Veyonda® and Radiotherapy Profiled at Key Oncology Meeting
18 September 2019 - 01:01AM
Noxopharm (ASX: NOX) (‘
Noxopharm’ or the
‘
Company’) is pleased to announce that Australian
clinicians will be presented updates on research relating to the
use of Veyonda® (idronoxil) with radiotherapy for the treatment of
prostate cancer at the Clinical Oncology Society of Australia
(COSA) annual scientific meeting in November this year. This
is the key meeting for oncologists in Australia and this year there
is a program focus on urological cancer. The Company is releasing
details of the presentations now as the meeting organisers have
released the scientific abstracts earlier than expected via the
meeting website.
An abstract on DARRT-1 interim results (as released on 2 May
2019) has been accepted at this conference. These results showed
that patients who were treated with the Company’s proprietary
treatment Veyonda® combined with externally-delivered radiotherapy
had a durable anti-cancer response rate lasting at least 6 months
(the length of the study) in a high proportion of men with
end-stage, metastatic, castration-resistant prostate cancer
(mCRCP).
http://cosa-2019.p.asnevents.com.au/days/2019-11-13/abstract/67209
There also is underway an investigator-led study, the LuPIN
study, looking at the effect of Veyonda® in combination with
intravenously-delivered radioactivity (177LuPSMA-617), also in men
with late-stage mCRPC. This study is independent work from
researchers at St Vincent’s Hospital Sydney, the Garvan Institute
of Medical Research and St Vincent’s Clinical School who have also
chosen to present their data at COSA.
http://cosa-2019.p.asnevents.com.au/days/2019-11-12/abstract/66985
In the abstract, the researchers are comparing two pieces of
work that have both previously been made public. In the first
study, patients were treated solely with the radioactive substance
177lutetium-PSMA-617; in the second, patients were treated with
177lutetium-PSMA-617 in combination with Veyonda® (as
released on 26 June 2019). The important aspect of this
abstract is that the two sets of data have been put together, and
the finding to date is that the combination treatment with Veyonda®
has resulted in a significantly better clinical response.
Statistically significant differences were seen in
- the ability of patients to stay on treatment longer
(potentially meaning that they are responding more favourably to
treatment or are tolerating treatment better)
- a reduction in PSA (prostate specific antigen) levels
- longer progression-free survival (the amount of time these
patients with advanced disease had improvement of, or no worsening
of, their symptoms)
The summary of the two sets of data is contained
in the EGM corporate presentation on the Noxopharm website and is
re-presented here.
|
177lutetium-PSMA-617 |
177lutetium-PSMA-617 +
Veyonda®
|
Number of patients |
14 |
|
16 |
|
Median starting PSA (ng/ml) |
88 |
|
147 |
|
PSA response* |
36% |
|
69% |
|
PFS** |
2.0 months |
8.4 months |
Able to complete 4 cycles |
21% |
|
69% |
|
* >50% decline in PSA levels from starting
level** Progression-free survival = time to disease progression
Dr Greg van Wyk, Noxopharm CEO and Chief Medical Officer, said:
‘Inclusion of studies relating to Veyonda® at this peak oncology
conference is validation of the work we have underway. The
abstracts have been peer-reviewed and found to be of value to
specialists working with cancer patients in Australia and
beyond.’
Dr Graham Kelly, Noxopharm Executive Chairman, said, ‘These data
support the Company’s strategy in developing two potential
transformative treatments for men who find themselves with
late-stage prostate cancer and no remaining standard treatment
options. The DARRT program is our major focus because of its
potential ability to be deployed across both early- and late-stage
prostate cancer. Also, the LuPIN data being presented suggests that
Veyonda® has
the ability to increase significantly the value of
177lutetium-PSMA-617 as a treatment option for late-stage prostate
cancer.’
Both Veyonda® studies continue. The DARRT-1 patients will
continue to be monitored and the results of the final group of
patients 24 weeks post-treatment will be available in late November
2019. The combined data from the trial will be presented at an
international scientific congress and will be submitted to a peer
reviewed journal in H1 2020. The LuPIN study also continues
in total 56 men with late-stage mCRPC and final results are
expected in late-2020.
About Veyonda®Veyonda®
(previously known as NOX66) is a suppository dosage formulation of
the experimental anti-cancer drug, idronoxil, that leads in the
body to the formation of a proprietary pro-drug form. Idronoxil
specifically inhibits the ability of cancer cells to respond to
stress, such as that induced by radiation, leading to loss of
pro-survival signalling via sphingosine-1-phosphate. Idronoxil also
promotes the STING mechanism, thereby activating the body’s innate
immune system.
About the DARRT program The Company’s DARRT
(Direct and Abscopal Response to Radiotherapy) Program is testing
the ability of Veyonda® to increase tumour
response to radiotherapy. The rationale of DARRT is to take
advantage of the radio-enhancing properties of
Veyonda® that stem from its inhibition of
sphingosine-1-phosphate pro-survival functions, combined with its
ability to stimulate the body’s first line immune defence cells
against cancer. The clinical outcome being sought is PSA and pain
reductions as well as greater shrinkage of irradiated tumours and
shrinkage of non-irradiated tumours (abscopal response). The DARRT
treatment regimen is being tested initially in prostate cancer, but
in due course is to be extended into other forms of solid cancer
that the Company believes will assist the Veyonda®
marketing approval process.
About DARRT-1DARRT-1 is a Phase 1b 26-subject
study being conducted in Georgia and Australia. The study is in 2
arms, with 14 subjects in the first arm and 12 in the second. The
first arm is for dose-finding entailing 3 cohorts receiving 400 mg,
800 mg and 1200 mg Veyonda® respectively. In the
second arm, all subjects are receiving the 1200 mg
Veyonda® dose. The DARRT treatment regimen entails
a 5-day course of radiotherapy (20 Gy) with
Veyonda® administered daily for up to 2 weeks. The
subjects are being assessed clinically at 6-, 12- and 24-
weeks.
About LuPIN LuPIN is an Investigator-Initiated
Phase Ib/IIa, single-arm, open label study enrolling 56 men with
mCRPC that is progressing despite docetaxel, cabazitaxel and either
abiraterone and/or enzalutamide. The study is divided into 4
cohorts of 400 mg (8 patients), 800 mg (8 patients), 800 mg (16
patients) and 1200 mg (24 patients) NOX66. The Phase Ib arm of the
study is intended to establish the safety of the combination
treatment. The Phase IIa expansion arm is intended to establish the
dose-response effect of increasing NOX66 levels on combination
treatment safety and efficacy. Imaging inclusion criteria include a
PSMA PET/CT with uptake intensity in metastases more than twice the
normal liver uptake and no discordant disease on FDG PET/CT. All
men receive up to 6 doses of 177 Lu-PSMA 617 at 6- weekly
intervals; the first 8 men received 400mg idronoxil (suppository)
daily cycle days 1-10. Following safety data review of the first
cohort (400 mg NOX66), the dose for patients 9-16 was escalated to
800mg NOX66 daily. The study then was expanded to recruit a third
cohort of 16 patients to receive 800 mg NOX66. With further
evidence of efficacy and good tolerability, the study was expanded
to include a fourth patient cohort (1200 mg NOX66).
About Noxopharm Noxopharm is a clinical-stage
Australian drug development company with offices in Sydney and New
York. The Company has a primary focus on the development of
Veyonda® and is the major shareholder in Nyrada
Inc, a spin-off company developing a pipeline of non-oncology
drugs.
www.noxopharm.com
|
|
|
Investor & Corporate Enquiries:
Noxopharm Ltd T: +61 2 9144 2223 E:
info@noxopharm.com |
|
Company Secretary: David FranksT: +61 2
9299 9690 E: David.Franks@automicgroup.com.au |
|
|
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Media Contact USA: Frank de Maria
Purposeful Communications T: +1 347 647 0284 E:
frank.demaria@purposefulcommunications.com |
|
Media Contact Australia Marianne
GouldNoxopharm LtdT: +61 429 216
194E: Marianne.gould@noxopharm.com |
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Noxopharm believes the forward-looking statements to be reasonable,
they are not certain. Forward-looking statements involve known and
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cases beyond the Company’s control that could cause the actual
results, performance or achievements to differ materially from
those expressed or implied by the forward-looking statement. No
representation, warranty or assurance (express or implied) is given
or made by Noxopharm that the forward-looking statements contained
in this announcement are accurate and undue reliance should not be
placed upon such statements.
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