Bone Medical Receives FDA Confirmation For Clinical Trial Strategy For Osteoporosis Product

Main Category: Bones / Orthopaedics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 20 May 2008 - 1:00 PDT

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Bone Medical Limited (ASX:BNE) has received clarification from the US FDA for the pivotal trial necessary to obtain approval for its oral calcitonin product, CapsitoninTM.

After reviewing the data generated in Bone's recent Phase II study, the FDA has confirmed that CapsitoninTM is eligible for registration via a 505(b)(2) pathway. It has also confirmed that demonstration of non-inferiority to a current nasally-administered form should be sufficient to obtain approval.

On the basis of this guidance, Bone now intends to file an IND prior to commencing a Phase III pivotal study comparing several different dose levels of CapsitoninTM with a nasal version, administered as a capsule once daily.

Calcitonin has been used as a safe treatment for osteoporosis for many years as an injection and recently as a nasal form. Both have disadvantages with compliance when treating the elderly for a "rest of life" treatment.

Osteoporosis is a disease affecting 1 in 3 women over the age of 50 and up to 1 in 5 elderly men. It has been described as a "silent epidemic" due to aging western populations and the insidious painless destruction of the bone over many years in the elderly.

"This FDA communication defines the design of our further clinical studies so we can proceed rapidly into the final stages of getting our product approved for marketing," said Troels Jordansen, CEO of Bone Medical Limited.

About Bone Medical Limited

Bone Medical 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,

Osteoporosis

- Capsitonin™ oral calcitonin
- CaPTHymone™ oral parathyroid hormone
- bone cell regulators BN005 & BN008

Arthritis

- TNF regulators BN006
- joint protection & collagen tolerance BN007

http://www.bonemedical.com