Mr. Thomas Smeenk reports

HEMOSTEMIX'S 4TH HEART STUDY PUBLISHED IN STEM CELL RESEARCH & THERAPY CONFIRMS BREAKTHROUGH TREATMENT FOR HEART DISEASE

Stem Cell Research & Therapy has published Hemostemix Inc.'s seventh peer-reviewed study of ACP-01 -- the third peer-reviewed study of ACP-01 as a treatment for heart disease (ischemic and non-ischemic dilated cardiomyopathy), which demonstrates ACP-01 regenerates and improves cardiac function by up to 24.1 per cent at 12 months in ischemic cardiomyopathy, and regenerates and improves cardiac function in non-ischemic cardiomyopathy patients by up to 47.1 per cent at 12 months (dLVEF per cent/iLVEF per cent).

Cardiomyopathy is chronic disease of heart muscle due to an acquired or hereditary condition. Ischemic cardiomyopathy is the most common form, resulting from inadequate blood flow to the heart, and affecting 2.5 million persons in the United States, with a mortality of 200,000 annually. Non-ischemic dilated cardiomyopathy -- due to autoimmune, infectious, infiltrative or familial (genetic) causes -- results in dilation and ineffectiveness of the heart wall, with a prevalence of approximately 400,000 persons in the U.S., annual mortality of 10 to 50 per cent and is a major cause for cardiac transplantation in children.

Stem cell transplantation is an emerging therapy for severe cardiomyopathy. Angiogenic cell precursors (ACP-01) are autologous cells (obtained from the patient in a simple blood draw), lineage-specific (programmed to form blood vessels), with strong potential to effectively engraft, and support tissue survival and regeneration.

This study, published in Stem Cell Research & Therapy, is an IRB-approved, peer-reviewed retrospective analysis of 53 adult patients who underwent endovascular implantation of ACP-01 through a catheter for treatment of ischemic cardiomyopathy and non-ischemic dilated cardiomyopathy. The study was not randomized. Cardiac function was assessed by measurement of the left ventricular ejection fraction (LVEF) -- the percentage of heart volume pumped out with each heart beat. A normal LVEF is 52 to 72 per cent in men and 54 to 74 per cent in women.

Four months after implantation of ACP-01, those patients with ischemic cardiomyopathy (n equals 41) improved by 4.7 per cent (p less than 0.004), and, by 12 months, the LVEF had increased from an initial 29.9 per cent to 38.2 per cent (p less than 0.004). The increase (dLVEF per cent/iLVEF per cent) represents an increase in cardiac function of 24.1 per cent at 12 months.

Improvements were more striking in the non-ischemic dilated cardiomyopathy subgroup (n equals eight) in whom LVEF increased by 7.5 per cent at four months (p less than 0.017) and 12.2 per cent at 12 months, from an initial 25.9 per cent to 38.1 per cent (p less than 0.003). The increase of LVEF in non-ischemic cardiomyopathy (dLVEF per cent/ iLVEF per cent) represents an increase in cardiac function of 47.1 per cent at 12 months.

The improvement was most marked in the patients with the most severe cardiomyopathy (LVEF less than 20 per cent), in whom there is a high risk of sudden death. In this group, the LVEF increased from 14.6 per cent before treatment to 28.4 per cent at 12 months.

Complications included one death from an unrecognized silent MI one month before treatment, two respiratory infections and two patients requiring cardioversion. There were no complications attributed to the ACP-01.

This study was not prospective and randomized. However, in the context of two previous studies of cardiomyopathy patients who underwent implantation of ACP-01 on a compassionate use basis, the significant results of this study provides a compelling impetus to proceed with a phase 2 randomized, prospective trial of ACP-01 for treatment of ischemic and non-ischemic dilated cardiomyopthy.

Published abstract

Methods: This IRB approved outcome analysis reports upon 74 consecutive patients who failed medical management for severe cardiomyopathy and were selected to undergo transcatheter intramyocardial or intracoronary implantation of ACP-01. Serious adverse events (SAEs) were reported. Cell analysis was conducted for each treatment. The left ventricular ejection fraction (LVEF) was measured by multigated acquisition scan (MUGA) or echocardiogram at four (plus/minus 1.9) months and 12 (plus/minus 5.5) months. Patients reported quality of life statements at six months (plus/minus 5.6 months).

Results: Fifty-four of 74 patients met requirements for inclusion (48 males, five females; age 68.1 plus/minus 11.3 years).The mean treatment cell number of 57 times 106 ACP-01 included 7.7 times 106 CD34 plus cells and 21 times 106 CD31 plus cells with 97.6 per cent viability. SAEs included one death (previously unrecognized silent MI), ventricular tachycardia (n equals two) requiring cardioversion and respiratory infection (n equals two). LVEF in the ischemic subgroup (n equals 41) improved by 4.7 per cent (plus/minus 9.7) from preprocedure to the first follow-up (four months plus/minus 1.9 months) (p less than 0.004) and by 7.2 per cent plus/minus 10.9 at final follow-up (n equals 25) at average 12 months (p less than 0.004). The non-ischemic dilated cardiomyopathy subgroup (n equals eight) improved by 7.5 per cent plus/minus six at the first follow-up (p less than 0.017) and by 12.2 per cent plus/minus 6.4 at final follow-up (p less than 0.003, n equals 6). Overall improvement in LVEF from preprocedure to postprocedure was significant (Fisher's exact test p less than 0.004). LVEF improvement was most marked in the patients with the most severe cardiomyopathy (LVEF less than 20 per cent) improving from a mean 14.6 per cent plus/minus 3.4 per cent preprocedurally to 28.4 per cent plus/minus 8 per cent at final follow-up. Quality of life statements reflected improvement in 33/50 (66 per cent), no change in 14/50 (28 per cent) and worsening in 3/50 (6 per cent).

Conclusion: Transcatheter implantation of ACP-01 for cardiomyopathy is safe and improves LVEF in the setting of ischemic and non-ischemic cardiomyopathy. The results warrant further investigation in a prospective, blinded and controlled clinical study.

"I want to thank the studies authors, including Jane R. Schubart, Amirhossein Zare , Roberto M. Fernandez-de-Castro, Hector Rosario Figueroa, Ina Sarel, Kelly Tuchman, Kaitlyn Esposito, Fraser C. Henderson Sr. and Ernst von Schwarz," stated Thomas Smeenk, chief executive officer. "This is our third peer-reviewed study of heart disease (41, 106 and 53 heart patients, respectively). Completed by three independent teams, each study confirms ACP-01 is a breakthrough treatment for ischemic and non ischemic cardiomyopathy."

Dr. Henderson., Hemostemix chief medical officer, commented, "This peer-reviewed study, though not prospective or randomized, provides clear data to suggest that transcatheter implantation of ACP-01 results in a significant improvement in cardiac function, especially in those most severely debilitated with very low left ventricular ejection fractions, and in those with non-ischemic dilated cardiomyopathy."

"The results of these three studies significantly derisk a phase II randomized clinical trial," stated Mr. Smeenk. "With it, we have attracted and assembled some of the most accomplished stem cell scientists, transplant surgeons and cardiologists at the McGill University Health Center, to complete this study. That will enable Hemostemix to make ACP available in the near future to the large number of patients suffering with cardiomyopathy," Mr. Smeenk said.

About Hemostemix Inc.

Hemostemix is an autologous stem cell therapy company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the company has developed, patented and is scaling a patient's blood-based stem cell therapeutics platform that includes angiogenic cell precursors, neuronal cell precursor and cardiomyocyte cell precursors.

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