Subject to FDA approval, CVBT
anticipates commencement of the Phase III trial for CVBT
-141B in 2011.
Daniel Montano, chief executive officer of CVBT, said that the Phase II clinical data, in conjunction with additional unpublished pre-clinical data CVBT obtained in the licensing agreement, clearly support the company's belief that CVBT-141B is a promising wound-healing drug candidate, both in efficacy and safety.
While CVBT is presently focused on seeking accelerated approval of CVBT-141B for diabetic wounds, it is also planning to expand the use of this drug candidate to other wound healing indications including venous stasis ulcers, surgical wounds, and burns, Montano continued.
According to the Nature article, unlike most biotech companies, CVBT
began creating its commercialization strategy very early on in the drug development process.
The study will provide much needed information for the development of a protocol utilizing FGF-1 to treat hypoxic/ischemic disc disease," said Daniel Montano, Chairman of CVBT
In addition to addressing the clinical needs of patients and physicians, CVBT
is seeking to address the healthcare value needs of payers by ensuring that CVBT
-141H is cost-advantageous.
had the option to engage many parties including investment bankers, we chose to instead work with BGI, for three key reasons.
We are also excited that in the Phase II trial we will use a less invasive, catheter drug delivery system, distributed by Biologics Delivery Systems Group, Cordis Corporation, who has worked closely with CVBT
in clinical site selection and the Phase II clinical protocol design.
is a biopharmaceutical company developing drug candidates with FGF-1 as their active pharmaceutical ingredient (API) for diseases characterized by inadequate blood flow to a tissue or organ.
is focused on further developing formulations of the protein drug candidate, human fibroblast growth factor 1 (FGF-1) that Dr.
We are thrilled to be recognized by Pharmaceutical Executive magazine for our work in the field of angiogenesis therapy," said Dan Montano, CEO, CVBT
The completion of this research marks the initiation of a new initiative by CVBT
to develop FGF-1 as a new treatment for osteoporosis.