NuvOx Pharma LLC, a wholly owned subsidiary of NuvOx Therapeutics Inc. (together, “NuvOx”) announced that it has received a Qualified Person’s Declaration Equivalence to UK / EU GMP for Investigational Medicinal Products Manufactured outside of EU (in Third Countries) . This declaration fulfills a key requirement to initiate the NOVEL clinical trial (“NanO2 in Large VessEL Occlusion Stroke”).
The declaration verifies that, based on audits of the manufacturing of NanO2TM that the manufacturing complies with good manufacturing practice (“GMP”) standards that are at least equivalent to European Union GMP requirements.
Evan Unger, MD, CEO of NuvOx, said, “The NanO2 in Large VessEL Occlusion Stroke trial is crucial in advancing our product, NanO2, in its next stage of clinical development. This trial is designed as a multi-center, single-blind, randomised, placebo-controlled blinded end-point clinical trial to evaluate the safety, tolerability and preliminary efficacy of perfluorocarbon in acute ischemic stroke due to large vessel occlusion.”
“This declaration is an impressive achievement for the NuvOx team,” added Rong Wang, President and COO of NuvOx. “GMP standard in the UK / EU is very stringent, especially since 2023, when the European standard for sterile product was further tightened. We went through a site inspection at end of Q1 2024, and had to plan and implement many upgrades in our operation and quality systems. Such upgrades were completed while we also ramped up our regular production to support our multiple clinical programs. This milestone showcases our passionate spirit.”
Calvin Koerner, (ex-FDA Consultant, I.Q. Auditing), said, “I have been advising NuvOx in its GMP compliance and evaluation since 2023. In the nearly 30 years that I have worked in the biopharma industry, obtaining the declaration, under the revised European Annex 1 (2022) in a relative short time, is a huge feat and very impressive. Their accomplishments and achievements are well deserved.”
The NOVEL study is funded by the Efficacy and Mechanism Evaluation (EME) Programme, a partnership between the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC).
About NuvOx
NuvOx is a privately held Phase IIb ready company developing a novel oxygen therapeutic where hypoxia plays a role. Hypoxia, or low oxygen, is responsible for resistance to cancer treatment, brain damage in stroke, and the death of COVID-19 patients with acute respiratory distress syndrome (ARDS).
The Company’s lead drug candidate- NanO2 represents a disruptive platform technology ad-dressing multiple unmet needs, with positive results demonstrated in two completed Phase Ib/II studies: one in glioblastoma as a radiosensitizer and the other in stroke as a neuroprotect-ant. It was shown to be the most effective oxygen therapeutic among 74 clinical-stage com-pounds in literature review. It has safety and efficacy data in 7+ indications in various preclinical and clinical stages, including Orphan Drug Designation for both glioblastoma and sickle cell anemia.
The product can refer to safety data in ~2,000 subjects. The product is designed to be synergis-tic, rather than competitive with standard of care. The company also has a strong IP portfolio: 11 Patent Families; 11 issued US patents and 32 foreign equivalents.
NuvOx is conducting a Phase IIb clinical trial as a radiosensitizer in treatment of primary brain cancer, glioblastoma, and also plans to start a Phase IIb clinical trial for NanO2 in treatment of acute ischemic stroke, and a Phase Ib clinical trial for NanO2 in treatment of respiratory distress.
About the National Institute for Health and Care Research (NIHR)
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
•Funding high quality, timely research that benefits the NHS, public health and social care;
•Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
•Partnering with patients, service users, carers and communities, improving the rele-vance, quality and impact of our research;
•Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
•Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
•Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NuvOx Contact:
NuvOx Pharma
Dr. Evan Unger, CEO
Rong Wang, President and COO
Forward looking statement
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