Polaris Group Polaris Pharmaceuticals-KY(6550TW) announces, Due to the impressive results of the Phase II clinical trial in soft tissue tumors, the trial host has been invited to give a live presentation in the most prestigious “oral presentation” format at the 2021 American Society for Clinical Oncology (ASCO).
The clinical trial involved four major medical centers in the U.S., including Washington University School of Medicine, Stanford University School of Medicine, USC Cancer Center and Columbia University School of Medicine, and all clinical funding was provided by the medical schools and subsidized by the U.S. National Institutes of Health (NIH). After the clinical trial is completed, Polaris retains all commercial rights and access to all data under the contract, which can be reported to the U.S. Food and Drug Administration (FDA). Dr. Brian Van Tine, a presenter of this project at ASCO, was invited to give a verbal presentation on the results of the Phase II clinical trial.
Malignant Soft Tissue Sarcoma is different from the general cancer carcinoma derived from epithelial tissue. Can occur at any age, anywhere. Usually the appearance is similar to the surrounding tissue, so it is easy to be misdiagnosed in the early stage. About half of bone cancer patients are forced to amputate because they cannot be diagnosed in time. And there are many subtypes, the treatment is difficult, and there is no more effective medicine.
The clinical trial was conducted as an “open trial”, using Gemcitabine + Docetaxel, the standard drug for ADI-PEG20 combination chemotherapy. In addition to proving efficacy, various adjustments were made to the dosage of chemotherapy drugs in order to reduce the side effects of chemotherapy if the dosage could be reduced in the future.
Polaris will release the report after May 19 in accordance with the ASCO annual meeting. The company plans to begin discussions with the U.S. FDA in May regarding Phase II data and planning for Phase III clinical trials, and will not rule out the possibility of obtaining Breakthrough Drug status in order to accelerate research and development and bring the drug to market as soon as possible.