FAQ

Frequently Asked Questions (FAQ)

We’ve put together some commonly asked questions to give you more information about TYME. If you have questions that you can’t find the answer to, please use our contact form. We also encourage you to speak with your doctor.

What is SM-88?

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. SM-88 is an investigational therapy that is not approved for any indication in any disease.

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Do you have a trial for pancreatic cancer?

Yes, we do have an ongoing trial evaluating our lead cancer metabolism-based therapy (CMBT), SM-88, as a potential treatment for patients with third-line pancreatic cancer. For more information, please visit us at TYMEtrials.com.

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Do you have a trial for sarcoma?

Yes, we do have an ongoing trial evaluating our lead cancer metabolism-based therapy (CMBT), SM-88, as a potential treatment for patients with Ewing’s and highrisk sarcoma. For more information, please visit us at TYMEtrials.com.

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Do you have a trial for prostate cancer?

Our clinical trial evaluating SM-88 as a potential treatment for patients with recurring prostate cancer is now completed. The purpose of this study was to evaluate the safety, pharmacokinetics, and efficacy of SM-88 in patients with prostate cancer that has not become metastatic.

The final data were presented at the European Society of Medical Oncology Congress (ESMO) held on September 27- October 1, 2019 in Barcelona, Spain. For more information, please visit us at TYMEtrials.com.

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Will you be opening trials for other cancers?

At this time, we do not have information to provide for the opening of trials for other cancers. Please visit TYMEtrials.com for any updates for the potential opening of new cancer trials.

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Do you know any medical center that has a trial using SM-88 for pancreatic or sarcoma cancers?

Please visit TYMEtrials.com for more information.

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Can I pay for SM-88?

SM-88 is an investigational therapy that is not approved for any indication and is not available for purchase.

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Can you send me literature on SM-88?

Overview of SM-88 can be found at tymeinc.com/pipeline/sm-88-overview/

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Why did PanCAN launch the Precision Promise<sup>SM</sup> adaptive clinical trial?

PanCAN created the Precision Promise adaptive clinical trial because traditional clinical trial designs are slow to evaluate new treatment options for pancreatic cancer patients. PanCAN’s novel clinical trial platform is designed to more efficiently test new therapies for their effectiveness in treating patients with pancreatic cancer by requiring fewer patients to understand if a potential new therapy is working. The platform is also designed to allow multiple investigational therapies to be tested simultaneously. For more information, visit: PanCAN Precision PromiseSM.

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Who can enroll in PanCAN Precision Promise<sup>SM</sup> adaptive clinical trial?

If a patient is interested in enrolling in PanCAN Precision Promise adaptive clinical trial, they will need to consult with their oncologist/healthcare team. A patient’s treating physician can determine if they are eligible to enroll. A patient would have to go to one of the 14 Precision Promise sites to enroll in the trial.

The trial will enroll patients with metastatic pancreatic cancer who have either received no treatment in the metastatic setting (first-line), or who have only received one prior treatment for their cancer in the metastatic setting (second-line). For more information, visit: PanCAN Precision PromiseSM

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Where is PanCAN’s Precision Promise adaptive clinical trial located, and when will the sites open?

There are 14 initial Clinical Trial Consortium sites across the United States. The sites will start opening in winter 2019, with the majority expected to be open in 2020. The Clinical Trial Consortium page will continue to be updated as sites open. For more information, visit: PanCAN Precision PromiseSM

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