Treatment of common side effects of radiotherapy and chemotherapy, the new drug phase 2 clinical results are positive
Treatment of common side effects of radiotherapy and chemotherapy, the new drug phase 2 clinical results are positive December 25, 2017 Source: WuXi PharmaTech Galera Therapeutics recently announced the positive results of its clinical candidate phase 2b trial of GC4419, a drug used to treat severe oral mucositis (SOM) in patients with head and neck cancer. In the intention-to-treat population, the 90 mg dose of GC4419 reached the primary study endpoint: the duration of SOM (grade 3 or 4 defined by WHO) had a clinically significant, dose-dependent reduction (p=0.024). For the pre-set secondary study endpoints and all efficacy measures, GC4419 showed consistent results. In the United States, more than 50% of cancer patients receive radiation therapy at certain times during treatment. For patients with head and neck cancer, radiation therapy is the main treatment, and 70% of patients receiving radiotherapy and chemotherapy will have severe oral mucositis. Oral mucositis can also have an adverse effect on the prognosis of cancer treatment. In addition, patients with severe oral mucositis may have significant pain and may develop serious infections. The cost of managing these side effects is extremely high, especially during hospitalization and/or surgical placement of PEG tubes. Importantly, severe oral mucositis may result in interruption of radiotherapy, which prevents these patients from achieving a good prognosis for tumor control. There are currently no drugs approved for the prevention or treatment of severe oral mucositis in patients with head and neck cancer. This is a randomized, double-blind, placebo-controlled clinical trial involving 223 patients with head and neck cancer. The patient was administered an infusion of 30 mg or 90 mg of GC4419 and placebo during the radiation therapy. Patients were randomized into three treatment groups at a 1:1:1 ratio. The primary end point of the trial was the duration of SOM in patients with head and neck cancer who received seven-week radiotherapy plus cisplatin. The results showed that GC4419 was well tolerated and the frequency of related side effects was similar in all treatment groups tested. ▲ Dr. Carryn Anderson, head and neck radiation oncologist at the University of Iowa (Source: University of Iowa) Dr. Carryn Anderson, head and neck radiation oncologist at the University of Iowa, said, "Oral mucositis is a common side effect of chemoradiotherapy in patients with head and neck cancer, which can cause many patients to eat for weeks. And drinking water, seriously affecting patients' quality of life, treatment outcomes and rehabilitation. New treatment options urgently need to reduce or eliminate this problem. GC4419 clinical phase 2b data propose a new method to reduce oral mucositis in patients with head and neck cancer, Prevent the damage of radiation to normal tissues." Dr. J. Mel Sorensen, President and CEO of Galera Therapeutics, said: "As high as 70% of patients with head and neck cancer have severe oral mucositis after receiving radiotherapy, GC4419 has the potential to become one of the disease areas that still lack innovative treatment at this stage. Important treatment options. The results of this trial confirm the mechanism of action of GC4419 mimicking superoxide dismutase and demonstrate its efficacy in reducing the side effects of radiotherapy. We look forward to discussing the results of this trial with the FDA and proceeding to the next step. †Reference materials: [1] Galera Therapeutics official website [2] Galera Therapeutics Reports Statistically Significant Results in a 223-Patient Phase 2b Trial of GC4419 for Severe Oral Mucositis in Patients with Head and Neck Cancer Sweetener is a food additive that provides a sweet taste like that of sugar while containing significantly less food energy. Some sugar substitutes are natural and some are synthetic. It allows you to enjoy sweet tasting foods without the extra kilojoules from sugar. It can be beneficial for anyone trying to lose weight and control their sugar intake. Sweetener also does not contribute to tooth decay, as they are not broken down to acid by bacteria in dental plaque. Natural Sweeteners,Xylitol Sweetener,Healthy Sweeteners,Food Sweeteners SINOCHEM PHARMACEUTICAL CO., LTD , https://www.sinochemnutrition.com
