After identifying the Guanylate Cyclase C enzyme in the early 1990s, Scott Waldman, MD, and Adam Snook, MD, are set to take a vaccine that targets the enzyme to destroy metastatic tumors to a phase II trial in 2017.
Here's what you should know.
1. Dr. Waldman and Dr. Snook are both professors at Thomas Jefferson University in Philadelphia, and Dr. Waldman is the chair of the department of pharmacology and experimental therapeutics.
They reported the enzyme has been "shown to be highly accurate for detecting the spread and predicting recurrence of colorectal cancer." The duo's vaccine instructs the immune system to stop metastatic tumor cells and destroy them.
2. Dr. Waldman said the preliminary findings on the vaccine "mean we have the potential to limit the aggressive nature of this disease and prevent metastases."
3. Exton, Pa.-based Targeted Diagnostics & Therapeutics holds the rights to the drug and has supported the work in Dr. Waldman's lab.
4. After 15 years of research and several lab and animal-based studies, Dr. Waldman's new drug application was approved by the FDA in 2013. His phase I trial tested the safety and tolerability of the drug in stage I and II cancer patients. It was safe and well-tolerated.
5. Dr. Waldman recently secured funding for a phase II trial. It's set to take place in 2017, pending FDA approval. It will assess the vaccine's effectiveness with intent of commercializing the vaccine. The trial will take two years.
6. If the trial can show efficacy, the physicians will seek Orphan Drug Status to "fast-track" it to the market.
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