NORWOOD IMMUNOLOGY LIMITED ANNOUNCES
IND FOR BONE MARROW TRANSPLANT TREATMENT HAS BEEN
ACCEPTED BY FDA
Trial performed in conjunction with prestigious consortium of cancer specialists, cofunded
by National Cancer Institute and the National Institute of Allergy and Infectious
Diseases.
Norwood Immunology Limited ( Norwood Immunology or 'the Company') (AIM: NIM),
the company focused on the rejuvenation of the immune system, is pleased to announce that
the Investigational New Drug (IND) application, which was filed in December 2004, has been
accepted by the U.S. Food and Drug Administration (FDA). This IND relates to the
commencement of the Company s first autologous (self-derived) Bone Marrow Transplant
(BMT) trial (NIM-LETR-02) in the U.S.A. with our partner, TAP Pharmaceutical Products
Inc. (TAP).
As previously reported, Dr. Richard Champlin, at M.D. Anderson Cancer Center in Houston,
Texas, U.S.A., will be the Principal Investigator on this trial. A consortium of other leading
clinicians and pre-eminent institutions in the field of cancer will also be involved, including
both the Dana-Farber Cancer Institute and the University of Minnesota. This consortium is
led by Dr. Lee Nadler, of the Dana-Farber Cancer Institute Harvard Medical School and is cofunded
by the National Cancer Institute and the National Institute of Allergy and Infectious
Diseases.
Norwood Immunology believes that this trial will significantly advance scientific and medical
understanding of how to rebuild the immune system in life-threatening conditions, such as for
cancer patients requiring bone marrow (haemopoietic stem cell) transplantation following
chemotherapy/radiotherapy. The key endpoints in this study will be the determination of
immune responses to four vaccines, as an indicator of improved immune function in patients
undergoing an autologous BMT. It is expected that the Phase II, double-blind placebo
controlled study will commence treating the first enrolled patient within the next three
months.
A second U.S.A. BMT trial (NIM-LETR-03) in allogeneic (donor derived) BMT patients is
scheduled to start after the autologous trial is initiated. It is anticipated that this second trial
will commence in the second half of 2005.
Richard Williams, Chief Executive of Norwood Immunology, said: I am pleased to
announce that this important IND application relating to our first U.S.A. trial has been
accepted by the FDA. It is the culmination of strategic planning and efficient teamwork
between our partner, TAP, and our clinicians, with whom we will continue to work closely
with to ensure the earliest possible enrolment of patients.
Page 2
For further information on Norwood Immunology visit
www.norwoodimmunology.com
For further information please contact:
Richard Williams
Chief Executive Officer
Norwood Immunology Limited
+44 (0) 7860 295153
U.S. Investor and Media Contacts:
Bernie Romanin Lippert/Heilshorn & Associates, Inc.
Snr. VP Corporate Development Kim Sutton Golodetz
Norwood Abbey Limited ([email protected])
+61-3-9782-7333 212-838-3777
Bruce Voss ([email protected])
Michael Kotowicz 310-691-7100
RADAR Investor Relations Chenoa Taitt ([email protected])
+61-2-8256-3333 212-838-3777
www.lhai.com
Background:
Norwood Immunology has licensed its immunology intellectual property to TAP for
commercialization in the United States, utilizing TAP s GnRH analogue, Lupron Depot®
(leuprolide acetate for depot suspension). This combined initiative is exploring the use of
Lupron Depot in regenerating the thymus gland and in turn re-booting the body s immune
system, enabling patients to better recover from life-threatening diseases.
TAP Pharmaceutical Products Inc., located in Lake Forest, IL., U.S.A., is a joint venture
between Abbott Laboratories, headquartered in Abbott Park, IL., U.S.A ., and Takeda
Pharmaceutical Company Limited of Osaka, Japan. TAP currently markets Lupron Depot
and Prevacid® (lansoprazole). For more information about TAP and its products, please visit
the company s web site at www.tap.com.
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