Bone Biologics Advances Preparations for NB1 Pilot Clinical Trial with Engagement of Contract Research Organization
January 26 2023 - 8:30AM
Business Wire
Bone Biologics Corporation (NASDAQ: BBLG), a developer of
orthobiologic products for spine fusion markets, announces it has
engaged Avania as the contract research organization (CRO) for the
Company’s pilot clinical trial with NB1. Avania is an integrated
global, full-service CRO with specialized expertise in medical
devices, novel technology and drug-device combination products. The
trial will evaluate the safety and effectiveness of Bone Biologic’s
novel NB1 in patients with degenerative disc disease undergoing a
Transforaminal Lumbar Interbody Fusion (TLIF) procedure.
This multicenter, parallel group, randomized trial is designed
to evaluate the safety and preliminary effectiveness of NB1 bone
graft in 30 subjects with degenerative disc disease undergoing a
TLIF. The trial is expected to be initiated in the second half of
2023, pending approval from the Monash Health system ethics
committee in Australia.
For the NB1 bone graft device, the inclusion of rhNELL-1
provides an ancillary osteopromotive effect that is expected to
increase both the quantity and maturity of bone and to increase the
rate of spinal fusion. The proposed mechanism of action for
rhNELL-1 to improve bone formation is based on published research
and involves classic receptor binding and intracellular signaling
transduction to the nucleus to promote osteogenic gene expression
and bone formation.
“We are encouraged by our progress in advancing NB1 into human
testing and engaging Avania supports our plans to enter the clinic
later this year,” said Jeffrey Frelick, chief executive officer of
Bone Biologics. “We have been steadfastly preparing for this trial,
and engaging a prominent CRO builds upon the recent engagement of a
contract manufacturer and finalizing the supply agreement with the
carrier.”
About Bone Biologics
Bone Biologics was founded to pursue regenerative medicine for
bone. The Company is undertaking work with select strategic
partners that builds on the preclinical research of the Nell-1
protein. Bone Biologics is currently focusing its development
efforts for its bone graft substitute product on bone regeneration
in spinal fusion procedures, while additionally having rights to
trauma and osteoporosis applications. For more information, please
visit www.bonebiologics.com.
Forward-looking Statements
Certain statements contained in this press release, including,
without limitation, statements containing the words ‘'believes,''
"anticipates," "expects" and words of similar import, constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements involve both known and unknown risks and uncertainties.
The Company's actual results may differ materially from those
anticipated in its forward-looking statements as a result of a
number of factors, including those including the Company's ability
to develop our lead product NELL-1 and other proposed products, its
ability to obtain patent protection for its technology, its ability
to obtain the necessary financing to develop products and conduct
the necessary clinical testing, its ability to obtain Federal Food
and Drug Administration approval to market any product it may
develop in the United States and to obtain any other regulatory
approval necessary to market any product in other countries, its
ability to market any product it may develop, its ability to
create, sustain, manage or forecast its growth; its ability to
attract and retain key personnel; changes in the Company's business
strategy or development plans; competition; business disruptions;
adverse publicity and international, national and local general
economic and market conditions and risks generally associated with
an undercapitalized developing company, as well as the risks
contained under "Risk Factors" and "Management's Discussion and
Analysis of Financial Condition and Results of Operations" in the
Company's Form S-1, Form 10-K for the year ended December 31, 2021
and the Company's other filings with the Securities and Exchange
Commission. Except as required by applicable law, we undertake no
obligation to revise or update any forward-looking statements to
reflect any event or circumstance that may arise after the date
hereof.
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version on businesswire.com: https://www.businesswire.com/news/home/20230126005289/en/
LHA Investor Relations Kim Sutton Golodetz 212-838-3777
kgolodetz@lhai.com
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