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Apoptosis: Promise or deception?

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Published Date May 7, 2005
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Quick Overview

In this publication, BioSeeker Group analyzes the latest progress made for 25 drug candidates targeting the cell death pathway, apoptosis. Additionally, more early stage candidates are also under investigation, which brings the total number of companies interested in this field to around 40.

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Executive Summary

In this publication, BioSeeker Group analyzes the latest progress made for 25 drug candidates targeting the cell death pathway, apoptosis. Additionally, more early stage candidates are also under investigation, which brings the total number of companies interested in this field to around 40.

The five major targets in apoptosis, p53, Bcl-2, TRAIL, IAP and Caspases, are the corner stones for further analysis in study to address whether they are successful cancer therapeutic targets or not and what level of competition is present. Only p53 and Bcl-2 are apoptotic targets with drug candidates that have reached Phase III clinical testing, although death receptors "TRAIL" are closing the gap. BioSeeker projects that the competition targeting the IAP family of molecules will be intense and Caspase inhibitor will take a year or two to reach clinical tests.

Apoptosis is central to the development of cancer and resistance to apoptosis has been attributed as a reason to why cancer therapies fail. A contributing factor for investing R&D in the cell death pathway is that apoptotic drugs add sensitization to chemotherapy and radiotherapy. Novel treatments have been designed to modulate apoptosis, using traditional small molecular drugs as well as modern biotechnology tools such as gene therapy, monoclonal antibodies, antisense, biological drugs and peptide/non-peptide mimetics.

In a relative short time more than 40 therapeutic companies have taken up the cell death pathway as an important target to kill cancer cells. Some have already candidate drugs in clinical trials, but the gross majority is still in a very early stage of development and has not yet presented any further information. To include these new entrants BioSeeker has relied on available patent information to further understand what the future holds in store, and what kind of research the pharmaceutical industry is interested in.

Because the mechanism of apoptosis started to be unraveled quite recently even the most advanced novel therapies are still only at the clinical trial stage. This including new approaches on the tumor-suppressor protein p53, a target that attracted many investigators years ago.

Although attempts to counteract defective p53 with gene therapy and oncolytic virus have met mixed result, BioSeeker Group has listed no less than 16 companies that conduct R&D on p53. One of the newer approaches that is about to revive the view on p53 are small molecular drugs that act as scaffold for p53/DNA and Mdm2/p53 interaction.

Genasense (Genta Inc, USA), the first oncology drug of its kind to directly target the biochemical pathway of apoptosis, has also experienced difficulties after completing Phase III trial in several indications. Its NDA was rejected by FDA for the treatment of patients with metastatic melanoma. However, this incidence has not stopped other investigators from applying and pursuing similar strategy. No less than nine companies are today actively working on to improve the antisense line of attack on apoptotic targets.

TRAIL, IAP and Caspases as molecular targets have taken a step forward. Positive news includes antisense drugs that offer a way around drug resistance. Monoclonal antibodies against TRAIL receptor have reached Phase II. Several candidate drugs targeting members of the IAP family of molecules are now in Phase I trial. BioSeeker list additional drugs involving Caspase which are expected to advance to clinical trials within a year or two.

Companies included
Abbott laboratories, Aegera, Amgen, Antisoma, Apoxis, Aprea AB ArQule, AVI BioPharma, Biomeasure, Bristol-Myers Squibb, Cambridge Antibody Tech, CEREP, Chroma Therapeutics, Cyclacel, Cyclis, De Novo, Eli Lilly and Company, Exelixis, Gemin X Biotechnologies, Genentech, Genta, Hoffmann-La Roche, Human Genome Sciences, Hybridon, Idun Pharmaceuticals, Incyte Genomics, Introgen Therapeutics, ISIS Pharmaceuticals, Kirin Brewery, Maxim Pharmaceuticals, Millennium Pharmaceuticals, Molecular Engines Laboratories

Key findings

Introduction

Figure 1. Generalized illustration, depicting the key elements involved in the apoptotic pathways.

Table 1. Common gene/protein defects in apoptotic pathways and associated mechanism

Multipathway Regulators

Table 2 Overview of Apoptosis Targets Under Development

Projects on the p53 Pathway Increasing Again

Box 1. The Agreement Between Sanofi-Aventis and Introgen Therapeutics

Table 3. Overview of p53 Based Therapies in Clinical Trial

New Attention to p53 Gene Therapy

Activating p53 with Small-Molecule Drugs

Are p53-MDM2 interacting peptides the future?

Will 2nd generation of antisense that targets mdm2 deliver?

Drug discovery to develop inhibitors of the p53-MDM2 interaction

The importance of Aurora Kinase inhibitors

The Bcl-2 Pathway: Antisense versus New Approaches

Table 4. Overview of Bcl-2 and Bcl-XL Based Therapies in Clinical Trial

Has Genasense Lost its Sting?

Box 2 The Collaboration Between Genta and Aventis

Improved Bcl-2 Antisense Takes Off

Peptides and Small Molecules Mimics: Option to Bcl-2 Antisense

Other Drugs Mediating a Bcl-2 Pathway-Induced Cell Death

Death Receptors a Powerful Way To Apoptosis

Table 5. Overview of Death Receptor Based Therapies in Clinical Trial

Monoclonal Antibodies Towards TRAIL Receptor: Expanded Clinical Trials

A Soluble Form of TRAIL Finally in Phase I trial

Attempts Made for Fas Ligand System

Time Ripe for Inhibitors of Apoptosis Proteins

Table 6. Overview of IAP Based Therapies in Clinical Trial

Way Around Drug Resistance

Survivin: Cell Death Inhibitor Or Not? Still an Excellent Target

Smac/Diablo: Peptides and Small Molecule Mimetics

Modulators of the Caspase Pathway on Way

Table 7. Overview of Caspase Based Therapies in Clinical Trial

Companies with Focus on Caspase

Newly Discovered Compound Affecting the Activity of Caspases

Appendix A Company Profiles

Abbreviation List

- Abbott laboratories
- Aegera
- Amgen
- Antisoma
- Apoxis
- Aprea AB ArQule
- AVI BioPharma
- Biomeasure
- Bristol-Myers Squibb
- Cambridge Antibody Tech
- CEREP
- Chroma Therapeutics
- Cyclacel
- Cyclis
- De Novo
- Eli Lilly and Company
- Exelixis
- Gemin X Biotechnologies
- Genentech
- Genta
- Hoffmann-La Roche
- Human Genome Sciences
- Hybridon
- Idun Pharmaceuticals
- Incyte Genomics
- Introgen Therapeutics
- ISIS Pharmaceuticals
- Kirin Brewery
- Maxim Pharmaceuticals
- Millennium Pharmaceuticals
- Molecular Engines Laboratories

Request Sample Pages or Access via 1stOncology™

  • You can request Free Sample Pages to Apoptosis: Promise or deception?.
    To find out more about Apoptosis: Promise or deception?, please read the product description below.
    We also are happy to email you out free sample pages which contain screen shots and more information on the methodology behind the product.

    Did you know that Apoptosis: Promise or deception? is part of the 1stOncology™ platform and can be accessed at no extra cost?

    1stOncology™ allows you to always stay on top of what is really going on in the world of cancer drug development and have an edge when it comes to Search & Evaluation, Indication Selection & Expansion, Target Scouting, First-in-Class analysis and much, much more.


    Or

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