Market Overview

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

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 the 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, Ph.D., 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
—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

About Minneamrita Therapeutics LLC

Minneamrita is an early clinical stage drug development company
developing the molecules for unmet cancer treatments. Minneamrita is
developing Minnelide for its use in various cancers (gastric,
pancreatic, breast and AML).

About Translational Drug Development (TD2)

TD2 is an oncology development organization that provides innovative
services for oncology-focused companies. Using a dedicated team of
professionals with broad experience and understanding in drug
development, TD2 is uniquely positioned to support improved and
accelerated development of medicines for life-threatening oncology
diseases. TD2 applies rigorous and high-throughput translational
preclinical development, combined with regulatory affairs expertise, to
customize clinical trial design and execution. TD2's suite of
capabilities encourages the timely selection of patient populations who
are most likely to benefit from a new agent, and the rapid
identification of clinically significant endpoints. TD2 is committed to
reducing the risks and uncertainty inherent in the drug development
process and to the acceleration of patient access to promising
treatments. For more information, visit

About HonorHealth Research Institute

HonorHealth Research Institute 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.
HonorHealth is a nonprofit health system serving an area of 1.6 million
people in the greater Phoenix area. The network encompasses five acute
care hospitals, an extensive medical group, outpatient surgery centers,
a cancer care network, clinical research, medical education, a
foundation and community services with approximately 11,500 employees,
3,700 affiliated physicians and 3,100 volunteers. HonorHealth was formed
by a merger between Scottsdale Healthcare and John C. Lincoln Health
Network. HonorHealth's mission is to improve the health and well-being
of those we serve. Learn more at

View Comments and Join the Discussion!
Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Daily Analyst Rating
A summary of each day’s top rating changes from sell-side analysts on the street.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at