MedicalResearch.com Interview with:
Dr. Giuseppe Del Priore, MD, MPH
Chief Medical Officer of Tyme Inc.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Metastatic breast cancer, sometimes also called “stage IV” or “advanced breast cancer,” is the most extensive stage of breast cancer. It is an invasive cancer that has spread to other parts of the body, most often bones, lungs, liver, and brain. The current standard of care for metastatic breast cancer is systemic drug therapies, such as hormone therapy, chemotherapy, targeted drugs or a combination of these. Because they reach every cell in the body, they have side effects that can worsen the patient’s quality of life. Existing treatments cannot cure metastatic breast cancer and are palliative in intent. This presents a great unmet need and challenge in treating patients with metastatic breast cancer.
SM-88 is a novel relatively non-toxic combination therapy that harnesses cancer’s unique cell metabolism and oxidative stress to selectively drive cancer cell death. Earlier studies with SM-88 therapy demonstrated its potential efficacy in breast and other metastatic cancers. In this current report, we assessed the efficacy of SM-88 in patients with metastatic breast cancer from the first in human “Phase 1” and compassionate use programs from 2012 to 2017. Data demonstrated the potential efficacy of SM-88 in metastatic breast cancer with favorable safety and quality of life profiles. In addition, there were no indications of cross-resistance based on hormone profile, previous treatments or metastatic site. This is an extremely important finding since most cancer deaths are due to resistance to subsequent therapies. As predicted by the SM-88 mechanism of action, we could not detect this problem with SM-88 use.
MedicalResearch.com: What should readers take away from your report?
Response: The unmet need for metastatic breast cancer is very clear. SM-88 is a potential therapy for patients with this incurable disease. Unlike standard therapies used to treat metastatic breast cancer, SM-88 is relatively non-toxic. Not only does it display clinical effectiveness in metastatic breast cancer, it is also well-tolerated and maintains the patient’s quality of life, which is negatively impacted by current treatments.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Toxic therapies have been the standard of care for breast and other metastatic cancers. Researchers and doctors need to be concerned about the quality of life of patients and should consider whether the benefit of the treatment outweighs the effect it has on quality of life. At Tyme, we are exploring optimal treatment of metastatic breast cancer with SM-88 and we look forward to providing a potential alternative to the toxic therapies that are available to patients.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: At Tyme, we are developing SM-88 not only as a safe and effective treatment for metastatic breast cancer, but also as a treatment that is broadly effective across most cancer types due to its unique mechanism of action. SM-88 has already reported clinical results in 13 different types of cancer. We are hopeful that the number of cancers treated will continue to grow as we further develop the therapy.
We are grateful to our collaborators who have participated in our multiple abstracts and overall ASCO efforts this year including: Dr. Dacian Bontà (Emory University School of Medicine), Marcus Smith Noel (University of Rochester James P. Wilmot Cancer Institute, Strong Memorial Hospital), Gerald H. Sokol (Uniformed Services University of the Health Sciences, Florida Cancer Institute), Wen-Tien Chen (State University of New York, Vitatex Inc) and Dr. Xinhua Zhu (Zucker School of Medicine at Hofstra/Northwell, Monter Cancer Center of North Shore – LIJ Health).
Citation:ASCO 2018 abstract (Publication-only abstract)
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