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[biotech-news] Bone Care International Announces Advancement of LR-103 Into Human Patients With
Bone Care International Announces Advancement of LR-103 Into Human
Patients With Stage 5 Chronic Kidney Disease
- New Vitamin D Hormone Replacement Therapy for Chronic Kidney
Disease -
Following the successful filing of the Investigational New Drug
(IND) Application in March, 2005, Bone Care International (Nasdaq:
BCII - News) announces plans to move the novel Vitamin D hormone, LR-
103, into human subjects with Chronic Kidney Disease (CKD).
The recently accepted IND focuses on the use of LR-103 to treat
secondary hyperparathyroidism in patients with CKD. Data available
from pre-clinical research indicate that LR-103 has the same potency
as calcitriol, but much lower toxicity. "Early safety data from an
ongoing Phase I clinical study with LR-103 in cancer patients
support the expanded testing of LR-103 in patients with chronic
kidney disease," said Charles W. Bishop Ph.D., Chief Scientific
Officer at Bone Care International. The initial study with LR-103 in
CKD will be a Phase I/II dose-ranging efficacy and safety study in
patients with Stage 5 CKD or end-stage renal disease. Additionally,
a separate study is being planned to study LR-103 in earlier stages
of CKD.
According to the National Kidney Foundation, more than 20 million
Americans have CKD and an additional 20 million are at risk.
About Bone Care International
Bone Care International (http://www.bonecare.com) is a specialty
pharmaceutical company engaged in the discovery, development and
commercialization of innovative therapeutic products to treat the
unmet medical needs of patients with debilitating conditions and
life-threatening diseases. Our current commercial and therapeutic
focus is in nephrology, utilizing Hectorol®, a novel vitamin D
hormone therapy, to treat secondary hyperparathyroidism in patients
with moderate to severe chronic kidney disease and end-stage renal
disease. In addition to chronic kidney disease, the company is
developing vitamin D hormone therapies to treat hyperproliferative
disorders such as cancer and psoriasis.
Contact:
Bone Care International, Inc.
Brian J. Hayden
Chief Financial Officer
(608) 662-7800
This press release contains forward-looking statements. Statements
relating to future sales, costs of sales, other expenses,
profitability, financial resources, or products and production
schedules, or statements that predict or indicate future events and
trends and which do not relate solely to historical matters identify
forward-looking statements. Forward-looking statements are made
pursuant to the safe harbor provisions of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934 and are based on management's beliefs as well as
assumptions made by and information currently available to
management. Accordingly, the Company's actual results may differ
materially from those expressed or implied in such forward-looking
statements due to known and unknown risks and uncertainties that
exist in the Company's operations and business environment,
including, among other factors, the ability of the Company and each
of its suppliers of doxercalciferol, Hectorol® Injection and
Hectorol® Capsules to meet the Company's anticipated production
schedules, technical risks associated with the development of new
products, regulatory policies in the United States and other
countries, risks associated with our ability to avoid or minimize
delays in/or interruption of the manufacture and supply of our
products, including the approvals of regulatory authorities in
connection therewith, reimbursement policies of public and private
health care payors, introduction and acceptance of new drug
therapies, competition from existing products and from new products
or technologies, the failure by the Company to produce anticipated
cost savings or improve productivity, the timing and magnitude of
capital expenditures and acquisitions, currency exchange risks,
economic and market conditions in the United States, Europe and the
rest of the world, and other risks associated with the Company's
operations. The Company disclaims any obligation to update any such
factors or to publicly announce any revisions to any of the forward-
looking statements contained herein to reflect future events or
developments.
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Source: Bone Care International
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