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ICON expands experience in the development of new cancer therapies

Posted on: 11 Sep 06

Summary

A new generation of oncology drugs is proving highly effective against certain cancers.

For decades, chemotherapy, hormonal therapy and radiation were the preferred treatments for many cancers.  
     However, a new generation of oncology drugs is changing the whole paradigm of oncology therapy. These drugs use very specific molecular and genetic approaches to attack specific cancers on the cellular level. The value of these new “targeted” drugs lies not only in their specificity (they target only cancer, not healthy cells) but in their relative lack of serious side effects, especially when compared with chemotherapy, hormonal therapy and radiation.
     In some ways, the term "targeted therapy" is a misnomer, since all therapies have a target upon which they act. With targeted anticancer therapy, however, the molecular target is known before the drug is developed, and the target is chosen precisely because it is believed to be important for the development or progression of cancer.

The tamoxifen story
     This concept is not new to cancer; tamoxifen, the most widely prescribed agent for the treatment of breast cancer, is used for its antiestrogenic properties. More recently, researchers have been focusing their efforts on agents that have even greater specificity for a particular receptor or pathway. For example, the epidermal growth factor receptor (EGFR) inhibitors such as gefitinib, erlotinib and cetuximab were developed because EGFR has been found to be overexpressed in many cancers;-trastuzumab was developed because HER-2/neu is overexpressed in some breast cancers. In essence, when preclinical studies show that certain molecules are necessary for cancer growth, researchers develop drugs that inactivate or modify the specific molecule or pathway.
    But the potential of targeted therapies may well go beyond treatment.  According to Scott Gottlieb, MD, deputy commissioner for medical and scientific affairs at the FDA, “New sciences like genomics and proteomics might allow us to tailor treatments to be highly effective against the underlying causes of diseases … perhaps even to prevent those diseases from occurring or progressing in the first place.”

A promising future
     “Targeted cancer treatments represent the future of oncology therapy,” says Andreas Dreps,  Ph.D., ICON’s global head of oncology. 
      Tom Williams, M.D., ICON’s senior director of oncology, agrees. “The majority of cancer drugs developed in the past 50 years were cytotoxic small molecules that could not differentiate between cancerous cells and other rapidly-dividing cells. This inability to differentiate between normal and cancerous cells often created serious and toxic side effects in patients.  But in targeted cancer therapy, the anticancer agent is specifically directed against cellular antigens, enzymes or pathways unique to specific cancers. Normal cells are unaffected, which greatly decreases side effects.”

Promising – but no “magic bullets”
While targeted drugs may be the most effective treatments for certain cancers, researchers still face significant challenges in developing targeted therapies that will work for all, or even most, cancer patients. Dr. Dreps believes that one key to solving this challenge is to more clearly define the targets.
    Dr. Dreps explains, “I think many investigators will agree that the success of targeted agents lies in a better definition of the subset of patients who will most benefit from the drug. In other words, we need a better understanding of the biological role of the target itself.
     “Take the case of Herceptin, a monoclonal antibody which targets the HER2 receptor in breast cancer. In fact, only about 30% of breast cancer patients have HER2 receptors. So from the beginning, 70% of patients have to be excluded. And even in the so-called “HER2-positive” patient population, only a subset of maybe 10% to 15% actually benefit from Herceptin treatment, depending on the HER2 expression level. So this is a good example of how much work still needs to be done to understand better the biology of tumors and the role of selected targets in tumor progression.”

Other traditional therapies remain important
      “Chemotherapy, hormonal therapy and radiation are still the most widely-used treatments, but more and more frequently they are being supplemented with targeted therapies,” says Dr. Dreps. “At many smaller biotech firms, up to 80% of cancer drug development is focused on molecular targeted therapy. In larger pharmaceutical companies, the ratio is more evenly divided – about 60% to 40% -- between targeted therapies and traditional chemotherapy agents.”
      “It must be remembered that while there is much excitement around the development of targeted drugs, chemotherapy is still the backbone of cancer treatment, and developing hypothetical chemotherapy agents will continue to be important for the industry,” said Dr. Dreps. “We still have a long way to go. Ideally, we will continue to develop both kinds of treatments until targeted therapies reach the point where they are effective for all patients.”
 
Oncology development
     The number of oncology trials worldwide has been increasing steadily over the last decade, according to Dr. Williams.
     “With over 3,000 studies in the US and EU alone, oncology research is one of the fastest-growing areas of drug development,” says Dr. Williams.
    “Targeted therapies require special expertise,” Dr. Williams adds. “Even though they’re less toxic than other therapies, there is still some toxicity. Allergic reactions are also not uncommon, depending on whether the compound is humanized or not.
     “The promise of targeted oncology therapies is balanced by the many challenges they present ---  target identification, optimal dosages, ethical endpoints, etc. ICON’s oncology teams have the experience to meet and anticipate these challenges. We are committed to being a leader in cancer research, and will continue to invest resources in this rapidly growing area.”

Global cancer statistics

• Over 35 million people worldwide have been diagnosed with cancer.

• The most commonly-diagnosed cancers are lung cancer (1.35 million), breast cancer (1.15 million), and colorectal cancer (1 million).

• The leading causes of cancer death are lung cancer (1.18 million deaths), stomach cancer (700,000 deaths), and liver cancer (598,000 deaths).

• The most prevalent cancer in the world is breast cancer, due to its high survival rate (4 million survivors 5 years following diagnosis).

• Eastern European men and Northern European women have the highest risks of dying from cancer.

• Annual sales of anti-cancer agents worldwide exceed $20 billion

• Since 1995, the number of new cancer drugs in development has been growing at nearly 30% annually.

* SOURCE: CA: A Cancer Journal for Clinicians, March/April 2005

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Last updated on: 27/08/2010 11:40:18

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