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Oncology Overview

In 1971, President Nixon declared a ‘War on Cancer.’ Today, over forty years and $210 billion in taxpayer dollars and donations later, nearly one in two men and more than one in three women are struck by cancer. Since the ‘War’ started, cancer rates have increased 58% in men and 29% in women. There will be nearly 8,000,000 cancer deaths worldwide this year alone. Due to environmental factors, lifestyle choices, and the aging population, within the next ten years cancer rates will escalate to epidemic proportions.

In fact, cancer is the second leading cause of death in the industrialized nations of the world today, trailing only heart disease. And owing to the grinding, inexorable way in which cancer claims its victims, there is probably no other diagnosis that produces more fear and anxiety. According to figures recently released by the World Health Organization (WHO), it is estimated that there are now approximately 11 million new cases of cancer worldwide each year and 8 millions deaths. By the year 2020, those numbers are expected to grow to 16 million and 13 million, respectively.

More specifically, lung cancer is the most lethal of cancers worldwide, and will soon cause more than 4 million deaths annually. This number is increasing. Only one in ten patients diagnosed with this disease (mostly those early stage) will survive five years. According to the WHO, in 2001 lung cancer was the most deadly form of cancer worldwide, accounting for nearly 2 million deaths. The American Cancer Society estimates that 213,380 cases of lung cancer will be diagnosed in the United States in 2007 and that approximately 160,000 people will die from it. The prevalence of lung cancer in America at any given point in time is approximately 230,000-255,000 people.
In countries such as the US, China, France, the UK, the Czech Republic, and India, pollutants, genetic factors, and smoking rates have increased non-small cell lung cancer (NSCLC) prevalence in both smokers and non. More women die of lung cancer than of breast and ovarian cancers combined and more men die of lung cancer than of colorectal and pancreatic cancers combined.

 

The following chart represents the market scope for NovaRx’s lead product candidate, Lucanix™ per geographic region (approximate number of newly diagnosed NSCLC cases per year):

 

United States 181,000

United Kingdom 45,000

Rest of Europe 142,000

China 990,000

Japan 59,000

India 163,000

Total ………………… 1,580,000
[Source: American Cancer Society and W.H.O.]


** Please note that these numbers reflect new cases. Existing cases comprise approximately an additional 60,000 patients in the US alone for a total of ~240,000 to 250,000.

*Also note that Lucanix™ will be expanded to additional indications pending Phase III NSCLC results. These figures only represent global NSCLC market scope. Additional indications that this platform technology has been tested and effective in (preclinical and Phase I) include ovarian, brain, colorectal, and prostate cancers. It is highly likely that Lucanix™’s clinical results will expand to other forms of cancer including breast, lymph, bladder, pancreatic, and liver. Furthermore, with the addition of new allogeneic cell lines to Lucanix™, the median survival results are likely to increase.

Though lung cancer is the most deadly form of cancer in both sexes, breast cancer is another leading cause of cancer deaths in women today and is the most common cancer among women, excluding nonmelanoma skin cancers. According to the World Health Organization, more than 1.2 million people will be diagnosed with breast cancer this year worldwide. The American Cancer Society estimates that about 213,000 women in the United States will be diagnosed with invasive breast cancer each year (Stages I-IV). The second leading cause of cancer deaths in men today is colorectal cancer. Someone dies of colorectal cancer every 9.3 minutes and upwards of 3.4 million people worldwide will be diagnosed with it this year. Moreover, brain (glioma), ovarian, prostate, and pancreatic cancers represent several of the most invasive cancers with over 2.7 million worldwide diagnoses per year, combined. NovaRx’s pipeline vaccines, including Lucanix™, have the potential to thwart these types of cancer in addition to lung.


Worldwide spending on all cancer medicines, which was $24 billion in 2004, is expected to rise to $55 billion in 2009, making oncology treatments the biggest drug category, according to IMS Health. Clearly, there is a huge market opportunity for any viable, non-toxic new treatment that can be developed for use in NSCLC and other cancers, such as breast, prostate, colorectal, glioma, and ovarian.

Once upon a time, we could not imagine having cures to measles, mumps, and rubella. Today, the vast majority of Americans receive those vaccines. There is no reason that we cannot have better interventions for cancer, even cures. The human ‘right to life’ is a modern extension of human rights. With the success of Lucanix, NovaRx has the potential to make an unprecedented impact on cancer treatment, the drug development system, and even the structure of the healthcare industry. NovaRx has the potential to represent one of the most powerful influences in finally winning the “War on Cancer.”