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Pharmaceutical giant Novarma is launching a clinical trial of a new adaptation of the cancer drug tahigna, which, surprisingly, is not another solid tumor, but Parkinson's disease.
that the clinical trial will begin next year and that Novart will work with three institutions, including the Michael J. Fox Foundation, the Van Andel Institute and Cure Parkinson. Novargo has launched a six-month Phase I safety trial that has yet to test the effectiveness of Tasigna's treatment for Parkinson's disease. However, a study conducted by Georgetown University has shown that Tasigna, which is lower than the dose of the treated tumor, can effectively reduce the synthesis of the protein that causes Parkinson's disease. Tasigna's role in tumor therapy is to promote autophagy of tumor cells, which can be removed in time rather than killed at one-and-a-third of the dose. The preclinical model of Tasigna's treatment of Parkinson's disease has been studied for several years. But so far, preclinical trials have been limited to safety, and the effectiveness has yet to be determined in the next clinical trial.
said it will work with the three agencies to design and fund a double-blind, placebo-controlled trial to assess whether Tasigna is effective in treating Parkinson's, which prevents the disease from progressing or relieves symptoms. Novaral said that while there are very limited treatments for Parkinson's, it is hoped that doctors and patients will not blindly use the drug until clinical trial results are available. Novaral and the three agencies, while announcing follow-up clinical trials, carefully discussed the limitations of the Georgetown university study and said further clinical trials were needed. They point out that the placebo effect cannot be ruled out because the sample size of Phase I clinical trials is too small, and that while lower doses may reduce side effects, the side effects of Tasigna become more pronounced as the patient population expands.
Tasigna is also very expensive, currently costing $10,360 a month in the U.S. and treating about 200 Parkinson's patients in the U.S., an adaptation that has not yet been approved by the FDA. Therefore, clinical trials will therefore need to determine the safety and effectiveness of Tasigna's treatment of Parkinson's disease as soon as possible for the benefit of patients with this neurologic disease.