THE CANCER BULLET

                                       "Giving Hope through Healing"

        Paclitaxel is encapsulated into the TargoSphere to target cells of the   immune system and generate immuno-chemotherapeutic anti-cancer activity 

The TargoSphere is a biologic nanocarrier, constructed with a carbohydrate targeting anchor that attaches to C-lectin receptors on cells of the immune system that are vital in maintaining health. When cancers develop, immune cells fail to recognize and destroy malignant cells, resulting in unchecked and wild growth of cancers.

The TargoSphere can deliver the chemotherapeutic agent, Paclitaxel, to cells of the immune system. Paclitaxel has been shown to have a positive influence on immune activities that retard cancer growth and metastatic spread.

The TargoSphere was invented and patented by Dr. Michael Scolaro and research scientists Dr. Robert Gieseler and Dr. Sean Sullivan at the Let There Be Hope Medical Research Institute, a 501 c 3 public nonprofit foundation.

The TargoSphere has been developed for  clinical applications by scientists at Rodos BioTarget GmbH in Germany, a for-profit company founded by Dr. Robert Gieseler, Dr. Joerg Ruppert, Dr. Marcus Furch and Dr. Michael Scolaro. For additional information,see: http://www.biotargeting.eu 

Publications, biographies, and details of the TargoSphere  may be found at: www.LetThereBeHope.org 

Clinical applications for the TargoSphere to treat Tuberculosis, Hepatitis, and HIV/AIDS .are currently being developed by Rodos BioTarget GmbH in Germany with global partners in Europe, Egypt, and Brazil.

Augustus Pharmaceutical Development LLC, a subsidiary of Augustus BioMed LLC in the US, is outsourcing the production of the encapsulated therapeutic to Rodos BioTarget, GmbH in Germany and has conducted early preclinical in-vivo testing at the Southern Research Institute, Birmingham, Alabama, in the US. It will enter into a collaborative agreement with a cancer division of the government to conduct its clinical trial in 22 pet dogs suffering with osteosarcoma, to be conducted at veterinary hospitals in the US and Canada. Subsequently, application for Orphan Drug approval will be submitted to the FDA for treatment of Osteosarcoma in children and young adults.

The final business goal of our company is to raise additional funding to complete clinical development and regulatory approval of our targeted therapeutic for other human malignancies.

                     JOIN US IN A NEW TREATMENT TO FIGHT CANCER

                            The TargoSphere-Paclitaxel Cancer Bullet

                                       "Giving Hope through Healing"

Our company, in collaboration with scientists from Germany, has invented a new cancer treatment that targets the immune system to stimulate death of cancer cells.

We are asking for funding to conduct our first study in the US for a new Targeted Treatment for Osteosarcoma, a common bone carcinoma in pet dogs.  Clinical trial results will allow us to ask FDA approval  for children and young adults who develop bone cancer similar to pet dogs, often resulting in limb amputation and frequently found to be incurable.

The second stage of development, with potentially high commercial returns, will be directed against human cancers of the  breast, ovaries, prostate, lung, colon, bladder, pancreas, esophagus, and brain, as well as malignant melanoma.

We offer a unique technology that targets immune cells with a one-of-its-kind biological nanocarrier, The TargoSphere, into which we successfully encapsulate Paclitaxel, an established oncologic drug, originally developed by the National Cancer Institute, and now available for commercial development in generic form.

Targeted delivery of Paclitaxel to immune cells has been shown to generate a therapeutic anti-tumor immune response in addition  to its well-established tumoricidal apoptotic activity against a variety of human malignancies.

Paclitaxel is approved globally against cancers of the breast, prostate, lungs, ovaries, bladder, esophagus, pancreas, and colon. It is also approved for Kaposi's Sarcoma and malignant melanoma. Our patented nanocarrier, the TargoSphere into which we encapsulate Paclitaxel has been studied extensively in pre-clinical trials and is rendered non-toxic and safe. It may be administered via diverse routes including intravenous,subcutaneous, intrapulmonary, intraperitoneal, and intranasal. It is preferentially distributed to all lymph nodes and lymphoid organs including the liver and spleen. Upon certain application routes and designs, it crosses the blood brain barrier and reaches microglia of the brain. Specific delivery of nanocarrier-encapsulated Paclitaxel to tumor-draining lymph nodes has been shown to therapeutically activate the immune system to slow tumor growth and kill cancer cells.

Our treatment targets the primary tumor as well as hidden metastatic cancer cells that cause tumor recurrence, despite surgery or radiation.

Nanocarrier-Encapsulation and Targeted Delivery of Paclitaxel to immune cells will improve its known anti-cancer efficacy by:

1) safely increasing therapeutic dosage when encapsulated into the TargoSphere by isolating toxic chemochemical effects against normal cells and tissues, as is seen with unencapsulated Paclitaxel delivery;

2) exclusive delivery only to immune cells in lymph nodes, lymphoid organs, and tumor sites---thereby sparing normal cells and tissues from the adverse effects of unencapsulated Paclitaxel;

3) generating immune control of cancers by delivery to key immune cells residing in tumor-draining lymph nodes and lymphoid tissues that are meant to naturally inhibit tumor growth.

The primary objective of this first clinical development is to improve the outcome of treatment of osteosarcoma in pet dogs and children.  The secondary objective is to enhance and improve the known tumoricidal activity of Paclitaxel, in a safer dosage form, against a variety of cancers for which it is currently approved.

                                     OUR ACCOMPLISHMENTS

Pre-clinical studies at Rodos BioTarget GmbH in Germany on biodistribution of the patented carbohydrate-modified nanocarrier, the TargoSphere, have shown uptake in all lymph nodes and lymphoid organs when administered by various routes. Analysis of brain tissue also showed uptake in brain microglia, indicating the nanocarrier successfully crossed the blood brain barrier following certain modes of applications.This latter finding suggests our TargoSphere encapsulated Paclitaxel may be a potential treatment for the human brain tumor, Glioblastoma.

A preliminary in-vivo Proof of Concept study at the Southern Research Institute by Augustus Pharmaceutical Development LLC using the carbohydrate  mannose, attached to an analog of Paclitaxel was conducted in mice inoculated with a human Glioblastoma brain tumor cell line. Positive results to treatment were seen with extended survival and decreased toxicity in the group treated with this carbohydrate analog of Paclitaxel, when compared to treatment with free unmodified Paclitaxel.

Developmental research studies at Let there Be Hope Medical Research Institute by our team of scientists had shown that different carbohydrates, when compared to mannose, had a significantly different degrees of specificity for immune targets. The carbohydrate ultimately chosen for attachment to the TargoSphere  had the highest degree of targeting specificity for all immune cells exhibiting C- Lectin receptors, thus permitting  treatment  designs that would allow higher dosages of active chemotherapeutic agents with decreased systemic toxicity or adverse side effects.

TargoSphere-Encapsulated Paclitaxel is highly competitive in the Pharma Marketplace!

Our findings are significant from a clinical and commercial perspective in that encapsulation of Paclitaxel into the carbohydrate-labeled nanocarrier, the TargoSphere, will result in more effective anti-tumor activity at higher dosaging schedules and decreased toxicity or adverse side effects when compared to all current forms of Paclitaxel sold globally by the pharmaceutical industry.

We are the first pharmaceutical company to develop a new clinical cancer treatment that targets immune cells with the chemotherapeutic agent, Paclitaxel, which has been shown to mobilize immune cells to inhibit tumor growth and metastatic spread.  This innovative treatment will enhance clinical outcome by moblizing the immune system to act in concert with the tumoricidal chemotherapeutic activity of Paclitaxel and other chemotherapy agents, which may be added in later developments. Successful clinical outcomes will enable us to develop this model treatment for a wide variety of human and animal cancers globally with high income valuation.

The figures for total Paclitaxel sales in the US for the year 2000: 1.6 Billion; The total Global sales for 2006 were 3.7 Billion, making Paclitaxel one of the world's leading chemotherapy agents.

We estimate sales of TargoSphere-encapsulated Paclitaxel for multiple human and veterinary cancer indications will eventually result in our company valuation for a minimum of $350 Million in the global market within 10 years.

Our company mission is to target the immune system with the patented TargoSphere-Encapsulated Paclitaxel Cancer Bullet to inhibit and eradicate malignancies and improve survival in domesticated and companion animals and humans.