Breast Cancer Vaccine Trials Prove Scientific Success, But Not Legal

Breast Cancer Vaccine Trials Prove Scientific Success, But Not Legal
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What you need to know

The results of a blind trial on a newly developed breast cancer vaccine, OBI-822, bear scientific and medical importance, but the drug is not allowed a permit under current regulations because it did not pass clinical trials. If OBI-822 passes future trials, Taiwan would be the first country in the world to develop a carbohydrate-based vaccine for breast cancer.

Compiled and translated by Bing-sheng Lee

OBI Pharma, a Taiwan biotech company, released the results of a blind trial on its latest breast cancer drug, OBI-822, in a press conference held on February 21. Although preliminary findings do not show statistical significance, OBI stressed that the experiments have significant scientific and clinical information, which provides clear direction for future product development. Experts deem the results to be a success in terms of science, but a failure when obtaining a drug permit license from the government.

UDN reports, the second and third-phase clinical trials of OBI-822, a new and investigational anti-cancer vaccine, were initiated in October 2010. The company originally planned to announce the results at the end of March this year, but since the number of cancer relapses did not reach the criteria for the trial during the experiment, so the researchers decided to move up the announcement to February 21.

Liberty Times reports, OBI Pharma Chairman Chang Nien-tzu points out that there was substantial improvement in the progression-free survival rate of the treatment group for OBI-822 if the patients generate IgG and IgM immune responses. These findings are critical for designing the global third phase study of the drug.

CNA reports, Liao Chang-liang, a pharmacy expert, says that the company cannot apply for a drug permit under current regulations because OBI-822 did not pass clinical trials. However, the research bears scientific and medical importance. OBI believes that if they redesign a clinical trial in the future based on what they found in the previous trials, the success rate of future trials would be greatly improved.

The China Post reports, the fact that OBI-822 did not pass the second and third-phase trial shows that OBI-822 cannot effectively combat breast cancer. In most cases, when products fail to pass phase three, pharmaceutical companies usually terminate their development plans for the products.

Another strategy would be to develop a drug for a disease other than breast cancer so the value of the drug and company would not collapse in an instant, but reassessments would be necessary.

UDN repost, Wong Chi-huey, president of Academia Sinica, says research shows that 98% of cancer cells and cancer stem cells in cancer patients contain special carbohydrate molecules that do not exist in normal cells. Once the vaccine triggers the immune system and helps the human body memorize that the special carbohydrate molecules are malign, cancer cells are eradicated without any medication. The trial that OBI Pharma conducted was trying to prove that the newly developed breast cancer vaccine could not only induce antibodies from the immune system, but also kill cancer cells effectively.

Wong adds that if OBI-822 passes future clinical trials, OBI Pharma would be the first in the world to develop a carbohydrate-based vaccine for breast cancer. 15 other types of cancers are currently known to contain the special carbohydrate molecules, including lung cancer, liver cancer, intestinal cancer, stomach cancer, pancreas cancer, prostate cancer, ovarian cancer, brain cancer, esophagus cancer, kidney cancer, cervical cancer, endometrial cancer, triple-negative breast cancer and gallbladder cancer. Continuous research might develop vaccines to treat different kinds of cancer.

Edited by Olivia Yang

Liberty Times
“Breast cancer drug trial ‘successful’" (The China Post)
“Tests on new cancer drug show no significance: OBI” (Taipei Times)