- Identification of Therapeutic Mechanism is Major Milestone on Path to FDA Clearance
SAN DIEGO, Oct. 9, 2017 /PRNewswire/ -- BioTech Holdings announced today identification and patenting of a biological mechanism by which its ProCell stem cell therapy prevents limb loss in animal models of critical limb ischemia. The Company, demonstrated that treatment with ProCell resulted in more than double the amount of limbs saved as compared to standard bone marrow stem cell administration. Interestingly, neutralization of the molecule HGF resulted in reduction of therapeutic effect.
Critical limb ischemia is a condition, primarily in diabetics, that causes 250,000 amputations per year in the USA. At present there is no medical treatment for this condition and surgical approaches are applicable to less than half of patients.
ProCell is a personalized stem cell therapy using the an FDA approved peptide hormone to stimulate new blood vessel production in patients whose tissues lack oxygen, a condition termed “ischemia.” In addition to critical limb ischemia, lack of oxygen is associated with heart failure and stroke.
“The identification of HGF-1 as a mechanism by which ProCell mediates its therapeutic effects is a major step forward in our developmental path towards FDA IND filing,” said Thomas Ichim, Ph.D, President and CEO of BioTech Holdings. “We are aggressively filing intellectual property on this useful biomarker, which will assist us in optimizing doses as we enter formal clinical trials in the USA.”
BioTech Holdings previously reported efficacy signals in a pilot study of critical limb ischemia patients. The Company plans to file its Investigational New Drug application with the FDA before year end.
Contacts
Thomas E Ichim, Ph.D
President and Chief Executive Officer
BioTech Holdings
9255 Towne Centre Drive, #450
San Diego, CA 92121
179878@email4pr.com
858 353 4303
Twitter: @biotechholdings
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SOURCE BioTech Holdings
