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Idronoxil - Kazia Therapeutics

Drug Profile

Idronoxil - Kazia Therapeutics

Alternative Names: NOX-66; Veyonda

Latest Information Update: 09 May 2020

At a glance

  • Originator Noxopharm
  • Developer Children Cancer Institute; Kazia Therapeutics; Noxopharm
  • Class Antineoplastics; Hormones; Isoflavones; Small molecules
  • Mechanism of Action 1 Phosphatidylinositol 3 kinase inhibitors; 1-phosphatidylinositol 4-kinase inhibitors; Cyclin-dependent kinase inhibitors; Sphingosine kinase inhibitors; Src-Family kinase modulators; Tumour-associated NADH oxidase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II Prostate cancer; Solid tumours
  • Preclinical COVID 2019 infections; Glioma

Most Recent Events

  • 07 May 2020 Efficacy data from a phase Ib trial in Prostate cancer released by Noxopharm
  • 02 Apr 2020 Preclinical trials in COVID-2019 infections in Australia (unspecified route)
  • 02 Apr 2020 Noxopharm plans clinical trial for COVID-2019 infections (associated with acute respiratory distress syndrome (ARDS) and multi-organ failure)

Development Overview

Introduction

An innovative formulation of idronoxil, designated NOX 66 is being developed by Kazia Therapeutics (previously Noxopharm) for the treatment of drug-resistance in cancer chemotherapy and COVID-2019 infections. Idronoxil specifically binds to and inhibits the activity of tumour-specific external NADH oxidase 2 (ENOX2; tumour-associated NADH oxidase). The ENOX2 protein is responsible for maintaining the transmembrane electron potential in the cancer cell's plasma membrane. Loss of this potential inhibits the ability of the cancer cell to maintain a wide range of pro-survival mechanisms, including resistance mechanisms, sensitising the cancer cell to the cytotoxic effects of chemotherapy drugs and radiotherapies, thereby restoring the ability of the cell to respond to standard chemotherapy drugs. By inhibiting cyclin dependent kinases, idronoxil inhibit cancer cells division and arrest them in G2M phase which make the cell's DNA more susceptible to damage by radiation. By inhibiting sphingosine kinase and 1-Phosphatidylinositol-3-kinase, idronoxil blocks DNA-repair enzymes, PARP-1 and topoisomerase 1 and 2 and inhibits the ability of the cancer cell to repair its damaged DNA. Idronoxil also modulate the src family of kinases which regulate the role of spleen tyrosine kinase (SyK) and activate the immune cells particularly natural killer (NK) cells. Clinical development as monotherapy and as combination therapy for solid tumours is underway in the US. Clinical development for the treatment of prostate cancer is ongoing in Australia, New Zealand and Georgia. Preclinical development is underway for COVID-2019 infections and glioma in Australia.

Noxopharm intends to develop idronoxil as a radio-enhancer in the treatment of both primary and secondary brain cancers in adults and children [1] . Noxopharm also intends to investigate idronoxil for the potential treatment of COVID-19 infections associated with acute respiratory distress syndrome (ARDS) and multi-organ failure [2] .

Human studies using idronoxil administered in oral and intravenous dosage forms have shown that the drug is highly susceptible to phase II metabolism, resulting in loss of bio-activity. NOX 66 is a new dosage formulation of idronoxil developed specifically to protect the drug from phase II metabolism and ensuring the retention of the majority of administered drug in a bio-active form.

Idronoxil (NOX 66) has emerged from Noxopharm's research programme of isoflavonoid based cancer therapeutics [see Adis Insight Drug profile 800046244].

Company Agreements

In December 2017, Kazia Therapeutics entered into a collaboration agreement with Noxopharm, to support the future development of idronoxil novel formulation (NOX 66). Under the terms of the collaboration, Kazia will provide certain technical and proprietary information to assist and expedite the successful development of idronoxil novel formulation. In return, Kazia will take a small equity interest in Noxopharm, to align the future interests of both companies. In January 2018, Kazia reported that it released Noxopharm from any claims of ownership associated with idronoxil novel formulation or the intellectual property and technology related to the formulation. The value of this assurance in terms of the shares was agreed to be a cap of 4.9% of the capital structure of Noxopharm over the next two years, with that equity escrowed for the next six months. There were no other ongoing payments such as milestones, licence fees, royalties associated with the agreement [3] [4]

Key Development Milestones

Soft tissue sarcomas

In February 2020, Noxopharm announced that the US FDA has approved IND application for clinical study of idronoxil in combination with doxorubicin in patients with soft tissue sarcomas [5] .

Prostate cancer

In November 2019, Noxopharm initiated a phase I trial to evaluate the safety and absorption of a new formulation of idronoxil in healthy volunteers (NOX66-006; 378739; 2019-09-824; ACTRN12620000002987). The open label trial intends to enrol approximately 24 volunteers in Australia [6] .

In April 2018, Noxopharm commenced an investigator-initiated, phase I/II LuPin trial to determine the efficacy and safety of two doses of idronoxil (400 and 800 mg), in combination with 177 Lutetium PSMA 617 (radiotherapy) [see Adis Insight RDI Profile 800050453], in PSMA-positive patients with metastatic castrate-resistant prostate cancer (374100; HREC17SVH19; U1111-1206-1132; ACTRN12618001073291l LuPIN-1). The internally-delivered radiotherapy 177 Lu PSMA 617 is administered in up to six monthly cycles, each cycle comprising a single intravenous injection of 177 Lu PSMA 617 followed by 10 days of idronoxil treatment. The open label, non-randomised, pilot study is enrolling approximately 52 males in Australia [7] [8] [9] . The first eight patients received 400 mg of Veyonda daily on days 1-10 of each cycle. Following a safety data review, the dose for patients 9-16 was escalated to 800 mg of Veyonda [10] . In September 2018, Noxopharm announced that the phase I LuPIN study has been granted approval for increasing the patient numbers from 16 to 32 males. Both treatment regimens of idronoxil (400 and 800 mg), in combination with radiotherapy was shown to be well tolerated [11] . In May 2019, interim efficacy and safety data from the trial were released by Noxopharm [12] . In September 2019, and February 2020, company released results from the study. The company also reported initiation of dosing of 1200mg dosage of idronoxil in combination with 177 Lutetium PSMA 617 in 24 patients [13] [14] [15] .

In February 2020, Noxopharm in collaboration with GenesisCare intends to provide the combination of idronoxil 177 Lutetium and PSMA 617 (radiotherapy) under a compassionate use program in Australia to patients with advanced, treatment resistant, metastatic prostate cancer (mCRPC) being treated with theranostics [16] [17] . In March 2018, Noxopharm released results from two clinical cases which were received as part of a compassionate use outside of the company's formal clinical trial programme [18] .

In March 2017, Noxopharm initiated a first-in-man phase Ib/IIa trial evaluating the safety and activity of idronoxil monotherapy and combination therapy with carboplatin, in patients with refractory solid tumours including progressive, late-stage breast, ovarian, lung or prostate cancer that are non-responsive to standard therapies (CEP-1; NOX66-001A; NCT02941523). The two part, open-label, dose escalation study is enrolling approximately 36 adult and elderly patients, in the US. The phase IIa part of study will be initiated based on results from the phase Ia/Ib part of the trial [19] [20] . In March 2018, Noxopharm presented the safety and efficacy results from the phase Ib part of the trial at European Society for Medical Oncology Congress (ESMO-2018) [21] . In June 2018, the company presented interim results at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO-2018) [22] . In November 2018, Noxopharm released final data from the phase Ib portion of the trial [23] .

Noxopharm initiated the DARRT (enhancement of external beam radiotherapy) and LUPIN (enhancement of intravenous brachytherapy radiotherapy) clinical programmes of idronoxil (NOX 66), in combination with radiotherapy, for late stage prostate cancer. The DARRT program is Direct and Abscopal Response to Radiotherapy, and related to the use of idronoxil to enhance the known abilities of radiotherapy both to kill cancer cells directly exposed to radiation (direct response), and to result in the death of cancer cells outside of the field of radiation (abscopal response). The DARRT programme involves a phase Ib DARRT-1 study and a second DARRT-2 study, a phase II study in 80 patients with solid tumours [24] [18] [9] .

In December 2019, Noxopharm announced that phase Ib DARRT-1 has achieved its primary and secondary endpoints of safety with no significant dose limiting toxicity and efficacy respectively were met. In November 2017, Noxopharm initiated a proof-of-concept phase Ib DARRT-1 (Direct and Abscopal Response to Radiotherapy- 1) study to investigate the efficacy, safety and tolerability of idronoxil, in combination with palliative dose of radiation therapy, in patients with metastatic castrate-resistant prostate cancer (NOX66-002A; NCT03307629). The open label, non-randomised, pilot, dose confirmation study is enrolling approximately 26 patients in Australia, New Zealand and Georgia [25] . The study is designed to treat patients in escalating dose level cohorts of NOX 66 (400 mg, 800 mg and 1200 mg in cohort 1, 2 and 3) of four patients in each cohort, total 12 patients and an expansion cohort of 12 patients (cohort 4), to determine the optimal dose for future radiation therapy combination studies [18] [9] . Idronoxil is administered daily for the duration of the radiotherapy treatment plus 7 days [8] . In April 2018, the company treated the first cohort of four patients [26] . In July 2018, the company released interim safety data [27] [28] . In December 2018, Noxopharm announced that the DARRT-1 study has been approved to move to its final stage, with enrolment of 12 patients at a dosage of 1200mg idronoxil [29] . Noxopharm completed enrolment in the trial, in May 2019. Subsequently topline results were released. Safety and efficacy results were presented by the company in December 2019 [30] [31] [32] [33] .

Glioma

In preclinical studies, idronoxil killed cancer cells in primary cell cultures, established by Children’s Cancer Institute, from diffuse intrinsic pontine glioma (DIPG) tumours. Additionally, the drug was able to sensitise the cells to radiation, thereby leading to a significantly higher cancer cell death, along with a constant dose of radiation [1] .

COVID-2019 infections

In preclinical studies, established by Hudson Institute of Medical Research in Melbourne, idronoxil inhibited a range of inflammatory mediators known as cytokines, including interleukin-6 (IL-6), involved in a cytokine response syndrome (or cytokine storm) [2] .

NIO sponsored trials

Royal North Shore Hospital initiated a phase I trial in August 2017, to assess the safety and clinical tumour response of idronoxil suppository in combination with palliative radiotherapy for metastatic prostate cancer (NOX66 version 1; NCT03041285). The open-label, sequential trial will recruit approximately 12 patients in Australia [34] .

Financing information

In February 2020, Noxopharm raised $US8 million through capital raising, comprised of a $US3.1 million equity placement and a $US5 million loan. The proceeds will be utilised to advance the development of clinical trials of idronoxil, including the planned phase II DARRT-2 trial [35] .

Noxopharm, in July 2019, secured a funding facility for up to AU$26 million. The facility comprises an AU$4 560 000 (face value) secured convertible security (with 6-month lock-up) and up to AU$22 200 000 in ordinary share placements over a 12-month period. The company intends to utilise the proceeds from the financing for expanding the clinical development of idronoxil into CEP-2, DARRT-2 and immuno-oncology clinical trials, to meet ongoing working capital needs [36] .

In August 2016, Noxopharm completed an initial public offering $AUS6 million, and the company intends to use the funding to conduct clinical trials of idronoxil [37] [19] .

Patent Information

Kazia Therapeutics has intellectual property protection for idronoxil novel formulation [3] .

The family of PCT patents relating to NOX 66 DARRT have proceeded into the national examination phase in upwards of 80 countries [31] .

Drug Properties & Chemical Synopsis

  • Route of administration Rectal
  • Formulation Suppository, unspecified
  • Class Antineoplastics, Hormones, Isoflavones, Small molecules
  • Target 1 Phosphatidylinositol 3 kinase; 1-phosphatidylinositol 4-kinase; Cyclin-dependent kinase; Sphingosine kinase; Src-Family kinase; Tumour-associated NADH oxidase
  • Mechanism of Action 1 Phosphatidylinositol 3 kinase inhibitors; 1-phosphatidylinositol 4-kinase inhibitors; Cyclin-dependent kinase inhibitors; Sphingosine kinase inhibitors; Src-Family kinase modulators; Tumour-associated NADH oxidase inhibitors
  • WHO ATC code

    J05A-X (Other antivirals)

    L01 (Antineoplastic Agents)

  • EPhMRA code

    J5B9 (Antivirals, others)

    L1 (Antineoplastics)

  • Chemical name 3-(4-Hydroxyphenyl)-2H-1-benzopyran-7-ol
  • Molecular formula C15 H12 O3
  • Chemical Structure
  • CAS Registry Number 81267-65-4

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Preclinical Australia unspecified / unspecified Noxopharm 02 Apr 2020
Glioma In children - Preclinical Australia unspecified / unspecified Children Cancer Institute, Kazia Therapeutics 10 Jul 2018
Prostate cancer in combination with radiotherapy Combination therapy, Late-stage disease, Refractory metastatic disease, Second-line therapy or greater Phase I/II Australia Rectal / Suppository Kazia Therapeutics 31 Aug 2017
Prostate cancer in combination with radiation therapy in combination with radiotherapy Combination therapy, Late-stage disease, Refractory metastatic disease, Second-line therapy or greater Phase I Georgia, New Zealand Rectal / Suppository Kazia Therapeutics 01 Nov 2017
Solid tumours - Late-stage disease, Monotherapy, Refractory metastatic disease, Second-line therapy or greater Phase I/II USA unspecified / unspecified Kazia Therapeutics 03 Mar 2017
Solid tumours in combination with Carboplatin Combination therapy, Late-stage disease, Refractory metastatic disease, Second-line therapy or greater Phase I/II USA unspecified / unspecified Kazia Therapeutics 03 Mar 2017

Commercial Information

Involved Organisations

Organisation Involvement Countries
Noxopharm Originator Australia
Kazia Therapeutics Owner Australia
Royal North Shore Hospital Collaborator Australia
Children Cancer Institute Collaborator Australia
The Hudson Institute of Medical Research Collaborator Australia

Brand Names

Brand Name Organisations Indications Countries
Veyonda Noxopharm Solid tumours, Soft tissue sarcoma Australia, USA

Scientific Summary

Adverse Events

In the first-in-man phase Ib/IIa CEP-1 trial in patients (n=19) with solid tumours, idronoxil was well tolerated as monotherapy. One patient in monotherapy arm reported with anaemia which was related to idronoxil treatment. In combination with carboplatin, idronoxil at 400mg and 800mg did not exacerbate carboplatin toxicity. Overall, 83% of patients reported one or more AEs of which, 95% AEs were reported in combination arm. The frequent AEs reported were anaemia, neutropenia and hypocalcaemia, of which 80% AEs were due to carboplatin. One patient in combination arm showed hypersensitivity to carboplatin at initial injection [23] . In interim data, four SAEs, including three deaths were reported, but none were considered related to idronoxil [22] . Serious toxicity was noted in one of 15 patient, who was withdrawn from trial due to allergic reaction to carbolatin [21] [20] .

Treatment with NOX 66, in combination with radiotherapy was well tolerated, led to occurrence of grade 1 adverse events (AEs), dry mouth, mucositis oral, fatigue, in 9 patients with prostate cancer. The AEs were deemed to be related to NOX 66 therapy. No drug-related toxicity were reported. The open-label, phase Ib DARRT-1 trial is designed to enrol 24 patients [28] [27] [25] .

In interim data from the phase Ib LuPin trial, idronoxil in combination with lutetium-177 PSMA 617 was generally well tolerated. However, one case of pneumonitis was reported in combination arm [15] [12] [7] .

In updated results from the phaseIb DARRT-1 trial combination of low-dose (20Gy) palliative radiotherapy and idronoxil was well tolerated and showed no new adverse safety signals at the end of six month of the trial. 9 patients had withdrawn, died or been lost to follow-up [31] [25] .

Pharmacodynamics

Summary

In a clinical study involving a 68-year old man with metastatic, castrate-resistant prostate cancer involving secondary tumours in bone and soft tissue , administration of idronoxil novel formulation combined with radiotherapy led to complete disappearance of irradiated tumours and the absence of any other visible tumours in the body. PSA levels (a blood marker of prostate cancer load) were normalised and the patient remained 3.8 years later in complete remission with undetectable PSA levels with no further requirement of treatment in that time. This was a complete abscopal response. In another clinical study involving a 70-year old woman with leiomyosarcoma, administration of idronoxil novel formulation combined with doxorubicin treatment had no effect, with a slight increase in the size of the lung metastases under observation. Subsequently, following a course of palliative radiotherapy to the primary tumour in the presence of idronoxil novel formulation, a significant reduction in the size of the lung metastases was observed, with the patient’s cough resolving, within one month of treatment. Six months later, the primary tumour was stable and the earlier response seen in the lung metastases remained intact. This was a partial abscopal response [18] .

Therapeutic Trials

In the first-in-man phase Ib/IIa CEP-1 trial in patients (n=19) with solid tumours, idronoxil showed chemo-sensitising effect and restored carboplatin sensitivity who had stopped responding to chemotherapy, including carboplatin. Idronoxil, in combination with low-dose carboplatin suppressed tumour progression for six months in 50% patients. Post completion of 3 cycle of combination treatment, 10 of 14 evaluable patients showed stable disease (SD) and three patients showed progressive disease (PD). Of 8 patients who completed further 3 cycle of treatment (6 cycle total), 5 patients showed stable disease (SD) and one patient displayed partial response (PR) with almost 100% reduction in tumour size at the end of study. Patients received idronoxil as a monotherapy for the first month and then in combination with two dosages of carboplatin (3 cycles of carboplatin followed by 3 cycles of carboplatin at 50% and 75%, respectively of a standard dose) over six months, with total seven months of treatment [23] [22] [21] [20] .

In updated results from the phaseIb DARRT-1 trial, approximately 66% men responded positively to idronoxil in combination with low-dose (20Gy) palliative radiotherapy to a single lesion, changed the course of the disease to a considerable degree in at least 66% of the men, with a halt to disease progression and high levels of pain relief lasting for the six months of observation. The study demonstrated 27% incidence of abscopal response (involves radiation directed at a single tumor which triggers resulting shrinkage of tumors well outside of the field of radiation) in soft tissue lesions using a combination of idronoxil and low-dose radiotherapy. Across all three idronoxi dosages (400, 800, 1200 mg); 1/15 patient had a partial response, 9/15 had stable disease and 5/15 had progressive disease, giving an overall tumour response rate of 66%, 5/16 patients (31%) had a PSA Response (>50% fall from baseline), with PSA reductions ranging from 61-98%, 10/16 patients (62%) had a Pain Response (>30% fall from baseline), with falls ranging from 43-100% (pain-free) [31] . Results from the DARRT-1 study demonstrated that no patients exhibited an abscopal response at 12-weeks in the 400mg cohort, while in the 800mg cohort, one patient had a partial abscopal response at 12-weeks. The first patient in the 1200mg cohort, reached the 6-week point and showed a partial abscopal response with a halving of the PSA count which was suggestive of a significant decrease in tumour load [28] . Highly durable disease control was demonstrated by progresion free survival of 57% (8/14) patients at 6 months. PSA response was achieved by 36% of patients at any point during follow up. Seven patients showed reduced pain levels at 3 months and pain resources were maintained in 5/7 patients at 6 months with two of these being pain-free [30] [33] [25] .

Results from the phase I/II LuPin trial, idronoxil in combination with lutetium-177 PSMA (177Lu-PSMA) demonstrated a median overall survival of 17.1 months. The combination treatment almost doubled the PSA (Prostate-Specific Antigen)response (69% with idronoxil vs 36% with 177Lu-PSMA alone). Progression-free survival was quadrupled through the addition of idronoxil (8.4 months vs 2.0 months with 177Lu-PSMA alone). The treatment duration was tripled to 69% from 21% with 177Lu-PSMA alone [15] . In interim data from the trial, idronoxil in combination with lutetium-177 PSMA 617 showed 69% higher PSA response rate (defined as a > 50% overall reduction in PSA) than with lutetium-177 PSMA 617 alone in 16 patients with mCRPC. PSA response rate in patients received 400mg and 800 dose was 62.5% and 75%, respectively. The PSA response rate was in favor with combination therapy than lutetium-177 PSMA 617 alone [14] [12] [7] .

Future Events

Expected Date Event Type Description Updated
01 Jan 2022 Regulatory Status Noxopharm intends to gain marketing approval for NOX 66 in 2022 [28] 16 Aug 2018
31 Dec 2020 Trial Update Noxopharm plans DARRT-2/DARRT-3 study in 2020 (700294344) [31] 20 Feb 2020
31 Dec 2019 Trial Update Noxopharm plans the phase Ib CEP-2 trial for Sarcoma (Combination therapy) in the US in fourth quarter of 2019 (700306452) [38] 10 Jan 2020
30 Sep 2019 Trial Update Noxopharm plans to initiate registrational adaptive phase II/III study in Prostate cancer for NOX 66 in third quarter of 2019 [39] 10 Jan 2020
30 Jun 2019 Trial Update Noxopharm plans the phase II DAART-2 trial for Lung cancer in second quarter of 2019 [39] 09 Dec 2019
30 Jun 2019 Trial Update Noxopharm plans the phase II DAART-3 trial for Sarcoma/rare cancer in second quarter of 2019 [39] 09 Dec 2019
30 Mar 2019 Trial Update Noxopharm plans an IND-enabling phase 0 trial in healthy volunteers in first quarter of 2019 [39] 26 Oct 2018
30 Apr 2017 Trial Update Royal North Shore Hospital plans a phase I trial for Prostate cancer (Metastatic disease, Second-line therapy or greater) in Australia (Suppository) (NCT03041285) 16 Mar 2018

Development History

Event Date Update Type Comment
07 May 2020 Scientific Update Efficacy data from a phase Ib trial in Prostate cancer released by Noxopharm [30] Updated 09 May 2020
02 Apr 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in Australia (unspecified route) [2] Updated 08 Apr 2020
02 Apr 2020 Trial Update Noxopharm plans clinical trial for COVID-2019 infections (associated with acute respiratory distress syndrome (ARDS) and multi-organ failure) [2] Updated 08 Apr 2020
26 Feb 2020 Regulatory Status Noxopharm intends to file an IND application with the US FDA in USA for late-stage Prostate cancer [5] Updated 27 Feb 2020
26 Feb 2020 Regulatory Status US FDA approves IND application for Idronoxil in combination with doxorubicin in Soft tissue sarcomas [5] Updated 27 Feb 2020
26 Feb 2020 Trial Update Noxopharm plans a Clinical trial for Soft tissue sarcoma (Combination therapy) in USA [5] Updated 27 Feb 2020
26 Feb 2020 Trial Update Noxopharm plans a Clinical trial for Prostate cancer (Late-stage disease) in USA [5] Updated 27 Feb 2020
18 Feb 2020 Trial Update Noxopharm and GenesisCare plans to provide idronoxil and 177 Lutetium PSMA 617 under a compassionate use programme for Prostate cancer in Australia [16] Updated 26 Feb 2020
16 Feb 2020 Scientific Update Updtaed efficacy data from the phase I/II LuPIN trial in Prostate cancer released by Noxopharm [14] Updated 19 Feb 2020
03 Dec 2019 Regulatory Status Noxopharm announces intention to submit IND for DARRT-2 studies to the US FDA, EMA and TGA [31] Updated 09 Dec 2019
03 Dec 2019 Regulatory Status Noxopharm announces intention to submit IND for DARRT-3 studies to the US FDA, EMA and TGA [31] Updated 09 Dec 2019
03 Dec 2019 Scientific Update Efficacy and safety data from a phase Ib DARRT-1 trial in Prostate cancer released by Noxopharm [31] Updated 09 Dec 2019
02 Dec 2019 Trial Update Noxopharm plans DARRT-2/DARRT-3 study in 2020 [31] Updated 20 Feb 2020
05 Nov 2019 Trial Update Noxopharm initiates enrolment in a phase I trial in healthy volunteers in Australia (ACTRN12620000002987) Updated 10 Jan 2020
30 Sep 2019 Scientific Update Efficacy and safety data from the phase I/II LuPIN trial in Prostate cancer released by Noxopharm [15] Updated 09 Oct 2019
30 May 2019 Trial Update Noxopharm completes enrolment in a phase I DARRT-1 trial in Prostate cancer (Combination therapy, Late-stage disease, Refractory metastatic disease, Second-line therapy or greater) in Australia, Georgia and New Zealand (Rectal) [18] (NCT03307629) Updated 03 Jun 2019
20 May 2019 Scientific Update Interim efficacy and adverse events data from the phase Ib LuPIN trial in Prostate cancer released by Noxopharm [12] Updated 23 May 2019
03 May 2019 Scientific Update Update interim efficacy data from the phase Ib (DARRT-1) trial in Prostate cancer released by Noxopharm [33] Updated 09 May 2019
10 Apr 2019 Trial Update Noxopharm plans the phase Ib CEP-2 trial for Sarcoma (Combination therapy) in the US in fourth quarter of 2019 [38] Updated 10 Jan 2020
27 Dec 2018 Other Chemical structure information added Updated 27 Dec 2018
29 Nov 2018 Scientific Update Interim efficacy and adverse events data from a phase Ib/II trial in Solid tumours released by Noxopharm [23] Updated 03 Dec 2018
22 Oct 2018 Trial Update Noxopharm plans to initiate registrational adaptive phase II/III study in Prostate cancer for NOX 66 in third quarter of 2019 [39] Updated 10 Jan 2020
22 Oct 2018 Trial Update Noxopharm plans the phase II DAART-2 trial for Lung cancer in second quarter of 2019 [39] Updated 09 Dec 2019
22 Oct 2018 Trial Update Noxopharm plans the phase II DAART-3 trial for Sarcoma/rare cancer in second quarter of 2019 [39] Updated 09 Dec 2019
22 Oct 2018 Trial Update Noxopharm plans an IND-enabling phase 0 trial in healthy volunteers in first quarter of 2019 [39] Updated 26 Oct 2018
08 Aug 2018 Regulatory Status Noxopharm intends to gain marketing approval for NOX 66 in 2022 [28] Updated 16 Aug 2018
08 Aug 2018 Scientific Update Efficacy and adverse events data from the phase Ib (DARRT) trial in Prostate cancer released by Noxopharm [28] Updated 16 Aug 2018
10 Jul 2018 Phase Change - Preclinical Preclinical trials in Glioma in Australia (unspecified route) Updated 13 Jul 2018
09 Jul 2018 Scientific Update Interim adverse events data from the phase Ib DARRT-1 trial in Prostate cancer released by Noxopharm [27] Updated 13 Jul 2018
01 Jun 2018 Scientific Update Interim adverse events and efficacy data from the phase Ib/IIa trial for Solid tumours presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO-2018) [22] Updated 02 Jul 2018
12 Apr 2018 Trial Update Noxopharm initiates enrolment in a phase I LuPin trial in Prostate cancer (Combination therapy, Late-stage disease, Refractory metastatic disease, Second-line therapy or greater) in Australia (Rectal) (ACTRN12618001073291) [8] Updated 10 May 2018
21 Mar 2018 Scientific Update Pharmacodynamics data from clinical studies of idronoxil novel formulation released by Noxopharm [18] Updated 26 Mar 2018
21 Mar 2018 Trial Update Noxopharm plans the DARRT-2 phase II trial for Solid tumours [18] Updated 26 Mar 2018
06 Mar 2018 Scientific Update Efficacy and adverse events data from the phase Ib CEP-1 trial in Solid tumours presented at the European Society for Medical Oncology Congress - 2018 (ESMO-2018). [21] Updated 16 Mar 2018
22 Jan 2018 Patent Information Kazia Therapeutics has intellectual property protection for idronoxil novel formulation [3] Updated 01 Feb 2018
27 Dec 2017 Licensing Status Kazia Therapeutics acquires idronoxil novel formulation from Noxopharm [4] Updated 01 Feb 2018
01 Nov 2017 Trial Update Noxopharm initiates enrolment in a phase I DARRT-1 trial in Prostate cancer (Combination therapy, Late-stage disease, Refractory metastatic disease, Second-line therapy or greater) in Australia (Rectal) [18] (NCT03307629) Updated 09 Apr 2018
01 Nov 2017 Phase Change - I Phase-I clinical trials in Prostate cancer (Combination therapy, Late-stage disease, Refractory metastatic disease, Second-line therapy or greater) in Georgia and New Zealand (Rectal) [18] (NCT03307629) Updated 26 Mar 2018
31 Aug 2017 Phase Change - I Phase-I clinical trials in Prostate cancer (Combination therapy, Late-stage disease, Refractory metastatic disease, Second-line therapy or greater) in Australia (Rectal) (NCT03041285) Updated 16 Mar 2018
03 Mar 2017 Phase Change - I/II Phase-I/II clinical trials in Solid tumours (Monotherapy, Late-stage disease, Refractory metastatic disease, Second-line therapy or greater) in USA (unspecified route) Updated 06 Apr 2017
03 Mar 2017 Phase Change - I/II Phase-I/II clinical trials in Solid tumours (Late-stage disease, Combination therapy, Refractory metastatic disease, Second-line therapy or greater) in USA (NCT02941523) Updated 03 Apr 2017
31 Jan 2017 Trial Update Royal North Shore Hospital plans a phase I trial for Prostate cancer (Metastatic disease, Second-line therapy or greater) in Australia (Suppository) (NCT03041285) Updated 16 Mar 2018
26 Jun 2016 Phase Change - Preclinical Preclinical trials in Cancer in Australia [19] Updated 03 Apr 2017
26 Jun 2016 Trial Update Noxopharm plans a phase I/IIa trial for Cancer, including solid tumours (Monotherapy, Combination therapy, Metastatic disease, Second-line therapy or greater) (NCT02941523) [19] Updated 29 Mar 2017

References

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    Media Release
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  4. KAZIA THERAPEUTICS LTD AND NOXOPHARM LTD.

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    ctiprofile
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    Media Release
  9. CORPORATE PRESENTATION: POSTINTERIM CLINICAL DATA RELEASE.

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  10. NOXOPHARM CORPORATE PRESENTATION.

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  11. NOX TO SUPPORT EXPANDED LuPIN STUDY.

    Media Release
  12. LuPIN Trial Demonstrates High Rates of Response.

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  13. Pronounced survival benefit in LuPIN interim trial data.

    Media Release
  14. LuPIN Trial Interim Results Indicate Striking Survival Benefit.

    Media Release
  15. Further Data Review Shows Major Clinical Benefits From Veyonda(Rm).

    Media Release
  16. Noxopharm Alliance With GenesisCare.

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  19. Australian Science Poised to Tackle Problem of Cancer Drug Resistance.

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    Media Release
  22. de Souza PL, Messina M, Minns I, Shavdia M, Chikhladze N, Kelly G. A phase 1 study of NOX66 in combination with carboplatin in patients with end stage solid tumours. ASCO-2018 2018; abstr. 2585.

    Available from: URL: http://abstracts.asco.org/214/AbstView_214_218999.html
  23. NOX Announces Positive Data from CEP-1 Study of Veyonda##61666##.

    Media Release
  24. A phase II clinical study of NOX66 in a broad spectrum of solid cancers including rare cancers

    ctiprofile
  25. NOX66 and Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer - a Phase 1b Proof of Concept and Dose Confirmation Study

    ctiprofile
  26. DARRT-1 CLINICAL STUDY COMMENCES.

    Media Release
  27. RELEASE OF DARRT-1 PRELIMINARY SAFETY DATA AT CLINICAL CONFERENCE.

    Media Release
  28. NOX MEETS WITH ADVISORS TO CONSIDER INTERIM NOX66 RADIOTHERAPY CLINICAL DATA.

    Media Release
  29. DARRT-1 STUDY ADVANCING ON BASIS OF POSITIVE CLINICAL DATA.

    Media Release
  30. Noxopharm Achieves Abscopal Responses in Prostate Cancer.

    Media Release
  31. Positive DARRT-1 Data in Late-Stage Prostate Cancer.

    Media Release
  32. DARRT-1 Study Fully Enrolled.

    Media Release
  33. DARRT Treatment Has Lasting Disease Control at Six Months.

    Media Release
  34. Phase I Study of Idronoxil Combined With Radiation Treatment in Men With Metastatic Prostate Cancer

    ctiprofile
  35. $8.1M Financing & Re-Set of Capital Structure.

    Media Release
  36. Noxopharm Announces AU$26 Million Funding Facility.

    Media Release
  37. Noxopharm to list on ASX on Tuesday, 9th August 2016.

    Media Release
  38. Veyonda##61666## Chemotherapy Enhancement Program to be Expanded.

    Media Release
  39. NOXOPHARM MAKES KEY EXECUTIVE APPOINTMENT.

    Media Release
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