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Improving Diabetes Therapy Through Advanced Insulin Design--DIABECORE MEDICAL INC

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Improving Diabetes Therapy Through Advanced Insulin Design--DIABECORE MEDICAL INC Powered By Docstoc
					DIABECORE MEDICAL INC.
Improving Diabetes Therapy Through Advanced Insulin Design

Company Description


Diabecore is a Toronto based company
Focus is new therapies for Diabetes Present activities are centred entirely on our new Hypoguard insulin

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The Medical Need -Insulin Therapy Is Lacking

Normalizing blood glucose with insulin is RARELY ACHIEVABLE because of hypoglycemia. A therapy that provides good glucose control while reducing hypoglycemic risk is needed. Our Hypoguard insulin is directed to this.

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The FDA & The Medical Need
“Severe hypoglycemia remains the biggest obstacle that diabetics face. A treatment which decreases the incidence of hypoglycemia is sorely needed”

(FDA Policy Statement)

Technology Description


Developed at the Hospital for Sick Children Hypoguard is a phosphorylated human sulin

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The phosphorylation produces a flatter ie safer dose response Target: The $7B Insulin Market

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INSULIN INJECTIONS - A RISKY BALANCE

VERY HIGH GLUCOSE

LOW INSULIN

VERY LOW GLUCOSE

INSULIN SLIGHTY HIGH

HYPOGUARD’S STEADY BALANCE

GLUCOSE IS NORMAL

HYPOGUARD VARYING BY 200%

GLUCOSE MODESTLY LOWER

4 Fold Higher HYPOGUARD

PLASMA GLUCOSE (mg/dl)

TIME (MIN)

IV BOLUS STUDIES - HYPOGUARD INSULIN MEAN + SEM, RESPONSES IN 5 DOGS
PLASMA GLUCOSE (mg/dL)
300
280

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Text and Table 240
220

260

200
180 160 140 120

100
80 60 40 20 -20 0 20 40 60 80 100 120 140 160 180 200 220

TIME (min)
CONTROLS
LOW DOSE 2X LOW DOSE 4X LOW DOSE

EUGLYCAEMIC CLAMP STUDIES DIABETIC DOGS MEAN / SEM N=5
25

GIR (mg/kg*min)
20

15

10

5

0 0 10 20 30 40 50 60 70

IIR (ng/kg*min)
INSULIN HYPOGUARD INSULIN

Mechanism of Action


Reduced maximal insulin pathway stimulation (phosphorylation). Target is confidential.

Diabecore’s Hypoguard Insulin
•Durable maintenance of near normal blood glucose concentration in diabetic dogs

•Hypoguard poses a 3.5-4 fold lower risk of hypoglycemia •No commercially available insulin has achieved such results in animals or in man.

Intellectual Property


ISSUED Patents: US, UK, Europe, Japan, Canada.



Most recent patent applications, 2006 - PCT & US. We enter national phase in December 2008

TIMELINES
YR 2008
3 6 9 12

YR 2009
3 6 9 12

MANUFACTURE

TOXICOLOGY

CTA SUBMISSION

PHASE I CLINICAL TRIALS

PHASE II A CLINICAL TRIALS

Diabecore’s Scientific Advisory Board
Dr. Lawrence A. Leiter, M.D. F.R.C.P., F.A.C.P.  Professor,University of Toronto, Endocrinologist, St.
  

Michael’s Hospital. Charles H. Best award for Distinguished Service in the Field of Diabetes Internationally recognized investigator in clinical diabetes. Extensive clinical trials with insulins and other phase II, III pharmaceuticals

Diabecore’s Scientific Advisory Board
Dr. Jean-Francois Yale, M.D., C.S.P.Q.


   

Director, Metabolic Day Centre, Royal Victoria Hospital (Montreal) & professor, Medicine and Nutrition and Food Science Centre, McGill University. Dr. Yale is an internationally published scientist in the field of diabetes. 1996-2003 chairman, Clinical Practice Guidelines for the Management of Diabetes in Canada Chairman (Clinical and Scientific Section), Canadian Diabetes Association (1992-1994). Dr. Yale has conducted ground breaking clinical studies on emerging therapeutics for diabetics and is the author of numerous important medical reviews (incl. Hypoglycemia)

Diabecore’s Scientific Advisory Board

Dr. Shinyo Ito, M.D.  Professor of Toxicology, University of Toronto, staff


toxicologist, Hospital For Sick Children, Toronto Dr. Ito has extensive experience in pharmacology as it related to drug development

Diabecore’s Management Team
William D. Lougheed, P.Eng. – CEO, President, Director
Former Scientific Investigator (Endocrinology) at Hosp. For Sick Children, discovered & developed Hypoguard insulin

Dr. Kusiel Perlman, M.D., F.R.C.P. –VP Scientific & Medical Affairs, Director
University of Toronto/Hosp. Sick Children. Distinguished career in insulin studies, clinical trials & pharmaceutical development

John Jeffries, B.A., M.B.A.- VP Business Development Director
20 years experience with emerging life science firms in areas of financing/investment and business development

The Market Opportunity


Medically recognized that diabetes is extremely difficult to manage well. Goal of lowering glucose back to normal is NOT ACHIEVABLE in the majority of patients Disease Complications are the result $7B world market

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The Investment Opportunity


$2.4M Private placement - $1.6M CDN of the subscription is unfilled



Use of proceeds – funding clinical trials & insulin manufacture

TIMELINES
YR 2008
3 6 9 12

YR 2009
3 6 9 12

MANUFACTURE

TOXICOLOGY

CTA SUBMISSION

PHASE I CLINICAL TRIALS

PHASE II A CLINICAL TRIALS

How to Proceed


Contact any of the following Diabecore representatives:
William Lougheed 416 484-8890 bill.lougheed@diabecore.com Dr. Kusiel Perlman kusiel.perlman@sickkids.ca

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Diabecore’s Competition


Existing insulin therapies (injection)

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-Unacceptable glycemic control Inhaled insulin (applicable to Hypoguard) Islet Transplantation Supply issues – donors can’t provide #’s Immunosuppression issues
Neuro-immunomodulating peptides Stem Cell Therapies long development time – major scientific hurdles

 

The Market Opportunity
Market Metrics
 

Over 200 million people have diabetes worldwide. Over 18 million diabetics in the US, over 2 million in Canada – over 6% of the population (and increasing).

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Approx. 1.5 million new diagnoses/year in Canada & US.
Fourth leading cause of death by disease in US, largely under-reported. Of people with diabetes for over 15 years only 38% have their disease under control (Canadian study).

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The Market Opportunity
The Clinical Need


Medically recognized that diabetes is extremely difficult to manage well. Goal of lowering glucose back to normal is NOT ACHIEVABLE in the majority of patients because it produces frequent and potentially fatal low blood sugar levels (hypoglycemia). The ensuing poor glucose control results in a greatly elevated risk of severe complications with associated increased mortality & lowered quality and duration of life. A therapy that provides better blood glucose control while reducing hypoglycemic risk is urgently needed to reduce the devastating effects of the disease.

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Lingjuan Ma Lingjuan Ma MS
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