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Acqui∫ci

400 4th Avenue

Belmar, NJ  07719

(732) 280-8425

Research@acquisci.com


Business Summary

AcquiSci Inc. is a privately held company whose corporate mission is to identify, acquire and develop undervalued and promising emergent medical technologies to commercial fruition.  AcquiSci has recently acquired a device-based proprietary multi-therapeutic platform; doseable-Oxidative Stressed Autologous Blood (d-OSAB), a systemic anti-inflammatory treatment of cardiovascular diseases wherein inflammation is an underlying etiology.  The Company’s initial clinical targets are Ischemic Brain Stroke (IBS) and Chronic Heart Failure (CHF), two inflammatory-based diseases with few viable treatment options. d-OSAB is based on a traditional therapy, OSAB-uc (for uncontrolled dosing), which has been in use for more than 20 years and generated a safety profile of non-toxicity in more than five million treatments delivered to more than 350,000 patients. However, OSAB-uc does not measure, or control, dosing and therefore does not have FDA or European regulatory clearance.  Hence, commercialization of OSAB-uc has been rendered impossible. d-OSAB represents a novel re-engineered formulation of this traditional therapy including a patented therapeutic-contact device, among other proprietary advantages allowing for precise dose measurement and control.

 

Clinical Target Background

   Stroke

Stroke is the second leading cause of death worldwide, responsible for more than 4.4 million deaths each year. Annually, more than 1.7 million people in the U.S. and Europe are stricken by stroke. According to 2005 American Heart Association statistics, 7.6 percent of ischemic stroke patients die within 30 days, 25% die within one year, and more than 50% of surviving patients are left with permanent disabilities that require nursing home or other long-term care. Currently the only FDA-approved therapeutic for treating Ischemic Brain Stroke patients is Tissue Plasminogen Activator (tPA), a “clot-busting” drug manufactured by Genentech Inc. and cleared by the FDA in 1995. However patients are eligible for tPA only within three hours from the onset of stroke; tPA use after three hours causes bleeding in the brain which may prove fatal. Consequently, only about 6% of stroke patients in the U.S. and less than 1% of stroke patients in Europe may be treated with tPA.

 

   Chronic Heart Failure

For more than five million American Chronic Heart Failure (CHF) patients there are no FDA-approved, long-term solutions that reverse deterioration, other than transplantation, and more than 300,000 deaths in the U.S. alone are linked to CHF each year. In September 2006, Vasogen Inc. released Phase III data on its 2400-CHF-patient ACCLAIM trial that utilized an oxidative-induced apoptotic cell therapy substantially similar to d-OSAB. Results indicate that 26% of treated Class II and III patients with no prior history of heart attack experienced a statistically significant reduction in risk of death or cardiovascular hospitalization.  Further, data evidence a 39% reduction in risk of death or first cardiovascular hospitalization in treated Class II heart failure patients. Although repeat studies with a homogenous patient base are required for FDA compliance, this data suggests that this therapeutic approach is a best-in-class treatment for CHF.

 

For CHF patients, it is widely recognized that chronic inflammation plays a major role in the typical progression of continually declining health that results in increased frequency of hospitalization and premature death. The Company believes its d-OSAB technology will be effective in treating inflammation related to CHF and produce beneficial results rapidly and effectively.

 

As a result, d-OSAB addresses the need for viable and regulatory-approved treatments for stroke and CHF; markets that exceed $20 billion annually in the U.S. and Europe.


d-OSAB Proposed Mechanism of Action

Ischemic Brain Stroke is caused by a blocked blood vessel that deprives surrounding tissue of blood and therefore oxygen.  Lack of oxygen causes this compromised brain tissue to swell and send out acute inflammatory cytokines which worsen the problem by further reducing blood flow and enlarging the oxygen-starved, swollen area. The two key goals of effective stroke treatment are to reduce inflammation and swelling, and restore blood flow and oxygen to compromised tissue.  d-OSAB targets both of these problems by halting production of pro-inflammatory cytokines while simultaneously stimulating production of anti-inflammatory cytokines; the result, a powerful, fast-acting, systemic anti-inflammatory effect that reduces inflammation and swelling.

 

d-OSAB technology involves passing a small volume of autologous blood through a patented therapeutic-contact device that precisely measures and controls the oxidative stressing of the blood, causing leucocyte apoptosis while maintaining the integrity of remaining cellular and proteinaceous constituents.  The treated blood is intravenously returned to the patient, wherein interaction between infused apoptotic leucocytes and a mosaic of target effector cells result in the net release of anti-inflammatory cytokines thereby producing a powerful and fast-acting anti-inflammatory response in inflamed, swollen tissue.

 

In clinical studies, OSAB therapy produced a 75% increase in brain blood flow and rapid, significant increases in oxygen levels to oxygen-starved tissue. In an unpublished study of 45 stroke patients treated with OSAB therapy, patients experienced rapid recovery from paralysis, cognitive deficit and slurred speech; recovery was generally observed to occur within 15-30 minutes of treatment. 

 

Based upon the significant safety profile of OSAB; the expansive volume of in vitro and in vivo studies evidencing the anti-inflammatory potential of infused apoptotic calls; and, to confirm these anecdotal therapeutic stroke findings, d-OSAB has received IRB and regulatory permission to commence a Phase IIa study in the treatment of acute ischemic stroke patients at a major University Hospital-based neurological Institute in Asia.