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 July 2004 (v04-n07)
Main Story - pgs. 1-16 Valentis
Macro Market Commentary - pgs. 17-20
Biotech Monthly Coverage Update - pg. 21-28
NIBM Model Portfolio - pg. 29
(Full outline below...)

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Valentis, located in Burlingame, CA, has a great deal going on in the form of products and corporate alliances, but only their Phase II trial for their lead drug Deltavasc (VLTS-589) is responsible for their recent increase in stock price. The company will release top-line data on this Phase II trial at the end of September. We will focus this issue almost exclusively on the Deltavasc product since it is the driver of the company’s valuation.

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Deltavasc is gene therapy. This comes with all the baggage that any gene therapy drug comes with. However, there are important differences that separate Deltavasc from other types of gene therapy.

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The following is an outline of this issue of the NIBM Newsletter.
Main Story - Valentis (VLTS)
Introduction
Table: Basic facts on Valentis
Disclosures
Investment Case
Peripheral arterial disease
Symptomology
Intermittent claudication
Treatments
Exercise
Pentoxifylline (Trental)
Cilostazol (Pletal)
Naftidrofuryl
Others
 
Ischemic heart disease
 
Deltavasc
Del-1
VEGF
The package
Staying put
Manufacturing
Side effects
Phase I trial
Phase II / DELTA-1 trial
Patients
Trial mechanics
Statistical considerations
Peak Walking Time
September Data Report
Clinical pathway
Competition
Ad5FGF-4 (GENERx)
Partnership
 
Other programs
IHD trial
Outlicensed technology
Table: Valentis outlicensing deals
 
Capital structure

What Can Go Wrong

Table: Valentis selected Milestones

Macro Market Commentary - "Slip-sliding away"

Biotech Monthly Coverage Updates

Dendreon
Graphic: Atrasentan M00-211 ITT analysis of TTP
Graphic: Atrasentan Meta-analysis TTP
Timeline delays
Forbes Medi-Tech
Indevus
Seattle Genetics
ID Biomedical
Clinical path
Table: FluINsure clinical pathway timelines
Investment case
Table: ID Biomedical summer/fall 2004 news flow
Introgen
Genta

NIBM Model Portfolio Performance

 
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