First-in-Human Thunder God Vine Trial-Minnelide
TGen and Scottsdale Healthcare launch Phase I 'Thunder God vine' trial for cancer
First patient receives treatment at Virginia G. Piper Cancer Center Clinical Trials
SCOTTSDALE, Ariz. — Sept. 12, 2013 — 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.
Individuals seeking information about eligibility to participate in this and other VGPCC clinical trials may contact the cancer care coordinator at (480) 323-1339, toll free at 1-877-273-3713 or via e-mail at firstname.lastname@example.org.
Individuals seeking information about eligibility to participate in this trial at the University of Minnesota Physicians Cancer Care, please contact the New Patient Access Center at (855) 486-7226.
About the Virginia G. Piper Cancer Center at Scottsdale Healthcare
The Virginia G. Piper Cancer Center at Scottsdale Healthcare in Scottsdale, Ariz. offers comprehensive cancer care and research through clinical trials, diagnosis, treatment, prevention and support services in collaboration with leading scientific researchers and community oncologists. Scottsdale Healthcare is the nonprofit parent organization of the Virginia G. Piper Cancer Center at Scottsdale Healthcare, Scottsdale Healthcare Research Institute, Scottsdale Healthcare Osborn Medical Center, Scottsdale Healthcare Shea Medical Center and Scottsdale Healthcare Thompson Peak Hospital. For more information, visit http://www.shc.org.
Virginia G. Piper Cancer Center at Scottsdale Healthcare
Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. TGen is focused on helping patients with cancer, neurological disorders and diabetes, through cutting edge translational research (the process of rapidly moving research towards patient benefit). TGen physicians and scientists work to unravel the genetic components of both common and rare complex diseases in adults and children. Working with collaborators in the scientific and medical communities literally worldwide, TGen makes a substantial contribution to help our patients through efficiency and effectiveness of the translational process. For more information, visit: http://www.tgen.org.
TGen Senior Science Writer
About Translational Drug Development (TD2)
Translational Drug Development (TD2) is an oncology drug development organization and is wholly owned by the Translational Genomics Research Institute (TGen). TD2 provides innovative services for oncology focused biopharmaceutical companies using a dedicated team of professionals with broad experience and understanding in drug development. TD2 is uniquely positioned to support the need for improved and accelerated development of new chemical entities (NCE's) for life-threatening diseases. TD2 uses a unique combination of experience gained through its contract research organization business, and an integrated suite of proprietary and non-proprietary tools, preclinical study execution, regulatory affairs assistance, clinical trial design and management, and drug development experts to successfully move therapeutics towards regulatory approval. TD2 is dedicated to reducing the risks and uncertainty inherent in the drug development process. For more information about Translational Drug Development, visit http://www.td2inc.com.
VP, Business Operations