Trial performed in conjunction with prestigious consortium of cancer specialists, co-funded by National Cancer Institute and the National Institute of Allergy and Infectious Diseases.
VICTORIA, Australia, Feb. 1, 2005--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 co-funded 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.”
For further information please contact:
Richard Williams, Chief Executive Officer, Norwood Immunology Limited
www.norwoodimmunology.com
+44 (0) 7860 295153
Lisa Baderoon, Mark Court, Mary-Jane Johnson, Buchanan Communications
+44 (0) 207 466 5000
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