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MEDIA RELEASE AND STOCK EXCHANGE ANNOUNCEMENT
19 July 2004
SUCCESSFUL COMPLETION OF PHASE I HUMAN TRIAL
BIOPHARMACEUTICAL development company Bone Limited
is pleased to announce it has
successfully completed the human Phase I component for its Oral Calcitonin
product, BN002.
The study confirmed the safety and tolerability of BN002 in human subjects.
The outcome of the clinical study represents a major step forward for
Bone in developing
product for early commercialisation and cashflow generation.
Bone is planning to list on the Australian Stock Exchange through a reverse
takeover of Revenir
Limited next month with a strategy of driving shareholder value through
striking early stage
joint ventures with major pharmaceutical manufacturers.
As a requirement of its stock swap with Revenir (ASX: REV), Revenir is
undergoing a capital
raising of up to $2.52 million through the issue of 4.2 million shares
at 60 cents each. Post
consolidation and capital raising the Company will have approximately
44.2 million ordinary
shares on issue.
Bone has several projects underway at various stages, some of which are
in the pre-clinical
animal and clinical human testing phase. The crucial point of difference
of Bone’s potential
treatments is that they can be administered orally rather than via injection,
infusion or nasal
spray.
BN002 Oral Calcitonin is Bone’s lead product and is designed to
treat the substantial and
growing number of people suffering globally from osteoporosis (currently
US$8.9 billion
annual drug expenditure per annum globally).
Calcitonin is a natural hormone that has been used to treat osteoporosis
by injection for over 25
years and more recently by nasal delivery. Currently total global sales
of calcitonin products are
approximately A$1 billion per annum.
Bone CEO Dr James Phillips said the completion of this Phase I study
was important for several
reasons.
“This is the first successful human trial result and represents
a significant milestone for the
company validating the safety and tolerability of BN002,” said
Dr Phillips.
“Additionally, the trial
is another significant step towards completing product development
and
our goal of achieving significant impact in the treatment of bone disease,” said
Dr Phillips.
After completing the reverse takeover of Revenir Limited, which will
change its name to "Bone
Medical Limited", it is expected to list on the ASX and commence
trading as Bone Medical
Limited under the symbol BML on 10 August 2004. Key Bone executives are
currently
conducting road show presentations in Sydney, Melbourne and Perth as
part of a book building
exercise for the capital raising.
Bone Limited
Bone Limited is an international biopharmaceutical development company
positioned to
exploit the growing market in the treatment of bone disease particularly
in osteoporosis and
arthritis. Bone has a portfolio of biopharmaceutical development projects
for the treatment of
bone disease including, Oral Calcitonin BN002, Oral Parathyroid Hormone
BN003, TNF
Regulators BN006, Bone Cell Regulators BN005/BN008 and Joint Protection & Collagen
Tolerance Programme BN007.
Bone has been granted exclusive licenses from three owned subsidiaries
of its controlling
shareholder, Proxima Concepts Limited (Proxima), for the intellectual
property of those
companies in the field of musculo-skeletal therapies.
For more information visit www.bone-ltd.com
Or contact:
John Fitzgerald
Chief Operating Officer Australia
+61 8 9355 5123
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