Cytorex Biosciences, Inc.
This presentation describes Cytorex
Bioscience, Inc.; a Florida based preclinical
stage Biopharmaceutical Company
developing new therapies based on its
expertise in pharmacologically active low
pH acidic formulations.
Cytoreg®, the Company’s lead drug
candidate, is currently in preclinical
development for various cancers.
• In 2007, worldwide sales of cancer therapies
totaled USD $42.2 billion.
• Within the 7 major markets (US, Japan, France,
Germany, Italy, Spain, and the United Kingdom),
sales amounted to USD $34.3 billion.
• These sales are expected to grow at a
compound annual growth rate (CAGR) of 12%
between 2006 and 2013, almost 3 times faster
than the pharmaceutical industry as a whole,
reaching USD $55 billion by 2012.
• Cytorex intends to initially focus development
efforts of Cytoreg® on cancer types with high
levels of unmet need: Glioblastoma Multiforme
(grade IV brain tumor); pancreatic cancer; and
• Cytoreg® may also be developed for brain
metastases. These four cancer types have low
survival rates, are currently underserved with
existing marketed therapies and have few
• Cytorex has developed a number of therapeutic
candidates based on its US patented
pharmacologically active low pH acidic technology
for a wide range of disorders, including cancer and
diseases of immunological origin.
• Cytoreg® is Cytorex lead drug candidate and is the
primary focus of this presentation.
• Cytoreg®, a novel cancer therapeutic candidate, is a
formulation of balanced acids, where hydrofluoric
acid (HF) is the key active ingredient.
• Cytoreg® may be used to treat several types of
cancers, including solid tumors and hematological
PRODUCT STAGE APPLICATION
Cytoreg™: Development Currently in preclinical development stage
for these indications: 1) Brain Tumors
(Glioblastoma Multiforme); 2) Pancreatic
Cancer and 3) Metastatic Melanoma (skin
cancer). Also being investigated in brain
CytoregUNO™ Development skin cancer such as basal cell cancer,
squamous cell cancer, sarcoma,
melanoma, and disorders caused by fungi,
viruses and bacteria on the skin.
CytoCardio™ Discovery Product for treatment of hypertension
CytoKStones ™: Discovery Product for treatment of Kidney Stones
CytoNeuroSys™ Discovery Product for treatment of MS, Alzheimer’s,
Parkinson’s, and chronic diseases like
CytoOS™ Discovery Product for treatment of Otosclerosis
CytoDiabet™ Discovery Product for treatment/regulation of
CytoAntioxidant™ Discovery Antioxidant
CytoHormone™ Discovery Product for treatment of hormonal disorders
Selectivity and MOA
• Preclinical studies in Glioblastoma Multiforme and other
cancer cell types have demonstrated that Cytoreg® has
high specificity and selectivity in targeting and inhibiting
cancer growth, as well as inducing selective apoptosis.
• Mechanisms of action studies have also been performed
to understand how Cytoreg® kills cancer cells. These
studies have demonstrated that Cytoreg®: disrupts the
cell membrane in brain cancer cell lines; acts
independently of the tumor suppressor gene p53 and
caspase cascade pathways; inhibits cancer cell growth
factor; and induces selective apoptosis.
Key product advantages
• A targeted therapy with multiple
mechanisms of action.
• Demonstrated potential to reduce
tumor mass and/or stops tumor
growth or even destroys the tumor.
• Favorable side effect profile, as
demonstrated in human
compassionate use program and in
preclinical studies performed to date.
• Very low manufacturing costs.
Clinical Development Plan &
• The Company expects that Cytoreg® will be brought to market
at a much faster pace than typical oncology products by
targeting indications with high levels of unmet need, including
Glioblastoma Multiforme; pancreatic cancer; and metastatic
• By focusing on these indications, Cytoreg® will be a candidate
for Fast Track and Orphan Drug designations, and potentially
accelerated approval by US Food & Drug Administration
• Our initial plan is to perform some preliminary clinical trials in
Latin America, get approval for at least two indications, and
then start the FDA/EMA approval process.
• If Funding is sufficient we may choose to initiate Clinical Trials
directly in the USA.
• Cytorex believes the Company’s intellectual property
(IP) position is secure. The Company has one issued
patent (US patent 7,141,251, “Pharmacologically
Active Strong Acid Solutions”) containing over 70
claims related to composition and therapeutic use.
• Cytorex has developed a detailed patent prosecution
strategy to further enhance its IP position in the US
and worldwide. Cytorex’ IP estate has been reviewed
by Mr. Michael Keller, Esq. Mr. Keller has over 20
years’ experience prosecuting biomedical drug,
diagnostic and device patents.
• Prof. David Martucci, Chairman, President, Chief
Executive Officer and Chief Scientific Officer
• Mr. William Jimenez, Director, Vice-President,
Treasurer and Chief Financial Officer
• Mr. Carlos M. Garcia, Director, Secretary & Chief
• Mr. Ramon Alvarez, Business Development
• Dr. Kris Dhandapani, Scientific Consultant
• Mr. Michael J. Keller, Intellectual Property
• Dr. Kris Dhandapani, PhD, Assistant Professor, Neurology Department,
Institute of Molecular Medicine and Genetics, Medical College of
Georgia. Research Interest: Brain Cancer Tumors & Brain Injuries.
• Dr. James Kumi-Diaka, DVM, PhD, Prof. of Cancer Biology (Florida
Atlantic University, Davie FL). Research Interest: Molecular Biology &
• Dr. Manzur Hassanhi, MD, Professor of Immunology (University of
Zulia, Venezuela). Research Interest: Clinical Oncology.
• Dr. Nelson Vicuña, MD, Professor of Toxicology (University of los
Andes, Merida, Venezuela), Research Interest: Toxicology &
• Dr. Paula Durante, PhD, Biological Research (Private Consulting)
Research Interest: Physiology and Cellular Biochemical Mechanisms
• Dr. Rosa de Jesús, PhD (University of Los Andes, Merida, Venezuela)
Research Interest: Animal Models
Cytorex Biosciences, Inc.
Carlos M. Garcia, Managing Director & COO
4474 Weston Road No. 108
Weston, FL 33331