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NOXOPHARM LIMITED — Capital/Financing Update 2017
May 23, 2017
65437_rns_2017-05-23_ec8c241c-3591-41ad-ac75-1f788b49bafb.pdf
Capital/Financing Update
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Date 24 May 2017 Sydney, Australia
ASX: NOX
NOXOPHARM MAKES STRATEGIC COMMITMENT TO TREATMENT OF RARE CANCERS
Noxopharm Limited
ABN 50 608 966 123
Registered Office:
Suite 1 Level 6 50 Queen St Melbourne VIC 3000 Australia
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Population of cancer patients with limited treatment options
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Conversion of compassionate use scheme into formal study
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Additional to existing clinical program
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Designed to provide data for future regulatory submission
Operations Office: Suite 3 Level 4 828 Pacific Highway Gordon NSW 2072 Australia
Board of Directors Mr Peter Marks Chairman Non-Executive Director
Dr Graham Kelly Chief Executive Officer Managing Director
Dr Ian Dixon Non-Executive Director
Sydney, 24 May 2017: In response to growing demand for the Company’s Compassionate Use Program, Noxopharm has decided to make its experimental anti-cancer drug, NOX66, available for the treatment of rare cancers in a formal clinical trial setting.
‘Rare cancers’ by definition are those with an incidence < 6 per year per 100,000 population and involve 186 different cancer types. Despite their very low incidence, collectively they account for about one-quarter to one-fifth of all cancer diagnoses, but about 40% of all cancer deaths. Because of their low incidence, collectively they receive very little research funding, rarely are the subject of clinical studies, and receive < 15% funding of treatment through the Australian Government’s Pharmaceutical Benefits Scheme.
Ian Minns, Noxopharm Director of Clinical Development and Medical Affairs, said, “for the past 6 months we have been making NOX66 available on a limited compassionate use basis to patients (including those with rare cancers) who have exhausted standard treatment options and who, because of their cancer’s rarity, would otherwise have little access to clinical trials.”
“We now have decided to put this informal use of NOX66 onto a formal clinical trial footing. First, because it will ensure that the use of the drug is better controlled. Second, it provides the opportunity to add to our experience with the drug across more cancer types, and third, importantly it means that the data will be available for use by us in future regulatory submissions, with the possibility of extending its approval of use,” Minns added.
Graham Kelly, Noxopharm CEO said, “It is uncommon for a biotech company to make an experimental drug available on a compassionate use basis in the early stages of the drug’s development. Our confidence in both the safety of NOX66 and its potential clinical benefit are the key reasons that we have been prepared to do so.”
“Converting a current compassionate use scheme into a formal clinical study makes good sense. A compassionate use scheme is essentially run as a community service with the company not owning the clinical data. We already had set aside an amount of drug for a certain number of patients, so we simply are converting that use into a more formal study but still potentially benefitting the same number of patients. It means that now we will own the clinical data which hopefully can be used to extend the drug’s approval range when it comes to market.”
The opportunity for the Company lies in the fact that NOX66 is not so much being used to treat selected cancers as most anti-cancer drugs are designed to do, but as a drug that makes existing chemotherapies and radiotherapy work more effectively across a broad spectrum of different cancer types. This rare cancer trial is designed to add to the Company’s storehouse of experience in the range of cancers where NOX66 is expected to provide a survival benefit.
The study will be conducted at a number of sites around Australia and New Zealand with details of the sites to be made available shortly.
About Rare Cancers
A rare cancer is a term that embraces both rare and less common cancers. A rare cancer is defined as one that has less than 6 incidences per year per 100,000 population. A less common cancer is one defined as one that has between 6 and 12 incidences per year per 100,000 population. About 42,000 Australians are diagnosed each year with rare cancers. A full list of rare cancers is available for download at the following address.
http://www.rarecare.eu/rarecancers/rarecancers.asp
About NOX66
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 including sphingosine kinase and PI3 kinase that regulate cell pro-survival mechanisms and which are over-expressed in cancer cells. Idronoxil also inhibits external NADH oxidase Type 2 (ENOX 2), an enzyme responsible for maintaining the transmembrane electron potential (TMEP) in the plasma membrane of cancer cells and whose expression is limited to cancer cells. Inhibition of these 3 key enzymes results in disruption of key downstream pro-survival mechanisms including resistance mechanisms, sensitizing the cancer cell to the cytotoxic effects of both chemotherapy drugs and radiotherapy.
About Noxopharm
Noxopharm is an Australian drug development company with offices in Sydney, Melbourne and Hong Kong. The Company has a primary focus on the development of drugs to address the problem of drugresistance in cancer cells, the major hurdle facing improved survival prospects for cancer patients. NOX66 is the first pipeline product, with later generation drug candidates under development. The Company also has initiated a pipeline of non-oncology drugs.
INVESTOR AND MEDIA ENQUIRIES: Prue Kelly
E: [email protected] T: + 61 2 9144 2223
Forward Looking Statements
This announcement may contain forward-looking statements. You can identify these statements by the fact they use words such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “plan”, “should”, “target”, “will” or “would” or the negative of such terms or other similar expressions. Forward-looking statements are based on estimates, projections and assumptions made by Noxopharm about circumstances and events that have not yet taken place. Although Noxopharm believes the forward-looking statements to be reasonable, they are not certain. Forward-looking statements involve known and unknown risks, uncertainties and other factors that are in some 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.