Monday, July 5, 2010

Research Breakthroughs and the Road Ahead

On Friday I got a phone call from the clinic that is conducting the clinical trial for Stimuvax, the trial drug I am taking. The research had been suspended because patients in the trial, for unknown reasons, had developed encephalitis. The phone call was to let me know that the trial had now been given the green light to go forward. I am due to get my next shots tomorrow.

Every six weeks for the past two years I have travelled to New Port Richey to receive these vaccinations. I will continue to go for the shots until there is progression of the disease, which is the first endpoint of the study. In the Phase II trials of this drug, time to progression was 36 months for people on Stimuvax versus 17 months for those taking a placebo. In August I will have been on the drug for 24 months. While I don’t know if I am getting the drug or a placebo, I’ve always suspected I was getting the drug. My continued good health is nothing short of a miracle.

The theory of Stimuvax is that it works to boost your immune system to fight cancerous cells – not exactly a novel idea. This was the approach used by Dr. Royal Rife back in the 1930’s; it is also the approach being used by various alternative treatment practitioners highlighted in Suzanne Somers’ book, “Knockout.” Interestingly, strengthening the body’s immune system to fight cancer is now becoming more of the conventional wisdom in drug therapy. At the ASCO (American Society of Clinical Oncology) Convention in Chicago last month study results from several new drugs that target the immune system got a lot of attention in the press.

One drug, ipilimumab, from Bristol Myers, is designed to enhance the immune system and increase the survival rate for people with advanced melanoma, a deadly form of skin cancer. Patients taking the new drug lived an average of 10 months versus 6 months for patients taking a comparison drug, GP100. More than 45% of patients taking the new drug were alive after one year, compared with 25% of the patients who received the GP100 vaccine. Ipilimumab is a monoclonal antibody, a biologic drug derived from living cells. It works by activating T-cells, part of the immune system, to help fight cancer cell growth.

Targeting drugs for people with certain genetic mutations also seems to be the wave of the future. Pfizer is now testing the drug crizotinib, which appears to shrink tumors in lung cancer patients with certain genetic mutations. The discovery was a lucky happenstance. Pfizer initially thought crizotinib would work to inhibit C-met, an enzyme that is alleged to feed tumor growth. Company researchers noticed that the drug also worked on another enzyme, anaplastic lymphoma kinase or ALK, also thought to be involved with tumor growth. Researchers in Japan subsequently found that fusion of ALK with another gene was a contributor to lung cancer.

Roughly 3 -5% of lung cancer patients or about 40,000 people annually worldwide, have the ALK mutation. Pfizer conducted a clinical trial on patients who have the mutation. Most were either light smokers or never smoked. The average age was 50. The drug, an oral pill, was taken twice daily. Results so far are very promising. Of the 82 patients tested, roughly 90% experienced tumor shrinkage or stabilization. Pfizer is now moving on to the Stage III Clinic trial.

The ASCO Convention also saw the announcement of two new drugs – Sprycel and Tasigna, to treat leukemia and possibly replace the miracle drug, Gleevec, which has been the standard of care for leukemia since it was first introduced in 2001.

I’m happy that research is finally starting to get somewhere. It is heartening to know that new avenues of treatment may be available to me down the road.

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