Synergistic Advantages of Drug Repurposing and Clinical Trial Off-shoring to India

August 19, 2007

John Maki President and CEO

2

Pipeline of Cancer Products

2008

Product Indication

Pre-clinical

Proof-of-ConceptPhase 3Pilot Trial Phase 2

VT-122

Cachexia

VT-211

Mucositis

VT-310

Fatigue

3

Understanding Weight Loss

Weight Loss

Nutrition

Inflammation ANS Dysregulation

Neuro-endocrine-Immune activation

NutritionXSevere Stress

Chronic Acute

Cachexia

NSAID Beta Blocker

Anorexia

Malnutrition

Function Diet

Starvation

Slower Metabolism

SystemicInflammatoryResponse (SIRS)

Normal response to severe injury, trauma or infection

Faster Metabolism

4

Enrollment Criteria

•Rapid loss: >5% weight loss in 2 vs. 6 months

•Advanced cancer: Stage IV

•Elevated heart rate

•Able to eat food

Severe stress, not malnutrition driven cachexia

5

Confounding Variables

Single Multiple

On Some Very Many

Off Few Many

Cancer TypesTh

era

py S

tatu

s

6

Enrollment Challenges

Not On Chemotherapy

60

30

61.2 0.6

010203040506070

Su

bje

cts

Per

Sit

e

90+ sites required to enroll 45 subjects

7

Off Shore Development

•Population, practice patterns and participation

•12 to 18x more subjects per site2x+ times more patients per investigator3x+ more not on chemotherapy3x+ participation rates

•5 to 7 sites versus 90+ sites

•80% cost savings (fixed not variable costs)

Optimal enrollment AND low cost

8

Repurposing/Off shoring Synergy

•High standard of ethics combined with many years of clinical experience

•No first in human regulatory limitation

•Leverage 505(b)(2)

•Investigator experience with class of drug

•Access to drug, especially generics

Synergy Creates Practical and Ethical Option

9

Off Shoring Locations

Latin America

Eastern Europe

Africa

China

India

Considerations: Population, Capability, Risks, Language, Costs

10

India: Concentrated Population

Equivalent of entire US population In 31 major urban centers

11

India: Significant Capability

•300 plus experienced clinical sites

•Fully equipped with sponsor-initiated improvements

•International and Pan-Indian CROs

•Expedited approval for FDA-approved studies

12

India: Reduced Risks

•60% of the MNCs are conducting studies in India

•208 studies underway (49 P2 and 131 P3)

•100s of site “audits” by multiple sponsors/CROs

•Data from studies submitted to FDA and EMEA

•Two FDA and EMEA audits noted no serious findings

13

Vicus Infrastructure

RelianceMumbai

Vicus IndiaBangalore(2 staff)

ContractManufacturers

Vicus U.S.Newark/Delhi14 Hours(2 staff)

14

Vicus Clinical Sites

Nashik

Pune

Bangalore

Delhi

Kolkatta

Patna(Satellite)

5 sites + 1 satellite10 million population base

15

Cachexia Time Line

Q3 06 Q4 06 Q1 07 Q2 07 Q3 07

FDA Pre-IND3 months

Submit IND

Accept in23 days

Vicus Hire Indian CRO

Recruit sites

Recruit Indian team

DCGI SubmitAccept 6 weeks

IEC Submit Accept2-12 weeks

Subjects 20 9 (July)

16

Summary

•Off-shoring enables testing of repurposed drug hypothesis in human models

-Enables optimal clinical trial design to reduce risks

-Significantly improves recruitment rate and costs

•Repurposing synergy makes off-shoring practical

•India offers advantages – especially for start-ups

•Local presence and service providers key to success

•VT-122 provides proof-of-concept of advantage