VANCOUVER, Oct. 23 /PRNewswire-FirstCall/ -- AnorMED Inc.
(NASDAQ:ANOR; TSX:AOM) today announced that it has completed
enrollment in the second pivotal Phase III clinical trial
evaluating its proprietary product MOZOBIL in cancer patients, and
that the Company is on track to meet its schedule of releasing
top-line data from both Phase III trials in the first half of 2007.
If the Phase III trials are successful, it would be possible to
file for marketing approval with the United States Food and Drug
Administration (FDA) in the second half of 2007 and with regulators
in Canada and Europe in 2008. The Phase III trials are evaluating
MOZOBIL's capacity to improve stem cell transplantation treatment
options for multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL)
patients whose immune systems have a reduced capacity to generate
stem cells as a result of extensive chemotherapy treatments. The
second pivotal Phase III trial has enrolled 300 NHL patients and
the first pivotal Phase III trial met its enrollment target of 300
MM patients on July 10, 2006. Dr. Gary Calandra, Vice President
Clinical Development, said, "We are pleased that we've met our
enrollment timelines for both Phase III trials and that we are on
schedule for releasing top-line data in the first half of 2007. If
the studies are successful and confirm the positive findings from
our Phase II clinical trials, the Phase III data and other
supporting information could be ready for filing for marketing
approvals in the U.S. in 2007." The most recently enrolled patients
will undergo their transplants over the next four to six weeks and
each patient will be followed over a period of 100 days. The
results of the study will be unblinded for analysis after all MM
and NHL patients have completed their 100-day follow-up. The trials
design is in accordance with a Special Protocol Assessment from the
FDA. The two Phase III trials are being conducted at up to 45 major
centres in the U.S., Canada and Europe. Both trials are randomized,
double-blind, placebo-controlled, comparative trials of MOZOBIL
plus G-CSF versus placebo plus G-CSF, the current standard drug
used to stimulate additional stem cells within bone marrow. New
data from pre-clinical, Phase I and II clinical studies involving
MOZOBIL will be presented at the annual conference of the American
Society of Hematology (ASH) scheduled to be held from December 8 to
12, 2006 in Orlando, Florida. Abstracts for these presentations are
scheduled to be made public in electronic form by ASH on or about
November 15, 2006. About MOZOBIL MOZOBIL is a stem cell mobilizer
used in stem cell transplants, a procedure used to restore the
immune system of cancer patients who have had chemotherapy
treatments that previously destroyed their immune cells. MOZOBIL
works by triggering the rapid movement of stem cells out of the
bone marrow and into circulating blood. Once in the circulating
blood, the stem cells can be collected for use in a stem cell
transplant. In Phase II studies, MOZOBIL consistently demonstrated
the capacity to improve the harvest of stem cells from cancer
patients, resulting in an increase in the potential for these
patients to be able to undergo successful stem cell transplants.
The Company is also advancing a new program to evaluate MOZOBIL in
the treatment of leukemia. A majority of leukemia patients treated
with chemotherapy relapse and a growing body of evidence suggests
that this occurs because bone marrow provides a safe haven for
cancer cells. AnorMED's pre-clinical data shows that Mozobil has
the potential to mobilize cancer cells from the marrow of leukemia
patients and into their bloodstreams, where the cancer cells are
sensitive to chemotherapy. In the next few months, the Company
expects to initiate clinical studies for MOZOBIL for use to improve
the effectiveness of chemotherapy regimens used in the treatment of
certain leukemia patients. About AnorMED Inc. AnorMED is a
chemistry-based biopharmaceutical company focused on the discovery,
development and commercialization of new therapeutic products in
the areas of hematology, oncology and HIV, based on the Company's
research into chemokine receptors. The Company's product pipeline
includes MOZOBIL, currently in pivotal Phase III studies in cancer
patients undergoing stem cell transplants; AMD070, currently in
proof of principle Phase I/II studies in HIV patients; and several
novel classes of compounds in pre-clinical development that target
specific chemokine receptors known to be involved in a variety of
diseases. Additional information on AnorMED Inc. is available on
the Company's website http://www.anormed.com/. On September 5,
2006, AnorMED filed with the United States and Canadian securities
regulatory authorities a Directors' Circular and Tender Offer
Solicitation/Recommendation Statement on Schedule 14D-9 in
connection with the offer from Dematal Corp., a wholly-owned
subsidiary of Genzyme Corporation. On October 17, 2005, AnorMED
filed with the United States and Canadian securities regulatory
authorities a Notice of Change to Directors' Circular and an
amendment to the Tender Offer Solicitation/Recommendation Statement
on Schedule 14D-9. The Directors' Circular, as supplemented by the
Notice of Change, describes the reasons for the Board's
recommendation that shareholders accept the Genzyme Offer.
Investors and shareholders are strongly advised to read the
Directors' Circular, Notice of Change and Tender Offer
Solicitation/Recommendation Statements on Schedule 14D-9, as well
as any amendments and supplements to those documents, because they
contain important information. Investors and shareholders may
obtain a copy of the Directors' Circular and Notice of Change at
http://www.sedar.com/ and the Tender Offer
Solicitation/Recommendation Statement on Schedule 14D-9 and the
amendments thereto from the SEC website at http://www.sec.gov/.
Free copies of these documents can also be obtained by directing a
request to AnorMED's Secretary at Suite 200 - 20353 64th Avenue,
Langley, British Columbia, Canada V2Y 1N5; telephone (604)
530-1057. Other reports filed by or furnished by AnorMED to the SEC
and applicable securities commissions in Canada may also be
obtained free of charge at http://www.sec.gov/,
http://www.sedar.com/ or from AnorMED's Secretary. More information
about AnorMED is available online at http://www.anormed.com/. YOU
SHOULD READ THE DIRECTORS' CIRCULAR AND NOTICE OF CHANGE, OR THE
TENDER OFFER SOLICITATION/RECOMMENDATION STATEMENT, AS AMENDED,
CAREFULLY BEFORE MAKING A DECISION CONCERNING THE GENZYME OFFER.
FORWARD LOOKING STATEMENTS This news release contains
forward-looking statements within the meaning of the United States
Private Securities Litigation Reform Act of 1995, and forward
looking information within the meaning of applicable securities
laws in Canada, (collectively referred to as "forward-looking
statements"). Statements, other than statements of historical fact,
are forward-looking statements and include, without limitation,
statements regarding the Company's strategy, future operations,
timing and completion of clinical trials, prospects and plans and
objectives of management. The words "anticipates", "believes",
"budgets", "could", "estimates", "expects", "forecasts", "intends",
"may", "might", "plans", "projects", "schedule", "should", "will",
"would" and similar expressions are often intended to identify
forward-looking statements, which include underlying assumptions,
although not all forward-looking statements contain these
identifying words. By their nature, forward-looking statements
involve numerous assumptions, known and unknown risks and
uncertainties, both general and specific, that contribute to the
possibility that the predictions, forecasts, projections and other
things contemplated by the forward-looking statements will not
occur. We caution readers not to place undue reliance on these
statements as a number of important factors could cause our actual
results to differ materially from the beliefs, outlooks, plans,
objectives, expectations, anticipations, estimates and intentions
expressed in such forward-looking statements. Although our
management believes that the expectations represented by such
forward-looking statements are reasonable, there is significant
risk that the forward-looking statements may not be achieved, and
the underlying assumptions thereto will not prove to be accurate.
Forward-looking statements in this news release include, but are
not limited to, statements about: AnorMED's expectation that it is
on track to meet its schedule of releasing top-line data from both
MOZOBIL Phase III trials in the first half of 2007; AnorMED's plans
to file a NDA for marketing approval with the U.S. FDA in the
second half of 2007, and with Canadian and European regulators in
2008; AnorMED's expectation that it will present additional data
relating to MOZOBIL at the ASH conference to be held in Orlando,
Florida from December 8 to 12, 2006; AnorMED's expectation that it
will initiate clinical studies for MOZOBIL for use as a
chemosensitizer for treatment of leukemia patients; and AnorMED's
expectation that it can clinically develop its second product,
AMD070, now in Phase I/II clinical trials in HIV patients. With
respect to the forward-looking statements contained in this news
release, the Company has made numerous assumptions regarding, among
other things: AnorMED's ability to meet its schedule of releasing
top-line data from both MOZOBIL Phase III trials in the first half
of 2007; AnorMED's ability to file a NDA for marketing approval
with the U.S. FDA in the second half of 2007, and with Canadian and
European regulators in 2008; AnorMED's ability to present
additional data relating to MOZOBIL in December 2006; AnorMED's
ability to initiate its clinical studies for MOZOBIL for use as a
chemosensitizer for treatment of leukemia patients; and AnorMED's
ability to clinically develop its second product, AMD070, now in
Phase I/II clinical trials in HIV patients. The foregoing list of
assumptions is not exhaustive. Actual results or events could
differ materially from the plans, intentions and expectations
expressed or implied in any forward looking statements, including
the underlying assumptions thereto, as a result of numerous risks,
uncertainties and other factors including: AnorMED may not have the
ability to meet its schedule of releasing top-line data from both
MOZOBIL Phase III trials in the first half of 2007; AnorMED may not
have the ability to file a NDA for marketing approval with the U.S.
FDA in the second half of 2007, and with Canadian and European
regulators in 2008; AnorMED may not have the ability to present
additional data relating to MOZOBIL in December 2006; AnorMED may
not have the ability to initiate its clinical studies for MOZOBIL
for use as a chemosensitizer for treatment of leukemia patients;
AnorMED may not have the ability to clinically develop its second
product, AMD070, now in Phase I/II clinical trials in HIV patients;
AnorMED may not be able to develop and obtain regulatory approval
for MOZOBIL in stem cell transplant indications and any future
product candidates in its targeted indications; AnorMED may not be
able to establish marketing and sales capabilities for launching
MOZOBIL in stem cell transplant indications; the costs of any
future products in AnorMED's targeted indications may be greater
than anticipated; AnorMED relies on third parties for the continued
supply and manufacture of MOZOBIL; AnorMED may face unknown risks
related to intellectual property matters; and AnorMED may face
competition from other pharmaceutical or biotechnology companies.
Although we have attempted to identify the forward-looking
statements, the underlying assumptions, and the risks,
uncertainties and other factors that could cause actual results or
events to differ materially from those expressed or implied in the
forward-looking statements, there may be other factors that cause
actual results or events to differ from those expressed or implied
in the forward-looking statements. In addition to the
forward-looking statements and associated risks set out in this
news release, investors and shareholders are strongly advised to
refer to the additional assumptions and risks set out in the
section entitled "CAUTION REGARDING FORWARD-LOOKING STATEMENTS" in
the Company's Directors' Circular dated September 5, 2006,
available free of charge at http://www.sedar.com/ or from AnorMED's
Secretary. We undertake no obligation to revise or update any
forward-looking statements as a result of new information, future
events or otherwise, after the date hereof, except as may be
required by law. CONTACT: Company Contact: Kenneth Galbraith,
Chairman and Interim CEO, Tel: (604) 889-5320 or Kim Nelson, Ph.D.,
Manager, Investor Relations, Tel: (604) 532-4654, Email: ; Media
Contact: Karen Cook, James Hoggan & Associates, Tel: (604)
742-4252 or (604) 739-7500, Email: or Shafiq Jamal, Tel: (604)
742-4269, Email: DATASOURCE: AnorMED Inc. CONTACT: Company Contact:
Kenneth Galbraith, Chairman and Interim CEO, Tel: (604) 889-5320 or
Kim Nelson, Ph.D., Manager, Investor Relations, Tel: (604)
532-4654, Email: ; Media Contact: Karen Cook, James Hoggan &
Associates, Tel: (604) 742-4252 or (604) 739-7500, Email: or Shafiq
Jamal, Tel: (604) 742-4269, Email:
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