Lamiflo™ is a new approach to an old problem

Fifty years of research has not provided a single clinically neuroprotective treatment of ischemic stroke exemplified by large vessel occlusion (LVO) stroke, the most prevalent and devastating form of stroke with approximately 800,000 new first strokes/year in the US. However, this number pales in comparison to the number of Americans aged 65+: 46 million today, and 98 million projected by 2060 in whom Cerebral Small Vessel disease (cSVd) is the leading cause of cognitive decline; Vascular Dementia: 6-12 cases per 1,000 persons over 70 years per year; Alzheimer’s Disease; affects 5.7 million Americans today, projected to increase to 14 million by 2050; and Mild Cognitive Impairment (MCI),76 per 1,000 person/year. Cerebral Ischemia or low cerebral blood flow (CBF) unable to meet the oxygen and nutrient needs of the brain ultimately leads to edema and isolation of the perfusion of brain tissue by the opening of microvascular shunts (MVS) with no nutrient or oxygen delivery and permanent brain damage.

The time sensitive nature of treating post stroke demands we treat efficiently and effectively. Thrombolysis can be instituted within 4.5 hrs of stroke onset after qualification by imaging whereas Intra-arterial thrombectomy can be instituted for up to 23 hrs after stroke onset but again with imaging qualification. After safety validation, Lamiflo™ could increase the duration of the penumbra or decrease both the penumbra and core tissue volume and thereby increase the number of patients qualifying for both thrombolysis and thrombecomy treatments which is currently at 1.8-3.8% of the 800,000 acute strokes in the US.

Sharing a final common pathway of lowflow and microvascular shunts. There are no reliably proven treatments for these cerebrovascular diseases but they all share a final common pathway of low flow and microvascular shunt formation. The low flow state in brain capillaries reduces the shear rate on the capillary endothelium sensed by the glycocalyx on the endothelial wall which exquisitely regulates endothelial function and enzyme activities described in the the chart below.

Safety of Long-Term Lamiflo™. Chronic intravenous injection of Lamiflo 2-3 times a week and over several months;*

Inhibited development of atherosclerosis significantly reducing plaque deposition and atherosclerotic lesions in animal models of atherosclerosis in rats, rabbits and pigeons;
Injected at namomolar CONCENT-RATIONS UP TO 50 TIMES HIGHER than those causing acute hemodynamic effects with NO TOXIC EFFECTS
PEO 4000 used as an excipient in two parenteral formulations
PEO 3500 used orally for constipation in Miralax in US.

*Kameneva MV. Microrheological effects of drag-reducing polymers invitro and invivo. Intl J Engineering Science. 59(2012) 168-183.
*Greene et al (19080). Effect of drag reducing polymers on initiation of atherosclerosis. Polymer Engr Sci, 20,499-504.