Cancer Therapeutics Inc. (CTHP)

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Tom McCarthy

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Cancer Therapeutics, Incorporated (OTCBB: CTHP) is a biotechnology business incubator, with a specific emphasis on disruptive treatments and nanotechnology. It seeks out disruptive cancer research and technology opportunities to invest in, develop, and commercialize. The end result will be therapies, treatments, and pharmaceuticals targeted at more efficiently and effectively attacking cancer. CTI seeks partners to co-develop drugs in various stages in the company's pipeline.^[1]

Business Overview

Cancer Therapeutics' business model is to partner with existing private companies and provide its partners and investments additional funding and guidance.^[2] The company recently announced its first acquisition- a 25% ownership in NanoTherapies, LLC.^[3] NanoTherapies products introduce disruptive technology into the treatment and detection of cancer through the use of calcium phosphate nanoparticles. These particles, about 350 times smaller than a human cell, provide both a safe and effective way to transport drugs and imaging materials into diseased cells.^[4]

Acquisition of NanoTherapies, LLC

NanoTherapies, LLC is run by Dr Mark Kester, a Distinguished Professor of Pharmacology, and the former Pharmacology Department Head at Penn State University College of Medicine. A leader in NanoMedicine at Penn State, he is a serial health care entrepreneur with notable technology commercialization successes in the fields of improved stents, nanoliposome’s, and the therapeutic applications of Ceramide for cancer treatment.^[5]

Contents 1 Business Overview 1.1 Acquisition of NanoTherapies, LLC 1.2 Products: The NanoJacket(TM) 2 Key Trends and Forces 2.1 Problems Associated With Current Cancer Treatments 2.2 Nanotechnology In Cancer Therapeutics 2.3 American Deaths Caused By Cancer 2.4 Cancer's Economic Burden

NanoTherapies was formed in an equity partnership with Keystone Nano (KN) to commercialize and fund further development of intellectual properties and patents developed by Keystone Nano creating distinctive cancer therapies by embedding pharmaceuticals inside smart calcium phosphate particles developed at Penn State University.^[6]

While many companies are working on dramatic new treatments, there are opportunities to make significant improvement to the present ones. This is NanoTherapies’s present objective. NanoTherapies plans to capitalize on this opportunity by employing an efficient strategy for commercialization, NDAs under 505(b) (2), and using external resources with the requisite skills and expertise, coordinated outsourcing. Used together these will minimize capital requirements and shorten the time to revenue and earnings thus crating significant value for investors. The Company’s lead product is a NanoJacketed Version of an existing and approved medication. The company intends to create a patent protected version of this medication that achieves sales of greater than $500 million a year. ^[7]

The company has the support of Keystone Nano, the Ben Franklin Partnership, Penn State, Hershey Medical, and a major corporate partner, Nalco. Given the status of competitors in this field NanoTherapies has the opportunity to commercialize an important Cancer Therapeutic through the application of a novel nanotechnology.^[8]

Products: The NanoJacket(TM)

NanoTherapies, LLC, through its equity partnership with Keystone Nano, has an exclusive license to Penn State patented technology that allows the creation of stable, non-toxic, 5 to 50 nm-composite particles that are trademarked as NanoJackets(TM). These NanoJackets(TM) can encapsulate drugs and/or fluorescent molecules. Key technological advantages include:^[9]

• made from several material systems including calcium phosphosilicate, a natural material. They do not use toxic, Cadmium based, semi-conductor materials, unlike other processes
• Our proprietary technology stabilizes the Nanojackets in suspension that are homogeneous and non aggregating
• During manufacturing we maintain specific control over the size and size distribution of resulting particles
• The synthesis approach is suitable for chemotherapeutics and pro-apoptotic lipids
• The suspensions are stable for long periods of time
• The surfaces can be modified to provide for cell type, specific targeting using a variety of targeting techniques
• Fluorescent nanoparticles are highly resistant to photo-bleaching and photo-degradation - they can last for months at a time
• The nano-composites can be designed to dissolve at a specific pH to facilitate intra-cellular delivery

Key Trends and Forces

Problems Associated With Current Cancer Treatments

Cancer is a terrible disease and many of its treatments are harsh, sometimes causing more damage than the disease. Chemotherapeutic drugs and radiotherapy are capable to shrink the tumor sizes only for short time (at the best), after which the irreversible growth of the tumor continues as before. Similarly, they do not solve the main problems of the tumor genesis. Moreover, they are themselves high toxic agents and therefore are carcinogens. ^[10] Early lab studies show a ten-fold reduction in toxicity with a seven-fold increase in effectiveness for drugs delivered using NanoJackets(TM).^[11] This means dramatically reduced side-effects owing to the severe toxicity of cancer drugs and increased effectiveness because the half-life of the drug is increased from minutes to hours. Most cancer drugs kill all the cells they contact and dissipate in less than thirty minutes. NanoJackets(TM) encapsulate the drugs for up to thirty hours before being cleared from the body or until the nanoparticle enters a cancerous cell and release the drug.^[12]

NanoJackets(TM) are able to increase the efficacy of existing cancer therapeutics including:^[13]

• Pfizer PFE oncology drug Palladia(TM) for the treatment of cutaneous mast cell tumors;
• Cell Therapeutics CTIC oncology drug Opaxio(TM), a chemotherapeutic agent for the potential treatment of non-small cell lung, ovarian, and other cancers;
• Dendreon Corp DNDN oncology drug Provenge(TM) for the treatment of asymptomatic, metastatic, and androgen-independent prostate cancer
• Hemispherx Biopharma, Inc HEB oncology drug Ampligen(TM), for the treatment of renal cell carcinoma;
• MannKind Corp. MNKD oncology candidate MKC1106-PP, for the treatment of various solid-tumor cancers, including ovarian, colorectal, pancreatic, renal, breast, non-small cell lung and prostate carcinomas, glioblastoma, and melanoma.
• Antigenics, Inc. AGEN oncology drug Oncophage(TM), a patient-specific therapeutic cancer vaccine registered for use in the Russia Federation, as well as under review by the European Medicines Agency for the treatment of kidney cancer patients with earlier-stage disease.

Nanotechnology In Cancer Therapeutics

Nanotechnology refers to the interactions of cellular and molecular components and engineered materials—typically, clusters of atoms, molecules, and molecular fragments into incredibly small particles—between 1 and 100 nm. Nanometer-sized particles have novel optical, electronic, and structural properties that are not available either in individual molecules or bulk solids. The concept of nanoscale devices has led to the development of biodegradable self-assembled nanoparticles, which are being engineered for the targeted delivery of anticancer drugs and imaging contrast agents. Nanoconstructs such as these should serve as customizable, targeted drug delivery vehicles capable of ferrying large doses of chemotherapeutic agents or therapeutic genes into malignant cells while sparing healthy cells. Such “smart” multifunctional nanodevices hold out the possibility of radically changing the practice of oncology, allowing easy detection and then followed by effective targeted therapeutics at the earliest stages of the disease. ^[14]

American Deaths Caused By Cancer

In 2009, about 562,340 Americans are expected to die of cancer, more than 1,500 people a day. Cancer is the second most common cause of death in the US, exceeded only by heart disease. In the US, cancer accounts for nearly 1 of every 4 deaths. The number of people with a personal history of cancer living in the US has continued to rise, and is expected to double by the year 2030 to more than 20 million. The National Cancer Institute (NCI) estimates that there are presently more than 11 million cancer survivors in the US, more than 3 times the number in 1970.

Cancer's Economic Burden

The financial costs of cancer treatment are a burden to people diagnosed with cancer, their families, and society as a whole. The National Institutes of Health (NIH) estimates overall costs of cancer in 2008 at $228.1 billion:

• $93.2 billion for direct medical costs (total of all health expenditures);
• $18.8 billion for indirect morbidity costs (cost of lost productivity due to illness);
• $116.1 billion for indirect mortality costs (cost of lost productivity due to premature death).