Orphan Drug Designation Granted for Veyonda by US FDA

CEP-2 sarcoma trial commences

Dr Gisela Mautner Commences as Chief Executive Officer and Managing Director

DARRT-2 Clinical Trial
Commenced in USA

Pharmorage In-Licences RNA Technology from Hudson Institute of Medical Research

IONIC-1 Trial. Veyonda^® and Opdivo^® IONIC Trial First Patient Dosed

Australia and Europe Grant Patent on Use of Veyonda® To Achieve Safer Chemotherapy

Veyonda® Achieves Important U.S Patent Claims for Radiotherapy

Pre-clinical Data Supports a Role for Veyonda in the Treatment of COVID-19

NOXCOVID Clinical Program to Expand Following Positive Phase 1 Clinical Results

NOX and US NCI announce brain cancer research collaboration (MCRADA)

European Patent Office issues official Notice of Allowance on Veyonda® patent - claims encompass administration of Veyonda in cancer patients receiving chemotherapy or radiotherapy.

DARRT-2 study Investigational New Drug (IND) approval from the FDA in USA received.

NOXCOVID study
Last patient enrolled

CEP-1 study

Peer reviewed publication in oncology medical journal Current Therapeuatic Research

IONIC-1. Agreement is reached for a study combining Veyonda with the Bristol Myers Squibb immune checkpoint inhibitor (CI) drug Opdivo®(nivolumab) aiming to demonstrate that in solid tumours 1) For cancer types that are known to respond to checkpoint inhibitors (CI’s) Veyonda combined Opdivo will result in a higher proportion of patients that respond to CI treatment and 2) For cancer types that don’t typically respond to CI therapy, the combination of Veyonda with Opdivo will result in a response

Pharmorage Pty Ltd is established as a wholly owned subsidiary of Noxopharm, dedicated to the discovery of treatments for septic shock and autoimmune diseases.

NOXCOVID study commences. The first patient hospitalised with moderate COVID-19 is treated with Veyonda with the aim to demonstrate that Veyonda is well tolerated and able to stop worsening of the disease

LuPIN data published in peer-reviewed oncology journal in Aug 2020

DARRT-1 and LuPIN data presented at ASCO in June

Pre-Clinical data:
Hudson Institute identifies anti-inflammatory properties of idronoxil as consistent with blocking ‘cytokine storm’ believed responsible for many COVID-19 deaths

Pre-Clinical data:
Two research groups demonstrate that idronoxil turns ‘COLD’ tumours into ‘HOT’

LuPIN trial fully recruited, combining Veyonda with 177Lutetium-PSMA-617 (Lu-PSMA), a radionuclide for the management of advanced prostate cancer that has stopped responding to standard therapy, investigating whether 1) the immuno-oncology action of Veyonda increases the proportion of men responding meaningfully to Lu-PSMA and 2) whether Veyonda in combination with Lu-PSMA increases the durability of the anti-cancer response

CEP-2. FDA grants Investigational New Drug status for Veyonda for combination treatment with doxorubicin in patients with soft tissue sarcomas enabling planning for CEP-2 study in the USA. This approval is based upon evidence that Veyonda may improve the response rate of sarcoma cancers to chemotherapy.  This group of cancers generally responds poorly to standard chemotherapy.

Nyrada Inc successful IPO. Nyrada lists on the ASX, raising $8.5M. Nyrada continues in its venture to develop therapies for cardiovascular and neurologial disorders, Noxopharm Limited retaining 30% of shares

DARRT-1 study: Study Completed

DARRT-1 and LuPIN study: Results presented at COSA Conference

Pre-clinical evidence of abscopal effect is seen in animal models in pre-clinical research. This is a rare response where radiation is applied to individual tumours and leads to a response both in the irradiated tumours as well as tumours elsewhere in the body.

DARRT-1 study fully enrolled. Combining Veyonda with radiotherapy (RT) in patients with metastatic castration-resistant prostate cancer (mCRPC) that had progressed on all available treatments. Aiming to demonstarte that 1) Veyonda is safe and well-tolerated when combined with low-dose radiotherapy and 2) Veyonda plus low-dose RT results in improved outcomes versus radiotherapy alone

Immuno-oncology effect. Pre-clinical studies demonstrate that idronoxil, the active in Veyonda activates the immune system, a potential anti-cancer actvity.

Pre-Clinical studies confirm that IDX activates immune system

CEP-1 study complete. A combination of Veyonda and low-dose carboplatin chemotherapy is safe and provides indication of suspension of tumour growth, or better, for at least 6 months in solid tumours (breast, ovarian, lung, prostate) in nearly 50% of patients considered unlikely to respond to further chemotherapy

First report of an abscopal response evident in patients in DARRT-1 study

Pre-clinical studies:
Veyonda demonstrates immune activating function (important anti-cancer effect)

DARRT-1 clinical study commences. The first cohort of patients commences treatment combining Veyonda with radiotherapy (RT) in patients with metastatic castration-resistant prostate cancer (mCRPC) that had progressed on all available treatments. The objective is to demonstarte that 1) Veyonda is safe and well-tolerated when combined with low-dose radiotherapy and 2) Veyonda plus low-dose RT results in improved outcomes versus radiotherapy alone

$10.9M raised via the placement of fully paid ordinary shares to sophisticated and institutional investors to support ongoing clinical program

Abscopal response - a rare response where radiation is applied to individual tumours and leads to a response both in the irradiated tumours as well as tumours elsewhere in the body. Evidence of an abscopal response in two patients receiving Veyonda on a compassionate use basis outside of the formal Noxopharm clinical trial program is presented at a national oncology conference.

LuPIN study. The first patient is treated in the LuPIN study, combining Veyonda with ¹⁷⁷Lutetium-PSMA-617 (Lu-PSMA), a radionuclide for the management of advanced prostate cancer that has stopped responding to standard therapy. Exploring whether 1) the immuno-oncology action of Veyonda increases the proportion of men responding meaningfully to Lu-PSMA and 2) whether Veyonda in combination with Lu-PSMA increases the durability of the anti-cancer response 

DARRT-1 study: Formal Study Approval attained

Nyrada Inc established. Noxopharm Limited announces the formation of the subsidiary company for the development of therapies for cardiovascular and neurologial disorders

Successful $5.5M fundraising to accelerate the clinical development program for Veyonda

CEP-1. Approval attained for patient recruitment for the first Noxopharm study investigating Veyonda alone, and in combination with low-dose carboplatin chemotherapy for patients with refractory solid tumours in the breast, head and neck, lung, prostate or ovaries.

LuPIN study: Formal Study Approval attained

CEP-1 study: Formal Study Approval attained

Noxopharm Limited IPO successfully raises $6M and the company began trading on the Australian Securities Exchange (ASX) on Tuesday 9 August 2016.

Noxopharm Limited established