MY5-FU ASSAY PROTOCOL

• One blood sample collected towards end of infusion.

• Sample injected with supplied stabilizer and sent to a clinical lab for analysis.

• Assay results used to adjust subsequent dose based upon published dose adjustment algorithm.

• Average of 3 adjustment cycles to reach optimal range. Periodic monitoring to ensure sustained optimal drug level.

The My5-FU Assay

REFERENCES

A: Adapted from Gamelin., J Clin Oncol, May 2008.

B: Gamelin, et al., J Clin Oncol 26:2099-2105, 2008.

C: Wilhelm, et al., CESAR Annual Meeting 2010.

D: Wenstrup, et al., Clin Colorectal Cancer, in press.

E: (1) de Gramont, et al., J Clin Oncol 18:2938-2947, 2000; (2) Saltz, et al.,

J Clin Oncol 26: 2013-2019, 2008; Cassidy, et al., J Clin Oncol 26:2006-

2012,2008; (3) Gamelin et al., ASCO GI, Abstract #356, 2009. Cost estimates

from Meropol, N.J. et al., J Clin Oncol 25:180-186, 2007; Wong, et al., ASCO

Annual Meeting, Abstract #3515, 2006 and internal estimates.

F: Gamelin, et al., J Clin Oncol 26:2099-2105, 2008; Gamelin, et al., ASCO

GI, Abstract #356, 2009; Capitain et al., ASCO GI, Abstract #429, 2008;

Eloxatin™ package insert: [Sanofi-Aventis, August 2002]; Camptosar® pack-

age insert: [Pfizer, March 2005].

116 Research Drive, Bethlehem, PA 18015 U.S.A.Tel:+610.419.6731 Fax:+610.849.5001

www.saladax.com

© 2011 Saladax Biomedical, Inc. My5-FU is a registeredtrademark of Saladax Biomedical Inc. All rights reserved. LIT 728-FNP-003, rev01 BECAUSE NO TWO PATIENTS ARE ALIKE.

BETTER EFFICACY

WITH FEWERSIDE EFFECTS

AT LOWER COSTS.

PERSONALIZEYOUR PATIENTS’

CAREWITH ONE

SIMPLE BLOOD TEST.

MY5-FU. APPLYING SCIENCE TO THE ART OF 5-FU DOSING.

IMPROVES OUTCOMES. REDUCES SIDE EFFECTS. LOWERS COSTS.

5-FU BSA-based dosing often results in inter-patient drug plasma

variability as high as 10-fold.

My5-FU reduces inter-patient pharmacokinetic

variability.

My5-FU reduces toxicity andimproves colorectal cancer treatment

at lower cost.

FIG. C

FIG.D

FIG. E

FIG. F

FIG. A

17%

68%

15% OPTIMAL THERAPEUTIC RANGE

TOO HIGH

TOO LOW5-FU

PLA

SMA

CO

NC

ENT

RA

TIO

N

FIG. B

• Toxicity • Premature treatment

termination• Compromised immunity• Higher treatment costs

• Lack of therapeutic response• Continued growth of cancer• Higher cost of recurrence

High Inter-Patient Variability ObservedConsistently in Evaluation Sites

5-FU Dose Management Improves FOLFOX Treatment Efficacy at a Lower Cost

5-FU Dose Management Substantially ReducesGrade 3/4 Toxicities*

Dose IntensityArm A (Fixed Dose) vs. Arm B (Adj Dose)

60

50

40

30

20-

10

0

AU

C m

g•h/

L

0 1 2 3 4

Cycle

50

40

30

20-

10

0

AU

C m

g•h/

L

0 1 2 3 4

Cycle

Num

ber

Of P

atie

nts

5-FU Weekly Dose (mg/m2)

Optimal AUC Range

Dose Adjustment Leads toMore Patients Within Target Levels

Optimal AUC Range