Noxopharm announced that the first cohort of 4 patients has commenced treatment in the Company’s key DARRT-1 clinical study.
The DARRT-1 study is being conducted at 11 centres in Australia, New Zealand and Georgia. It involves men with late-stage prostate cancer (metastatic, castrateresistant disease) receiving NOX66 in combination with a palliative (low) dose of radiotherapy. The first four patients have been recruited in Australia (1) and Georgia (3).
Patients with late-stage prostate cancer that have failed to respond to standard therapiestypically have multiple secondary tumours in their skeleton and soft tissues such as lymph nodes. Radiotherapy often is used in an attempt to achieve relief from symptoms such as pain or spinal compression by irradiating a small number (1-3) of the largest tumours. Such treatment is referred to as palliative treatment because it is intended to provide symptomatic relief and not to be curative.
The rationale behind the DARRT-1 study, and the development of NOX66 in combination with radiotherapy, is that NOX66 potentially will enhance the anticancer effect of the radiation in two ways: first, that those tumours exposed to direct radiation will respond better and for longer; second, that all remaining tumours not exposed to radiation also will shrink (so-called abscopal response). The abscopal response is a rare phenomenon and would not be expected in these patients.
DARRT-1 involves exposing between 1 and 3 individual tumours to external beam radiotherapy, daily for 5 days. NOX66 is given daily for up to 15 days. The treatment is completed within 2 weeks; tumour response is assessed by scans after 6, 12 and 24 weeks. Side effects of treatment will be monitored throughout.
The study involves 24 men divided into 4 cohorts. The protocol calls for the first cohort of 4 men to undergo treatment with the lowest daily dosage (400 mg) of NOX66 as a safety review. If that treatment is well tolerated, as the Company anticipates, then the study will recruit a further 4 patients to receive 800 mg NOX66 (Cohort 2) , followed by a further patients to receive 1200 mg NOX66 (Cohort 3). The dose for the remaining 12 patients (Cohort 4) will be decided based on the review of the first 12 patients after all have been assessed at 6 weeks. It is anticipated that this milestone will be met in July 2018, with the remaining patients recruited into the study by August 2018.
The advice given by Kalkine Pty Ltd and provided on this website is general information only and it does not take into account your investment objectives, financial situation or needs. You should therefore consider whether the advice is appropriate to your investment objectives, financial situation and needs before acting upon it. You should seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice) as necessary before acting on any advice. Not all investments are appropriate for all people. Kalkine.com.au and associated websites are published by Kalkine Pty Ltd ABN 34 154 808 312 (Australian Financial Services License Number 425376). The information on this website has been prepared from a wide variety of sources, which Kalkine Pty Ltd, to the best of its knowledge and belief, considers accurate. You should make your own enquiries about any investments and we strongly suggest you seek advice before acting upon any recommendation. Kalkine Pty Ltd has made every effort to ensure the reliability of information contained in its newsletters and websites. All information represents our views at the date of publication and may change without notice. To the extent permitted by law, Kalkine Pty Ltd excludes all liability for any loss or damage arising from the use of this website and any information published (including any indirect or consequential loss, any data loss or data corruption). If the law prohibits this exclusion, Kalkine Pty Ltd hereby limits its liability, to the extent permitted by law to the resupply of services. There may be a product disclosure statement or other offer document for the securities and financial products we write about in Kalkine Reports. You should obtain a copy of the product disclosure statement or offer document before making any decision about whether to acquire the security or product. The link to our Terms & Conditions has been provided please go through them and also have a read of the Financial Services Guide. On the date of publishing this report (mentioned on the website), employees and/or associates of Kalkine Pty Ltd do not hold positions in any of the stocks covered on the website. These stocks can change any time and readers of the reports should not consider these stocks as advice or recommendations.