Noxopharm Combo with Radiotherapy Delivers Clinical Benefits

Interim (12-week) DARRT-1 readout
 Combination Veyonda + low-dose
radiotherapy well tolerated
 PSA, pain and tumour responses at higher doses
 24-week readout to indicate longevity of
response.
Noxopharm (ASX: NOX) announces interim (12-week)
results from the dose-ranging component of the DARRT-1 study.
1. Key findings:
 combining Veyonda with low-dose radiotherapy applied to a single
metastasis (lesion) is able to produce an anti-cancer response in both the
irradiated and non-irradiated lesions as evidenced by PSA response, pain
reduction, and/or tumour measurements
 a dose-response was observed, with the 1200 mg dose confirmed as the
therapeutic dose
 clinical responses were achieved with no serious side-effects related to
Veyonda.
2. Rationale: The DARRT treatment regimen involves using Veyonda to trigger a generalised anticancer response to radiotherapy against cancer cells throughout the body. This is known as an
abscopal response and is thought to involve a generalised immune response. Veyonda has been
shown to activate the body’s innate immune system, an action that the company believes will provide
a transformative approach to the use of radiotherapy in oncology, enabling low dosages of focused
radiation to be used to create a generalised anti-cancer effect.
3. DARRT and prostate cancer: The Company’s ultimate goal in prostate cancer is to evaluate the
DARRT treatment regimen across the full spectrum of prostate cancer from early-stage to late-stage.
The DARRT-1 study is the starting point in this program involving end-stage prostate cancer.
Prostate cancer preferentially spreads to bone and lymph nodes. Late-stage (metastatic castrateresistant) prostate cancer typically involves multiple secondary lesions in the skeleton (vertebrae, ribs,
pelvis, hips, skull, long bones) and pelvic lymph nodes; secondary lesions in soft tissues such as the
lungs, liver and brain are less common. The tumour burden in Stage IV prostate cancer generally is
greatest in the skeleton and is associated with significant pain. Treatment in these men nearing end

of life is palliative, with pain relief a major objective through the use of radiotherapy and pain
medications.
NOX is developing the DARRT regimen in advanced prostate cancer with the dual objectives of
providing better palliation (pain relief) and extending survival and doing so in a well-tolerated way.
4. Interim data: The DARRT-1 study has two stages. Stage 1 involving 12 patients was designed to
provide an indication of the benefit:risk profile of three different doses of Veyonda (400, 800, 1200
mg daily) including four patient per dose. Patients included in this phase were required to have at
least one soft tissue lesion that was amenable to accurate radiographic measurement (according to
RECIST 1.1).
Stage 2 involved expansion into an additional 12 patients at a dose selected by an independent data
safety monitoring board (DSMB). As previously announced, Stage 2 of the trial was initiated at the
1200 mg dose following DSMB review of the 6-week data. Stage 2 includes patients who lack a soft
tissue lesion and whose lesion requiring radiatherapy is located in the bone, which often cannot be
accurately measured (according to RECIST 1.1). Determination of a generalised (abscopal) response in
such patients will be on the basis of PSA and pain responses. The final 4 patients in this stage have
been screened and the study is expected to be fully enrolled within 2 weeks.
Today’s announcement concerns the 12-week data on the 12 patients in Stage 1.

https://www.noxopharm.com/site/PDF/1816_3/VeyondaandRadiotherapyDeliversClinicalBenefits