SM-88 as Potential Alternative to Existing Toxic Treatments for Metastatic Pancreatic Cancer Interview with:

Dr. Marcus Smith Noel, MD University of Rochester James P. Wilmot Cancer Institute Strong Memorial Hospital

Dr. Smith Noel

Dr. Marcus Smith Noel, MD
University of Rochester James P. Wilmot Cancer Institute
Strong Memorial Hospital What is the background for this study? What are the main findings?

Response: Pancreatic cancer outcomes are poor even despite improvement in the overall prognosis for many cancers. Early detection of pancreatic cancer is uncommon because early stage pancreatic cancer often has few symptoms. Unfortunately, most cases are diagnosed at more advanced stages, which is in part why the disease is so lethal. Current standard of care treatments are highly toxic and not effective long-term, as about 90% of patients diagnosed with advanced or metastatic pancreatic cancer do not survive a year.

SM-88 is a relatively non-toxic novel combination therapy designed to utilize cellular metabolism and oxidative stress to drive cancer cell death. This therapy has previously demonstrated activity in various metastatic cancers, such as pancreatic cancer, and is currently being evaluated in an ongoing Phase II trial for metastatic pancreatic cancer.

This study is a trial in progress report of Tyme’s Phase II trial in patients with metastatic cancer. The Phase II trial is designed as an open-label, multi-center study of SM-88 in patients with metastatic pancreatic cancer who have failed at least one prior line of therapy. In the first stage of the trial, 36 patients will be randomized 1:1 to receive a dose of either a currently utilized active regimen or a double dose per day of SM-88. Primary endpoints are overall response rate (ORR) and overall survival (OS). Secondary endpoints include progression-free survival (PFS), disease control rate, duration of response and time to subsequent treatment. The purpose of the first stage of the study is to analyze the safety, efficacy and pharmacokinetics of SM-88 in patients.  The selected dose of SM-88 will be continued into the second stage of the trial for approximately 81 additional patients. What should readers take away from your report?

Response: Current treatment options for pancreatic cancer are few, toxic and have shown limited efficacy, demonstrating a large unmet need. When pancreatic cancer is advanced and standard of care treatments are unable to offer much benefit, palliative care is the only treatment option left. SM-88 has the potential to be an alternative to the existing toxic therapeutic treatments for metastatic pancreatic cancer. What recommendations do you have for future research as a result of this study?

Response: Pancreatic cancer is very difficult to treat. Although it is not a common cancer, it is one of the deadliest, with some estimating that it could be one of the top four causes of cancer death by 2020. Estimates such as this relay a great sense of urgency to focus research on new treatment options with better outcomes. Patients with pancreatic cancer need safer and more effective therapies, which is why my co-investigators including Dr. Allyson J. Ocean (Weill Cornell Medical College), Dr. Gerald H. Sokol (Florida Cancer Institute and the Uniformed Services University), Steve Hoffman (Tyme Technologies, Inc.) and Dr. Giuseppe Del Priore (Tyme Technologies, Inc.). and I are working to develop SM-88. Is there anything else you would like to add? Any disclosures?

Response:  Data from 10 pancreatic cancer patients treated with SM-88 in Tyme’s First Human Study or compassionate use program have shown clinical responses while maintaining or improving patients’ quality of life. In these studies, 40% of patients showed survival of longer than 12 months, which is considerably longer than would be expected in this patient population. SM-88 was well tolerated in all patients with no reported drug-related serious adverse events.

Tyme is focused on developing SM-88 as a potentially safe and effective treatment for metastatic pancreatic cancer, a devastating disease that lacks safe and effective treatment options. In addition to showing efficacy in pancreatic cancer, SM-88 has also demonstrated efficacy in the treatment of other advanced cancers, such as prostate cancer and breast cancer, with no significant toxicity and serious adverse events.

Citation: ASCO 2018 Sunday, June 3, 2018
SM-88 in advanced cancers of the pancreas (SMACP).

Marcus Smith Noel,et al

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Last Updated on June 4, 2018 by Marie Benz MD FAAD