Earlier this week, biotechnology company Time Technologies announced that its drug candidate SM-88 received Orphan Drug Designation from the FDA for the treatment of pancreatic cancer. The FDA defines orphan drugs as:
those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
But what is SM-88, and why is it such a compelling candidate?
SM-88
Developed by Tyme Technologies, which aims to create low toxicity and broadly effective cancer treatments, SM-88 is an orally administered tyrosine derivative. Also known as racemetyrosine, this investigational therapy prompts cancerous cell death by leveraging immune response and oxidative stress.
In previous clinical trials, SM-88 prompted tumor response in lung, prostate, breast, and pancreatic cancer, as well as 11 other subtypes. Additionally, it was generally well-tolerated, with few adverse reactions. Next, researchers will continue to study the investigational therapy in the TYME-88-Panc trial. You can learn more about this trial, or enroll, here.
The TYME-88-Panc clinical trial will test the safety and efficacy of SM-88 for patients with pancreatic cancer who have not responded to prior treatment. Participants must have tried and failed at least two prior therapies. Through the trial, patients will receive SM-88 alongside methoxsalen, phenytoin, and sirolimus.
Pancreatic Cancer
As the name suggests, pancreatic cancer occurs in the pancreas, a hormone and enzyme-releasing organ that plays a role in digestion and blood sugar management. Pancreatic cancer can either be exocrine or neuroendocrine based on its location. The latter is the more rare form. Risk factors include smoking, obesity, and a family history of pancreatic cancer. Generally, it affects patients over the age of 45. Additionally, males are more at risk of developing pancreatic cancer than females. Around 57,000 U.S. citizens are diagnosed with pancreatic cancer each year.
For many patients, symptoms do not develop until the cancer progresses into its later stages. However, when they appear, they include:
- Unintended weight loss
- Abdominal and back pain
- Diabetes
- Nausea and vomiting
- Appetite loss
- Fatigue
- Jaundice
- Depression
- Dark urine
- Blood clots
- Enlarged liver and gallbladder
Learn more about pancreatic cancer here.
