NuvOx Pharma is a company that has created a unique drug delivery system. This system involves injecting drugs intravenously, which then travel through the bloodstream to the lungs to pick up oxygen. The drugs then make their way to hypoxic tissue, where they passively deliver the oxygen. NuvOx's drug has potential applications in a range of conditions, including stroke, oncology, and sickle cell crisis.

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Cardiovascular Diseases

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Nervous System Diseases

Small molecule drug

Contrast agent

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Disease Domain	Count

Hemic and Lymphatic Diseases	1
Nervous System Diseases	1
Neoplasms	1

Top 5 Drug Type	Count

Small molecule drug	2
Unknown	1
Contrast agent	1

Drugs associated with Nuvox Pharma LLC

Perflenapent

Target-

Mechanism

Oxygen carriers [+1]

Active Org.

Nuvox Pharma LLC

Originator Org.

Nuvox Pharma LLC

Active Indication

Ischemic stroke [+2]

Inactive Indication

Acute Ischemic Stroke

Drug Highest PhasePhase 2/3

First Approval Ctry. / Loc.-

First Approval Date-

NVX-508

Target-

Mechanism

Oxygen carriers

Active Org.

Nuvox Pharma LLC

Originator Org.

Nuvox Pharma LLC

Active Indication

Vaso-occlusive crisis

Inactive Indication

Anemia, Sickle Cell

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

NVX-308

Target-

Mechanism

Oxygen carriers

Active Org.

Nuvox Pharma LLC

Originator Org.

Nuvox Pharma LLC

Active Indication

Myocardial Infarction

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Nuvox Pharma LLC

NCT06658535 / Not yet recruitingPhase 1

Novel Oxygen Therapeutic NanO2 for Mild Respiratory Distress in Phase 1b

EXTEND is a dose escalation study of NanO2™ in patients with mild respiratory distress who are at risk for mechanical ventilation. The study will establish dosing guidelines for a Phase 2 study.

Start Date01 Oct 2024

Sponsor / Collaborator

Nuvox Pharma LLC

NCT05389748 / Not yet recruitingPhase 2/3

Phase IIb to Restore Oxygen in Large Vessel Occlusion Patients En Route for MT Using NanO2

A two stage phase 2 study with an interim analysis to provide evidence that subjects provided with early administration of NanO2 who are located at small rural spoke hospitals and identified with large vessel occlusion ischemic strokes as well as viable penumbra prior to transfer to larger hub hospitals and who continue dosing NanO2 until revascularization is achieved by intravenous alteplase and/or mechanical thrombectomy, will experience stroke recovery by shifting ischemic brain tissue to normal tissue pO2 environments.

Start Date01 Apr 2023

Sponsor / Collaborator

Nuvox Pharma LLC

[+3]

NCT03862430 / RecruitingPhase 2

A Phase II Double-blind, RandomizEd, Prospective, Placebo Controlled STudy of NanO2TM Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma multiformE: RESTORE

This clinical trial is testing the safety and efficacy of NanO2TM administered via intravenous infusion in combination with standard radiation and chemotherapy.
NanO2TM is being developed to increase the amount of oxygen delivered to tumors which is hoped to increase the effectiveness of radiation therapy.

Start Date31 Mar 2023

Sponsor / Collaborator

Nuvox Pharma LLC

100 Clinical Results associated with Nuvox Pharma LLC

0 Patents (Medical) associated with Nuvox Pharma LLC

Literatures (Medical) associated with Nuvox Pharma LLC

01 Dec 2024·Artificial cells, nanomedicine, and biotechnology

Dodecafluoropentane emulsion as an oxygen therapeutic.

Review

Author: Unger, Evan ; Johnson, Jennifer L H

Dodecafluoropentane emulsion (DDFPe) is a fluorocarbon (FC) under clinical development as an oxygen therapeutic and is regulated as a blood substitute. Compared to all the prior FCs studied, DDFP is the most advantageous for oxygen delivery and it is active at a lower concentration (1/200th to 1/1000th the weight of other FCs). DDFP has a boiling point of 29 °C, is more water soluble than prior FCs, and following IV administration clears via exhalation. Prior FCs had boiling points ≥ 140 °C and were retained long-term in the body causing adverse events. DDFP is a gas at biological temperature while prior FCs were liquids. Gases deliver roughly 1000 times more oxygen than liquids. DDFPe has two mechanisms of action: (1) The size of the molecule is the smallest that is a liquid at room temperature; on a molar volume basis this equates to more dissolution of oxygen. (2) Because of its boiling point close to physiologic temperature, DDFP delivers oxygen more effectively than liquid FCs.Highlight PointsFluorocarbons (FCs) dissolve oxygen and other respirable gases.FC emulsions generally do not have biological effects of and by themselves, but rather they increase the oxygen carrying capacity of the blood.There are a variety of FCs that were developed in the past as blood substitutes but they all caused accumulation in humans leading to toxic responses.Dodecafluoropentane emulsion (DDFPe) is being developed as an oxygen therapeutic to increase the oxygen carrying capacity of the blood and oxygen delivery to tissues.

01 Aug 2023·Cancer research communications

Dodecafluoropentane Emulsion as a Radiosensitizer in Glioblastoma Multiforme.

Article

Author: Mason, Ralph P ; Stea, Baldassarre ; Becker, Jennifer ; Zhou, Heling ; Lickliter, Jason D ; Unger, Evan ; Jennens, Ross ; Gzell, Cecelia ; Ruben, Jeremy ; Kichenadasse, Ganessan

PurposeGlioblastoma multiforme (GBM) is a hypoxic tumor resistant to radiotherapy. The purpose of this study was to assess the safety and efficacy of a novel oxygen therapeutic, dodecafluoropentane emulsion (DDFPe), in chemoradiation treatment of GBM.Experimental DesignIn this multicenter phase Ib/II dose-escalation study, patients were administered DDFPe via intravenous infusion (0.05, 0.10, or 0.17 mL/kg) while breathing supplemental oxygen prior to each 2 Gy fraction of radiotherapy (30 fractions over 6 weeks). Patients also received standard-of-care chemotherapy [temozolomide (TMZ)]. Serial MRI scans were taken to monitor disease response. Adverse events were recorded and graded. TOLD (tissue oxygenation level-dependent) contrast MRI was obtained to validate modulation of tumor hypoxia.ResultsEleven patients were enrolled. DDFPe combined with radiotherapy and TMZ was well tolerated in most patients. Two patients developed delayed grade 3 radiation necrosis during dose escalation, one each at 0.1 and 0.17 mL/kg of DDFPe. Subsequent patients were treated at the 0.1 mL/kg dose level. Kaplan-Meier analysis showed a median overall survival of 19.4 months and a median progression-free survival of 9.6 months, which compares favorably to historical controls. Among 6 patients evaluable for TOLD MRI, a statistically significant reduction in tumor T₁ was observed after DDFPe treatment.ConclusionsThis trial, although small, showed that the use of DDFPe as a radiosensitizer in patients with GBM was generally safe and may provide a survival benefit. This is also the first time than TOLD MRI has shown reversal of tumor hypoxia in a clinical trial in patients. The recommended dose for phase II evaluation is 0.1 mL/kg DDFPe.Trial Registration: NCT02189109.SignificanceThis study shows that DDFPe can be safely administered to patients, and it is the first-in-human study to show reversal of hypoxia in GBM as measured by TOLD MRI. This strategy is being used in a larger phase II/III trial which will hopefully show a survival benefit by adding DDFPe during the course of fractionated radiation and concurrent chemotherapy.

08 Nov 2022·Circulation

Abstract 15543: Fibrin-Targeted Phase Shift Microbubbles Outperform Fibrin-Targeted Microbubbles for the Treatment of Microvascular Obstruction

Author: Acosta, Maria Fernanda ; Hanrahan, Dillon ; MEUILLET, Emmanuelle ; Amjad, Muhammad Wahab ; Pacella, John ; Unger, Evan ; Chen, Xucai X ; Mohammed, Soheb Anwar

Introduction: Mortality from AMI has decreased in recent years; however, microvascular obstruction (MVO) occurs frequently, and is associated with rising post-AMI CHF, and has no definitive therapy. To address this urgent unmet need, we have developed an image-guided acute therapy, termed ‘sonoreperfusion’ (SRP), that resolves MVO via ultrasound-targeted microbubble cavitation (UTMC). We previously used standard-size, fibrin-targeted MBs and demonstrated enhanced reperfusion compared to standard-size, non-targeted MBs. However, phase shift microbubbles may allow greater clot penetration and perhaps more effective SRP, owing to their much smaller size Vs. standard MBs (~200 nm vs. 3 μm). Thus, we compared the SRP efficacies of fibrin-targeted phase shift microbubbles (FTPSMBs) (Microvascular Therapeutics, Inc), to standard-size fibrin-targeted microbubbles (FTMBs) for the treatment of MVO Methods: MVO of the rat hindlimb ( n=6 ) was created by injecting porcine microthrombi into the left femoral artery under contrast-enhanced ultrasound (CEUS) guidance. DEFINITY ® MBs (Lantheus Medical Imaging) were infused (2 mL/hr) through the right external jugular vein for CEUS. Following 10 min of stable MVO, a transducer was positioned vertically above the hindlimb to deliver therapeutic US pulses during concomitant administration of FTMBs/FTPSMBs (3 mL/hr). CEUS cine loops with burst replenishment were obtained at baseline (BL), 10 min post-MVO, and after each of the two SRP treatment sessions (TX1, TX2) and video intensities were analyzed (MATLAB_R2021a) Results: FTPSMBs treatment resulted in a greater increase in the blood volume (dB) and flow rate (dB/sec) than FTMB after each 10-minute treatment session (Figure 1) Conclusions: US-guided FTPSMB cavitation causes more rapid and complete reperfusion of MVO than FTMB, likely owing to their small size and more effective thrombus penetration. Studies to explore the underlying mechanisms are underway

News (Medical) associated with Nuvox Pharma LLC

30 Apr 2021

·www.biospace.com

NuvOx Completes Construction of Expanded Manufacturing Facility.

April 30, 2021 10:00 UTC TUCSON, Ariz.--(BUSINESS WIRE)-- NuvOx Pharma has completed construction and initiated operation of its GMP production facility for manufacturing its injectable pharmaceutical products at its Tucson, Arizona facility. Construction of the GMP facility was financed by ImaRx Investments, LLC. The facility comprises an 1,800 square foot hard shell exterior space addition to the existing building located at 1635 East 18th Street. A 900 square foot ISO 5 cleanroom is housed within the exterior space. Olivia Longacre, Chief Operating Officer of NuvOx, oversaw construction of the exterior space and installation of the cleanroom. Olivia Longacre said, “This same ISO 5 modular cleanroom, manufactured by Terra Universal, has been successfully used by large and small pharmaceutical companies to manufacture pharmaceutical products commercially. It is our goal to manufacture our lead product, NanO2TM, for pivotal clinical trials and commercial supply after FDA approval. We have invested in our Quality Management System intended to meet all FDA regulatory requirements.” Jon Saxe, BSChE, JD, LLM, Board Member of NuvOx and former Chairman of the Mobilizing for Quality Task Force responsible for corporate oversight of quality at Hoffman La Roche Inc., said, “I am impressed with the knowledge and commitment to quality of the staff at NuvOx and their capability to successfully execute on their manufacturing program.” Evan Unger, MD, co-Founder and CEO of NuvOx, added, “We have active Phase IIb programs for NanO2 in ischemic stroke and brain cancer following successful phase Ib/II studies in both of these indications. Our own manufacturing facility allows us to control costs, maintain continuous quality improvement and support our clinical development programs.” NuvOx Pharma is a privately held biotech company based in Tucson, Arizona. For further information, visit or contact Evan Unger, MD at eunger@nuvoxpharma.com. 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. View source version on businesswire.com: Contacts Evan Unger, MD eunger@nuvoxpharma.com Source: NuvOx Pharma View this news release online at:

100 Deals associated with Nuvox Pharma LLC

100 Translational Medicine associated with Nuvox Pharma LLC

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Pipeline Snapshot as of 23 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Perflenapent	Ischemic stroke More	Phase 3 Clinical
NVX-508	Vaso-occlusive crisis More	Preclinical
NVX-308	Myocardial Infarction More	Preclinical
NVX-408	Hemorrhage More	Pending
NVX-428	Brain Injuries More	Pending

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