Minneamrita Announces FDA Clearance of Investigational New Drug (IND) Application and Initiation of a Phase I Clinical Trial of an Oral Formulation of Minnelide in Patients with Advanced Cancer.
Minneamrita today announced that an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1 trial of an oral formulation of the company’s Minnelide for patients with advanced cancers is now active. The first patient to participate in this exciting clinical trial received treatment this past week at HonorHealth Research Institute.
Dr. Erkut Borazanci, the Principal Investigator at HonorHealth Research Institute, states, “Minnelide has shown promising activity in several different types of preclinical models of cancer. The promise of the drug as an oral formulation, along with combining it with additional chemotherapy like Abraxane, gives us another great option for those with cancer.”
HonorHealth participated in the trial for the intravenous form of Minnelide and is the first clinical site to be open for enrollment for this clinical trial of the new and improved oral formulation. Additional sites are planned to be opened and enrolling patients in the coming months, including the Mayo Clinic.
“With the responses seen in the Phase I trial with the IV formulation, we are hopeful that the improved and more convenient oral administration will demonstrate the same or improved clinical benefit,” said Daniel D. Von Hoff, MD, FACP, and the Virginia G. Piper Distinguished Chair for Innovative Cancer Research.
“We have developed an oral formulation to have an ease of administration, compliance and efficacy. Patients with advanced gastrointestinal cancers and breast cancer can participate in this trial,” said Mohana R. Velagapudi, MD, Chief Executive Officer and Co-Founder of Minneamrita Therapeutics LLC, the trial’s sponsor.
“While we have made significant progress in the treatment of various cancers, patients with cancers arising from gastrointestinal tract, especially pancreatic cancer, continue to have very poor prognosis. Minnelide has had very promising results in preclinical studies and the Phase I trial. Thus, we are hopeful that it will change the face of these deadly cancers,” said Ashok Saluja, PhD, Chief Scientific Officer and Co-Founder of Minneamrita Therapeutics.
Minneamrita chose Translational Drug Development (TD2) as its regulatory and clinical partner in 2012 and has continued its efforts in the development of the oral formulation of Minnelide. “We are honored that Minneamrita selected TD2 as its regulatory and clinical team,” said Dr. Stephen Gately, President and Chief Executive Officer of TD2. “We are proud of the successful IND application filings we have completed for them over the years, and the TD2 team is excited to manage the clinical trial for this important new medicine for patients with cancer.”
Minnelide is a drug derived from the thunder God vine (Tripterygium wilfordii)—also known as lei gong teng—and is native to China, Japan and Korea. Traditional Chinese medicine has used this 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
Individuals seeking information about eligibility to participate in this trial at HonorHealth may contact Joyce Schaffer, MSN, RN, AOCNS, at 480-323-1339 or via email at Joyce.firstname.lastname@example.org.