TGen and Scottsdale Healthcare launch Phase I 'Thunder God vine' trial for cancer
Taking a page from Chinese herbal medicine, Scottsdale Healthcare and the Translational Genomics Research Institute (TGen) today initiated the first-in-human clinical trial for pancreatic cancer patients using a compound derived from a plant known as "Thunder God vine."
The first patient to participate in this clinical trial received treatment today at Scottsdale Healthcare's Virginia G. Piper Cancer Center Clinical Trials, a partnership of Scottsdale Healthcare and TGen.
The Thunder God vine (Tripterygium wilfordii), also known as lei gong teng, is native to China, Japan and Korea. Traditional Chinese medicine has used the vine for more than 2,000 years as a treatment for everything from fever to inflammation and autoimmune diseases, such as multiple sclerosis and rheumatoid arthritis.
A chemical compound called triptolide is among the more than 100 bioactive ingredients derived from the Thunder God vine. Preclinical studies showed a pharmaceutical version of triptolide called Minnelide proved effective against pancreatic cancer cells, according to a study by Dr. Ashok K. Saluja, Professor and Vice-Chair, Department of Surgery, University of Minnesota and Chief Scientific Officer and Co-Founder of Minneamrita Therapeutics LLC, published in the journal Science Translational Medicine.
The U.S. Food and Drug Administration (FDA) recently approved use of the compound Minnelide for a clinical trial of gastrointestinal cancer patients—including pancreatic cancer.
"We have known for years about the potential beneficial use of Thunder God vine, but only recently with the advent of Minnelide have we created a form of triptolide that can be easily administered to patients," said Dr. Mohana R. Velagapudi, Chief Executive Officer and Co-Founder of Minneamrita Therapeutics LLC, the trials sponsor. "This clinical trial will hopefully provide the proof of concept so patients beyond the trial can benefit as well."
Noted pancreatic cancer authority Dr. Daniel D. Von Hoff is the principal investigator for the trial opening at Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare. Von Hoff is Chief Scientific Officer for Virginia G. Piper Cancer Center Clinical Trials and TGen's Physician-In-Chief.
"The preclinical results of Minnelide were outstanding," Von Hoff said. "The level of positive preclinical activity gives us hope that this is a new lead for trying to help patients battling pancreatic cancer."
With more than 40 active clinical trials for advanced or rare cancers, Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, through its partnership with TGen, is one of the leading centers for Phase I oncology trials in the nation. These clinical trials provide clinical care options that did not exist before to Phoenix-area patients as well as patients from all over the country.
"Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research," said Dr. Ramesh Ramanathan, Medical Director for Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare. "The Minnelide trial is another example of how we're bringing added benefit to cancer patients through these first-in-human clinical trials."
Translational Drug Development (TD2), a pharmaceutical development subsidiary of TGen, designed and manages the trial. TD2 worked with Minneamrita Therapeutics LLC to secure regulatory approval for the Phase I trial, which, in addition to the VGPCC Clinical Trials Program, also opened at the University of Minnesota Masonic Cancer Center, where Dr. Edward Greeno, Medical Director of University of Minnesota Physicians Cancer Care, is the principal investigator.
"Minnelide is a remarkable drug and we are happy to have helped bring its potential clinical benefit to patients here first in Scottsdale," said Dr. Stephen Gately, President and Chief Scientific Officer of TD2.