CD47 inhibitors(Cluster of differentiation 47 inhibitors), MYC inhibitors(Myc proto-oncogene protein inhibitors), NLRP3 inhibitors(NACHT, LRR and PYD domains-containing protein 3 inhibitors)

Therapeutic Areas

NeoplasmsRespiratory DiseasesMouth and Tooth Diseases+ [4]

Active Indication

Small Cell Lung CancerStomatitisHead and Neck Neoplasms+ [5]

Inactive Indication

Advanced cancerAdvanced CholangiocarcinomaAdvanced Malignant Solid Neoplasm+ [15]

Originator Organization

EPICENTRE Biotechnologies LLC

Active Organization

SciClone Pharmaceuticals (China) Co., Ltd

EpicentRx, Inc.

Inactive Organization

SciClone Pharmaceuticals LLC

Drug Highest PhasePhase 3

First Approval Date-

RegulationFast Track (US)

Structure

Molecular FormulaC5H6BrN3O5

InChIKeyJODKFOVZURLVTG-UHFFFAOYSA-N

CAS Registry925206-65-1

Clinical Trials associated with Nibrozetone

NCT05966194 / RecruitingPhase 2

A Randomized Placebo-Controlled Trial of Two Schedules of RRx-001 for the Attenuation of Severe Oral Mucositis in Patients Receiving Concomitant Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with the chemotherapy agent, cisplatin. Patients will receive RRx-001 or placebo before start of standard of care treatment.

Start Date02 Apr 2024

Sponsor / Collaborator

EpicentRx, Inc.

NCT04525014 / TerminatedPhase 1

A Phase 1 Trial of RRx-001 in Combination With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors

The PIRATE study tests the experimental drug RRx-001 in combination with 2 chemotherapy drugs that are commonly used in patients with cancer. RRx-001 has been used alone and with other anti-cancer medicines in adults. However, the investigators do not know what effects it will have in children and young adults.

Start Date26 Jan 2023

Sponsor / Collaborator

EpicentRx, Inc.

[+1]

CTR20221527 / RecruitingPhase 3

REPLATINUM：RRx-001 与含铂类二联疗法序贯给药或含铂类二联疗法单独给药作为小细胞肺癌三线或后续治疗的一项对照、开放、国际随机化 III 期研究

[Translation] REPLATINUM: A controlled, open-label, international, randomized phase III study of RRx-001 administered sequentially with a platinum-based doublet or alone as third-line or subsequent treatment for small cell lung cancer

比较双重主要有效性终点，包括无进展生存期（PFS）和总生存期（OS），PFS 定义为两组从随机分组至疾病进展（RECIST 1.1）或全因死亡之间的时间。疾病进展是由盲态独立中心审查（BICR）根据 RECIST 1.1 评估的，这是PFS 定义的依据。OS 定义为从随机分组至全因死亡的时间。

[Translation]

Dual primary efficacy endpoints were compared, including progression-free survival (PFS) and overall survival (OS), with PFS defined as the time from randomization to disease progression (RECIST 1.1) or death from any cause in both groups. Disease progression was assessed by blinded independent central review (BICR) according to RECIST 1.1, which was the basis for the definition of PFS. OS was defined as the time from randomization to death from any cause.

Start Date25 Aug 2022

Sponsor / Collaborator

SciClone Pharmaceuticals (China) Co., Ltd

100 Clinical Results associated with Nibrozetone

100 Translational Medicine associated with Nibrozetone

100 Patents (Medical) associated with Nibrozetone

Literatures (Medical) associated with Nibrozetone

01 Oct 2023·International journal of radiation oncology, biology, physics

Secondary Analysis of RRx-001 on the Incidence of Related Toxicities in Patients Treated with Concomitant Chemoradiation for Locally Advanced Head and Neck Cancer.

Article

Author: Caroen, S ; Oronsky, B ; Sonis, S ; Reid, T ; Abrouk, N

PURPOSE/OBJECTIVE(S):

The results of an open-labeled Phase 2a trial (PREVLAR) suggested that infusion of RRx-001 (bromonitrozidine), a nitrogen-containing NLRP3 inhibitor and Nrf2 activator, attenuated the course and severity of severe oral mucositis (SOM) associated CRT (cisplatin/IMRT) in cancers of the mouth or OPC without impeding tumor response.¹ Given its mechanism of action and the shared biology of radiation injury pathogenesis among other exposed tissues, we investigated the potential halo effect of RRx-001 on other regimen-related toxicities.

MATERIALS/METHODS:

PREVLAR was a multi-center, open-label randomized trial in which patients (n = 46) having locally advanced, histologically confirmed SCC of the OC or OPC were centrally randomized to one of four arms. Arms 1-3 received 2 weekly doses of RRx-001 (4 mg/dose) beginning 2 weeks before the start of CRT. Arm 2 (n = 11) received 2 additional RRx-001 infusions during weeks 2 and 5 and patients in Arm 3 (n = 13) received weekly RRx-001 for the first 6 weeks of CRT. 10 mg of dexamethasone was administered before RRx-001 infusions. Arm 4 (n = 10), the control, received CRT only. Adverse events (AEs) were assessed using CTCAE v5. All patients received standard regimens of IMRT (daily fractions of 2-2.2 Gy/minimum cumulative dose of 55 Gy) plus either weekly or tri-weekly cisplatin.

RESULTS:

Consistent with the observation that RRx-001 was most efficacious in attenuating the course of SOM when administered only prior to CRT (Arm 1) or prior to CRT with additional dosing on weeks 2 and 5 (Arm 2), compared to Arm 3 or control, the same dosing schedule appeared to be impactful on signs and symptoms of radiation-associated damage with tissues such as salivary glands and skin (Table 1). In particular, compared to control patients, patients in Arms 1 and 2 had a lower incidence of dry mouth (none vs. 60%), dysphagia (none vs. 70%), salivary duct inflammation (none vs. 30%), candida infection (9.1% vs 40%), radiation associated skin injury (Arm 1 none, Arm 2 18.2%, control 70%) and weight loss (none vs. 50%) as examples.

CONCLUSION:

In this small proof of concept trial, RRx-001 infusion resulted in a reduction of multiple, biologically-related, side effects associated with a standard chemoradiation regimen used to the treatment of head and neck cancers. KEVLAR, a larger Phase 2b trial is planned to begin enrollment in Q4 of 2023 at about thirty sites in North America.

01 Sep 2023·Clinical and translational science

Data Management 101 for drug developers: A peek behind the curtain.

Review

Author: Oronsky, Bryan ; Williams, Jeannie ; Abrouk, Nacer ; Caroen, Scott ; Stirn, Meaghan ; Coyle, Angelique ; Burbano, Erica ; Brechlin, Joanne ; Cabrales, Pedro ; Reid, Tony R

In drug development a frequently used phrase is "data-driven". Just as high-test gas fuels a car, so drug development "runs on" high-quality data; hence, good data management practices, which involve case report form design, data entry, data capture, data validation, medical coding, database closure, and database locking, are critically important. This review covers the essentials of clinical data management (CDM) for the United States. It is intended to demystify CDM, which means nothing more esoteric than the collection, organization, maintenance, and analysis of data for clinical trials. The review is written with those who are new to drug development in mind and assumes only a passing familiarity with the terms and concepts that are introduced. However, its relevance may also extend to experienced professionals that feel the need to brush up on the basics. For added color and context, the review includes real-world examples with RRx-001, a new molecular entity in phase III and with fast-track status in head and neck cancer, and AdAPT-001, an oncolytic adenovirus armed with a transforming growth factor-beta (TGF-β) trap in a phase I/II clinical trial with which the authors, as employees of the biopharmaceutical company, EpicentRx, are closely involved. An alphabetized glossary of key terms and acronyms used throughout this review is also included for easy reference.

01 Sep 2023·Recent patents on biotechnology

Patent and Marketing Exclusivities 101 for Drug Developers

Review

Author: Oronsky, Bryan ; Stirn, Meaghan ; Caroen, Scott ; Kumar, Raj ; Brinkhaus, Franck ; Reid, Tony

Abstract::

Despite an ever-increasing need for newer, safer, more effective, and more affordable therapies to treat a multitude of diseases and conditions, drug development takes too long, costs too much, and is too uncertain to be undertaken without the conferment of exclusionary rights or entry barriers to motivate and sustain investment in it. These entry barriers take the form of patents that protect intellectual property and marketing exclusivity provisions that are provided by statute. This review focuses on the basic ins and outs of regulatory and patent exclusivities for which new chemical entities (NCEs), referring to never-before approved drugs with an entirely new active ingredient, are eligible and uses RRx-001, a small molecule aerospace-derived NCE in development for the treatment of cancer, radiation toxicity, and diseases of the NLR family pyrin domain containing 3 (NLRP3) inflammasome, as a “real world” example. This is intended as a ‘101-type’ of primer; its aim is to help developers of original pharmaceuticals navigate the maze of patents, other IP regulations, and statutory exclusivities in major markets so that they can make proper use of them.

News (Medical) associated with Nibrozetone

23 May 2024

·www.prnewswire.com

EpicentRx Announces Oral Presentation for the Most Clinically Advanced TGF-β Ligand Trap, AdAPT-001, at the Upcoming 2024 ASCO Annual Meeting

Data affirm positive immune effects of AdAPT-001 plus a checkpoint inhibitor in sarcomas and triple negative breast cancer with established checkpoint-inhibitor resistance The paucity of immune related adverse events suggests that AdAPT-001 may protect against them. TORREY PINES, Calif., May 23, 2024 /PRNewswire/ -- EpicentRx, a clinical-stage biopharmaceutical company, announced that The American Society of Clinical Oncology (ASCO) has invited Dr. Anthony P. Conley, an MD Anderson Cancer Center (MDACC) Sarcoma Specialist and Lead PI, to give an oral presentation on the unprecedented clinical activity of AdAPT-001 plus an immune checkpoint inhibitor (ICI) in the ongoing Phase 2 open-label BETA PRIME clinical trial that has so far enrolled close to 70 patients. This activity includes complete responses and several durable partial responses in established checkpoint inhibitor-resistant tumor types like sarcoma and triple negative breast cancer, with some patients on treatment for nearly two years. To date, no dose-limiting toxicities or AdAPT-001 related serious adverse events have occurred and only one immune related adverse event (irAE) has been reported. This lack of irAEs suggests that AdAPT-001 may prevent or attenuate ICI-mediated immune attack on normal tissues but not cancerous ones. Lead EpicentRx therapy, AdAPT-001, is the most clinically advanced TGF-β ligand trap that antagonizes the immunosuppressive effects of TGF-β and augments responses to ICIs, even ICIs which patients previously failed. BETA PRIME is a multicenter Phase 2a clinical trial led by Dr. Anthony P. Conley from MDACC and Dr. Lucy B. Kennedy from the Cleveland Clinic. AdAPT-001 is dosed every two weeks in combination with an ICI. "This is incredibly exciting news to have been selected for an oral presentation at ASCO, where the most important trials are presented, discussed, and reviewed," said lead PI, Dr. Anthony P. Conley. "It is a great honor and an indication of the activity, safety, and tolerability of AdAPT-001 in combination with a checkpoint inhibitor. Credit to our clinical trial patients, the EpicentRx team and everyone from MDACC associated with the management of the BETA PRIME clinical trial." The abstract is available on ASCO.org/abstracts. Presentation details: Abstract Number for Publication: 2506 Abstract Title: Phase 1/2 study of the TGF-β-trap-enhanced oncolytic adenovirus, AdAPT-001, plus an immune checkpoint inhibitor for patients with immune refractory cancers. Session Type and Title: Oral Abstract Session – Developmental Therapeutics - Immunotherapy About AdAPT-001 AdAPT-001 is an investigational immunotherapy with a TGF-β receptor-immunoglobulin Fc fusion trap, designed to neutralize isoforms 1 and 3 of the profibrotic, proangiogenic, prohypoxic, and immunosuppressive cytokine, TGF-β, and to sensitize resistant tumors to checkpoint blockade. It is the most clinically advanced TGF-β ligand trap in development. In the ongoing Phase 2 BETA PRIME trial, AdAPT-001 was administered as single-agent and in combination with checkpoint inhibitors to patients with treatment-refractory tumors. Importantly, AdAPT-001 plus checkpoint inhibitors improved toxicity and AE profile over what is typically observed with checkpoint inhibitors. No dose limiting toxicities, AdAPT-001 related serious adverse-events, or dose reductions have been observed to date. About EpicentRx EpicentRx is at the epicenter of innovative drug development with therapies like AdAPT-001 and RRx-001 that target diseases and toxicities of hugely unmet medical need. For more information about the trial and EpicentRx's pipeline, please visit . Business Development Contact: Sa'ar Yaniv EpicentRx [email protected] Media Contact: Ashley Thomaz MCS Healthcare Public Relations [email protected] SOURCE EpicentRx, Inc.

ImmunotherapyPhase 2ASCO

06 Nov 2023

·www.prnewswire.com

EpicentRx To Present Nibrozetone (RRx-001) Data on Parkinson's Disease and ALS/MND at Neuroscience 2023

TORREY PINES, Calif., Nov. 6, 2023 /PRNewswire/ -- EpicentRx, Inc. ("EpicentRx"), a clinical-stage biotechnology company with two therapeutic platforms that address cancer and inflammatory diseases, has been selected for oral and poster presentations at the prestigious Society for Neuroscience's Neuroscience 2023, an international conference taking place in Washington, D.C. from Saturday, November 11 to Wednesday, November 15, 2023. The oral presentation by Dr. Richard Gordon, associate professor at the Queensland University of Technology and an internationally recognized expert on inflammasome signaling in neurodegenerative diseases, will present groundbreaking data on nibrozetone (RRx-001), a Phase 3 small molecule anticancer and chemoprotective agent with central nervous system (CNS) permeability and nanomolar potency against inflammasome activation. "Nibrozetone (RRx-001) has the potential to be an attractive neuroprotective treatment for disease modification of Parkinson's disease, an area of medical research that needs new and improved therapies," said Dr. Richard Gordon. "It has shown great potential against the blood-brain barrier in neurogenerative diseases and I'm looking forward to sharing the latest science and research on this potentially game-changing treatment." Details on the presentation include: Title: The CNS-permeable NLRP3 inhibitor RRx-001 is neuroprotective in experimental models of Parkinson's disease (NANO86.06) Session Title: Parkinson's Disease: Preclinical Models and Therapeutic Strategies Location: WCC 147A Session Date and Time: Wednesday, November 15 at 1:00pm ET EpicentRx will also showcase a poster at the conference titled, "PSTR200.18 – Evaluation of the phase-3 clinical candidate RRx-001 as a novel therapeutic agent for Amyotrophic Lateral Sclerosis." Following Neuroscience 2023, EpicentRx's Chief Executive Officer, Dr. Tony Reid, will present at the 2023 Inflammasome Therapeutics Summit on Thursday, November 30 at 9:30am ET. Dr. Reid's talk is entitled, "Exploring the Development of RRx-001: the NLRP3 Small Molecule Inhibitor for a Variety of Inflammatory Diseases." About Nibrozetone (RRx-001) Nibrozetone (RRx-001) is a highly selective NLRP3 inhibitor, Nrf2 agonist, and hypoxic nitric oxide donor with anti-inflammatory and antioxidant properties. Nibrozetone (RRx-001) is under investigation in a Phase 3 trial for the treatment of small cell lung cancer (SCLC), and a soon-to-start Phase 2b trial for protection against oral mucositis in first line head and neck cancer. It is also under development as a medical countermeasure for toxic exposures, and as a treatment for endometriosis and neurodegenerative diseases like Parkinson's and ALS/MND. About EpicentRx, Inc. EpicentRx Incorporated is a privately held biopharmaceutical company with two innovation-driven platforms of which nibrozetone (RRx-001) and AdAPT-001 are the lead compounds, respectively. The company's mission is disease remission, which it hopes to accomplish with novel, well-tolerated therapies that target a diverse range of unmet needs in cancer and non-cancer indications. Nibrozetone (RRx-001), a multimechanistic small molecule, is designed and currently under clinical investigation to preferentially target diseased tissues like tumors even as it shields normal cells from harm. It is in a Phase 3 trial called REPLATINUM for the treatment of small cell lung cancer (SCLC). A soon-to-start trial is KEVLARx for protection against chemoradiation-induced oral mucositis in first line head and neck cancer. Media Contact: Oliwia Barteczko (908) 234-9900 [email protected] SOURCE EpicentRx, Inc.

Phase 2Phase 3

07 Sep 2023

·www.pharmaceutical-technology.com

UK rejoins EU’s Horizon Europe science programme

Adam Zamecnik @a_zamecnik The UK has rejoined EU’s Horizon Europe science research programme. Image Credit: Shutterstock / vlastas The UK has re-joined the EU’s Horizon Europe science research programme after the country’s post-Brexit absence and long-stalled talks. British scientists will now be able to apply for grants and bids to take part in Horizon Europe projects, based on the UK Government’s 7 September announcement. Recommended Reports Reports LOA and PTSR Model - RRX-001 in Gliosarcoma GlobalData Reports State of the Biopharmaceutical Industry 2022 GlobalData View all As an EU member state at the time, the UK was part of the EU’s past Horizon 2020 research funding programme. This programme has since been succeeded by Horizon Europe, which uses its budget of €95.5bn to support research across the region. The programme not only offers funding for research but also provides a chance for collaboration across Europe and beyond such as Armenia, Israel, and New Zealand. “The UK’s decision to re-join the Horizon Europe funding programme will be welcomed warmly by researchers across the EU and Great Britain today,” said Dr Harshil Pate, head of scientific development at Seqera Labs after the announcement. “Tackling the many challenges facing humanity in the 21st century requires international collaboration that sees past borders, uniting our innovative research sectors to improve human health through cutting-edge discoveries in RNA vaccines, DNA analysis and more.” Whilst the UK was initially supposed to be a part of the programme as an associate, its membership was halted by disagreements with the EU over the future of trade rules in Northern Ireland. While a breakthrough in the Northern Ireland talks opened the possibility of readmission , the process faced further delays as reported by outlets at the time. However, the country has now re-joined the scheme and will be a fully associated member of the programme until it concludes in 2027, based on the 7 September announcement . The UK will start financially supporting the Horizon Europe scheme only in January 2024. Furthermore, the UK will also have a new automatic clawback that gives it compensation rights in case that British scientists receive less funding from the programme than what the country will invest. The European Commission estimates that the UK will pay almost €2.6bn per year for its participation in Horizon Europe and the Copernicus earth observation programme, which the country will also rejoin, based on a 7 September European Commission press release. However, the country will not rejoin the EU’s atomic Euratom programme. “We have worked with our EU partners to make sure that this is the right deal for the UK, unlocking unparalleled research opportunities, and also the right deal for British taxpayers,” said UK Prime Minister Rishi Sunak in the statement. The political agreement must now be approved by the European Council before being formally adopted in the EU-UK Specialised Committee on Participation in Union Programmes, per the European Commission’s statement.

100 Deals associated with Nibrozetone

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB12060

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Small Cell Lung Cancer	Phase 3	US	EpicentRx, Inc.	24 Dec 2018
Squamous cell carcinoma of the oral cavity	Phase 2	US	EpicentRx, Inc.	12 Jul 2018
Squamous Cell Carcinoma of the Oropharynx	Phase 2	US	EpicentRx, Inc.	12 Jul 2018
Stomatitis	Phase 2	US	EpicentRx, Inc.	12 Jul 2018
Advanced Cholangiocarcinoma	Phase 2	US	EpicentRx, Inc.	16 Jul 2015
EGFR-mutated non-small Cell Lung Cancer	Phase 2	US	EpicentRx, Inc.	01 Jun 2015
Neuroendocrine Tumors	Phase 2	US	EpicentRx, Inc.	01 Jun 2015
Refractory Ovarian Carcinoma	Phase 2	US	EpicentRx, Inc.	01 Jun 2015
Small Cell Carcinoma	Phase 2	US	EpicentRx, Inc.	01 Jun 2015
Metastatic Colorectal Carcinoma	Phase 2	US	EpicentRx, Inc.	01 May 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02452970 (EPIC, CTgov)	Phase 2	Advanced Cholangiocarcinoma	4	gemcitabine+cisplatin+RRx-001	ktuswegyal(fjzsykacbl) = nivvpzzuqg xqgnfsyfsr (udxinsbhmw, hwfaxmdmlr - cewcvchqli) View more	-	24 Apr 2024
NCT02489903 (ASCO_GU2023) Manual	Phase 2	Solid tumor Third line	40	RRx-001+etoposide +cisplatin	ympksakcij(zkoiioseun) = ktlsttxevq otsbklaxpz (xfyvdgpahb ) View more	Positive	21 Feb 2023
NCT02096354 (ROCKET, ASCO_GI2023) Manual	Phase 2	Colorectal Cancer Third line	34	4 mg RRx-001 + irinotecan	ktwbtorckm(fhldmglxvs) = wxxeashive kwvgbvxwxi (gylsotfjyu ) View more	Positive	24 Jan 2023
				160 mg regorafenib + irinotecan	ktwbtorckm(fhldmglxvs) = vxihtczjfl kwvgbvxwxi (gylsotfjyu ) View more
NCT03515538 (PREVLAR, ASCO2022)	Phase 2	Head and Neck Neoplasms	53	RRx-001 pretreatment only + CRT	vaxvblcovv(fypygdkdir) = RRx-001 were well tolerated with no associated serious adverse events wpmsnuqkhy (ucxkhnxwjq ) View more	Positive	02 Jun 2022
				Standard-of-care
NCT02215512 (BRAINSTORM, Pubmed \| Int J Radiat Oncol Biol Phys) Manual	Phase 1/2	Brain metastases	31	Radiation Therapy+RRx-001	qxpcvimvce(hvvjbctdru) = kwxctiyizf yttoctauwl (fnjfcuoegs ) View more	Positive	01 Jul 2020
NCT02801097 (PAYLOAD, ASCO2020) Manual	Phase 1	Advanced Malignant Solid Neoplasm	12	Irinotecan Hydrochloride+RRx 001	pstsxlbvej(brtqkgbewe) = 2 events （leukopenia and anemia only related to irinotecan） nqobdfhxnn (dngivjalxo ) View more	Positive	29 May 2020
NCT02518958 (ASCO2020) Manual	Phase 1	Neoplasms	12	RRx-001+nivolumab	tgbdaaeuca(xybqwutwsf) = pain on infusion (33.3%) qxeswgukpz (bqfmyuslwh ) View more	Positive	29 May 2020
NCT02096354 (ASCO2020)	Phase 2	Colorectal Cancer	18	RRx-001 blood mix	lahsrxlcba(oqkddxecmn) = The main adverse event attributed to RRx-001 treatment, which involved once weekly peripheral or central infusion, was a painful infusion-related superficial phlebitis in 80% of patients. iiizysvqea (wzhtxbjapb ) View more	Positive	25 May 2020
				Regorafenib + irinotecan
NCT03515538 (ASCO2020)	Phase 2	Advanced Head and Neck Carcinoma	53	RRx-001	tatafauojn(jdcankckqc) = ldnhbpxfwr snihesbmxh (vpkxebjebc )	Positive	25 May 2020
				RRx-001 (Standard of care)	tatafauojn(jdcankckqc) = xfustluglw snihesbmxh (vpkxebjebc )
NCT02518958 (PRIMETIME, SITC2019)	Phase 1	Neoplasm Metastasis CD47 \| tumor associated macrophages (TAMs)	12	RRx-001	qtsoxmcvtp(kmhrnmswtk) = 8.3% umhowaqykb (hyficlrzge ) View more	Positive	01 Nov 2019
				Nivolumab

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