SONO-PHOTODYNAMIC THERAPY

HYPERTHERMIA

&

ANTONIO JIMENEZ

M.D.

42nd ANNUAL CANCER CONVENTION 2014, CANCER CONTROL SOCIETYHope4Cancer Institute | Baja California | Mexico

OTHER TREATMENTS

Why Is It Important to Integrate Multiple Therapies Against Cancer?

• Multiple functional characteristics and an inherent survival instinct gives cancer cells a distinct ability to evade and develop resistance against targeted treatment such as chemotherapy and radiation.

• In most cases, cancer grows as a result of multiple influences over a period of time. Integrative medicine goes beyond treating the manifestation (symptoms), and focuses on treating the causes.

The Seven Hallmarks of Cancer

Eighth Hallmark: Inflammation

Our Multidimensional Approach

to Cancer Treatment

The Seven Key Principles of Cancer Therapy

Non-Toxic Cytolytic

& Cytostatic Therapies

Enhance & Optimize

the Immune System

Full Spectrum Nutrition

Detoxification (Heavy Metals & Toxins)

Eliminate Microbes

& Pathogens

Oxygenation

Spiritual & Emotional Integrity

Non-Toxic Cytolytic

& Cytostatic Therapies

OUR SELECTION CRITERIA FORNON-TOXIC CANCER

THERAPIES Non-toxic therapies, safer to normal cells and

that do not harm vital, healthy organs

None or very few side effects

Clinically demonstrated to target cancer cells, including metastatic ones

Avoids stimulating existing cancer stem cells

Stimulates (does not suppress) immune system

Improve quality of life and prolonged health

Enhance & Optimize

the Immune System

+

Sono-Photo Dynamic Therapy(SPDT)

How Does SPDT Work?

                                                  

Cancerous tumor cells are illuminated (orange). This picture was taken 24 hours

after treatment with our Sensitizer.

                                           

Cancerous Tumor cells (orange)72 hours after treatment with our Sensitizer,

showing massive cell death.

Tissue Culture

Photoluminiscence Studies

d2 d2

d8 d8

d8 d8

SDT treated (T) Control (C)

T C

On d8, the tumor in control mouse was very huge. The tumor invaded into muscle and sternum, and resulted in malignant ascites.

 

On d8, the tumor in SDT treated mouse was confined in the original site without ascites.

Animal Study

Sono Dynamic Therapy

Portable Ultrasound Device for

Sono Dynamic TherapyPortable Pulsed LED Pad for

Photo Dynamic Therapy

Intranasal Light

Photo Dynamic Therapy

Aspects to the Effects of Photo Dynamic Therapy (PDT) on the Immune

Response against Cancer

• PDT Induces production of anti-tumor inflammatory immune system cells.

• PDT generates long-term anti-tumor immune response.

• Phototoxic damage (to cancer cells) creates the inflammatory stimulus.

Agarwal et al., 1993 Yamamoto et al., 1991

Hyperthermia(Local & Whole

Body)

What Is Hyperthermia?• In hyperthermia, body tissue is exposed to high

temperatures (as high as 105 oF). Research has shown that high temperatures can damage and kill cancer cells, with minimal injury to normal tissues.1

• There are two types of hyperthermia: local, which treats small areas of tissue and whole body, that treats the entire body.

• In the non-toxic cancer therapy protocols at Hope4Cancer, we have found that hyperthermia helps to synergize the effect of other cancer treatments while having powerful anti-cancer effect of its own.

• Hyperthermia has also shown the ability to stimulate the immune system into action.

1. Hildebrandt B, Wust P, Ahlers O, et al. The cellular and molecular basis of hyperthermia. Critical Reviews in Oncology/Hematology 2002; 43(1):33–56.

How Does Hyperthermia Work?

Healthy cells have a large negative potential – meaning that cells have a larger net negative charge inside them relative to the outside environment.

Cancer cells have a smaller negative potential, which means that the extracellular fluid around it resonates and hence experiences greater heating effect at a ~10 MHz radiofrequency.

How Does Hyperthermia Work?

This vibration is strong enough to destroy the cell. The destruction of the cancer cells awakens of immune system and stimulates it into

action.

How Does“INDIBA”

Hyperthermia Work?

The cell temperatures are raised by passing radiofrequency through electrodes

placed above and below the area to be treated waves at a particular frequency tuned to the radiofrequency at which the intracellular fluid

in cancer cells vibrate.

Clinical Outcome Studies at

Hope4Cancer Institute

(SPDT + HT)

CLINICAL PARAMETERSWhat Do We Observe to Measure Short-Term Success

Providing short-term successes is an important step towards securing long term gains for cancer patients, especially in highly advanced cases. These are some parameters that we observe to measure improvement:

TUMOR HYPERVASCULARITY. Tumors form small blood microvessels that grow and connect to the body’s nutrient supply (angiogenesis). Reversing tumor blood supply can starve the tumors and eventually kill them. Tumor blood flow can be measured using Color Doppler Ultrasound techniques.

CHANGES IN THE TUMOR. As the patient’s prognosis improves, they start showing changes in their tumors. These changes could include development of necrosis (caused by cell death), reduction in tumor size, changes in consistency (typically becoming softer and less dense).

QUALITY OF LIFE. Maintaining a high quality of life is a signature of our therapies since they are designed to selectively attack the cancer, while we improve the conditions in the body improving the feeling of “well being”. Quality of life can include a range of parameters, the most important being energy level, appetite and reduction in specific symptoms.

ANGIOGENESIS IN TUMORS

Demographics of Study:  • 100 random patients (admitted between Jan ‘12 – Jun ‘14)• Age Range: 36 – 80 years• Main Therapy: Sono-Photo Dynamic Therapy+ Hyperthermia• Duration of stay at clinic: 3-4 weeks• Average reduction in hypervascularity: 48% observed within 3-

4 weeks of treatment at Hope4Cancer.

Male Female0

10

20

30

40

50

60

70

36.3

63.4

% of Each Gender in Study

Series1

RETROSPECTIVE CLINICAL STUDY I REDUCTION IN HYPERVASCULARITY (SPDT + HT)

Breast Cancer (38)

Prostate Cancer (11)

Colorectal Cancer (18)

Ovarian Cancer (8)

Other (25)

Cancer Distribution

RETROSPECTIVE CLINICAL STUDY II REDUCTION IN HYPERVASCULARITY

FOR BREAST, PROSTATE & COLORECTAL CANCERS

Demographics of Study:  51 random patients (admitted between Jan ‘13 – Jul ’14)Duration of Stay at Clinic: 3 to 4 Weeks

Main Therapies:  Sono-Photo Dynamic Therapy + Hyperthermia

19

15

17

Cancer Distribution(# of patients)

Colorectal Breast

Prostate

• Average reduction in hypervascularity after initial 3 weeks was 43%.

Data by cancer type:• Breast cancer patients showed a decrease of 48%.• Prostate cancer patients showed a decrease of 41%.• Colorectal cancer patients showed a decrease of 38%

RETROSPECTIVE CLINICAL STUDY IIREDUCTION IN VASCULARITY

• Hope4Cancer offers a free once every quarter 2-day 1-night return visit to patients for an evaluation and treatments. This data reviews hypervascularity changes in these patients.

• Number of patients studied = 14.

• Average reduction in hypervascularity after their 3 weeks’ stay at Hope4Cancer was 61%.

• All 14 patients showed decreased hyper-vascularity after initial treatment.

RETURNING PATIENTS STUDYREDUCTION IN HYPER VASCULARITY

RETURNING PATIENTS STUDYREDUCTION IN HYPER VASCULARITY

3 Months Later at their 1st Quarterly Visit

78.5% (11/14) Patients sustained or improved on their baseline reduction in hypervascularity, while continuing their SPDT therapy at home.

RIGVIR®

CANCER VIROTHERAPY

[

WHAT IS ONCOLYTIC VIROTHERAPY?Using a Virus As a Cancer Treatment

An oncolytic virus can tell the difference

between a normal cell and a cancer cell. This

biological radar like quality is known as

oncotropism.

The virus replicates in the cancer cell.

The virus breaks down the cell in a

step called oncolysis.

Virus makes immune system

aware of the malignant cells

and infects neighboring cells.

NORMAL CELL

CANCERCELL

UNIQUE FEATURES OF VIROTHERAPY• Selectively targets tumor

cells over healthy cells.

• Chances of any side effects are largely diminished.

• No toxic residues from harmful chemotherapy drugs or residual radiation.

• While other treatments usually suppress it, virotherapy activates the immune system and helps it recognize the cancer cells by uncloaking them.

VIROTHERAPY –IN THE NEWS• Mayo Clinic used the

measles virus to successfully treat a patient with multiple myeloma in 2013.

• Pharmaceutical giant Amgen is in Phase III clinical trials for its herpes simplex virus based product, T-VEC obtained from the acquisition of BioVex.

• University of Texas has an oncolytic virus based on the common cold virus (adenovirus) with which they are targeting brain cancer (glioblastoma).

RIGVIR® – WHAT MAKES IT UNIQUE?• All current oncolytic viruses

are based on the genetic modification of pathogenic viruses (measles, common cold, HIV, etc). Rigvir® is based on a genetically unaltered virus, found in the intestines of young children. The virus is non-pathogenic, even in its native state.

• Extensively clinically tested for efficacy and safety in almost 2000 cancer patients. No reported side effects.

RIGVIR® – 40+ YEARS OF RESEARCH• Discovered in the 1960s by

a group of virologists led by Dr. Aina Muceniece who were previously engaged in finding a cure for smallpox.

• After over 40 years of clinical research, Rigvir® was approved as a cancer “drug” in Latvia for the treatment of melanoma in 2004.

• No genetic modification to remove pathogenic properties has been necessary to develop this product as an effective treatment.

MECHANISM OF ACTIONRigvir® Unmasks Tumors From the Complement System

Cancer cells inhibit a global immune system called the complement system that gets triggered by an infection or foreign presence. These cancer cells have cell surface receptors(such as CD-55/DAF-3) that mask them from immune surveillance.

Rigvir® binds to these receptors and disable their masking function, making the cancer cells vulnerable to complement attack.

RIGVIR® IN ACTIONThis is How Rigvir® Affects Melanoma Cells

I. Melanoma cells before application of Rigvir® II. Cells from the same patient after several courses of Rigvir® start

showing apoptotic tumor cells, lymphocytes, and plasma cells.III. This image shows a melanoma cell surrounded by recruited

lymphocytes after Rigvir® application.

Muceniece A, Venskus D. How to assess immunity- the melanoma model. 2007. p. 116-117

III III

Latima Confidential Material

RIGVIR® IN MELANOMAViability of Melanoma Cells in Culture

Latima Confidential Material

FM9

FM55

FM94

SK-Me126

Control0 h

Control 24 h

Rigvir® 24 h

Scale Bar: 100 μm

RIGVIR® IN OTHER CANCERSViability of A Variety of Cancer Cells in Culture

Latima Confidential Material

Control0 h

Control 24 h

Rigvir® 48 h

MCF7

HPAF II

THP-1

Breast Cancer

Pancreatic Cancer

Monocytic Leukemia

Scale Bar: 100 μm

RIGVIR® IN OTHER CANCERSViability of A Variety of Cancer Cells in Culture

Latima Confidential Material

Control0 h

Control 24 h

Rigvir® 24 h

AGS

A549

SSC-25

Stomach Cancer

Colorectal Cancer

Lung Cancer

Tongue Cancer

Scale Bar: 100 μm

RIGVIR® SURVIVAL STUDIES

Latima Confidential Material

Stomach Cancer

Non-Melanoma Percent Cancer Survival With Rigvir®

Rigvir®

Rectal Cancer

Rigvir®

Control48

24

71

58

71

41Control

Stages II-IV Only

N = 21N = 60

780

196

Safety &Efficacy

Efficacy Only

Types of Cancer in Safety & Efficacy Study

(N = 196) Stomach Cancer

Rectal CancerColorectal Cancer

Lung Cancer

Gastronintestinal Cancers Percent Survival with

Rigvir(5-Year Study)

RIGVIR® SURVIVAL STUDIES

Latima Confidential Material

Melanoma

Melanoma Percent Cancer Survival With Rigvir®

Rigvir®

Control80

55

N = 919 patients

819

100Eye Melanoma Efficacy

MelanomaEfficacy

Melanoma Percent Survival

with Rigvir (5-Year Study)

Melanoma pT1-3

RIGVIR® 5-YR % SURVIVAL DATA

Latima Confidential Material

Rigvir® vs. Standard Immunotherapy*

Melanoma pT4-5

Rigvir®

Rigvir®

Other

81

7053

29

Other

*Immunotherapy treatment included C. parvum, Levamisol, Splenin.

Melanoma(based on depth of invasion)

Less Invasive More Invasive

No Metastasis With Metastasis

Rigvir®

Other

60

21

Rigvir®

73 76

Other

Localized Spread to Lymph Nodes

Melanoma(based on degree of metastasis)

N = 67

N = 29N = 35

N = 19

N = 111N = 53

N = 20

N = 14

RIGVIR® 5-YR SURVIVAL DATA

Latima Confidential Material

Stomach Cancer

Gastrointestinal Percent Cancer Survival With Rigvir®

Rigvir®

Rectal Cancer

Rigvir®

Control48

24

71

58

71

41Control

Stages II-IV Only

N = 21N = 60

RIGVIR® CLINICAL STUDIES

Latima Confidential Material

Melanoma Patient Case Study

Patient was tracked for 3 years following the start of Rigvir® therapy in 2008

February 2008Before start of Rigvir®

April 2010During Rigvir® Treatment

CANCERS TREATEDCancers Known to Be Sensitive to Rigvir®

Initial Clinical Experience with

Rigvir® at Hope4Cancer

Institute

RIGVIR® AT HOPE4CANCERPATIENT DISTRIBUTION

Rigvir® introduced at Hope4Cancer

® in March

2014

MARCH APRIL MAY JUNE JULY AUGUST

14 8 11 6 8 8

55

2014

# Patients on Rigvir®Breast (12)

Colorectal (9)

Prostate (8)

Ovarian (4)

Lung (3)

Endometrial (2)

Pancreatic (2)

Kidney (1)

Osteosarcoma (1)

Angiosarcoma (1)

Glioblastoma (1)

Esophageal (1)

Stomach (1)

Bladder (1)

Melanoma (1)

Non-Hodgkin's (1)

Unknown (1)

Non-Cancer (5)

RIGVIR® AT HOPE4CANCERPATIENT DISTRIBUTION

• A total of 39 patients were reviewed whose primary therapy was Rigvir® Cancer Virotherapy, after eliminating patients who were given Rigvir for non-cancer indications, and patients who passed away because of extremely poor initial health condition.

• Parameters observed during study:• Overall health condition• Quality of life• Changes in tumor

INITIAL CLINICAL EVALUATION STUDY

RIGVIR® VIROTHERAPY

INITIAL CLINICAL EVALUATION STUDY

RIGVIR® VIROTHERAPY

Most people who come to Hope4Cancer are already at advanced stage of disease. In this case, about 37% of admitted patients were in poor or very poor

overall health condition and 78% were in Stage 4, which is representative of the overall statistics of patient admission at the clinic (~ 80% Stage 4).

22

15

1526

22

Overall Health Condition on Ad-mission (%)

Very Poor (22%)Poor (15%)Stable (15%)Good (26%)Very Good (22%)

INITIAL CLINICAL EVALUATION STUDY

RIGVIR VIROTHERAPY

91% of patients reported that their quality of either improved or did not worsen during the initial course of the treatment.

91

9

Quality of Life Improvement (%)

Improved or Stayed SteadyWorsened

INITIAL CLINICAL EVALUATION STUDY

RIGVIR VIROTHERAPY

71% of patients were reported to show an improvement or no worsening in their health condition during the initial course of the treatment

71

29

Improvement in Overall Health Condition (%)

Improved or Stayed SteadyWorsened

• 11 patients had tumors that were palpable or visible.

• 7 out of 11 patients reported changes in tumors• 2 reported tumor tissues becoming necrotic• 2 reported tumors becoming smaller• 3 reported tumors becoming softer

INITIAL CLINICAL EVALUATION STUDY

RIGVIR VIROTHERAPY

Tumor changes and signs of tumor lysis are very evident in patients with exteriorized and palpable tumors.

CONCLUDINGREMARKS

• The Seven Principles provide a holistic framework within which we use potent anticancer therapies with clinically established effectiveness. We target the “cause”, not the “symptoms”.

• The foundational principle of all our treatments is “do no harm”. Our treatments are non-toxic and do not cause side effects.

• Our treatments are focused on improving quality of life rather than tearing it down.

THE HOPE4CANCER PHILOSOPHY

SEVEN PRINCIPLES TO SUCCESS

PAM HAMMONDDirector of Admissions

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