Hemostemix's ACP-01 dementia trial to be led by Shankle

Executive Summary

• Hemostemix Inc. announced that Dr. William R. Shankle will lead the Phase I clinical trial of its investigational cell therapy, ACP-01, for the treatment of vascular dementia (VaD).
• The Phase I protocol has been submitted to an Institutional Review Board (IRB) for ethical review; initial comments have been addressed, and the revised protocol is being resubmitted for final approval.
• Dr. Shankle is prescreening up to 30 patients from his database of approximately 500 individuals with cognitive impairment to identify candidates primarily suffering from vascular-origin conditions for potential enrollment.

Key Details

• Lead Investigator: Dr. William R. Shankle, MS, MD, FACP, a neurologist specializing in cognitive disorders and founder of The Shankle Clinic in Newport Beach, Calif.
• Trial Phase: Phase I clinical trial.
• Indication: Vascular Dementia (VaD).
• Drug/Therapy: ACP-01 (Angiogenic Cell Precursors), an autologous, blood-derived cell therapy designed to promote angiogenesis and microvascular repair.
• Regulatory Status: Protocol submitted to IRB; initial comments received and addressed; revised protocol pending final IRB approval.
• Recruitment Strategy: Dr. Shankle is reviewing a database of ~500 patients with cognitive impairment to prescreen up to 30 patients with primarily vascular-origin conditions for the trial.
• Study Objectives: Assess safety, feasibility, and preliminary efficacy of ACP-01 in patients with vascular contributions to cognitive impairment.
• Company Background: Hemostemix Inc. is an autologous stem-cell therapy platform company founded in 2003. It has completed seven clinical studies involving 318 subjects, with results published in 11 peer-reviewed publications. ACP-01 is currently approved for other indications (e.g., peripheral arterial disease, chronic limb threatening ischemia) but is not FDA or Health Canada approved for vascular dementia.

Notable Quotes

• "Across his more than 35 years of medical practice, Dr. Shankle has been featured in numerous clinical programs and public education initiatives dedicated to the prevention, early diagnosis and management of cognitive decline," stated Thomas Smeenk, chief executive officer.
• "As a leader in this filed, he has approximately 500 individuals diagnosed with cognitive impairment, and is identifying and prescreening up to 30 patients whose condition is primarily vascular in origin to enrol in the trial."