NuvOx in the News

FDA allows NuvOx Pharma to run a Phase II Clinical Trial in Brain Cancer

PR Dot COM

The FDA has allowed an Investigational New Drug (IND) application to initiate a Phase II clinical trial for NuvOx Pharma’s oxygen therapeutic, NVX-108, in patients with the hypoxic solid brain tumor, glioblastoma multiforme (GBM). NVX-108 is an injectable drug that travels through the bloodstream arriving first at the lungs to pick up oxygen and finally to hypoxic tissue where it passively delivers the oxygen. It is designed to reduce tumor hypoxia in order to make tumors more sensitive to radiation therapy and chemotherapy. Read more...

The NHLBI Grants NuvOx Pharma a $300k Grant to Study the Effects of their Oxygen Therapeutic on in Myocardial Infarction in a Pig Model.

PR Dot COMEvan Unger, MD, President and CEO of NuvOx Pharma, announced that NuvOx Pharma has been awarded a grant from the National Heart, Lung, and Blood Institute (NHLBI) entitled “Dodecafluoropentane Prevents Ischemia Reperfusion Injury in Contemporary Acute Myocardial Infarction Management”, for a total of $317,743. This grant will be used to support research to study NVX-308 as a cardioprotectant to reduce damage to the heart following myocardial infarction (heart attack). Read more...

NuvOx Pharma and the University of Arkansas Initiate Phase Ib/II Clinical Trial in Stroke

UAMS NuvOx Pharma announces that the first patients have been dosed in a Phase Ib/II clinical trial for NVX-208, an oxygen therapeutic being developed for acute ischemic stroke. The trial is being performed at the University of Arkansas for Medical Sciences in Little Rock, Arkansas under the direction of Dr. William Culp, the Jonathan Fitch Distinguished Chair in Stroke. Dr. Culp said, “We have studied NVX-208 in a number of animal stroke models and found that administration of NVX-208 decreased the brain damage from stroke by over 80%. The only approved drug to treat stroke is the thrombolytic drug t-PA, which has a risk of bleeding and is approved for use only up to 3 hours following stroke. Administration of NVX-208 prior to t-PA extended the time window of efficacy to at least 9-hours in rabbits.”

This Phase Ib/II trial is a randomized, placebo controlled, blinded, dose escalation trial that will enroll up to 24 patients. The primary endpoint is to find the maximum tolerated dose for NVX-208. Although the drug will not be used to extend the time-window for the clot-busting drug t-PA in this trial, it may still have a beneficial effect on outcomes in stroke patients and the researchers will look to see if there is a trend in NIH Stroke Scale, a measurement of stroke severity in the patients. NuvOx Pharma CEO, Evan Unger MD, says, “NVX-208 has great potential to improve both treatment and outcome of stroke patients. Stroke is the fifth leading cause of death in the US and a leading cause of serious long term disability. It costs the US an estimated $33 Billion per year. Improved treatment could not only decrease mortality and morbidity but also decrease health care costs. Subsequent clinical trials will be needed to see if NVX-208 can become approved by regulators.”

Disclaimer: Certain statements in this release may constitute “forward-looking statements.” Actual events or results may differ substantially as a result of risks and uncertainties facing us. The forward-looking statements are based on current expectations as of the date of these statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of future events, new information, or otherwise.

NuvOx Pharma and Jiangsu Nhwa Pharmaceutical Co., Ltd. sign Licensing Agreement for Hemorrhagic Shock and Perioperative Blood Loss

First-wordTucson, AZ, January 6th, 2017 - NuvOx Pharma LLC and Jiangsu Nhwa Pharmaceutical Co., Ltd. (SZSE: 002262) have signed a licensing agreement for the exclusive development and sales of NVX-408 for China for treating hemorrhagic shock and perioperative blood loss. NVX-408 is an oxygen therapeutic that is injected intravenously, flows through the lungs and picks up oxygen, then flows through the blood and passes hypoxic tissue then releases oxygen. Pre-clinical studies show that it can improve survival during severe blood loss. Read More ...

NuvOx Awarded NIH Grant to Develop Technology to Increase Sensitivity and Specificity of Breast Cancer Diagnosis.

PR Dot COMOctober 28th, 2016 -NuvOx Pharma, a Tucson-based biotechnology company, has been awarded a grant from the National Cancer Institute for $298,820.00 entitled, “B7-H3-Targeted Contrast Agent for Ultrasonic Imaging of Breast Cancer”. Evan Unger, MD, co-founder of NuvOx, a co-principal investigator of the grant, said, “This project draws upon NuvOx’s expertise in nanotechnology to more specifically and effectively diagnose breast cancer. Juergen Willmann, Professor of Radiology and Clinical Division Chief, Body Imaging, Department of Radiology at Stanford University Medical Center, and co-principal investigator on the project said, “A continuing challenge in the diagnosis of breast cancer is the differentiation of normal breast tissue from tumor and further differentiation of benign tumor from malignant tumor which requires immediate clinical intervention. In patients with dense breast tissue the challenge is greatly magnified and not well served by current ultrasound methodology. We have developed a targeting vector which will be incorporated into a new microbubble platform developed by NuvOx and are optimistic that the new targeted microbubbles will advance the sensitivity, and especially important, the specificity of ultrasound diagnosis of breast cancer in order to determine whether clinical intervention is needed. The increased diagnostic accuracy is expected to decrease costs associated with breast cancer medicine due to earlier intervention for malignancies and also the avoidance of unnecessary clinical intervention due to inaccurate characterization of normal tissue or benign tumor as malignant tumor.” Read More ...

NuvOx Pharma Awarded NIH Grant to Develop Technology to Treat Endocarditis

PR Dot COMTUCSON, Ariz. - Aug. 27, 2016 -NuvOx Pharma, a Tucson-based biotechnology company, has been awarded a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health for $243,164.00 entitled, “Fibrin Targeted Microbubbles and Ultrasound for Treatment of Endocarditis.” Evan Unger, MD, co-founder of NuvOx, a co-principal investigator of the grant, said, “This project draws upon NuvOx’s expertise in nanotechnology to more effectively treat localized disease, in this case endocarditis, particularly in pediatric patients.” Shelby Kutty, MD, MS, PhD, Associate Professor of Pediatrics and Internal Medicine at University of Nebraska Medical Center, co-principal investigator on the project said, “In endocarditis, an infection of the heart, a vegetation composed of platelets, fibrin and bacteria can form which prevents adequate penetration of antibiotics into the area of infection. Read More ...

Nuvox’s stroke candidate could triple window of time compared to tPA

bioworldBy Michael Fitzhugh, August 24, 2016 -Chasing improved safety and decreased brain damage for stroke sufferers, Nuvox Pharma LLC is preparing for a fourth quarter start to a phase Ib study of NVX-208 (dodecafluoropentane emulsion), one of multiple oxygen therapeutics the company is advancing. Read More ...

FDA Allows NuvOx Pharma’s IND to Initiate Phase Ib Clinical Trial in Stroke

PR Dot COMTUCSON, Ariz. - Aug. 18, 2016 -Evan Unger, MD, President and CEO of NuvOx, announced that the FDA has allowed an investigational new drug application (IND) for NVX-208 (dodecafluoropentane emulsion) to be tested in a Phase Ib trial in stroke patients. The trial will be performed at the University of Arkansas Medical System in Little Rock, Arkansas under the direction of Dr. William Culp, Jonathan Fitch Distinguished Chair in Stroke. Dr. Culp said, "We have studied NVX-208 in a number of pre-clinical stroke models and found that administration of NVX-208 decreases the brain damage from stroke by over 80%. Read More ...

NuvOx Pharma Awarded STTR Grant from NCI for Ultrasound Contrast Agent to Diagnose Pancreatic Cancer

Prlog Press Release DistributionTucson, AZ, May 26, 2016 - Evan Unger, MD, President and CEO of NuvOx Pharma, a Tucson-based biotechnology company, announced that the company has been awarded a grant from the National Cancer Institute to develop an ultrasound contrast agent to diagnose pancreatic cancer. The Phase I Small Business Technology Transfer (STTR) grant is a joint development project between NuvOx and Stanford University. The two principal investigators on the project are Drs. Unger and Juergen Willmann, MD, Chief of Body Imaging, Professor of Radiology, Stanford University, School of Medicine. Read More ...

NuvOx Pharma wins Venture Madness Competition
Phoenix Business Journal

Phoenix Business JournalPhoenix, AZ, March 4, 2016 -113 early stage companies applied to compete in the third annual Venture Madness competition - a bracket-style business competition modeled after the NCAA March Madness basketball tournament. The applicant pool was narrowed down to 64 companies which began competing head-to-head online to try to enter the Sweet 16. The top 16 finalists including NuvOx competed in an in-person live pitch event at the Talking Stick Resort in Scottsdale over a three day period. The event brought in more than 200 business leaders and notable investors from the Invest Southwest community with the goal of connecting them to young companies and supporting the start-up community. Evan Unger led NuvOx Pharma from the Sweet 16 and into the Elite Eight, the Final Four, and finally to a Championship victory! This win resulted in a cash prize of $60,000 plus investment commitments for $25,000 from Mario Martinez of MRTNZ Ventures and $25,000 from Grayhawk Holdings, who both committed to investing in each of the top four competitors. NuvOx would like to thank its mentors, employees, and investors for help making this win possible. Read More ...

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