A Promise for Stroke Therapy June 2009 Non-confidential

1. A Promise for Stroke TherapyJune 2009Non-confidential

3. The Plasminogen Activator Inhibitor-1 (PAI-1) derived peptide (THR-18) is a modulator of thrombolysis for the treatment of embolic stroke.  Additional indications for the Thrombotech’s THR-18 peptide include: Acute Myocardial Infarction (AMI) (~900,000 patients/year) Pulmonary Embolism (PE) (~ 650,000 patients/year) Peripheral Arterial and Venous Occlusion (~1,000,000 patients/year).

4. When given together with current thrombolytic agents (tissue plasminogen activator , (tPA), or urokinase), THR-18 eliminated their adverse side effects and markedly extended their therapeutic time window. 

5. The Innovation Has Received Worldwide Recognition 

6. Solid proofs of:  Mechanism Principle Concept were established in in vitro & in vivo studies for the core technology Animal efficacy studies were conducted by three different independent laboratories, demonstrating efficacy and safety in different models and in various rodent and large animal species. Findings: Administration of THR-18 together with tPA to stroke-induced animal models markedly improved the clinical outcome in terms of mortality, infarct size, edema and the prevalence of intracranial hemorrhage. Extension of tPA therapeutic time window was demonstrated in a rat stroke thromboembolic model

7. Additional GLP toxicity tests Phase I study GMP production infrastructure Completion of the requirements for an IND submission

9. Approximately 750,000 patients suffer new ischemic strokes annually in the US; worldwide, the incidence of stroke is estimated to be between 2-2.5 per thousand. About 150,000 US patients die as a result of the disease as well as 4.5 million worldwide. The combined direct and indirect annual costs of stroke in the US are currently estimated to exceed $51 billion.

10. Despite a more-than-50-year effort to develop effective treatments, tPA remains the only FDA-approved treatment for acute stroke. In addition to its brief therapeutic window, the significant side-effects of tPA – which include symptomatic intra-cerebral hemorrhage (ICH) – have constrained its clinical use to only 3%-5% of patients.

11. Thrombotech is developing an innovative peptide that can address tPA’s unmet needs by extending its therapeutic time window and reducing its adverse side effects. Extending tPA’s therapeutic time window from 3 to 9 hours is expected to increase the tPA market from 3%-5% to 85% of the embolic stroke market

30. FDA offered unsolicited advice about the possibility of a single confirmatory pivotal study as part of the overall clinical development program. Based on this meeting, it is predicted that there would be no barrier to obtaining Fast Track designation. Thrombotech is pursuing an ‘Orphan’ product designation for a treatment within tPA’s therapeutic time window (up to three hours after stroke).

33. Former CEO and founder of PharmaSense Ltd., a biotechnological company that specialized in the treatment of CNS disorders. Postdoctoral positions:* National Institute of Neurological Disorders and Strokes at the National  Institutes of Health (NIH) Bethesda, Maryland. * The Molecular Genetics Department, Weizmann Institute of  Science, Ness Ziona, Israel. Ph.D. in Pharmacology, Faculty of Medicine, Unit of Pharmacology, Technion – Israel Institute of Technology, Haifa, Israel.

34. Former co-founder, chief technical officer and managing director of Bio Technology General Corp. CEO of Mediwound Ltd. (2000-2007)  Ph.D Weizmann Institute of Science, Rehovot, Israel

35. Former head of preclinical department at Biotechnology General Ltd., Kiryat Weizmann, Israel Director of Toxicology at Pharmos Ltd., Kiryat Weizmann, Israel. Ph.D. Weizmann Institute, Rehovot, Israel.

36. Thank YouItschak Lamensdorf, Ph.D.CEOitschak@thrombotech.com