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Angiogen LLC

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Angiogen's cocktail produces Angiostatin4.5 is produced naturally 'in vivo' Angiogen combines existing FDA approved drugs in a novel 'Cocktail' ... – PowerPoint PPT presentation

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Title: Angiogen LLC


1
ANGIOGEN LLC
  • Gerald A. Soff M.D.
  • Mark G. Arizmendi

2
Angiogen LLC
  • Angiogen is a Chicago based biotechnology firm
  • Founded to developing novel cancer therapies
    using FDA approved drugs in an Angiostatic
    Cocktail
  • Angiogenesis Inhibitor therapies for cancer are
    scientifically proven and sound
  • 4.0 billion in Research and Development has
    attracted 200 biotech and pharmaceutical
    companies
  • Clinical trials are supported by Genentech
  • Broad patent coverage
  • Angiogens therapy produces the desired protein
    to inhibit cancer in vivo

3
Cancer Statistics
  • Approximately 1.3 million people are diagnosed
    with cancer in the United States each year
  • Approximately 50 of those diagnosed have solid
    tumors
  • Approximately 550,000 people in the US die
    annually from metastatic cancer

4
Existing Cancer Therapies
  • Typical approach combination of chemotherapy,
    radiation, surgery
  • Surgery is invasive
  • Chemotherapy and radiation have severe side
    effects
  • Varying degrees of effectiveness
  • Mortality rates are high in advanced cases

5
Scientific Overview Angiogenesis
  • New blood vessel formation
  • Induction of a new blood supply
  • Promoted by growth factors
  • Focal point of ongoing cancer research

6
The Competitions Approach to Vascular Tumors
  • Targeting vascular endothelial growth factor
    (VEGF)
  • VEGF is emitted by oxygen deprived cells and
    mutating cancer cells
  • Potential resistance to VEGF therapy
  • Other growth factors
  • Selective targeting (the needle in a haystack)
  • Failed trials and recombinant proteins in vitro

7
Angiogens Approach
  • Angiostatin is a proven and potent angiogenesis
    inhibitor
  • Angiogens cocktail produces Angiostatin4.5 is
    produced naturally in vivo
  • Angiogen combines existing FDA approved drugs in
    a novel Cocktail
  • FDA approvals may be quicker
  • Broad based therapy

8
Angiogens Technique Target the Endothelial
Cells
  • Angiostatin4.5 targets endothelial cells
  • Endothelial cells naturally respond to
    Angiostatin
  • Genetically normal
  • Replicating the bodys own cancer fighting
    mechanism instead of exogenous production of
    inhibitory proteins

9
The Angiostatic Cocktail In Vivo Generation Of
Angiostatin4.5
  • The key components of the Angiostatic Cocktail
  • Tissue Plasminogen Activator or Urokinase
  • Free Sulfhydryl Donor
  • Angiostatin generated directly in the blood
  • Replication of natural Angiostatin generation
  • Angiogens broad patent

10
Preliminary Human Results With Angiostatic
Cocktail
  • 2001 Pilot Study 8 patients
  • Terminal cancer patients who had failed
    conventional radiation and chemotherapy
  • A phase 1 trial has been completed at
    Northwestern to determine the optimal dose and
    schedule

11
Administration Of Angiostatic Cocktail Generates
Angiostatin In The Blood Of Cancer Patients
12
Angiogens Advantage
  • Transforming Technology
  • Only one competitive anti-angiogenic drug has
    been approved
  • Angiogen is directly targeting the endothelial
    cells
  • Pervasive therapy
  • Potentially Short Time To Commercial Success.
  • FDA approved agents are used in the Angiostatic
    Cocktail
  • Angiogen has to show efficacy of the Cocktail
  • The FDA does not recognize the cocktail as a new
    chemical entity. Good manufacturing processes
    and safety are already proven.

13
Angiogens Advantage
  • The founder is world renowned in
    anti-angiogenesis research and application
  • Angiogen has a broad patent
  • The main Phase I trial is underway
  • The preliminary Phase I trial elicited positive
    data
  • Genentech and Northwestern University support
  • Broad range of metastatic cancer with a large
    potential market

14
Does it Work? Case Study 1 14 Yr Girl With
Ewings Sarcoma
  • A 14 year old girl, with relapsed Ewings
    Sarcoma, was treated with the Angiostatic
    Cocktail
  • The girl had failed all conventional therapy
    (chemo, radiation, transplant)
  • Was treated with the Angiostatic Cocktail and
    achieved a complete remission
  • Relapsed due to inability to continue treatment

15
CT ScansA 14 Yr Girl With Ewings Sarcoma
6 Weeks of Treatment (Tumor Liquefaction)
Prior to Treatment
At 12 Weeks. No Evidence Of Disease.
16
Valuation and Capitalization
  • Angiogen is seeking 5,000,000 in 2004 for
    Research and Development expenses for the next 2
    years
  • These funds will allow Angiogen to develop the
    Angiostatic Cocktail
  • Licensure will be made when optimal for
    investors and The Company

17
Projected Timeline and Milestones
  • 1996 Original patent application filed
  • 1998 First patent granted
  • 1999 Angiogen LLC formed
  • 1998-2001 The Angiostatic Cocktail is
    administered to patients on a compassionate use
    basis
  • 2001-2003 Preliminary Phase I
  • 2003 Second patent granted
  • 2004 Phase I commenced at Northwestern
    University Memorial Hospital
  • 2005-2006 Phase II expected to commence
  • 2006-2007 Phase III begins, if necessary
  • 2007 Angiogen intends to sign a licensing
    agreement or merge with a major biotech or
    pharmaceutical company

18
Pro Forma Income Statement
  • All dollars amounts in thousands
  • 2003 2004 2005 2006 2007 2008
  • Revenue 0 0 900 900
    7,413 24,640
  • COGS 0 107 270 3,381 13,249 19,324
  • Operating Expense 0 202 369 766
    1,430 2,324
  • Pre-Tax Net Income 0 ( 309)
    261 (3,247) ( 7,266) 2,992
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