sherman biotech. drug development for anxiety in fragile x and autism diagnostic test development...
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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) Autism (ASD)
Behavioral disorder, varying degrees of severity
Genetic (multiple chromosomes)
~1 in 200
Abnormal motor, sensory and communication
Anxiety
Other autistic behaviors
Behavioral disorder, varying degrees of severity
Genetic (X chromosome)
~1 in 2000
Abnormal motor, sensory and communication
Anxiety
Autistic-like 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
Anxiety areas in the brain
hippocampus
Small MoleculeCell-Cell Signaler
SB15
ANXIETYANXIETYDECREASED
Anxiety areas in the brain
hippocampus
Glutamate Small MoleculeCell-Cell Signaler
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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)
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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
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The Drug Development Process
Drug Discovery Completed
In Progress
6 - 9 Months
2 Months*
TASK STATUS
Optimize Delivery
Animal Studies
Human Studies
* Clinic identified Patients recruited
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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
Anxiety areas in the brain
hippocampus
Normal
Glutamate
Glutamatereceptor
FXMP
Signalenzymes
Protein
Fragile X
Diagnostic Test
SB15
IMPROVEMNET
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Diagnostic Development Process
Test Discovery Completed
In Progress
6 - 9 Months*
6 Months**
TASK STATUS
Laboratory Version
POC Version
OTC Version
* Pan Probe Inc
** Overlapping
SHERMAN BIOTECH
Drug and Diagnostic Development Expertise
David Schwartz, PhD, Chief Science OfficerDrug and Diagnostic Test Development Experience
Sam Hopkins, PhD, AdvisorDrug Development Experience (FDA Pre-Clinical)
Clive Taylor, MD, PhD, AdvisorChairman, 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, AdvisorDrug Development Experience (FDA Phase 1-3)