According to a story from BioSpace, the biotechnology company Tyme, Inc. has just announced that it has earned Orphan Drug designation for its experimental product candidate SM-88. SM-88, also known as racemetyrosine, was awarded the designation from the US Food and Drug Administration (FDA) as a treatment for pancreatic cancer. Tyme focuses on developing metabolic therapies for cancer.
About Pancreatic Cancer
Pancreatic cancer is one of the most dangerous forms of cancer. The disease affects the pancreas, which is a glandular organ that is situated behind the stomach. Part of the reason that pancreatic cancer is so dangerous is that it rarely produces noticeable symptoms until it has reached an advanced stage and begun to spread. However, even when detected earlier, it is difficult to treat effectively. Risk factors for pancreatic cancer include being male, old age, African-American ancestry, family history, smoking, obesity, diabetes, chronic pancreatitis, and a diet heavy in red meat, processed meat, or meat cooked at very high temperatures. Symptoms include depression, upper abdominal pain, jaundice, diabetes, constipation, weight loss, and appetite loss. Treatment approaches for this cancer include surgery, chemotherapy, and radiation therapy. Even with heavy treatment, pancreatic cancer almost always returns. The five year survival rate is just five percent. To learn more about pancreatic cancer, click here.
About Orphan Drug Designation
Orphan Drug designation is typically reserved for therapies that are being developed to treat diseases that are considered rare. This is defined as any disease that affects less than 200,000 people in the US. To qualify, the experimental therapy must display advantages in safety or effectiveness over current treatments; alternatively, it must have the potential to satisfy a currently unmet medical need. Orphan Drug designation confers several benefits to the recipient company, such as tax breaks, the waiving of certain fees, and a seven year period of market exclusivity if the drug is ultimately approved for use by the FDA.
SM-88 is derived from tyrosine. Its mechanism of action is intended to break down cancer cell defenses through the disabling of its metabolic processes. This should expose the cell to immune system attack and oxidative stress. Trial data so far suggests that SM-88 could be effective in a variety of cancers, such as sarcomas, prostate cancer, lung cancer, and breast cancer. A total of 15 different cancers could potentially respond to SM-88. Only continued testing will prove whether it will be effective.