SAN DIEGO, Oct. 25, 2017 /PRNewswire/ -- Biotech Holdings announced today a collaboration with Biorasi, a global CRO specializing in delivering Clinical Research Optimized™ and accelerated development of innovative therapeutics. As part of the partnership, Biorasi will provide regulatory and clinical trial support to Biotech Holdings as the Company advances its ProCell microbiome activated stem cell therapy through the FDA approval process.
"Biorasi is unique in its ability to apply a multidisciplinary, highly focused and goal-oriented approach during clinical trials in order to provide optimized results in an extremely accelerated manner. We are very eager to engage in this collaboration with a proven industry leader, and excited to take advantage of their TALOS™ platform for trial management and optimization," said Thomas Ichim, Ph.D, President and CEO of Biotech Holdings. "Given that Biorasi has a strong history in the Regenerative Medicine space, as well as ability to rapidly initiate and execute clinical trials, we are honored to partner with this organization in the development and eventual commercialization of Procell."
Biotech Holdings is the first company to utilize microbiome derived compounds to enhance the activity of stem cells. The Company is currently pursuing disease indications associated with deficient circulation such as critical limb ischemia and congestive heart failure. To date the Company has demonstrated efficacy in small animal trials and demonstrated preliminary safety in a pilot clinical investigation.
"We at Biorasi are eager to deploy our TALOS™ platform for industry leaders advancing development of novel means of treating human illness. It is our honor to participate in the development of the first stem cell therapeutic that harnesses the power of the microbiome," said Boris Reznik, Ph.D, Chairman of Biorasi. "The collaboration we are embarking on, if successful, will provide a new means of increasing the potency of stem cell therapeutics, which applies to almost unlimited areas of medicine."
About Biotech Holdings
Biotech Holdings was founded on technologies and patents developed by Dr. Amit Patel and Dr. Thomas Ichim focused on identifying interactions between gut bacteria (microbiome) and stem cells. The Company has identified several bacterially derived compounds that enhance stem cell activity and is applying these to chronic diseases associated with circulation deficiencies. Initial therapeutic indications the company is targeting are: Critical Limb Ischemia and Ischemic Heart Failure. The Company has 10 patent applications filed covering stem cell modulation, augmentation, and differentiation by bacterial compounds.
About TALOS™:
TALOS™, Biorasi's groundbreaking clinical research optimization platform, guides our clinical project teams to deliver Clinical Research Optimized™ in the most challenging trials using a data-driven approach to trial management. Using innovative systems, supported by best-in-industry training and a culture that embraces growth and ownership, TALOS™ guides Biorasi towards success in the most challenging clinical trials.
About Biorasi:
Biorasi is an award-winning Clinical Research Optimized™ CRO. From study design to execution success, optimization is ingrained in TALOS™, the most robust and innovative trial management and optimization platform in the industry. Equipped with TALOS™, Biorasi's full-service project teams have help pharmaceutical companies around the world develop numerous drugs, biologics and devices approved by the FDA, EMA and other regulatory agencies. Founded in 2002, Biorasi is headquartered in Miami, FL and has regional offices and operations across North America and around the world. It has been featured on the Inc. 500 list of the fastest growing US companies, and has received multiple awards for quality and service in pharmaceutical development.
Contacts
Thomas E Ichim, Ph.D
President and Chief Executive Officer
BioTech Holdings
9255 Towne Centre Drive, #450
San Diego, CA 92121
[email protected]
858 353 4303
SOURCE Biotech Holdings
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