CereScan,® (CereHealth Corporation), a national network of functional brain imaging and analytics centers, have received approval of its Littleton, CO, location as a qualified imaging facility for a Sun Pharma Advanced Research Company (SPARC) sponsored Phase II, randomized, double-blind, placebo controlled study of K0706 in subjects with early Parkinson’s disease. CereScan will serve as the SPECT imaging center for Denver Neurological Research, the approved independent private clinical research site, which conducts Phase I through Phase IV trials and specializes in the neurosciences.
The study is conducted to evaluate the efficacy, safety, and tolerability of two doses of K0706 compared to placebo in subjects with early Parkinson’s Disease who are not receiving dopaminergic therapy. The interventional trial will evaluate the efficacy and safety of ABL tyrosine kinase inhibition using the K0706 pharmaceutical. The study is targeting 504 participants, including individuals diagnosed with “Clinically Probable PD” with documented onset of symptoms within three years of the screening.
Parkinson’s Disease a Growing Crisis
The Parkinson’s Foundation reports “nearly one million people will be living with Parkinson’s Disease (PD) in the U.S. by 2020,” which is more than the combined number of people diagnosed with multiple sclerosis and Lou Gehrig’s disease (or Amyotrophic Lateral Sclerosis). Direct and indirect PD costs total near $52 billion per year. There is no cure.
CereHealth CereScan Clinic Participation
CereHealth’s CereScan clinic in Littleton, CO, will provide scans of the participants’ brains using DaT SPECT, an imaging tool that shows the density of healthy dopamine neurons. The clinical investigational site contracted with the industry sponsor—SPARC—is Denver Neurological Research. CereScan introduces technology-driven automation and machine learning into imaging.
CereHealth Corp is a brain imaging and data analytics company with proprietary, scalable AI platform called CereMetrix®. The company positions itself as an emerging leader in multivariable analysis of quantitative biomarkers for central nervous system (CNS) disorders.
Who is Denver Neurological Research?
Denver Neurological Research is an independent, private clinical research site conducting Phase I through IV trials, specializing in the neurosciences. They are currently conducting clinical trials focusing on migraine, Parkinson’s Disease, Multiple Sclerosis and Alzheimer’s Disease/Dementia. Clinical investigators are Dr. Adam J. Wolff and Dr. Justin S. Moon.
What is K0706?
It is described as an orally bioavailable, Bcr-Abl tyrosine kinase inhibitor (TKI) with potential antineoplastic activity. Upon administration, Bcr-Abl kinase inhibitor K0706 selectively targets and binds to the Bcr-Abl fusion oncoprotein, including various Bcr-Abl mutant forms, such as those with the ‘gatekeeper’ resistance mutation T315I. This inhibits proliferation of Bcr-Abl-expressing tumor cells. The Bcr-Abl fusion protein is an aberrantly activated tyrosine kinase produced by certain leukemia cells. T315I, a threonine (T) to isoleucine (I) amino acid substitution at position 315 in the tyrosine-protein kinase ABL1 portion of the Bcr-Abl fusion protein, plays a key role in resistance to certain chemotherapeutic agents, and its expression is associated with poor prognosis.
Who is SPARC?
Based in India, SPARC is a clinical stage bio-pharmaceutical company focused on improving standards of care for patients globally. Formed in 2007 through a “demerger” from SUN PHARMA, a global leader in specialty generics, they focus on novel, branded new therapeutic targets in oncology, neuro degeneration, ophthalmology, dermatology and abuse deterrent formulations.
Call to Action: Interested in tracking this Phase II clinical trial—TrialSite News will be monitoring outcomes.