APPENDIX 4C – MARCH 2018 QUARTER
Successful capital raise concluded - $10.0M (net) raised
3 clinical studies underway
Next phases of clinical program well funded.
Sydney, 27 April 2018: Noxopharm (ASX: NOX) is pleased to release its Appendix 4C for the quarter ended 31 March 2018, as well as providing guidance for the current quarter.
The key activities during this quarter were as follows.
1.
Clinical program
Achieving marketing approval for NOX66 remains the Company’s primary focus, and identifying the most certain, most economic and quickest route to achieving that goal is the basis of the current clinical development program.
Three separate programs are underway, titled DARRT, LUPIN and CEP. Each program has a Phase 1 study underway, and significant progress was made in this quarter across all 3 studies under the direction of Ian Minns, Director of Clinical Development and Medical Affairs.
(i) DARRT Program (Direct and Abscopal Response to Radiotherapy).
This program is using NOX66 to enhance the cancer-killing effect of externally delivered radiotherapy. The program involves patients with late-stage, metastatic cancer with no remaining treatment options, where radiotherapy is being used on a palliative (non-curative) basis to relieve pain from certain large tumours. Often these tumours are in sensitive areas such as in the spine or close to the heart, meaning that the dose of radiotherapy needs to be even more limited.
The rationale of DARRT is that adding NOX66 to this standard form of radiotherapy has two possible outcomes. The first outcome is that the 1 or 2 tumours receiving radiotherapy will show greater shrinkage (a direct response). The second is that all other tumours also will respond (an abscopal response).
The first study in this program (DARRT-1) is testing this concept in 24 late-stage prostate cancer patients. The study is being conducted in 11 clinical sites in Australia, New Zealand and Georgia. Treatment involves 5-10 days of radiotherapy combined with up to 15 days of NOX66 treatment.
The first 4 patients have completed their combination treatment, and the next 4 patients recruited. The study is on schedule to be fully recruited by the end of May 2018.
(ii) LUPIN Program (Lutetium-PSMA In combination with NOX66).
This program is using NOX66 to enhance the cancer-killing effect of internally administered radiotherapy in late-stage prostate cancer. 177Lutetium-PSMA-617 brachytherapy is becoming increasingly used in men with late-stage prostate cancer who have failed to respond to standard forms of therapy. Details of this type of therapy are available at the following link:
http://endocyte.com/
The study is being conducted at St Vincent’s Hospital, Sydney, with 16 men who are to receive up to 6 injections of 177Lutetium-PSMA-617 every 3-4 weeks in combination with NOX66 therapy. Scans to be conducted at 6, 12 and 52 weeks after commencement of treatment.
The first 4 have commenced therapy. A safety review of these 4 patients was conducted recently, and in the absence of any adverse events, cleared the study to continue with further recruitment. Complete enrolment of all 16 subjects is anticipated by August 2018.
(iii) CEP Program (Chemo-Enhancement Program).
This program is using NOX66 to enhance the anti-cancer effect of certain common chemotherapy drugs in order for those drugs to be used at dosages generally considered to be sub-optimal in terms of anti-cancer activity, but associated with fewer side-effects. Commonly-used chemotherapy drugs such as cisplatin, carboplatin, paclitaxel and vincristine are associated with significant side-effects. Some of those side-effects, such as nausea, vomiting and hair loss last only for the duration of treatment, while others such as bone marrow depression (low red and white blood cell levels) and nerve damage (peripheral neuropathy, ototoxicity) can persist for long periods post-treatment and be significantly debilitating. The CEP program is seeking to use NOX66 to minimise or even avoid the worst of these side-effects, without compromising the anti-cancer effect of the chemotherapy. Achieving this objective could represent a major step forward in the use of chemotherapy.
CEP-1 (also known as the SCAN Study) is nearing completion, with the last patient due to come off study at the end of April 2018.
2. Pre-clinical program
The pre-clinical program, under the direction of Dr John Wilkinson, Chief Scientific Officer, has 3 major objectives:
(i) The first is designed to support the current NOX66 clinical program, including generating data that will be required to conduct a Phase 3 clinical study and then to support marketing approval. As part of this process, the Company initiated contact in this quarter with the US FDA as part of its aim to obtain IND (Investigational New Drug) status ahead of conducting clinical studies in North America later this year. The required data has been identified and is being acted on.
(ii) The second is to obtain proof of concept data for using NOX66 in combination with radiotherapy in the treatment of adult (GBM) and paediatric (DIPG) brain cancer. The Company is pursuing this important indication because of the ability of NOX66 to cross the blood-brain barrier. Those in vitro studies (being conducted in collaboration with the Lowy Cancer Research Institute and the Sydney Children’s Hospital) are nearing completion and on the basis of successful data, are due shortly to progress into animal studies.
(iii) The third is to investigate the basis of the nature of the radio-enhancing effect of NOX66. This information is considered vital in supporting the introduction of NOX66 into the market postregistration. This work is being conducted in collaboration with the Olivia Newton John Cancer Research Institute. These studies are progressing and continuing to deliver important insights.
3. Funding
The Company had cash of $11.88M at 31 March 2018. This followed a successful capital raising that closed on 23 March 2018, raising $10.8M (before costs). The Raise was conducted in 2 tranches: Tranche 1 placement of 7,264,966 shares at 90 cents ($6.53M) and Tranche 2 placement, subject to shareholder approval on 15 May 2018, of 4,735,034 shares at 90 cents ($4.27M).
The funds are earmarked principally for the clinical and pre-clinical programs, and particularly to allow the Company to identify and plan a multi-national Phase 3 registration clinical study that will form the basis of an application for marketing approval.
4. Guidance for the current quarter
The primary objectives for the June 2018 quarter are:
Complete the CEP-1 study; lock, clean and review data
Present near-complete data from CEP-1 at ASCO Conference, Chicago, June 2018
Complete planning in conjunction with Medical Advisory Board on nature of CEP-2 study
Complete enrolment in DARRT-1 study
Complete planning and site selection for DARRT-2 study (in broader cancer types)
Have enrolled 12 patients in the LUPIN study (75% enrolment)
Commission NOX66 medium-scale GMP production facility.
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