Capesaris is an oral selective estrogen receptor modulator (SERM) that GTx is developing as a first-line androgen deprivation therapy (ADT) in advanced prostate cancer. By utilizing this approach, GTx hopes that use will be devoid of many of the adverse effects of historical medical castration products such as diethylstilbestrol (DES, an estrogen replacement therapy), and the luteinizing hormone receptor hormone (LHRH) agonists that form the current standard of care. This report explores the validity of that premise, the probability of phase III success, the regulatory path to approval, and the market into which it will launch, if successful.

Published: December 26th, 2011

Number of pages: 35

Authors: Dr. Ellen Brady and Dr. Ilana Fogelman


TABLE OF CONTENTS:
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INTRODUCTION AND BACKGROUND
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1. Prostate cancer
- Epidemiology
- Clinical presentation, diagnosis, and staging
- Current treatments
2. GTX-758 (CAPESARIS)
- Preclinical data
- Clinical data

CLINICAL AND REGULATORY DISCUSSION
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1. What do (and don’t) the early data tell us?
2. Does the use of a selective ERα agonist make sense?
3. What is current FDA guidance relative to prostate cancer therapy?
4. What do precedents teach us?
- Leuprolide (Lupron Depot, Abbott)
- Goserelin (Zoladex, AstraZeneca)
- Degarelix (Firmagon, Ferring)
5. Other non-ADT agents used in advanced, metastatic disease
6. Are there class issues that warrant attention and concern?
7. What are the implications of this environment for GTx-758?

MARKET ISSUES
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1. Overview
2. Pipeline
3. Competitive issues/summary

SUMMARY OPINION