions of Securities
Legislation
Not
applicable.
7.
Omitted Information
No
significant facts remain confidential in, and no information has been omitted
from, this report.
8.
Senior Officers
For
further information please contact Shane A. Ellis, Corporate Secretary and
Vice
President
of Legal Affairs, at (416) 798-2200 (ext. 300).
9.
Statement of Senior Officer
The
foregoing accurately discloses the material change referred to
herein.
DATED
at Toronto, Ontario, this 18th day of
October,
2005.
By:
“Shane A. Ellis”
Shane
A. Ellis
Corporate
Secretary and Vice President , Legal Affairs
Lorus
Therapeutics. Inc.
Contacts:
|
Lorus
Therapeutics Inc.
|
Media
Contacts
|
US
Investor Relations
|
|
Bruce
Rowlands
|
Eliza
Walsh / Emily Brunner
|
Tim
Clemensen
|
|
Senior
Vice President
|
Mansfield
Communications
|
Rubenstein
& Co.
|
|
(416)
798-1200 ext. 338
|
(416)
599-0024 / (212) 370-5045
|
(212)
843-9337
|
|
browlands@lorusthera.com
|
eliza@mcipr.com
/ emily@mcipr.com
|
tim@rir1.com
|
Lorus
announces results of Virulizinâ
Phase III Clinical Trial
TORONTO,
CANADA, October 18, 2005 - Lorus Therapeutics Inc. ('Lorus'), a
biopharmaceutical company specializing in the development and commercialization
of pharmaceutical products and technologies for the management of cancer,
today
announced the top-line results of their randomized Phase III clinical trial
of
Virulizinâ
in the first-line treatment of pancreatic cancer.
The
trial compared Virulizinâ
plus gemcitabine to placebo plus gemcitabine for treatment of chemonaive
patients with locally advanced or metastatic pancreatic cancer. For
the efficacy evaluable population, the study showed that the addition of
Virulizinâ
to gemcitabine resulted in a median overall survival of 6.8 months and a
one-year survival rate of 27.2%, compared to 6.0 months and 16.8% for placebo
plus gemcitabine. In the intent to treat population the median
overall survivals were 6.3 months for Virulizinâ
plus gemcitabine (one year survival rate of 25.9%) compared to 6.0 months
for
placebo plus gemcitabine (one year survival rate of 17.6%). While
comparison of the median overall survival times did not reach statistical
significance, exploratory analysis did show promising trends in specific
patient
populations. Several examples are provided below.
Patients
on Virulizinâ
plus gemcitabine treatment with ECOG performance status of 0 or 1 (comprising
68% of the efficacy evaluable population), showed a median overall survival
of
8.2 months compared to 6.3 months for ECOG 0/1 patients treated with placebo
plus gemcitabine. While this analysis was exploratory, the result
approached statistical significance with a p value of 0.063. The
company is encouraged by this observation and the observed clinical benefit
of
increased survival of almost 2 months for this particular patient
population.
Additionally,
one year survival rates in the efficacy evaluable population were 32.2% in
the
Virulizinâ
plus gemcitabine patients compared to 20.1% in the gemcitabine plus placebo
treatment arm in this ECOG 0/1 population.
When
reviewing patients with metastatic (as distinguished from locally advanced)
pancreatic cancer (comprising 73% of the efficacy evaluable population) those
on
the Virulizinâ
plus gemcitabine treatment arm showed a positive trend in median overall
survival of 6.1 months compared to 5.0 months with placebo plus
gemcitabine. As well, one year survival rates in this population were
24% in the Virulizinâ
plus gemcitabine treatment arm compared to 11% in the placebo plus gemcitabine
treatment arm in the metastatic study population.
The
trial allowed for an optional second line therapy stage, whereby patients
could
continue to receive the study drug or best supportive care after disease
progression. Median overall survival in the intent to treat and
efficacy evaluable populations were 8.0 and 8.2 months respectively for the
Virulizinâ
plus gemcitabine group, compared to 7.0 months for both intent to treat and
efficacy evaluable population control groups. Statistical analysis
showed a trend to significance favouring continued Virulizinâ over
placebo
with p values of 0.066 for the intent to treat population and 0.068 for the
efficacy evaluable population.
Virulizinâ
treatment was well tolerated with no major differences observed between the
Virulizinâ
plus gemcitabine arm and the control group.
Lorus
thanks the patients, their caregivers, and the dedicated clinicians and research
co-ordinators who participated in this study. The Company will be
analysing the complete dataset with potential partners, and will determine
the
next course of action in the further development of Virulizinâ
for the treatment of this devastating disease.
Dr.
Bruce A. Silver, FACP, Vice President, Oncology, Global Product Development
Services, PRA International, was the CRO Medical and Safety Monitor for the
trial for the last three years and participated in the review of the top
line
results.
“The
preliminary review of the data is extremely encouraging that one or more
sub-groups of patients has benefited from Virulizinâ added
to gemcitabine. Our task now is to continue to perform the necessary
analyses and the immunologic correlations that will allow us to more precisely
define this population,” said Dr. Silver. “Performing such analyses to define
the specific population that benefits from modern oncologic therapies has
become standard operating procedure in contemporary cancer drug development
and is one more necessary step that will bring us closer to defining the
proper
role of Virulizinâ
in the management of this disease.”
Dr.
Donald P. Braun, Professor in the Department of Surgery and Administrative
Director of the Medical University of the Ohio Cancer Center, who participated
in the review of the top line results, said: “Virulizinâ
appeared to benefit pancreatic cancer patients with metastatic disease who
have
a good performance status. Because Virulizinâ
was well tolerated in these patients when given in combination with
chemotherapy, it would be appropriate to conduct further analyses with the
aim
of optimizing the drug in this sub-group of patients.”
Dr.
Jim Wright, CEO of Lorus, stated: “Lorus is committed to developing innovative,
well tolerated therapies for the management of cancer. We are
achieving this through the development of a broad diversified technology
base to
mitigate risks in the drug development process. Although we have not
reached statistical significance for the primary survival endpoint in this
Virulizinâ
trial, we are very encouraged with the initial results from the sub-group
analysis, and look forward to further analysis of the data from this trial,
including the complete audited dataset.”
Dr.
Wright added: “We also have two additional drugs in eight clinical trials, a
small molecule anticancer drug intended for clinical study, and an innovative
preclinical program that has identified additional anticancer drug candidates.
We have created a strong technology base to support success and further growth
of Lorus.”
Lorus
invites analysts and media to participate in a conference call today, October
18, 2005 at 2:00 p.m. Eastern N.A. time. Shareholders are invited to
listen to the call by telephone and the call will be available on the website
(http://www.lorusthera.com/) following completion. Dial in numbers are
below:
Toronto:
416-640-4127
Toll-free:
800-814-4860
Switzerland:
00 800 0022 8228
UK:
00 800 0000 2288
About
Pancreatic Cancer
Pancreatic
cancer is one of the most lethal human cancers and continues to be a major
unsolved health problem at the start of the 21st century. This is due to
the
disease’s cryptic presentation usually at advanced stage and the lack of
effective treatment. Despite efforts in the past 50 years, conventional
treatment approaches such as surgery, radiation, chemotherapy, or combinations
of these, have had little impact on the course of their aggressive
neoplasm. Therefore, continuing development of novel therapeutics for
the treatment of this type of cancer is important to improve patient
prognosis.
About
Virulizinâ
Virulizinâ
is a novel immunotherapy that stimulates a patient's innate immune system
through the activation of macrophages and the infiltration of NK cells into
tumors. Virulizinâ
has been awarded orphan drug, fast track status and a Special Protocol
Assessment (SPA) from the F.D.A. in the U.S.
About
Lorus
Lorus
is a
biopharmaceutical company focused on the development and commercialization
of
cancer therapies. 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, 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
development and marketing may be done in cooperation with strategic
pharmaceutical partners. Lorus currently has
three
products in human clinical trials with a pipeline of eight clinical trials
in
Phase II clinical trial programs and one Phase III registration clinical
trial.
Lorus Therapeutics Inc. is a public company listed on the Toronto Stock Exchange
under the symbol LOR, and on the American Stock Exchange under the symbol
LRP.
Virulizinâ
is a registered trademark of Lorus Therapeutics Inc.
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 forms, 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. Lorus Therapeutics Inc.'s press releases are
available through the Company's Internet site:
http://www.lorusthera.com/.