Docstoc

SHERMAN BIOTECH

Document Sample
SHERMAN BIOTECH Powered By Docstoc
					SHERMAN BIOTECH

SHERMAN BIOTECH

• Drug Development for Anxiety in Fragile X and Autism • Diagnostic Test Development for Fragile X and Autism

SHERMAN BIOTECH

• Drug Development for Anxiety in Fragile X and Autism

SHERMAN BIOTECH

• Drug Development for Anxiety in Fragile X and Autism – Lead drug SB15

SHERMAN BIOTECH

Fragile X (FXS)
Behavioral disorder, varying degrees of severity Genetic (X chromosome) ~1 in 2000 Abnormal motor, sensory and communication Anxiety Autistic-like behaviors

Autism (ASD)
Behavioral disorder, varying degrees of severity
Genetic (multiple chromosomes) ~1 in 200 Abnormal motor, sensory and communication Anxiety Other autistic behaviors

“Most common known cause of autism”

SHERMAN BIOTECH

Anxiety in Fragile X and Autism
Significantly interferes with social development and learning Controlling anxiety can greatly improve therapies Current anti-anxiety drugs are broad acting and usually ineffective Valium, Prozac, amphetamines, anti-psychotics etc “Hit or Miss”, singly or in combination

Targeted drugs are needed
SB15 - a targeted “Glutamate Blocker”

Glutamate

Small Molecule Cell-Cell Signaler

hippocampus Anxiety areas in the brain

Glutamate

Small Molecule Cell-Cell Signaler

ANXIETY DECREASED
hippocampus Anxiety areas in the brain

SHERMAN BIOTECH

Summary
Glutamate transmits signals between nerve cells Glutamate is in parts of the brain that have a role in anxiety Uncontrolled Glutamate stimulation is associated with anxiety

SB15 blocks Glutamate and decreases anxiety

SHERMAN BIOTECH

SB15 Summary to date
• • Inhibits anxiety in animals and humans Mechanism of action is targeted and different from antidepressants, amphetamines antipsychotics etc Non-sedative, non-muscle relaxant, non addictive and no interaction with alcohol Easily synthesized ($ 0.1- 0.3 / dose)

•

•

SHERMAN BIOTECH

SB15 Challenges
Short life in blood, variation in patients

Solutions Exist
Controlled / Prolonged release capsules Targeted release to brain Skin patch development to prolong release Drug stabilization

SHERMAN BIOTECH

The Drug Development Process
TASK
Drug Discovery Optimize Delivery Animal Studies Human Studies

STATUS
Completed In Progress 6 - 9 Months 2 Months*
* Clinic identified Patients recruited

SHERMAN BIOTECH

Sales Projections*
Fragile X 100,000 diagnosed 50% will take drug $20 / day 50,000 x $20 x 365 = $365 M / yr.

Autism
1,200,000 diagnosed Off-label usage ?%

$20 / day
600,000 x $20 x 365 = $4,380 B/yr

Sherman Biotech will licenses the drug to a large pharmaceutical company for a percentage of gross sales. 10-15%

SHERMAN BIOTECH

Experienced Resources:
Albert Einstein Medical School, Columbia University Scynexsis Contract Research Laboratory Fragile X Clinic, Rush Medical School Fragile X Foundation

SHERMAN BIOTECH

•
•

Drug Development for Anxiety in Fragile X and Autism
Diagnostic Test Development for Fragile X and Autism
– Hospital Laboratory – Point Of Care – Over The Counter

SHERMAN BIOTECH

The Need for a Screening Test for Fragile X and Autism
• • • • • Diagnosis is based on complicated behavioral evaluation May be delayed 2-3 years after birth Can be confused with other disorders, e.g., ADD, ADDH etc Genetic test for fragile X is expensive, restricted and under-utilized Most families want to know* * Various studies

SHERMAN BIOTECH

Latest Research May Provide a Test

Glutamate: Chemical Signaler

hippocampus Anxiety areas in the brain

Glutamate

Glutamate receptor Signal enzymes

Diagnostic Test

FXMP

Protein

Normal

IMPROVEMNET Fragile X

SHERMAN BIOTECH

Diagnostic Development Process
TASK Test Discovery Laboratory Version POC Version OTC Version STATUS Completed

In Progress
6 - 9 Months* 6 Months**
* Pan Probe Inc ** Overlapping

SHERMAN BIOTECH

Drug and Diagnostic Development Expertise

David Schwartz, PhD, Chief Science Officer
Drug and Diagnostic Test Development Experience

Sam Hopkins, PhD, Advisor
Drug Development Experience (FDA Pre-Clinical)

Clive Taylor, MD, PhD, Advisor
Chairman, Department of Pathology, USC Medical School

SHUIJE CIU, MD,PhD
President, Pan Probe Inc

SHERMAN BIOTECH

Clinical Trial Expertise

Elizabeth Berry-Kravis, MD, PhD
Founder, Fragile X Clinic, Rush Medical Center

Sue Ellen Krause, PhD
Consultant, Fragile X Clinic, Rush Medical Center

Sam Hopkins, PhD, Advisor
Drug Development Experience (FDA Phase 1-3)


				
DOCUMENT INFO
Shared By:
Categories:
Stats:
views:42
posted:11/8/2009
language:English
pages:22