CHANDLER, Ariz.--(BUSINESS WIRE)--#AZBW--The Arizona Bioindustry Association will honor NuvOx
Pharma with an AZBio Fast Lane Award at the 2017
AZBio Awards.
Arizona life science and business leaders as well as guests from across
the country will be on hand to applaud the NuvOx Pharma team for their
progress in developing new therapies for patients.
NuvOx Pharma is a biotechnology company based in Tucson, Arizona that is
developing an innovative nanotechnology for oxygen delivery to treat
life-threatening diseases where hypoxia plays a role. The company is
ready to start a Phase II clinical trial in brain cancer, is in a Phase
Ib/II clinical trial in stroke, is Phase Ib ready in sickle cell crisis,
and has animal studies in heart attack, hemorrhagic shock, and traumatic
brain injury.
The company is led by Evan C. Unger, MD who serves as President & CEO.
Dr. Unger has founded three biotech companies. His first company, ImaRx
Pharmaceutical, developed 3 FDA approved drugs and was acquired by
DuPont yielding a > 20x ROI. Dr. Unger’s second company, ImaRx
Therapeutics, went public and performed clinical trials using a
pioneering new technology to treat stroke. Dr. Unger co-founded NuvOx
and is an inventor on 115 issued US patents. He is a board-certified
radiologist and has an appointment as a Professor of Radiology and
Biomedical Engineering at the University of Arizona.
Teaching an old drug new tricks.
NuvOx's formulations are based on dodecafluoropentane emulsion (DDFPe).
Upon intravenous administration, DDFPe travels through the bloodstream
arriving first at the lungs to pick up oxygen and finally to hypoxic
tissue where it passively delivers the oxygen. Animal studies have shown
efficacy in several indications including cancer, stroke, sickle cell
disease, hemorrhagic shock, traumatic brain injury, and heart attack.
Compared to other oxygen delivery technologies studied previously,
NuvOx’s DDFPe is active at less than 1/200th the dose because it
delivers oxygen so much more effectively. Lower doses often result in
less side effects which is an additional benefit for patients.
DDFPe was originally developed as an imaging agent. It was tested in
2,200 patients and approved in Europe, but never marketed due to
competitive pressures. NuvOx was formed to reposition the drug for its
oxygen carrying capability, and the company has benefited from the
abundance of data from the original developers, saving millions of
dollars in development costs. The FDA has allowed NuvOx to reference
that data as they build a case for the drug in new indications. The
company also has data from over 20 animal studies showing oxygen
delivery and or therapeutic benefit in multiple indications.
The company is currently in clinical trials for brain cancer and
stroke.
NuvOx completed enrollment in a Phase Ib/II clinical trial in brain
cancer. The results of the trial showed safety, statistically
significant evidence of tumor reoxygenation (the primary mechanism of
action of the drug), and evidence of increased survival. The resulting
data allowed NuvOx to file an Investigational New Drug (IND) Application
for a Phase II clinical trial.
In April 2017, the FDA allowed the IND for a randomized, placebo
controlled Phase II clinical trial in brain cancer. The trial will be
led by Dr. Baldassarre Stea from the University of Arizona and will be
performed at 4 different clinical sites, Banner – University Medical
Center Tucson (AZ), Banner Gateway MD Anderson (AZ), Barrow Neurological
Institute (AZ), and Miami Cancer Institute (FL). This is one of three
IND’s allowed in the last 18 months.
Another IND that the FDA allowed was for a randomized,
placebo-controlled Phase Ib/II clinical trial in acute ischemic stroke.
This was allowed in August 2016. In February 2017, NuvOx and the
University of Arkansas collaborated to enroll the first patients in the
Phase Ib/II clinical trial in stroke.
The FDA also allowed an IND for a Phase Ib clinical trial in sickle cell
disease. NuvOx is on track to start the trial near the end of this
summer in collaboration with the University of Pittsburgh.
The company also continues to develop its pre-clinical pipeline.
In January of 2017, the company signed a licensing agreement with a
corporate partner, Jiangsu Nhwa Pharmaceutical Co. Ltd. Nhwa paid
up-front fees, will pay for clinical trials for the drug for
peri-operative blood loss and hemorrhagic shock and registration in
China. NuvOx will receive milestone and royalty payments. NuvOx retains
rights in the rest of the world for treatment of hemorrhage and right of
reference to the Chinese data.
In March of 2017, NuvOx won a grant for $317,000 for a pre-clinical
study in heart attack in collaboration with the University of Nebraska.
Successful results of the study could allow the technology to move into
clinical trials in heart attack.
“Drug development is a long and challenging process,” stated Joan
Koerber-Walker president & CEO of AZBio. “NuvOx has made tremendous
advancements in the past 18 months as they have progressed in clinical
trials for their indications in both brain cancer and stroke. This work,
combined with new partnerships to explore additional indications for
health challenges that affect millions of patients, is an excellent
example of how innovative thinking and perseverance can lead to new life
science innovations that make life better for patients.”
A ceremony honoring NuvOx Pharma will take place at the AZBio
Awards on October 11, 2017 at the Phoenix Convention Center.
The AZBio Awards ceremony celebrates Arizona’s leading educators,
innovators and companies. Each year, AZBio honors bioindustry leaders
from across the state of Arizona who are illustrative of the depth,
breadth and expertise of its bioscience industry. The AZBio Awards
ceremony is held annually during Arizona
Bioscience Week. AZBW 2017 was proclaimed by the Arizona Senate
earlier this year. Multiple educational events focused on the value of
life science innovation will take place from October 8, 2017 to October
14, 2017 including the BMES
Annual Meeting in Phoenix. The Biomedical Engineering Society (BMES)
is the world’s leading society of professionals devoted to developing
and using engineering and technology to advance human health and
well-being. Attendees at BMES 2017 in Phoenix are expected to include
nearly 4,000 professional scientists, engineers, researchers and
students from academia and industry who are leaders in biomedical
engineering.
For registration and more information, go to www.azbioawards.com
For more information on Arizona Bioscience Week, visit www.AZBio.org/AzBW2017
About AZBio
A key component in Arizona’s life science ecosystem, the Arizona
Bioindustry Association (AZBio) is the only statewide organization
exclusively focused on Arizona’s bioscience industry. AZBio membership
includes patient advocacy organizations, life science innovators,
educators, healthcare partners and leading business organizations. AZBio
is the statewide affiliate of the Biotechnology Innovation Organization
(BIO) and works in partnership with AdvaMed, MDMA, and PhRMA to advance
innovation and to ensure that the value delivered from life-changing and
life-saving innovation benefits people in Arizona and around the world.
For more information visit www.AZBio.org
and www.AZBio.TV
Photos available upon request.
Contacts
Arizona Bioindustry Association
Joan Koerber-Walker, 480-332-9636
or
Amanda
Vega, (480) 275-9797
or
NuvOx
Pharma
John McGonigle
