Download SaliMark™ OSCC

SaliMark™ OSCC
Investigator Meeting
Salivary Transcriptome Markers for
Oral Squamous Cell Carcinoma Detection
SaliMark™ OSCC
Study Organization
Sponsor: PeriRx, LLC
Chief Medical Office – Dr. Jack Martin
CEO – Stephen M. Swanick
PI:
Dr. Marc Surkin
Statistician/Regulatory Consultant:
Dr. Richard Chiacchierini Former Director FDA IVD
SaliMark™ OSCC
NIH & Salivary Dx: Vision & Investments
By 2013, determine the efficacy of using
salivary diagnostics to monitor health and
diagnose at least one systemic disease.
SaliMark™ OSCC
Tumors are known to produce mediators
(hormones/cytokines/lymphokines) that can
modulate the activities and gene expression
patterns of distal organs (salivary glands) through
the vasculature.
SaliMark™ OSCC
mRNA Markers for OSCC Initially Discovered 2004
Subsequently verified in multiple ethnic groups before
National Cancer Institute – Early Detection Research
Network Study
SaliMark™ OSCC
395 subjects studied by National Cancer Institute –
Early Detection Research Network
Conclusions:
The validation of these biomarkers showed their
feasibility in the discrimination of OSCCs
A prospective blinded trial was necessary
SaliMark™ OSCC
PeriRx Prospective Blinded Validation Study
•
Study Population (n=168) – 71% of patients with T1/T2 lesions
•
Highly statistically significant increase in all six pre-specified mRNA markers
(DUSP1, OAZ1, SAT, IL1B, IL8 and S100P, p <0.001 for all)
•
2 – nearly 4 fold increased levels
•
Five of 6 mRNAs significantly upregulated in dysplasia
•
Prior NCI Multi-marker Model Validated
•
New Highly Discriminatory Multi-marker Models Developed in Intended Use
Population of Patients with Suspicious Oral Lesions
•
Test score is based on a weighted average of the expression of 3 cancer genes
relative to “housekeeping” genes – “gene expression footprint”
SaliMark™ OSCC
PeriRx Prospective Blinded Validation Study
•
Study Population (n=168) – 71% of patients with T1/T2 lesions
•
Highly statistically significant increase in all six pre-specified mRNA markers
(DUSP1, OAZ1, SAT, IL1B, IL8 and S100P, p <0.001 for all)
•
2 – nearly 4 fold increased levels
•
of patients
T1/T2
lesions
Five71%
of 6 mRNAs
significantly with
upregulated
in dysplasia
•
Prior NCI Multi-marker Model Validated
•
•
Over 800 subjects enrolled in Clinical Trials of
NewSaliMark™
Highly Discriminatory
Multi-marker
Models Developed in Intended Use
OSCC
Biomarkers
Population of Patients with Suspicious Oral Lesions
Test score is based on a weighted average of the expression of 3 cancer genes
relative to “housekeeping” genes – “gene expression footprint”
SaliMark™ OSCC
How to Use the SaliMarkTM OSCC Test Score
The goal of salivary testing
Is to get appropriate patients
to specialists sooner
Lesion
Suspicious For
OSCC
SaliMarkTM
OSCC Test
Low Risk
Test Score:
Follow Up Within 4
Weeks
Moderate Risk
Test Score:
Second Opinion
from Specialist*
High Risk
Test Score:
Refer for Consideration
of Biopsy
*Specialist decision on biopsy and follow up to be based on quantitative
test score, physical examination and risk factors in medical history
(smoking, alcohol consumption, age, gender and ethnicity)
SaliMark™ OSCC
Dual Approval Pathway - We Need Additional Cases!
Current data supports CLIA Approved Laboratory Developed Test
Additional cases necessary to support FDA submission
SaliMark™ OSCC
Getting started
 Online CITI Program training course on ethical issues in research
required by IRB for one investigator in each practice
 Sign financial disclosure statement
 Sign contract with PeriRx, LLC
SaliMark™ OSCC
Exclusion Criteria
Inclusion Criteria
 18 years and older
 Oral lesion requiring biopsy
 Recently diagnosed OSCC not as yet treated
 Diagnosis of cancer within the last 5
years, excluding non-melanoma skin
cancer or OSCC within 2 years
 If > 5 years since other cancer
diagnosis, must be free of known
disease
& not on current treatment for
cancer
Enrollment as easy as spitting in a cup
 Prior Immunosuppressive therapy (in
last 2 months) or current autoimmune
disorder
Enrollment Tips  HIV or Hepatitis (in last 2 months)
 Review practice schedule on Fridays for potential cases
 Alert Priority Express Courier at 610-364-3300
(Available 24/7/365) OR Email if scheduled in advance at
[email protected]
Account Name: PeriRx, Account # 10277
 Physician support for the importance of this trial is key to successful enrollment
 Stress the noninvasive/painless nature of the study, the absence of risk and the
benefits
SaliMark™ OSCC
 Just Do It! – once you enroll the first patient the rest is easy
Saliva Collection Steps
• The patient should fast for 1 hour
• Have the patient rinse their mouth with water
• Collect 2 cc of saliva into Falcon tube (to top of
cone section)
• Label the tube with provided waterproof label
• The specimen is identified by the study ID (for
example - Surkin 001, 002, etc.)
• Place the capped tube in bag with ice
• Call the courier service
SaliMark™ OSCC
Conclusions
We Need
Additional
Subjects for
an FDA
Submission
SaliMark™ OSCC