NOX to Present Clinical Data at COSA Annual Meeting
- Clinical Oncology Society of Australia
- Provides updates on CEP-1 and DARRT-1 clinical studies
- Confirms tolerability of Veyonda®
- Evidence of durable halt of tumour progression in both studies
SYDNEY, Australia, Nov. 13, 2018 (GLOBE NEWSWIRE) -- Noxopharm (ASX: NOX) announces that it is presenting two posters at the 45th Annual Meeting of the Clinical Oncology Society of Australia (COSA) which is being held November 13-15 in Perth, Australia.
Details of the presentations are as follows:
Title: Trial in Progress: NOX66 in Combination with Palliative Radiotherapy in Patients with mCRPC – a Phase 1 Safety and Dose-Finding Study
Authors: Isabell Vocks PhD, Anne Capp MB BS
Date and time: 14th November; 3:20 pm
Location: Poster #343
This first presentation provides an update on the Company’s ongoing open-label Phase 1b study evaluating Veyonda® in combination with palliative external beam radiotherapy in men with metastatic castrate-resistant prostate cancer (mCRPC) (DARRT-1). The study is in two parts. The first part is a dose-finding study of 400, 800 and 1200 mg of Veyonda®; 4 patients in each cohort (Cohorts 1, 2 and 3 respectively). In the second part of the study, a final group of twelve patients (Cohort 4) then will use the dose of Veyonda® determined to be the optimum. The first 3 Cohorts have been fully enrolled and have completed their treatment. Cohort 4 is due to begin enrolment in December 2018.
Dr. Greg van Wyk, Noxopharm Chief Medical Officer, explained, “Our last report on this study referred to four patients in Cohort 1, two in Cohort 2, and one in Cohort 3 who had undergone treatment and reached at least the 6-week review point. The COSA data relates purely to the two to three months of additional follow-up on these seven patients.”
“Over the last couple of months we have fully enrolled Cohorts 2 and 3 and these patients now have completed their treatment. The next step is a scheduled review of all Cohort 1-3 patients at the end of November 2018 and we look forward to releasing the outcome of that review in December.”
The purpose of DARRT-1 is to assess the safety and efficacy of a short course of Veyonda® in both boosting the anti-cancer effect of radiation and in stimulating an immune response intended to lead to an abscopal response. Clinical response is being determined by scans using RECIST (Response Evaluation Criteria in Solid Tumors) criteria that measure the size and number of all measurable tumours in the body, and determine whether the disease has progressed, remained stable, or responded (partially or completely). In patients whose tumours are difficult to measure, clinical response is being determined on the basis of PSA levels and pain scores.
Cohort 1 (400 mg Veyonda®): 3 patients (Patients # 1-3) were assessed at 12 weeks as having stable disease by scan (RECIST assessment). At 24 weeks, Patients #1 and 3 remain stable on the basis of scans, while Patient # 2 has progressed.
Cohort 2 (800 mg): 1 patient (#7) was assessed at 12 weeks as having a partial response. At 24 weeks this patient continues to have a partial response including a strong decreasing PSA response.
Cohort 3 (1,200 mg): Patient #9 at 12 weeks continues to have a partial response and a strong decreasing PSA response.
Dr. Kelly, Noxopharm Chief Executive Officer, commented, “Notwithstanding the low patient numbers at this stage, Veyonda®, when administered at the likely therapeutic doses of 800 mg or 1,200 mg, appears to provide a high rate of response that also appears to be durable. The implication here is that we are seeing a clinical benefit in men who have progressive, late-stage, metastatic disease and who have exhausted all available treatment options. That we have been able to achieve a meaningful anti-cancer effect in these men with only palliative doses of radiotherapy in combination with a short course of Veyonda® is highly encouraging.”
“To achieve marketing approval, Veyonda® is going to need to show an ability to delay tumor progression to a meaningful extent, which for a number of drugs in the past has only needed to be several months. That is why the apparent durability of the responses in this study for 6 months to date, including PSA levels continuing to fall well after treatment has stopped, is so encouraging. We believe the combination of Veyonda® and palliative radiotherapy represents a potentially transformative treatment for late-stage prostate cancer and we look forward to the additional data from DARRT-1 in coming weeks.”
Title: A Phase 1 Study of NOX66 in Combination with Carboplatin in Patients with End-Stage Solid Tumours
Authors: Marinella Messina PhD, Ian Minns, Paul de Souza MB BS, Mikheil Shavdia MD, Nana Chikhladze MD, Graham Kelly PhD
Date and time: 14th November 2018: 3:20 pm
Location: Poster #427
The second presentation provides a more detailed analysis of the safety and efficacy end-points than previously reported on the Company’s open label Phase 1b study, known as CEP-1, evaluating Veyonda® in combination with carboplatin.
The CEP (Chemotherapy Enhancement Program) program is evaluating the ability of Veyonda® to restore responsiveness to carboplatin in chemo-resistant cancers to the extent that even lower, better tolerated dosages of chemotherapy can be used. This first-in-human trial of Veyonda® was an important proof-of-principle study for the Company, confirming the drug’s safety and patient acceptance. The study, which concluded in July 2018, was conducted in Georgia, using sites subject to FDA audit.
Dr. van Wyk said, “End-of-trial data typically undergoes comprehensive analysis and review lasting up to 6 months. We anticipate receiving the top line report for the CEP program by the end of November after which it will be released publicly. The COSA data is headline data ahead of that report.”
CEP-1 recruited 19 people with late-stage metastatic solid cancers who had stopped responding to chemotherapy, including carboplatin, and for whom no remaining standard treatment options were available. All patients entered the study with progressive disease. Veyonda® was administered as monotherapy for the first month and then in combination with carboplatin (between 50 and 75% of standard dosages) over six months. The key findings were: (i) that no dose-limiting toxicity was observed with the combination therapy, and (ii) 45% of patients had stable disease or better (1 patient with metastatic breast cancer had a partial response) at the end of the seven-month study.
Graham Kelly said, “We originally saw the CEP approach as being a treatment option for the significant number of patients considered for various health reasons to be unsuitable for further chemotherapy. On top of which a significant number of cancer patients also decline further treatment when faced with the prospect of side-effects. The original CEP concept was to offer these patients the opportunity to be able to use chemotherapy without experiencing damaging side-effects. The good tolerance of the Veyonda®/carboplatin combination shows that this can be done. And the 45% clinical response rate for late-stage cancers with no standard treatment options is particularly encouraging considering only half of study participants received the higher dosage of Veyonda®.”
“These data suggest that there may be a role for Veyonda® more broadly and not just in patients considered unsuitable for chemotherapy. While the sample size is small, the response rate in the five breast cancer patients in the study is a particularly noteworthy outcome and potentially could inform the future direction of this program,” Kelly added.
About COSA
The COSA Annual Scientific Meeting (ASM) is Australia’s premier cancer meeting, held over three days each year, usually in November. The ASM is a multidisciplinary meeting, inviting participation from doctors, nurses, allied health professionals and scientists working in cancer care nationally and internationally. A different state hosts the ASM each year, with a specific theme and focus on a specific cancer type.
About Veyonda®
Veyonda® (previously known as NOX66) is an innovative dosage formulation of the experimental anti-cancer drug, idronoxil, developed specifically to preserve the anti-cancer activity of idronoxil in the body and to enhance its drug-like behaviour. Idronoxil is a kinase inhibitor that works by inhibiting a range of enzymes, pre-eminent among which is sphingosine kinase, a key regulator of cell pro-survival mechanisms, and which is over-expressed in many cancer cells. Idronoxil also is an immuno-oncology drug, activating the body’s innate immune system eg. natural killer (NK) cells.
About DARRT
The Company’s DARRT (Direct and Abscopal Response to Radiotherapy) Program is testing the ability of Veyonda® to increase tumour response to palliative dosages of radiotherapy. The DARRT treatment regimen entails a 5-day course of radiotherapy (20-30 Gy) in 5 fractionated dosages targeting 1-2 larger tumours, and the Veyonda® administered daily for up to 3 weeks. The rationale of DARRT is to combine the radio-enhancing properties of Veyonda® that stem from its sphingosine kinase inhibition, with its ability to stimulate the body’s first line immune defence cells against cancer. The clinical outcome being sought is greater shrinkage of irradiated tumours and shrinkage of all non-irradiated tumours (abscopal response).
About CEP
The Company’s CEP Program (Chemotherapy Enhancement Program) is testing the ability of Veyonda® to restore sensitivity of cancer cells to carboplatin in patients whose late-stage cancers have stopped responding to chemotherapy, and to do that to the extent that the dosage of carboplatin can be lowered to a level unlikely to cause serious adverse side-effects. The clinical outcome being sought is the ability to offer a well tolerated chemotherapy regimen to patients considered unsuitable for standard dosage due to age or illness.
About Noxopharm
Noxopharm is a clinical-stage Australian drug development company with offices in Sydney, Hong Kong and New York. The Company has a primary focus on the development of drugs based on an isoflavonoid chemical structure. Veyonda® is the first pipeline product, with 3 other drug candidates for non-oncology indications under development in a subsidiary company.
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Forward Looking Statements
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