Clinical-stage drug development company, Noxopharm Limited (ASX: NOX) continues to show its potentially transformative therapy in late-stage prostate cancer where few or no remaining standard treatment options currently exist.
Noxopharm’s lead drug candidate Veyonda® (NOX66) trial developments
Noxopharm intends to bring its novel anti-cancer drug Veyonda® (NOX66) to the market, and it is believed that this has the potential to be a game-changer in existing cancer treatments, based on the groundwork of its promising interim trial results to date from both its DARRT (Direct and Abscopal Response to Radiotherapy) and LuPIN studies. Both these trials continue to progress well, potentially adding investment value as per Noxopharm.
In the DARRT study, the radiation is delivered externally, while the LuPIN study involves the radiation injected intravenously.
Veyonda® (NOX66), a novel patented formulation of idronoxil, is a first-in-class immuno-oncology molecule. Veyonda® (NOX66) is believed to reinstate the ability of the body’s immune system to fight and potentially reduce cancer.
Noxopharm has made encouraging progress in a short span of time, underpinned by its novel and strategic implementation of clinical developmental programs.
Noxopharm Presents DARRT-1 and LuPIN Data
In a recent announcement, Noxopharm confirmed the presentation of both DARRT-1 interim data and LuPIN trial Data using Veyonda® (NOX66) at the 46th Annual Scientific Meeting of the Clinical Oncology Society of Australia scheduled from 12th -14th November 2019.
- DARRT-1 interim data was presented to the conference by Noxopharm CMO, Dr. Gisela Mautner (MD PhD)
- LuPIN data was presented by a team of researchers at St Vincent’s Hospital, Sydney and the Garvan Institute of Medical Research.
DARRT-1 Study: Durable anti-cancer effects with NOX66 in combination with radiotherapy
DARRT-1 treatment regimen is Noxopharm’s novel immuno-oncology therapy aiming to utilise radio-enhancing and immune-stimulating properties of Veyonda®(NOX66) in combination with external beam radiotherapy. This combination treatment is to-date, well-tolerated in men with late-stage prostate cancer (metastatic castrate-resistant disease) with no remaining treatment options.
The DARRT-1 study involves a total of 25 patients and is divided in two parts:
- Part 1 is a dose-escalation arm (400/800/1200 mg NOX66) involving 14 men;
- Part 2 is a dose-expansion arm, using the highest (1200 mg) dose of NOX66 in 11 men.
It is to be noted that the data presented at the conference included the interim results for the 14 men initially enrolled in the first arm of the study and who have completed their six-months review.
The key objectives of DARRT-1 study are as follows-
- To demonstrate that NOX66 is safe,
- To provide better symptom (pain) relief,
- To stabilize or reduce disease activity.
Noxopharm is expecting to release the six-months data on the final patients in the DARRT-1 study in late-November 2019.
The Company is planning to initiate the next phase (Phase II) of a multi-national DARRT study in prostate cancer - DARRT-2, aiming to further determine the safety and efficacy of NOX66.
LuPIN Study: Veyonda®(NOX66) and the anti-cancer effect of 177Lu-PSMA-617 therapy
Noxopharm is also conducting a 56-patient Phase Ib/IIa LuPIN study in collaboration with St Vincent’s Hospital, under the supervision of Associate Professor Dr. Louise Emmett.
LuPIN trial is an investigator-initiated, open-label clinical trial study, designed to determine the effect of NOX66 combined with a novel cancer therapy 177Lu-PSMA-617 in men with metastatic, castration-resistant prostate cancer (mCRPC) where the disease has progressed in spite of 2 lines of taxane treatment (cabazitaxel and docetaxel), and either enzalutamide or abiraterone.
A comparative analysis of the results of the first 16 men who received a combination therapy of NOX66 combined with 177Lu-PSMA-617, versus 14 men who received monotherapy in which men were dosed with 177Lu-PSMA-617 alone is being presented. This data has already been reported earlier on 30 September 2019 (ASX 30.09.2019).
Interestingly, although there are some limitations in comparing data sets from different studies, the NOX66 combination treatment with 177Lu-PSMA-617 was found to be superior to the monotherapy with following observations:
These are encouraging results suggesting that even at this late stage adding Veyonda® (NOX66) appears to be making a difference in a number of late-stage cancer patients, with an important end-point to take note of being the number of men who were able to start the fourth cycle of treatment.
Noxopharm anticipates more data to be released over the coming six months, heading towards reaching the conclusion of the LuPIN study at the end of 2020.
NOX stock traded at $0.360 on 18 November 2019 (2:05 PM AEST).
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